SOP

Standard Operating Procedures
Human Ethics Committee
Tata Memorial Centre

Tata Memorial Hospital
Dr Ernest Borgest Road,
Parel, Mumbai
Contents
S. No. Title Pg. Nos.
1. List of Acronyms xiv-xv
Chapter 1 Preparing Standard Operating Procedures (SOPs): 5

Writing, Reviewing, Distributing & Amending SOPs for the
Human Ethics Committee (HEC), TMC
1.1 Purpose 7
1.2 Scope 7
1.3 Responsibility 7
1.4 Detailed instructions
1.4.1 Identify the need for new or amendment to SOP 8
1.4.2 Appointing the SOP team 8
1.4.3 List of relevant SOPs 8
1.4.4 Design a format and layout 8
1.4.5 Write, Review and Approve SOP 9
1.4.6 Review by Consultation 9
1.4.7 Preparation and submission of final draft 9
1.4.8 Final Approval of new and revised SOP 10
1.4.9 Implement, distribute and file all SOPs 10
1.4.10 Review and request for a revision of an existing SOP 10
1.4.11 Manage and archive superseded SOPs 10
References 11
Glossary 12
List of Annexure
AX 1 V1/SOP01/V1 List of SOPs of Ethics Committee for 13
Research on Human Subjects
AX 2 V1/SOP01/V1 Template for SOP 14
Contents Page iii

AX 3 V1/SOP01/V1 Document History of the SOP 15

AX 4 V1/SOP01/V1 Log of the HEC members receiving SOPs 16
AX 5 V1/SOP01/V1 Request for Formulation of new SOP/ Revision of an SOP 17
AX 6 V1/SOP01/V1 Log of SOP Recipients 18
Flow chart 19
Chapter 2 Constitution of Human Ethics Committee, TMC 21

2.1 Purpose 23
2.2 Mandate 23
2.3 Scope 23
2.5 Ethical Basis 24
2.6 Composition 25
2.6.1 Membership 26
2.6.2 Terms of Appointment 26
2.6.2.a Duration 26
2.6.2.b Renewal 27
2.6.2.c Resignation / Replacement procedure 27
2.6.2.d Termination / Removal procedure 27
2.6.3 Conditions of Appointment 28
2.6.4 Independent Consultants 28
2.7 Office Bearers 28
2.7.1 Chairperson 28
2.7.2 Member Secretary 29
2.7.3 Secretariat 10-12 29
2.8 Roles and Responsibilities of the HEC members 30
2.9 Quorum Requirements 30
2.10 Decision making 31
2.11 Education for HEC Members 31
2.12 Prepare an annual activity report of the HEC for submission to the Director, TMC 32
References 32
Glossary 33
Contents Page iv
List of Annexure
AX1 V1/SOP02/V2 Confidentiality & Conflict of Interest Agreement 34
Form for HEC Members
AX2 V1/SOP02/V2 Confidentiality Agreement Form for 37
Independent Consultants
AX3 V1/SOP02/V2 Confidentiality Agreement Form for Observer 38
Attendees to HEC, TMC Meetings
Flow chart 39
Chapter 3 Management of Protocol Submissions 41

3.1 Purpose 43
3.2 Scope 43
3.4 Detailed process 43
3.4.1 Receive submitted packages 43
3.4.2 Verify Contents of Submitted Package 43
3.5 Detailed description of Study Project Submission 44
3.6 Resubmission of Protocols with corrections 45
3.7 Research Protocol Amendments and other study related documents 45
3.8 Annual Continuing Reviews of Approved Protocols 46
3.9 Protocol Completion 46
Reference 46
Glossary 46
List of Annexure
AX1 V1/SOP03/V2 Project Submission Application Form for Initial Review 47
AX2 V1/SOP03/V2 Checklist of Documents 64
AX3 V1/SOP03/V2 Document Receipt Form 65
AX4 V1/SOP03/V2 Guidelines for devising ICF and Sample format 67
of an Informed Consent Document.
AX5 V1/SOP03/V2 Child Information Sheet and Assent Form 72
Flow Chart 76
Chapter 4 Initial Review of Submitted Protocol 77

4a.1 Purpose 79
4a.2 Scope 79
Contents Page v
4a.3 Categorization of protocols 79

4a.4 Initial Review 79
4a.5 Elements of Review 81
4a.5.1 Scientific Design and Conduct of the Study 81
4a.5.2 Care and Protection of Research Participants 81
4a.5.3 Protection of Research Participant Confidentiality 82
4a.5.4 Informed Consent Process 82
4a.5.5 Community Considerations 82
4a.5.6 Recruitment of Research Participants 83
4a.6 Responsibility 83
4a.7 Detailed instructions 83
4a.8 Review the protocol 84
4a.9 Use of study assessment forms 84
4a.9.1 Gather the assessment reports 84
4a.10 AT HEC meeting 84
References 85
Glossary 85
List of Annexure
AX1 V1SOP04a/V2 Study Assessment Form 87
Flow chart 92
Chapter 4b Expedited Review of Submitted Protocol 93

4b.1 Purpose 94
4b.2 Categorization of protocols 94
4b.3 Expedited Review 94
4b.4 Scope 96
4b.5 Responsibility 96
4b.6 Detailed Instructions 96
4b.6.1 Receipt of protocols/documents 96
4b.6.2 Expedited process 96
4b.6.3 Communication between the HEC and the investigator 97
Reference 97
Glossary 97
Flow chart 98
Contents Page vi
Chapter 4c Exemption from the Ethical Review for Research Projects 99

4c.1 Purpose 101
4c.2 Categorization of protocols 101
4c.3 Exemption from review 101
4c.4 Scope 102
4c.5 Responsibility 102
4c.6 Detailed Instructions 102
4c.6.1 Receipt of protocols/documents 102
4c.6.2 Determine protocols eligible for exemption from review 102
4c.6.3 Exemption Process 102
4c.6.4 Communication between the HEC and the investigator 103
Reference 103
Glossary 103
List of Annexure
AX1 V1/SOP04c/V2 Review Exemption Application Form 104
Flow chart 108
Chapter 5 Agenda Preparation, Meeting Procedures and 109

Recording of Minutes
5.1 Purpose 111
5.2 Scope 111
5.4 Detailed instruction 111
5.4.1 Receive submitted packages 111
5.4.2 Distribution of Protocol/ Documents Packages to the HEC Members 111
5.4.3 Preparation for the meeting 112
5.4.4 During the Meeting 112
5.4.5 Decision Making Process 112
5.4.6 After the HEC meeting 113
5.4.6 a Preparing the minutes and the decision letters 113
5.4.6 b Approval of the minutes and the decision 113
5.4.6 c Filing of the minutes of the meeting 114
5.4.7 Communicating Decision 114
Reference 115
Contents Page vii

Glossary 115
List of Annexure
AX1 V1/SOP05/V2 Agenda format 116
AX2 V1/SOP05/V2 Approval letter format 117
AX3 SOP05/V2 Format for Conditional Approval 120
Flow chart 121
Chapter 6 Review of Amended protocol / Protocol related documents 123

6.1 Purpose 125
6.2 Scope 125
6.4 Review amended protocols/documents/letters: 125
6.4.1 Decision 125
6.4.2 Storage of Documents 126
6.4.3 Minor amendments and notifications 126
Reference 126
Glossary 126
List of Annexure
AX1 V1/SOP06/V2 Project Amendment/Document Amendment Approval letter 127
AX2 V1/SOP06/V2 Amendment Reporting Form 128
Flow chart 129
Chapter 7 Continuing review of study Protocols 131

7.1 Purpose 133
7.2 Scope 133
7.4 Detailed Instructions 133
7.4.1 Determine the date of continuing review 133
7.4.2 Notify the Principal Investigator or the study team 134
7.4.3 Manage continuing review package upon receipt. 134
7.4.4 Verify the contents of the package. 134
7.4.5 Filing the continuing review package 134
7.4.6 Notify the Members of the HEC 135
Contents Page viii

7.4.7 Prepare meeting agenda 135

7.4.8 Protocol Review Process 135
7.4.9 Store original documents 135
7.4.10 Communicate the HEC Decision to the Principal Investigator 135
Reference 136
List of Annexure
AX1 V1/SOP 07/V2 Continuing Review Application Form 137
AX2 V1/SOP 07/V2 Reminder letter by the HEC to investigator 140
AX3 V1/SOP 07/V2 HEC Decision on Continuing Review Report 141
AX4 V1/SOP 07/V2 Project Report Approval Letter 142
Flow chart 143
Chapter 8 Reporting of Protocol Deviation / Non-Compliance / Violation / 145

Waiver
8.1 Purpose 147
8.2 Scope 147
8.4 Detailed instructions 147
8.4.1 Detection of Protocol deviation / non-compliance / violation 147
8.4.2 Noting protocol deviation / non-compliance / violation by the Secretariat 148
8.4.3 Board discussion, Decision, and Action 148
8.4.4 Notify the investigator 149
8.4.5 Records and follow up to be kept by IRB secretariat 149
References 149
Glossary 150
List of Annexure
AX 1 V1/SOP08/V2 Deviation / Non-Compliance / Violation / 151
waiver Reporting form
Flow chart 152
Chapter 9 Review of Serious Adverse Events (SAE) Reports 153

9.1 Purpose 155
9.2 Scope 155
Contents Page ix

On site SAEs 155
9.4.1 SAE related activities before HEC meeting 155
9.4.2 Actions to be taken by Member Secretary, HEC 156
9.4.3 Actions to be taken by Chairperson, HEC 156
Off Site SAEs 157
9.5 During the HEC meeting 157
9.6 After the review of SAE 158
References 159
Glossary 159
List of Annexure
AX1 V1SOP09/V2 Review Report for SAE Serious Adverse Event 160
AX2 V1SOP09/V2 Off site SAE Classification Form 163
AX3 V1SOP09/V2 Off Site SAE Log Report 164
Flow charts 165-166
Chapter 10 Maintenance of Active Project Files, Archival of Closed Files 167

and Retrieval of documents
10.1 Purpose 169
10.2 Scope 169
10.4 Maintain the active study files 169
10.5 Disposal of closed files 169
10.6 Accessibility / Retrieval 169
10.7 Final Disposal of Master files 170
Glossary 170
List of Annexure
AX1 V1/SOP10/V2- Document Request Form 171
AX2 V1/SOP10/V2- Format of written off register 172
Flow chart 173
Contents Page x
Chapter 11 Documentation of the HEC activities 175

11.1 Purpose 177
11.2 Scope 177
11.4.1 HEC records 177
11.4.2 Access to HEC records 177
Flow Chart 178
Chapter 12 Review of study completion reports 179

12.1 Purpose 181
12.2 Scope 181
12.4.1 Before each board meeting 181
12.4.2 Before and during board meeting 181
12.4.3 After the board meeting 181
References 182
List of Annexure
AX1 V1/SOP 12/V2 Study Completion Report Form 183
Flow Chart 184
Chapter 13 Management of Premature Termination / Suspension / 185

Discontinuation of the study of the study
13.1 Purpose 187
13.2 Scope 187
13.4.1 Receive recommendation for study termination/ 187
suspension/discontinuation
13.4.2 Review and discuss the Termination / suspension/ 187
discontinuation Package
13.4.3 Notify the PI 188
13.4.4 Store the protocol documents 188
Contents Page xi
References 188
List of Annexure
AX 1 V1/SOP13/V2 Premature Termination / Suspension / 189
Discontinuation Report
Flow chart 190
Chapter 14 Request for Waiver of Written Informed Consent 191

14.1 Purpose 193
14.2 Scope 193
14.5 Type of research projects which may qualify for consent waiver 193
References 195
List of Annexure
AX 1 SOP14/V2 - Application form for requesting waiver of consent 196
Flow Chart 197
Chapter 15 Site Monitoring 199

15.1 Purpose 201
15.2 Scope 201
15.4.1 Selection of study sites 201
15.4.2 Before the visit 201
15.4.3 During the visit 202
15.4.4 After the visit 202
Glossary 203
List of Annexure
AX1 V1/SOP15/V1 Site Monitoring Visit Report 204
Flow chart 206
Contents Page xii

Chapter 16 Dealing with participants / patients requests and complaints 207

16.1 Purpose 209
16.2 Scope 209
16.5 Filling the request document 210
References 210
List of Annexure
AX1 V1/SOP 16/V1 - Request Record Form 211
Flow chart 212
Appendices 213
1. Policy on Recruitment osf TMC Students and Staff 215
2. Policy on the Recruitment of Research Subjects 216
3. Policy on Research Costs to Subjects 217
4. Guidelines on Compensation for Research Subjects 218
5. Policy on the Use of Third Party/Surrogate Consent in Research at TMC 219
6. Policy on Blood Withdrawal for Research Purposes 220
7. Guidelines and Policy on Informed Consent 222
8. Policy for Documentation of Informed Consent 224
9. Health Record Research 227
10. Guidelines for Research Protocols That Require Collection 229
and /or Storage of Genetic Materials
11. Guidelines for Submission and EC Review of Gene Therapy / 231
Gene Transfer Protocols
12. Recommended Terms for Use in Consent Forms 234
Contents Page xiii

List of Acronyms
Acronym Full Title/Description
AAHRPP Association for the Accreditation of Human Research Protection Programs

ACTREC Advanced Centre for Treatment, Research and Education in Cancer
ADR Adverse Drug Reaction
AE Adverse Event
AIIMS All India Institute of Medical Sciences
ASU Ayurveda, Siddha, Unani.
BA Bio-availability
BARC Bhabha Atomic Research Centre
BE Bio-equivalence
BIS Bureau of Indian Standards
CDC Center for Disease Control and Prevention
CDSCO Central Drugs Standard Control Organization
CFR Code of Federal Regulations
CIOMS Council for International Organizations of Medical Sciences
CoI Conflict of Interest
CONSORT Consolidated standards of reporting trials
CRF Case Record Form
CRO Contract Research Organization
CRS Clinical Research Secretariat
CTA Clinical Trial Agreement
DAE Department of Atomic Energy
DBT Department of Biotechnology
DCGI Drug Controller General of India
DCR Drugs and Cosmetic Rules, 1945
DGFT Directorate General of Foreign Trade
DHHS Department of Health and Human Services
DSMB Data Safety Monitoring Board
DSMSC Data Safety Monitoring Sub Committee
DTAB Drugs Technical Advisory Board
List of Acronyms Page xiv

ELSI Ethical, Legal and Social Issues
FDA Food and Drug Administration
FDC Fixed Dose Combination
FERCAP Forum for Ethical Review Committees in Asia and the Western Pacific Region
GCP Good Clinical Practice
GMP Good Manufacturing Practices
HEC Human Ethics Committee
HIPAA Health Insurance Portability and Accountability Act
HMSC Health Ministrys Screening Committee
IAEA International Atomic Energy Agency
IB Investigator’s Brochure
ICF Informed Consent Form
ICH International Committee on Harmonization
ICJME International Committee of Medical Journal Editors
ICMR Indian Council of Medical Research
IDE Investigational Device Exemption
IMDRA Indian Medical Devices Regulatory Authority
IND Investigational New Drug
IRB Institutional Review Board
ISI Indian Standards Institute
MOU Memorandum of Understanding
MTA Material Transfer Agreement
NAC-SCRT National Apex Committee for Stem Cell Research and Therapy
NCE New Chemical Entity
NDA New Drug Application
NIH National Institutes of Health
NOC No-objection Certificate
OHRP Office for Human Research Protections
PI Principal Investigator
RCT Randomized Controlled Trial
SAE Serious Adverse Event
SOPs Standard Operating Procedures
SRC Scientific Review Committee
TMC Tata Memorial Centre
TMH Tata Memorial Hospital
TRAC TMC-Research Administration Council
WHO World Health Organization
WMA World Medical Assembly
List of Acronyms Page xv

Human Ethics Committee, Tata Memorial Centre (HEC, TMC)
SOP Codes SOP 01/V1, SOP 02/V2, SOP 03/V2, SOP 04a/V2, SOP 04b/V2, SOP 04c/V2,
SOP 05/V2, SOP 06/V2, SOP 07/V2, SOP 08/V2, SOP 09/V2, SOP 10/V2, SOP 11/
V2 SOP, 12/V2, SOP 13/V2, SOP 14/V2, SOP 15/V1, SOP 16/V1
Authors:
Name and Position on the HEC Signature with date
Dr. Medha Joshi (Member Secretary HEC-II)
Dr. Sangeeta Desai (Member Secretary HEC-I)
Ms. Abhidnya Kandalkar (IRB Jr. Administrator)
Approved by:
Ms. Shirin Bharucha (Chairperson HEC I)
Dr. Urmila Thatte (Chairperson HEC-II)
Accepted by:
Dr. R. A. Badwe, Director, TMC
Page 1
Reviewed by:
Name and Position on the HEC - I Signature with date
Dr. Geeta Koppikar, Co Chairperson
Dr. R.C. Mistry, Member
Dr. Nithya Gogtay, Member
Mr. Gul Kripalani, Member
Ms. Viji Venkatesh, Member
Ms. Mrunal Marathe, Member
Dr. Pradnya Talawadekar, Member
Dr. S. K. Shrivastava, Member
Dr. S. D. Banavali, Member
Dr H.K.V. Narayan, Member
Dr. Parul J. Shukla, Member &

Jt. Secretary, DSMSC
Dr. A. Gajiwala, Member
Dr. Vikram Gota, Alternate Member
Page 2
Reviewed by:
Name and Position on the HEC-II Signature with date
Dr. R. F. Chinoy, Co-Chairperson
Dr. V.R. Joshi, Member
Dr. R. Munagekar, Member
Mr. P.K. Rao, Member
Ms. Tessie George, Member
Dr. Reena Nair, Member
Dr. A. Puri, Member, &

Jt. Secretary, DSMSC
Dr. M.A. Muckaden, Member
Dr. P.S. Pai, Member
Page 3
SOP 01/V1
Effective Date: 01.09.2009 HEC, TMC
Title: Preparing Standard Operating Procedures (SOPs): Writing,

Reviewing, Distributing & Amending SOPs for the Human Ethics
Committee (HEC), TMC
SOP Code: SOP 01/V1 Date : 01/09/2009 Pages: 16
Preparing SOPs - Writing, Reviewing, Distributing & Amending SOPs for Human Ethics Committee (HEC) Page 5
SOP 01/V1
1.1 Purpose
This SOP defines the process for writing, reviewing, distributing, and amending SOPs within the
HEC, TMC.
The SOPs will provide clear, unambiguous instructions to conduct activities of the HEC in accordance
with the ICMR guidelines 2006, Schedule ‘Y” (Drugs and Cosmetic Act 1940: Amendment 20th
Jan 2005), WHO Operating Guidelines for Ethical Review Committee that Review Biomedical
Research, and ICH (International Conference on Harmonization) Good Clinical Practice (GCP).
1.2 Scope
This SOP covers the procedures of writing, reviewing, distributing, and amending SOPs within
the HEC, TMC
1.3 Responsibility
It is the responsibility of Chairperson of the HEC to appoint the SOP Team to formulate the
SOPs. SOP team comprising of Member Secretaries of the HECs draft an SOP, get it reviewed
and approved by the HEC members and amend it as and when required. All members of HEC
I and II will review the SOPs and approval will be given by Chairs of both HEC I and II. The
SOPs will be also signed off by Director, TMC as these are Institutional Ethics Committees.
Secretariat of HEC / IRB:

Co-ordinates activities of writing, reviewing, distributing, and amending SOPs
Maintains on file all current SOPs and the list of SOPs
Maintains an up-to-date distribution list of each SOP circulated to HEC members
Maintain a record of the investigators to whom SOPs are distributed against a
requisition
Ensures all HEC members and involved administrative staff have access to the SOPs
Ensures the HEC members and involved staff are working according to current
version of SOPs
Maintain a file of all past SOPs of the HEC
Assist in the formulation of SOP procedure
SOP team (will consist of Member Secretaries of both HEC – I and HEC - II and one or two other
members)
Assess the request(s) for SOP revision in consultation with the Secretariat and
Chairperson
Propose new / modified SOPs as needed
Select the format and coding system for SOPs
Draft the SOP in consultation with the HEC members and involved administrative
staff
Review the draft SOP
Submit the draft for approval to Chairperson
SOP 01/V1
Chairperson of the ethics committee
Appoint one or more SOP Teams
Reviews and approves the SOPs
Signs and dates the approved SOPs
HEC members and involved administrative staff

Review, sign and date SOPs
Maintain a file of all SOPs received
Return all out-of date SOPs to IRB office
1.4.1 Identify the need for new or amendment to SOP
Any member of the HEC, secretariat or administrative staff or investigators, can make a request
for revision or notices an inconsistency / discrepancy / has any suggestions on how to improve
the existing SOPs or requests to design an entirely new SOP can put forth his request by using
the Request Form for Formulation of new SOP / Revision of an SOP Form (AX5-V1/SOP01/V1)
to make a request. This AX form is submitted to the Chairperson, HEC. The Chairperson will
inform all HEC members about this request in a regular full board meeting.
If HEC members agree to the request, the Chairperson will appoint an appropriate SOP team
comprising of Member Secretaries of both committees. The Chairperson may also appoint one
or two committee members as members of SOP team, if necessary. This designated team will
proceed with the task of revision / formulation process of the SOP. If HEC members do not
agree to the request, no further action will be taken.
The Chairperson will inform the person / HEC member who made the request for modification
of the SOP in writing about the decision.
1.4.2 Appoint the SOP team
The Chairperson will constitute an SOP team consisting of the Member-Secretary and two or
more members of the HEC who have a thorough understanding of the ethical review process.
The SOP writing team will carry out the subsequent steps (1.4.3-1.4.7).
1.4.3 List of relevant SOPs
Write down step by step all the procedures of the HEC

Organize, devise and, name each process
Make a list of SOPs with coding reference (AX1-V1/SOP01/V1)
1.4.4 Design a format and layout
Each SOP should be given a number and a title that is self-explanatory and is easily understood.
SOP 01/V1
A unique code number with the format SOP xx / Vy will be assigned to each SOP by the
secretariat. xx will be a two-digit number assigned specifically to a particular SOP. “V” refers to
version of the SOP and “y” will be a number identifying the version e.g. SOP01/V1 is SOP
number 01 with V=version no.1.
Each AX will be given unique code number with the format AXn–Vp/SOP xx/Vy. e.g. AX1–V1/
SOP01/V1 indicates AX is Annexure, n is Annexure no.1, version 1, belonging to the SOP 01/V1
Each Appendix will be given unique code number with the format APPn/Vy e.g. APP1/V1
indicates APP is Appendix, n is Appendix no 1, V1 is version no.1.
Each SOP will be prepared according to the template for Standard Operating Procedures in AX2
– V1/SOP01/V1. Each page of the SOP will bear a header with the effective date which is the
date of approval of the SOPs signed and dated by the Chairperson, HEC, and approved by the
Director.
The SOP number will be on the left hand corner of the header while the left hand corner of the
footer will bear the title of the SOP and page number as Page—of—total pages.
The first two pages of each SOP document will be signed and dated by the authors, the HEC
members who have reviewed the SOPs, HEC Chairpersons who have approved and Director,
TMC who has accepted the SOPs and subsequently the SOP will be implemented from that
date.
1.4.5 Write, Review, and Approve SOP
With reference to section 1.4.1 and 1.4.2, the draft SOP will be prepared by the SOP team.
1.4.6 Review by Consultation
The draft SOP will be discussed with members of both HECs and all administrative
staff.
The SOP should be approved by all involved in that particular task.
The final version will be forwarded to the chairperson for review and approval.
1.4.7 Preparation and submission of final draft
All the members of HEC-I and HEC- II will review the draft / revised SOP.
During respective HEC meetings, members can put forth their suggestions / comments
on the draft / revised SOP.
The suggestions agreed upon unanimously by all HEC members will be incorporated
and the final draft SOP will be formulated.
The SOP team would stand automatically dissolved once the HEC takes final decision
regarding the SOP.
SOP 01/V1
1.4.8 Final Approval of new/revised SOP
The final version will be presented to the Chairpersons of both committees for review
and approval. The Chairpersons will sign and date the SOP on the first page of the
SOP document. This date of approval is declared as the effective date for implementing
the SOP.
This approved document will then be submitted to the Director, TMC for acceptance.
1.4.9 Implementation, distribution, and filing all SOPs
Approved SOPs will be implemented from the effective date.

The secretariat will discuss the approved SOPs with the administrative staff and
instruct them to implement the SOP accordingly.
Approved SOPs will be distributed to HEC members and IRB staff according to the
distribution list (AX4 –V1/SOP 01/V1)
When revised version is distributed, the old version will be retrieved from all members
and destroyed. A copy of the old version will be archived in a master file.
One complete original set of current SOPs will be archived in the SOP master file,
by the IRB Secretariat and maintained in the IRB Office.
A copy of the SOP master file will be maintained in the individual offices of HEC,
and DSMSC.
Photocopies made from these official paper versions of the SOP can be considered
current or official, if stamped and signed by Member Secretary or authorized individual
for distribution, a log of which should be maintained (AX6 –V1/SOP 01/V2)
1.4.10 Review and request for revision of an existing SOP
Any member of the HEC, secretariat or administrative staff who notices that current
SOPs have some lacunae or have any suggestions to improve a procedure should
make a written request, using a form (AX5-V1/SOP 01/V1)
If HEC agrees with the request, the Chairperson will appoint an appropriate team to
proceed with the revision process. If the committee does not agree, the chairperson
will inform the concerned individual who made the request for revision.
Revised SOPs will be reviewed and approved in the same manner as new SOPs
(Section 1.4)
The secretariat is expected to review the SOP at least once every 2 years and record
the dates of review in the SOP master file.
1.4.11 Manage and archive old SOPs
Old SOPs should be retained and clearly marked “superseded” and archived in a file by the
secretariat. The process of evolution of previous SOPs of the HEC will be documented in a
defined format (AX3 –V1/SOP01/V1).
SOP 01/V1
References
1. WHO Operational Guidelines for Ethical Review Committee that Review Biomedical Research
(Geneva 2000). Retrieved from - www.who.int/tdr/publications/publications / accessed 24
March 2008
3. International Conference on Harmonization, Guidance on Good Clinical Practice (ICH
GCP) (1996). Retrieved from - http://www.ich.org/LOB/media/MEDIA482.pdf accessed on
24 March 2008.
3. ICMR Ethical Guidelines for Biomedical research on Human Participants, ICMR (2006),
Retrieved from - http://www.icmr.nic.in/ethical guidelines.pdf accessed 24 March 2008.
4. Schedule Y (Drugs and Cosmetic Act 1940; amendment 20th January 2005) Retrieved from
- http://www.cdsco.nic.in/html/Schedule-Y 20 (Amended 20Version- 2005) accessed 24 March
2008.
SOP 01/V1
Glossary
Effective date: The date of approval of the SOPs signed and dated by the Chairperson, HEC,
TMC, and subsequently the SOP is implemented from that date
HEC members: Individuals serving as regular members of the Human Ethics Committee, TMC.
The Committee has been constituted in accordance with the EC membership requirements set
forth in Schedule Y (20th January 2005)
Master SOP files: An official collection of the Standard Operating Procedures (SOP) of HEC,
TMC accessible to all staff, HEC members, auditors and government inspectors as a paper copy
with an official stamp on each page and the approval signatures
Past SOPs of the HEC: A collection of previous official versions of a SOPs and relevant information
regarding changes and all preplanned deviations
Requestors: Investigators, Sponsors, CROs, Regulatory authorities, Hospital administrators, and

such others
Revision date: Date/year by which the SOP may be revised or reviewed.
Recipients: Stakeholders who would receive a copy of SOP, viz., two categories 1) HEC
members 2) Non-HEC members i.e. investigators/sponsors
SOP (Standard Operating Procedure): Detailed, written instructions, in a certain format,

describing activities and actions undertaken by the HEC to achieve uniformity of the performance
of a specific function. The aim of the SOPs and their accompanying checklists and forms is to
simplify the functioning, whilst maintaining high standards of Good Clinical Practice
SOP Team: A team of members selected from the HEC, TMC including the Member Secretary,
administrative staff, and any other member of HEC as identified by the chairperson who oversee
the creation, preparation, review, and periodic revision of the HEC, TMC SOPs
SOP 01/V1
AX1-V1/SOP 01/V1
List of SOPs of Human Ethics Committee
Sr. SOP TITLE SOP

No CODE
1. Preparing Standard Operating Procedures (SOPs): O1/V1

Writing, Reviewing, Distributing, & Amending SOPs for the
Human Ethics Committee (HEC), TMC
2. Constitution of Human Ethics Committee, TMC 02/V2
3. Management of Protocol Submissions 03/V2
4. 4a Initial Review of Submitted Protocol 04a/V2
4b Expedited Review of Submitted Protocol 04b/V2
4c Exemption from the Ethical Review for Research Projects 04c/V2
5. Agenda Preparation, Meeting Procedures and Recording of Minutes 05/V2
6. Review of Amended protocol / Protocol related documents 06/V2
7. Continuing review of study Protocols 07/V2
8. Reporting of Protocol Deviation / Non-Compliance / Violation / Waiver 08/V2
9. Review of Serious Adverse Events (SAE) Reports 09/V2
10. Maintenance of Active Project Files, Archival of closed files 10/V2

and Retrieval of documents
11. Documentation of the HEC activities 11/V2
12. Review of study completion reports 12/V2
13. Management of Premature Termination / Suspension / 13/V2

Discontinuation of the study
14. Request for Waiver of Written Informed Consent 14/V2
15. Site Monitoring 15/V1
16. Dealing with participants / patients requests and complaints 16/V1
SOP 01/V1
AX2-V1/SOP01/V1
Template for Standard Operating Procedures
Title: Title which is self-explanatory and is easily understood
SOP No: SOPxx/Vy Page: a of b
SOP Code: SOP xx/Vy
Effective date: DD/MM/YYYY

Authors: xxxxxxxxx
Reviewed by: xxxxxxxx
Approved by: xxxxxxxxx
SOP 01/V1
AX3-V1/SOP01/V1
Document History of the SOP
Name of the author Version Effective date

(dd-mm-yy)
Details of superseded SOP
Name of the Team Version Type Date Describe the

(draft/final) (dd-mm-yy) main change
SOP 01/V1
AX4-V1/SOP01/V1
Log of the HEC members receiving SOPs
No. Name of Designation SOP No. of Signature Date

Recipients code Copies
number
1 XXXX Chairperson
2 XXXX Member Secretary
3 XXXX Member
4 XXXX Member
5 XXXX Member
6 XXXX Member
SOP 01/V1
AX5-V1/SOP01/V1
Request for Formulation of new SOP / Revision of SOP
This form is to be completed by any member whenever a problem or a deficiency in an SOP is

identified and maintained with the SOP until an authorized replacement is in place.
SOP No.
Title:
Details of problems or deficiency in the existing SOP
Need to formulate an entirely new SOP (i.e. SOP not existing previously)
Identified by: Date (DD/MM/YYYY):
Discussed in HEC Meeting held on :-
SOP revision required: Yes No
New SOP to be formulated: Yes No
If yes, to be carried out by whom?
If no, why not?
Date SOP revised:
Date SOP approved:
Date SOP becomes effective:
SOP 01/V1
AX6-V1/SOP01/V1
Log of SOP recipients
No. Name of Designation SOP No. of Date

Recipients code Copies
number
1. XXXX XXXX
2. XXXX XXXX
3. XXXX XXXX
4. XXXX XXXX
5. XXXX XXXX
6. XXXX XXXX
SOP 01/V1
SOP 02/V2
Title: Constitution of Human Ethics Committee, TMC
Constitution of Human Ethics Committee, TMC Page 21

SOP 02/V2
The Hospital Ethics Committee is constituted by Director, Tata Memorial Centre (TMC) under
authority vested by Governing Council of the TMC
The Hospital Ethics Committee (HEC) of TMC was established in 1996.
2.1 Purpose
The HEC was established to formalize and specify the Institution’s commitment to promotion of
high ethical standards in patient care, professional education, clinical research, and community
interests.
2.2 Mandate
The HEC through its delegated sub-committees functions independently for maintaining consistent
ethical framework in patient care and research, and in the integration of ethical values into
practice, policy relationships, and organizational activities.
The purpose of HEC is to cultivate a pluralistic and democratic exchange of ethical

values, concerns and to critically analyze them looking for opportunities to enhance
the ethical integrity of the Institution
The mandate of HEC, TMC essentially targets patient care and ethical aspects of
research and education.
The terms of reference for the HEC are as follows:
o To improve the standards of ethics practiced in TMC and to issue guidelines
on dilemmas relating to patient care services at TMC
o To ensure that all proposed research projects conform to standard ethical
guidelines.
o To initiate and commission research studies on ethical aspects of practice in
TMC
o Continuing education in research bioethics and ethical aspects of clinical practice
by seminars, workshops and interactive discussions for all categories of staff
members including nursing and paramedical staff
o To function as a forum for redressal of complaints on ethical issues, from
patients and their families
The Ethics committee endeavours to produce guidance on a broad range of topics.
Disclosures of diagnosis, diagnosis of brain death, indications for stopping
resuscitation, true informed consent, etc. are some examples
The committee does not address or interfere in matters of an administrative nature,
nor does the committee function as a grievance cell for staff members.
2.3 Scope
The SOP applies to the formation of the HEC

SOP 02/V2
2.4 Responsibility
HEC has responsibility within the institution with the following objectives:
To ensure the competent review and evaluation of all ethical aspects of research
projects received, to ensure compliance with the appropriate laws and safeguard
welfare of subjects.
Clinical ethics consultation
Education of professional, administrative, and support staff about ethical issues
Creation, developing revising and implementing ethical guidelines (SOPs)
Initiate studies in ethics
Continuing education and training programs to ensure that HEC members are qualified to
perform their specific duties.
2.5 Ethical Basis
The committee consists of members who collectively have the qualifications and
experience to review and evaluate the scientific, medical, and ethical aspects of a
proposed research project.
The HEC recognizes that the protocols it approves may also be approved by national
and / or local ethics committees prior to their implementation in specific localities.
In evaluating protocols and ethical issues, the HEC is aware of the diversity of laws,
cultures and practices governing research and medical practices in various countries
around the world
The HEC also seeks to be informed, as appropriate, by national / other local ethics
committees and researchers of the impact of the research it has approved.
The HEC is guided in its reflection, advice and decision by
o The ethical principles expressed in Declaration of Helsinki (Adopted by the
18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by
the 29th World Medical Assembly, Tokyo, Japan, October 1975; 35th World
Medical Assembly, Venice, Italy, October 1983; 41st World Medical Assembly,
Hong Kong, September 1989; 48th World Medical Assembly, Somerset West,
Republic of South Africa, October 1996; and the 52nd World Medical Assembly,
Edinburgh, Scotland, October 2000; Note of Clarification on Paragraph 29
added by the World Medical Assembly, Washington 2002; Note of Clarification
on Paragraph 30 added by the World Medical Assembly, Tokyo 2004, 59th
WMA general Assembly, Seoul, October 2008)
o It makes further reference to the International Ethical Guidelines for e.g. The
Nuremburg Code (1945), the Council of International organizations of Medical
Sciences (CIOMS), the Belmont Report 1979, the International Ethical Guidelines
for Biomedical Research Involving Human Subjects (Geneva 2002), and the
European Convention on Human Rights and Biomedicine 1977
The HEC establishes its own Standard Operating Procedures based on the ICMR
guidelines (2006), Schedule Y (Drugs and Cosmetics Act 1940., amendment

SOP 02/V2
20th Jan 2005), Operational Guidelines for Ethics Committees that Review Biomedical
Research (WHO 2000), and ICH-GCP, 1996 and the local regulations
The HEC seeks to fulfill the requirements for international assurances and is established
and functions in accordance with the national law and regulations
Due to amendment in Schedule Y, TMC, being a premier cancer institute in the
country, has become a hub for oncology based trials. Moreover, scientific rigor and
research atmosphere inculcated in this institution has led to significant increase in
clinical trials. For various reasons, clinical trials are also coming under close public
scrutiny. Hence there is a strong need for impeccable and efficient management of
clinical trials to ensure human rights protection. Speed, time, and maintenance of
high ethical standards for HEC review process are very important factors for
multinational clinical research
In view of the tremendous growth of clinical research in the institution, the Director,
TMC in 2008, constituted two Human Ethics Committees to function as panels with
the same purpose & SOPs to ease the work load. These two committees were
renamed as Human Ethics Committee I and II to expedite and maintain high standard
of ethical review
2.6 Composition
Each HEC will be multidisciplinary and multi-sectorial in composition.

Each committee is composed of a minimum of 7, and maximum of 15 members. The members
are selected to have an equitable representation of all specialties in the institution. It includes
scientific and non-scientific, clinicians and non - clinicians, Clinical pharmacologist, members of
the community, a lawyer/expert in ethics, a social worker / layperson / patient representative to
represent different point of view.
Each committee will comprise of a Chairperson, Co-Chairperson, a Member Secretary, and 7-15
active members who represent an appropriate balance of professional, ethical, legal, cultural,
educational, and community interests
The committee should have adequate representation of age, gender, community, etc. to safeguard
the interests and welfare of all sections of the community / society. Members are expected to be
aware of local, social and cultural norms, as this is the most important social control mechanism
The member should have various backgrounds to promote complete and adequate review of
research activities commonly conducted by that given institute / centre.
Composition of HEC
The composition should be as follows:-

1. Chairperson (not – affiliated to TMC)
2. Co-Chairperson (not – affiliated to TMC)
3. Member secretary (TMC Staff members)
4. 1-2 clinicians (not affiliated to TMC)

SOP 02/V2
5. Basic medical scientists
6. Clinical Pharmacologist.
7. One legal expert or retired judge or medico-legal expert
8. One social scientist / representative of non-governmental voluntary agency
9. One philosopher / ethicist / theologian / lay person from the community
2.6.1 Membership
All members will be appointed by the Director, TMC in consultation with the Chairperson, HEC
and Member Secretaries.
Criteria for selection of members:

Members are selected on their personal capacities, based on their interest, ethical
and/or scientific knowledge and expertise, experience in domain field and profile.
Conflict of interest will be avoided when making appointments, but where
unavoidable, there will be transparency with regard to such interests.
New members will be identified according to the requirement i.e. as per the
composition specified in Section 2.6. of this SOP and provided the potential member
fulfils the conditions of appointment as defined in 2.6.2 of this SOP.
The following qualities are sought in HEC members:

interest and motivation
time and effort
commitment and availability
experience and education
respect for divergent opinions
integrity and diplomacy
2.6.2 Terms of Appointment
2.6.2.a Duration
The members of the HEC, TMC will be appointed for duration of 2 years.
The appointment procedure for membership will be followed so that it allows for
continuity, the development and maintenance of expertise within the HEC, and the
regular input of fresh ideas and approaches.
The members can be continued and there will be no limit on the number of times
the membership is extended. Extension of membership will be based on the
recommendation of the Chairperson & Member Secretary of HEC.
All HEC-I members will be alternate members for HEC-II and vice versa. Alternate
member may also be appointed in case of absence of a regular member with the
concurrence of other HEC members.
A Member Secretary, Chairperson or member may be newly appointed before the
completion of the tenure of the existing appointed committee. This appointment
will be effective for the remaining tenure of the existing committee.

SOP 02/V2
2.6.2.b Renewal
The membership will be renewed after the stated term of 2 years

The process of renewal will be as follows :
Selection of Member Secretary and other members should be done 6 months and 1
month in advance respectively. Member secretary designate should be inducted in
the committee as a member before he/she takes on the mantle in the new HEC.
Other members designate may attend the board meeting as observers before starting
their tenure as HEC member
Designated members of the HEC who wish to attend HEC meetings as observers
should read, understand, accept and sign the agreement contained in the
Confidentiality / Conflict of Interest form (AX3 – V1/SOP02/V2) at the beginning of
the HEC meeting and/or before ethical review tasks of the HEC commence
If a regular member resigns, or ceases to be a member due to disqualification, or
death, a new member will be appointed for the remaining term as per the Conditions
of appointment stated below – section 2.6.3
2.6.2.c Resignation / Replacement procedure
The members who have resigned may be replaced at the discretion of the appointing authority
for the same. HEC members who decide to resign must provide the Director, TMC and
Chairperson, HEC the written notification of their proposed resignation date at least 30 calendar
days prior to the next scheduled meeting. In case of resignation, Director, TMC would appoint
a new member, falling in the same category of membership ex. NGO representative with NGO
representative. The recommendations may be sought from the resigning member. Appointment
may be made in the consultation with Member Secretary and /or Chairperson
2.6.2.d Termination / Disqualification procedure
A member may be relieved or terminated of his/her membership in case of

Conduct unbecoming for a member of the Ethics Committee
Inability to participate in the meetings on any grounds
If a regular member fails to attend more than 3 meetings of HEC. The membership
shall be reviewed by the HEC if the member is a regular defaulter. If deemed
necessary, the HEC may decide to terminate the membership and recommend to the
Director, TMC, by the Chairperson HEC for necessary action
Relocate to another city or any such matter
In all such situations/circumstances, Director, TMC will serve a letter of termination

to the member. Documentation of the termination will be recorded in the meeting
minutes of the next duly constituted HEC meeting and HEC membership circular/
roster will be revised.

SOP 02/V2
2.6.3 Conditions of Appointment
Name, age, gender, profession, and affiliation of HEC members will be publicised.
Members must accept the appointment in writing.
Submit one page CV and training certificates in Ethics and /or GCP.
Conflict of interest, if any, must be disclosed.
Members must apprise themselves of the relevant documents, codes, GCP, ICH
guidelines and the ICMR code & HEC, TMC SOPs Members are required to sign the
confidentiality agreement (AX1-V1/SOP 02/V2) at the start of their term. The
confidentiality agreement protects the privacy and confidentiality of all parties whose
information may be disclosed to the HEC/IRB in the course of its work.
An investigator can be a member of the HEC; however, the investigator-as-member
cannot participate in the review and approval process for any project in which he or
she has presence as a PI, Co-PI or CI or potential conflict of interest.
2.6.4 Independent Consultants
The HEC may call upon, or establish a standing list of, independent consultants who
may provide special expertise to the HEC on proposed research protocols, when
the Chairperson / Member secretary or the HEC members determine that a study
will involve procedures or information that is not within the area of expertise of the
HEC members. These consultants may be specialists in ethical or legal aspects,
specific diseases or methodologies, (e.g. genetic disorders, stem cell research etc.)
or they may be representatives of communities, patients, or special interest groups.
These consultants must sign the confidentiality agreement (AX2-V1/SOP02/V2)
regarding meeting, deliberations, and related matters. These consultants or subject
experts cannot vote for decision.
2.7 Office Bearers
The HEC will have the following office bearers who have the expertise and professional
qualifications to review what comes in.
2.7.1 Chairperson
The HEC Chairperson should be a highly respected individual preferably from outside the
institution, fully capable of managing the HEC and the matters brought before it with fairness
and impartiality. The task of making the HEC a respected part of the institutional community
will fall primarily on the shoulders of this individual. The HEC must be perceived to be fair and
impartial, immune from pressure either by the institution’s administration, the investigators
whose protocols are brought before it, or other professional and nonprofessional sources.
Co-Chairperson- The HEC Co-Chairperson should be a highly respected individual preferably

from outside the institution, fully capable of managing the HEC and the matters brought before
it with fairness and impartiality, in absence of the Chairperson.

SOP 02/V2
2.7.2 Member Secretary
The Member Secretary will be a staff member of institute, committed to the task of coordinating
and managing the activities of the committee. He/she will be responsible for scheduling the
meetings, describing the agenda and ensuring that the function of the committee is conducted
as per the norms and policies described in this SOPs.
In absence of Member Secretary of HEC-I, the Member Secretary of HEC-II will function as
acting Secretary of HEC-I and vice-versa.
2.7.3 Secretariat
Secretariat is composed of Member Secretary, HEC and the administrative supporting staff. The
supporting staff consists of staff members of the TMC appointed by the Director, TMC.
The secretariat shall have the following functions:
Organizing an effective and efficient tracking procedure for each proposal received
Preparation, maintenance and distribution of study files
Organizing HEC meetings regularly
Preparation of agenda and minutes of the meetings
Maintaining HEC documentation and archive
Communicating with HEC members and PIs
Arrangement of training for personnel and HEC members
Providing necessary administrative support for HEC related activities to the Member
Secretary, HEC
To receive IRB processing fees and issue official receipts for the same
The HEC Administrative Staff: Working Rules
1. There will be administrative officer/s and attendant/s /helper/s who will help the
HEC Chairperson and Member Secretary in executing functions of the HEC. Additional
staff may be appointed and duties assigned; as and when deemed necessary by the
HEC. The eligibility criteria for new staff to be appointed will be laid down depending
on the required job profile. The need for appointment of administrative staff, job
profile and qualifications may be recommended by HEC members during regular
HEC meeting and will be recorded in minutes; these are forwarded to the Director,
TMC.
2. The administrative staff will be appointed by conducting formal interviews (to be

conducted by panel of experts appointed by Director, TMC.
a. Duties of the administrative officer/s/staff
b. Correspondence with the HEC members and external experts
c. Correspondence with the investigators
d. Pre and post arrangements of HEC meetings

SOP 02/V2
e. Preparing agenda and minutes of the HEC meetings
f. Answering queries of the investigators
g. Filing study related documents
h. Archiving and maintaining the study files
3. Duties of the attendant/s /helper/s

a. Assisting the secretariat in arranging the HEC meetings
b. Dispatching sets of study documents to HEC members and external experts
c. Receiving the study related documents from and dispatching the HEC letters
to the investigators
d. Filing study related documents
e. Archiving and maintaining the study files
f. Correspondence with the HEC members and external experts
4. The administrative staff will report to the Chairperson and/or Member Secretary.
5. The office timing for the administrative staff will be as per TMC rules & regulations.
6. The administrative staff will avail leave as per TMC norms.
2.8 Roles and Responsibilities of the HEC members
The Committee’s primary responsibilities will be protection of safety, rights and

confidentiality of the research subjects.
Participate in the HEC meeting.
Review & discuss research proposals submitted for evaluation.
Review progress reports and monitor ongoing studies.
Monitor SAEs and recommend appropriate action(s).
Maintain confidentiality of the documents and deliberations of the HEC meetings.
Declare conflict of interest, if any.
To carry out work delegated by Chairperson, Co-Chairperson & Member Secretary.
To participate in continuing education activities in biomedical ethics and biomedical
research.
To provide information and documents related to training obtained in biomedical
ethics and biomedical research to the HEC secretariat
2.9 Quorum Requirements
A minimum of five (5) members is required to form the quorum without which a
decision regarding the project should not be taken. The quorum requirements of
HEC should have the following representation:
(a) basic medical scientists (preferably one pharmacologist)
(b) clinicians
(c) legal expert
(d) social scientist or representation of non-governmental voluntary agency or

SOP 02/V2
philosopher or ethicist or theologian or similar person
(e) lay person from the community
In any case, the ethics committee must include at least one member whose
primary area of interest/ specialization is nonscientific and at least one member
who is independent of the institution / trial site. Besides, there should be
appropriate gender representation on the HEC
A quorum should include at least one member whose primary area of expertise
is in a non-scientific area, a clinician and at least one member who is
independent of the institution/research site
No quorum should consist entirely of members of one profession or one
gender
In absence of the Chairperson, Co-Chairperson will chair the meeting. In absence
of both, member who is independent of the institution will chair the meeting
as Acting Chairperson.
2.10 Decision making
Decision is arrived at by consensus, if consensus not possible, voting is carried out

Opinions of absent members that are transmitted by mail or telephone or fax may
be considered by the attending members during discussion but may not be counted
as votes or quorum for formally convened full board meetings
Any committee member with a conflicting interest in a proposal will abstain from
deliberations and in decision making process on that proposal, except to provide
information as requested by the committee. Such abstentions will be recorded in the
minutes. Decision is arrived at by consensus, if consensus not possible voting is
carried out
2.11 Education for HEC Members
HEC members have a need for initial and continued education regarding the ethics and science
of biomedical research.
All HEC members must be conversant with ICMR Guidelines for Research involving Human
Subjects 2006, Schedule Y of Drugs and Cosmetics Act and ICH-GCP guidelines.
HEC members will receive introductory training material in research bioethics and functioning
of HEC and will be exposed to ongoing opportunities for enhancing their capacity for ethical
review.
Training of the HEC members in Research Bioethics

A new member will be inducted 1 month prior and will be requested to be an
‘observer’ for the first board meeting. An introductory training will be imparted by
the Member Secretary.

SOP 02/V2
The HEC members will be encouraged to receive ongoing training by attending
workshop at least once every year.
The HEC will conduct workshops from time to time to impart training to the HEC
members and Institutional faculty members.
The training programmes should be scheduled and spread over the year.
2.12 Prepare an annual activity report of the HEC for submission to the Director,
TMC.
A quantitative evaluation of the activities of the committee in a year

List of the research proposals reviewed in a year
Status of each research proposal
References
1. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
Retrieved from- http://www.cioms.ch/frame guidelines nov 2002.htm accessed 13th September
2008)
2. European Convention on Human rights and Biomedicine (1997). Retrieved from-http://
conventions.coe.int/treaty/en/treaties/html/164.htm accessed 13th September 2008
GCP) 1996. Retrieved from-http://www.ich.org/LOB/media/MEDIA482.pdf accessed 13th
September 2008
4. ICMR Ethical Guidelines for Biomedical research on Human Participants, ICMR (2006)-
Retrieved from - http://www.icmr.nic.in/ethical guidelines.pdf accessed 13th September 2008
5. Schedule Y (Drugs and Cosmetic Act 1940; amendment 20th January 2005) Retrieved from
- http://www.cdsco.nic.in/html/Schedule-Y 20(Amended 20Version- 2005) 20 original .htm
accessed 13th September 2008
6. World Health Organization, Operational Guidelines for Ethics Committees that Review
Biomedical Research, 2000. (Geneva 2000) Retrieved from- www.who.int/tdr/publications/
publications/ accessed 13th September 2008

SOP 02/V2
Glossary
Confidentiality: Prevention of disclosure, to other than authorized individuals, of information

and documents related to HEC
Human Ethics Committee (HEC) : It is an independent body whose responsibility is to

ensure the protection of the rights, safety and well-being of human subjects involved in a
clinical trial and to provide public assurance of that protection
Independent Consultants: Professionals with advanced training and expertise in the medical
or non-medical areas related to the protocol being reviewed

SOP 02/V2
AX1-V1/SOP02/V2
Confidentiality and Conflict of Interest Agreement form for HEC Members
In recognition of the fact, that I, Dr……… herein referred to as the “Undersigned”, has been
appointed as a member of the Human Ethics Committee (HEC), would be asked to assess
research studies involving human subjects in order to ensure that they are conducted in a
humane and ethical manner, with the highest standards of care according to the applied national,
local regulations, institutional policies and guidelines;
Whereas, the appointment of the undersigned as a member of the HEC is based on individual
merits and not as an advocate or representative of a home province/ territory/ community nor
as the delegate of any organization or private interest;
Whereas, the fundamental duty of an HEC member is to independently review research protocols
involving human subjects and make a determination and the best possible objective
recommendations, based on the merits of the submissions under review;
Whereas, the HEC must meet the highest ethical standards in order to merit the trust and
confidence of the communities in the protection of the rights and well-being of human subjects;
The undersigned, as a member of the HEC is expected to meet the same high standards of
ethical behavior to carry out its mandate.
This Agreement thus encompasses any information deemed Confidential or Proprietary provided
to the Undersigned in conjunction with the duties as a member of the HEC. Any written information
provided to the Undersigned that is of a Confidential, Proprietary, or Privileged nature shall be
identified accordingly.
As such, the Undersigned agrees to hold all Confidential or Proprietary trade secrets (“information”)
in trust or confidence and agrees that it shall be used only for contemplated purposes, shall not
be used for any other purpose or disclosed to any third party. Written Confidential information
provided for review shall not be copied or retained. All Confidential information (and any
copies and notes thereof) shall remain the sole property of the HEC.
The Undersigned agrees not to disclose or utilize, directly or indirectly, any Confidential or
Proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the
Undersigned confirms that my performance of this agreement is consistent with the Institute’s
policies and any contractual obligations they may have to third parties.

SOP 02/V2
Conflict of Interest
It has been recognized that the potential for conflict of interest will always exist but has faith in
the HEC and its Chairperson to manage the conflict issues so that the ultimate outcome is the
protection of human subjects.
In accordance of the policy of the HEC, I shall not participate in the review, comment or
approval of any activity in which I have a conflict of interest, except to provide information as
requested by the HEC.
Undersigned Signature Date
The Undersigned will immediately disclose to the Chairperson of the HEC any actual or potential
conflict of interest that I may have in relation to any particular proposal submitted for review by
the committee, and to abstain from any participation in discussions or recommendations in
respect of such proposals.
If an applicant submitting a protocol believes that a HEC member has a potential conflict, the
investigator may request that the member be excluded from the review of the protocol.
The request must be in writing and addressed to the Chairperson. The request must contain
evidence that substantiates the claim that a conflict exists with the HEC member(s) in question.
The committee may elect to investigate the applicant’s claim of the potential conflict.
When a member has a conflict of interest, the member should notify the Chairperson and may
not participate in the HEC review or approval except to provide information requested by the
Committee.
Examples of conflict of interest cases may be any of the following:

A member is involved in a potentially competing research program.
Access to funding or intellectual information may provide an unfair competitive advantage.
A member’s personal biases may interfere with his or her impartial judgment.
Agreement on Confidentiality and Conflict of Interest.
In the course of my activities as a member of the HEC, I may be provided with confidential
information and documentation (which we will refer to as the “Confidential Information”). I
agree to take reasonable measures to protect the Confidential Information; subject to applicable
legislation, including the access to it, as per the right to Information Act, not to disclose the
Confidential Information to any person; not to use the Confidential Information for any purpose
outside the Committee’s mandate, and in particular, in a manner which would result in a benefit

SOP 02/V2
to myself or any third party; and to return all Confidential Information (including any minutes or
notes I have made as part of my Committee duties) to the Chairperson upon termination of my
functions as a Committee member.
Whenever I have a conflict of interest, I shall immediately inform the committee not to count me
toward a quorum for consensus or voting.
I, Dr. …….. have read and I accept the aforementioned terms and conditions as explained in this
Agreement.
Director of the TMC Date

SOP 02/V2
AX2-V1/SOP02/V2
Confidentiality Agreement Form for Independent Consultants
I, ___________________ (Name and Designation) as a non-member of HEC understand that the

copy (ies) given to me by the HEC is (are) confidential. I shall use the information only for the
indicated purpose as described to the HEC and shall not duplicate, give or distribute these
documents to any person(s) without permission from the HEC.
Upon signing this form, I agree to take reasonable measures and full responsibility to keep the
information as confidential.
Chairperson of HEC Date
I, ________________________ (Enter name) acknowledge that I have received a copy of this

Agreement signed by Chairperson, HEC and me.
Signature of the recipient Date

SOP 02/V2
AX3-V1/SOP02/V2
Confidentiality Agreement Form for Observer Attendees to HEC, TMC Meetings
I, _________________________________, understand that I am allowed to attend the HEC meeting
scheduled on ___________ at _______am/ pm as an Observer.
The meeting will be conducted in the IRB Meeting room, 3rd Floor Main Building, TMH.
In the course of the meeting of the HEC some confidential information may be disclosed or
discussed.
Upon signing this form, I ensure to take reasonable measures to keep the information and
discussion as confidential.
Signature of the Guest
Date
Chairperson of HEC
Date
I, ___________________________ (Enter name) acknowledge that I have received a copy of this

Agreement signed by Chairperson, HEC and me.

SOP 02/V2

SOP 03/V2
Title: Management of Protocol Submissions
Management of Protocol Submissions Page 41

SOP 03/V2
3.1 Purpose
This SOP is designed to describe and act as a guideline for the IRB Secretariat of the IRB to
manage research protocol submissions.
3.2 Scope
The scope includes the following -

Submission for initial review
Resubmission of protocols with modifications
Protocol amendments and any other amendments
Continuing review of approved protocols
Protocol completion/termination
3.3 Responsibility
It is the responsibility of the IRB secretariat to receive record and distribute the protocols for
review by the SRC/HEC and communicate the decisions to PI in a prescribed format.
All project proposals submitted (both hard and soft copies) for initial reviews are first forwarded
by IRB Secretariat to SRC for reviewing its scientific merit. The project is tabled for HEC review
after SRC approval.
3.4 Detailed process
3.4.1 Receive submitted packages
The PI can submit research proposal to the HEC for review and approval under any of the 5
sections mentioned below :
Initial Review Application

Resubmission of Protocols with Corrections
Protocol Amendment or any other Amendments
Continuing Review of Approved Protocols
Protocol Completion / Termination
3.4.2 Verify Contents of Submitted Package
Check the applicable documents to ensure that all required forms and materials are
contained within the submitted package. Checking is done as per checklist (AX2-V1/SOP
03/V2) for submissions for initial review.
Verify contents of the submitted package which should include
o Original Application Form for Initial Review or Project submission Form (AX1-V1/
SOP 03/V2)
o Study protocol

SOP 03/V2
Other related documents necessary for initial review (AX 2-V1/SOP 03/V2)
Check completeness of necessary information and signature at all appropriate places in
the application form submitted for initial review.
Notify the applicants, if a package is incomplete.
State clearly the items missing in the package on the Protocol submission / document receipt
form (AX 3-V1/SOP03/V2) along with SRC approval document.
The Secretariat will

Stamp, sign & date of receipt on the cover letter confirming receipt of the documents.
Make a photocopy of the completed document receipt form (AX 3-V1/SOP03/V2) and
return the original copy of the (AX 3-V1/SOP03/V2) to the applicants for their records
Count for correct numbers of hard copies (Initially 15 copies for investigator-initiated
studies and 15 copies for pharma-sponsored studies)
Store the hard copies and soft copy of the research project. The hard copies will be
stored in locked cupboards in HEC office and soft copy of IRB submission form /study
protocol accepted by email will be saved on HEC computer.
The project file is numbered as serial number / P or E or I /Year / Number e.g. 628/P/09/
01 will indicate – 628 as serial no of project, P – Pharma, 09 – year, number 01 project of
the year 2009. (where P = Pharma sponsored trials, E = Extramural funding, I = Intramural
funding). This coding system will be maintained on the excel sheet (inventory of projects)
and also labeled on each project file.
All correspondence for the projects, should quote only the serial number i.e 628 this
unique identity number
Record the date of receipt, no. of copies and the name of the receiver in register.
Store the received packages, which include original protocol file and copies of the
protocol to be distributed for review.
3.5 Detailed description of Study Project Submission
The study protocol should be accompanied with the following relevant supporting documents
for scientific and ethical review. These are –
1. Checklist (Refer AX 2-V1/SOP 03/V2)

2. Project Submission Form
A. Grouping of Project
B. Project Fact Sheet
C. Project Submission Overview
D. Budget Sheet for the Proposed Study
3. Essential Documents
a. Informed Consent Documents (Refer (AX4-V1/SOP 03/V2)
b. Participant Information Sheet
4. Decision of other Ethics Committees (If required / asked for)

SOP 03/V2
Details of Essential Documents along with protocol
1. Participant Information Sheet, Informed Consent Forms (ICFs), Assent Forms and Parent
consent forms (if children / adolescents between 7 – 18 years of age are participants in
the trial) - in English, Hindi and Marathi (Refer (AX5-V1/SOP 03/V2)
2. Investigator’s Brochure
3. CRF
4. One page, recent, signed and dated curriculum vitae of the investigators indicating
qualifications and relevant experience.
5. Agreement to comply with national and international GCP protocols for clinical trials
6. Details of Funding agency / Sponsors and fund allocation
7. Regulatory clearance for all types of studies from appropriate regulatory authorities i.e.
DCGI approval, DGFT approval (for export of study samples), ICMR, DBT, other local
government agencies (as applicable)
8. For exchange of biological material in international collaborative study a MOU / MTA
between the collaborating partners and of Health Ministry Screening Committee (HMSC)
9. CTA or MOU between the collaborators
10. Insurance/Indemnity policies, indicating who are covered
11. Any other information relevant to the study
3.6 Resubmission of Protocols with corrections as per HEC suggestions
For resubmitted protocol, the PI will submit one copy of the amended Protocol and
related documents along with justification for amendment, and clearly highlighted /
demarcated sections which have undergone amendment
The IRB Secretariat will verify the completeness and reconfirm that the copy contains the
modification highlighted with respect to the earlier protocol
The IRB Secretariat will perform the steps 3.4.2 as mentioned in initial review application.
The protocol related documents which do not require to be changed and are already
submitted to the HEC during initial review are need not be submitted again
3.7 Research Protocol Amendments and other study related documents
The PI will submit 15 copies of the protocol amendments or any other study related
documents to the IRB Secretariat.
The IRB Secretariat will verify the completeness as per checklist for the contents of
submitted package
The PI will highlight the modification/s in the amendment, along with a summary of
changes and whether these changes would entail changes in the ICF.
The Member Secretary in consultation with Chairperson will decide whether to:
o Carry out an expedited review in case of minor administrative amendment.
o Table for discussion at the full board meeting / or revert back for SRC review
This is process is further elaborated in SOP 06/V2.

SOP 03/V2
3.8 Annual Continuing Reviews of Approved Protocols
The HEC will send reminders for annual report to Individual PI, 15 days prior to the expiry
date of approval, which usually is one year from the date of approval letter
The HEC will receive a copy of Annual Study / Continuing Review Report in the prescribed
format and related documents (as per SOP 07/V2) for the approved protocol
The IRB Secretariat will verify the completeness of the Continuing Review Application
Form (AX1-V1/SOP 07/V2) Progress report/Request letter for extension of approval of
the project. The IRB Secretariat will sign and date the documents.
The progress or continuing review report will be tabled in the full board meeting of
HEC.
3.9 Protocol Completion
The HEC will send reminders for annual report to Individual PI, 15 days prior to the date
of completion.
The HEC will receive a copy of Study Completion Report in the prescribed format (as per
SOP 12/V2).
The IRB Secretariat will verify the completeness of the Study Completion Report Form
(SOP12/V2) filled by the PI.
The study completion report will be tabled in the full board meeting of HEC.
Reference

GCP) 1996 Retrieved from - http://www.ich.org/LOB/media/MEDIA482.pdf , accessed 14th
September 2008
Glossary
Investigator’s Brochure: The Investigator’s Brochure (IB) is a compilation of the clinical and
non-clinical data on the investigational product(s) that are relevant to the study of the product(s)
in human subjects.
Study Protocol: A document that describes the objective(s), design, methodology, statistical
considerations and organization of a trial.

SOP 03/V2
(AX1-V1/SOP 03/V2)
Project Submission Form for review by SRC & HEC
Project No.:
Title:
PI:
Please complete the questionnaire for submitting the research proposal for
TMC-SRC/HEC
Study Group
(Please circle the applicable Y/N neatly)
Group Detail Yes No
Controlled trials
01 A1 a Is this a randomized controlled trial? Y N
02 A1 b Is this a non-randomized controlled trial? Y N
03 A1 c Is this a controlled trial that seeks new indication for Y N

establishing drug, process or a procedure?
Uncontrolled trials
04 A2 a Is this a prospective trial testing new intervention, drug, Y N

or device on patients?
05 A2 b Is this a prospective trial designed to test new (unproven) Y N

indication for established drug, process, procedure or
device on patients?

SOP 03/V2
06 A2 c Is this a pilot trial on new intervention, drug, and Y N

device on patients?
Trial involves transfer of data / material from TMC
07 A3 a Is this a multi-centre trial? Y N
08 A3 b Does this trial involves transfer of patients’ data to Y N

another site (including industry)?
09 A3 c Does this trial involves transfer of patients’ blood, serum, Y N

DNA, tissue to another site?
Intramural Funding
10 A4 a Are you seeking intramural funding? Y N
11 A4 b Does this trial use additional resources of TMC beyond Y N

the usual patients’ work-up (e.g. IHC, molecular profiling,
MRI etc. which is not a routine part of work-up)?
Extramural Grants
12 A5 a Are you submitting application for extra-mural grant Y N

for this trial?
13 A5 b Is this trial partly or wholly supported by grants from Y N

sponsored industry?
14 A5 c Is this a phase IV / marketing trial undertaken on behalf Y N

of the industry?
Modification in approved trials
15 A6 Are you seeking modification/s in the TMC-SRC/HEC Y N

approved trial?
Study participants to bear the cost of trial
16 A7 a Will the study participants bear the cost of experimental Y N

intervention or drug therapy?
17 A7 b Will the study participants undergo additional blood sample Y N

collection, biopsy, endoscopy, procedure etc.?
18 A7 c Will the study participants bear the cost of complications Y N

arising from experimental treatment?

SOP 03/V2
19 A7 d For the trial purpose, does the study participants have to Y N

spend Rs. 5000/- or more above the usual expenses
(for any reason such as drug therapy, additional
investigation, prolonged stay or repeated travel)?
Community or screening trials
20 A8 a Will this trial be undertaken in the community? Y N
21 A8 b Will this trial involve the screening? Y N
Trials involving genomics & proteomics
22 A9 Does this trial involve conducting genomics or Y N

proteomics studies on study participants specimens?
Trials with conflict of interest
23 A10 Will this trial involve development of a device, drug Y N

or test leading to profits or patent?
GROUP- B
Trials that should be notified to SRC secretariat
for entry in to the “TMH TRIAL REGISTER”.
24 B1 Is this a prospective follow-up study Y N

(documentation of parameters only) of patients who are
being offered standard treatment at TMH?
25 B2 Is this a phase II-IV trial restricted to standard intervention / Y N

treatments published in EBM book?
26 B3 Is this a feasibility study for introduction of new treatment, Y N

recently shown in major international studies,
to be beneficial / superior and need to be started at TMC?
27 B4 Is this a retrospective or prospective analysis of charts and Y N

audit of procedures / tests / treatments?
28 B5 Is this a retrospective or prospective review of pathology Y N

specimen (may involve some additional
staining techniques)?
29 B6 Is this a retrospective or prospective review of radiology Y N

reports and their clinical correlation?

SOP 03/V2
30 B7 Is this a retrospective or prospective review of Y N

laboratory reports and their clinical correlation?
Procedure / demonstration at workshops etc.
31 B8 Are you demonstrating an experimental procedure which Y N

is ‘not established standards of care’ at a workshop,
or a public meeting?
32 B9 Are you performing a procedure in workshop at TMH by Y N

non-TMH staff member?
(Please check other requirements also)
Name of PI: Signature:

SOP 03/V2
Project No.
(To be filled by the Secretariat)
Date of receipt by IRB

Project Title
Key Words title (2-4 options)
Principal Investigator
Co-Principal Investigators (if any)
Co-investigators
Contact number Principal Investigator
Site/sites where study is to be
conducted i.e. TMH / ACTREC / Both.
(Please specify).
Number of ongoing studies,
PI is involved?
Agency or Sponsor
Total estimated budget
Conflict of interest, if any
Duration of the Project (months)
Suggested date of starting the study
Total number of patients to be
accrued in study
(including TMC,
if multi-institutional study)
Number of patients from
TMC to be accrued
Will biological products be sent out
of the country? If yes,
has ICMR/HMSC/DGFT
permission/NOC been obtained?
Signature of PI
Date of submission

SOP 03/V2
Project No.
Trial Register No.
Project Title (To be filled by PI) ..
Revised Title if any (To be filled by IRB)
Principal Investigator ..
TMC - SCIENTIFIC REVIEW COMMITTEE APPROVAL
The above titled project with all the accompanying documents listed above was reviewed by
the members of the TMC - Scientific Review Committee present on ……………………….. at
Tata Memorial Centre. The committee has granted approval on the scientific content of the
project. The proposal may now be reviewed by the Human Ethics Committee for granting
final approval.
Secretary …………..……..…………….……. Chairperson …..………...………….…………
Name: …………..……..…………….…….…. Name: …………..……..…………….…….….
Date: ………………………………..…...….... Date: ………………………………..…...…....
HUMAN ETHICS COMMITTEE APPROVAL
The members of the Human Ethics Committee met on …………………… at Tata Memorial
Centre and reviewed the above named project with all the documents listed above. The
ethics committee after careful deliberations has granted final approval to the project. The
above mentioned project / study may now be undertaken at Tata Memorial Centre in accordance
with the study protocol submitted by the investigators, subject to fulfilling other institutional
regulations.
Secretary …………..……..…………….……. Chairperson …..………...………….…………
Name: …………..……..…………….…….…. Name: …………..……..…………….…….….
Date: ………………………………..…...….... Date: ………………………………..…...…....

SOP 03/V2
Investigators Declaration
01. This research project (including collection of blood or tissues samples for research) will
not be started until the final approval of the HEC has been obtained.
02. We agree to undertake research proposal involving human subjects in accordance with
the ICH-GCP and ICMR ethical guidelines, 2006. We will not modify the research protocol,
consent, etc without prior approval by the HEC.
03. The investigators agree to obtain a properly informed and understood consent for all
trial subjects before their inclusion in the trial in the informed consent form that is
approved by the HEC. Participants will receive an ‘information sheet’ which will detail
the project design in simple understandable layperson’s language.
04. The investigators agree to report within a week all serious adverse events (SAE) associated
with the trial in the SAE form to the HEC. In the event of a death of the trial subject, the
Secretary, HEC and DSMSC, will be informed within 24 hours.
05 The investigators agree to submit periodic 6 monthly progress report of the trial in the
appropriate form. A final report will be submitted at the end of the trial.
06 Full details on funding and a proposed budget are included with the trial proposal. The
proposed budget is presented on the specific budget sheet of this form.
07 We understand that the HEC is concerned about transparent financial transactions during
the trial. A report on how the trial funds were utilized will be presented to the EC along
with the final project report at the end of the trial.
08 The investigators agree to transfer 15% of the total budget to TMC as service charges.
This will not apply to intramural projects, those projects co-sponsored by TMH / CRI /
ACTREC / DAE and ICMR / DBT /DST/WHO/IAEA funded projects.
09 The investigators agree that the grant money will be spent in accordance with the
budget proposal only. The funds will not used for any other purposes without prior
approval from the HEC. Thirty percent of the surplus grant if left over at the end of the
study will be credited to TMC. The remaining 70% of the surplus grant money may be
used by the investigators for conducting intramural research, improving teaching facilities
in the department, providing financial assistance to investigators for conferences, etc
after obtaining permission from the HEC.
10 For all research proposals that are sponsored by a pharmaceutical or biomedical company,
we the investigators will ensure that the Sponsor Company will underwrite all expenses
such that neither the hospital nor the study participants are made to spend while
participating in the trial. The investigators will also ensure that in the event of complications
arising directly due to the trial or litigation, the cost of management or legal fees will be
borne by the Sponsor Company totally.
11. The investigators state that they do not stand to gain financially from the commercial
sponsor and don’t have conflict of interest in the drug or product by way of consultations,
shareholding, etc.

SOP 03/V2
12. The investigators will ensure that personnel performing this study are qualified, appropriately
trained and will adhere to the provisions of the Human Ethics Committee. TMC, approved
protocol.
13. All data collected during the research project, including those supported by commercial
sponsors (e.g. pharmaceutical company), will remain the property of Tata Memorial
Centre.
14. The salaries to staff employed for the research project will be as shown in the budget
sheet and at par with the prevailing TMC salary scales.
15. The case records (source documents) will be made available to members of the SRC or
HEC any time for random verification and monitoring. The case records (source
documents) will be preserved in the premises of TMC for at least 5 years after the last
approval of application or publication.
16. The investigators promise to ensure that there is no falsification of data when compared
to the source documents. We agree to clarify any doubts or discrepancies that may arise
during the data monitoring evaluation.
17. All the findings and conclusions of the proposed project such as review of case records,
analysis of forms of treatment, investigations, etc will be first presented to the staff
members of TMC before they are released or presented elsewhere. The investigators
will submit a copy of the abstract to the SRC and HEC well in advance of any proposed
presentation at national or international conferences or seminars.
18. The investigators will not issue any press release before the data and conclusions have
been peer-reviewed by the TMC staff or published in a peer-reviewed journal.
19. All serious injuries arising from the trial will be the responsibility of the investigators.
The investigators agree to ensure that the sponsors undertake a product liability insurance
to cover any expenses for injury or compensation arising from the study treatment.
20. The investigators will constantly inform the HEC about amendments in the study protocol,
data collection forms, informed consent forms, budget expenses, salaries, other trial
documents, etc. as and when they occur. No major changes in the treatment arms or the
study protocol or randomization technique will be carried out without prior permission
of the HEC.
21. The investigators realize that the HEC is particular that all aspects of the study are in
accordance with the ICH-GCP and ICMR ethical guidelines, 2006. The investigators will
comply with all policies and guidelines of the TMC and affiliating/collaborating institutions
where this study will be conducted, as well as with all applicable laws regarding the
research.
We the investigators of the proposed trial have read all the statements listed above and
agree to observe / undertake these HEC requirements while conducting our proposed
project / trial.

SOP 03/V2
We understand that serious protocol violations and/or non-compliance during the trial by the
investigators may result in withdrawal of project approval by Human Ethics Committee
CC No. Investigator Email Status Sign & Role &

if available Name (PI, Co-PI, CI) date responsibility
Role & responsibility of investigator is categorized from A to Z as follows:

A. Concept
B. Design
C. Screening of patients
D. Selection & Recruitment of patients
E. Laboratory investigations
F. Laboratory report interpretation
G. Treatment decision
H. Patient evaluation
I. SAE evaluation and reporting
J. Examination of patients on follow-up
K. Data collection and monitoring of data
L. Interpretation of data
M. Statistical analysis & Interpretation
N. Maintaining patients file and master file of project
O. Drafting final report
P. Publication
Z. Any other, please specify
Please mention the category in column of role & responsibility.
Note: Investigators may clarify any of the points in this undertaking with the IRB secretariat

SOP 03/V2
To,
The Secretary
Scientific Review & Human Ethics Committee
Project entitled: …………………………………………………………………….
Name of PI:
I hereby declare that I have no conflict of interest in my project.

I have following conflict of interest:
Signature of PI Date
Consent of Head of the PI’s Department

Date:……….
I have reviewed the above project submitted by ……………………………………… Principal
Investigator from my Department. I endorse the project and have ‘no objection’ for submission
for consideration by Scientific & Ethics committee.
I concur with the participants / investigators included in the study.
Signature & date Name Department
Consent from Working Group

Date:……….
The above project submitted by ………………………………………………. ., Principal

Investigator, has been discussed in the ………………….working group and has been accepted
to be submitted for submission for Scientific & Ethics committee consideration.
The investigators / participants included in the study are acceptable to the members.
Signature & date Name (senior member of working group)

SOP 03/V2
Title
Names of all Investigators

(underline principle investigator)
Introduction / background
Give the background, including human or
animal research relevant to the design of the
proposed study. When new techniques or
procedure are to be used, provide a description
of preliminary work. When an investigation drug
is to be used, animal data and phase I or II data
on the drug should be included. A summary of
how the study may help in the future should
be included in the protocol.
Aims / Objectives
Clearly state the aims or objectives of the study.
Whenever possible this should be in the form
of a hypothesis.
Design of the Study
Phase-I, Phase-II, Phase-III, Phase-IV, NA
Randomized [Double or single blind], Open [ ]
If multicentric, is TMH the co-coordinating
centre?
Epidemiological [ ] Survey [ ] Observational [ ]
Case control [ ], Any other (Specify)
Study methodology
Explain, in sequence, the conduct of study and
all data collection procedures.
Describe the involvement of human subjects
including initial evaluation procedures and
screening tests, phases, medical/surgical
procedures and sequence of the study. Separate
standard and experimental aspects of the study
as much as possible. Give brief account of
procedures for treatment, dose adjustments, etc.
Describe the randomization procedure, if
applicable. Specify if procedure involves
banking of biological samples. Define stop
points and criteria for withdrawing subjects from
the study.

SOP 03/V2
Eligibility
(Explain inclusion and exclusion criteria; To be
stated clearly in the summary)
(specific explanation if participants will include
Minor, Pregnant woman, Neonate, Person
incompetent to give informed consent, Normal/
Healthy volunteer, Student, Staff of the institute).
How many subjects will be screened? How many
subjects are likely to be enrolled?
Describe benefits to the subject/participant in
this study. Also describe the benefits, if any, to
the society.
Power estimates
Describe power calculations, if the study
involves statistical comparisons between two or
more groups. Mention evidence to support that
adequate number of subjects can be enrolled
during the study period by the investigators.
Variables to be estimated
(e.g. response, survival, toxicity, age, etc)
Enumerate the variables, outcomes and end
points that will be measured. Try to separate
variables as response and explanatory variables.
Describe the type and frequency of tests,
admissions, outpatient visits, etc used to obtain
these variables or variables.
Analysis of the variables
Describe how the variables obtained during the
study will be statistically analyzed. e.g.
Univariate comparison or Cox- proportional
hazards model, etc
Describe all possible risks and discomfort
for subjects due to use of intervention and /
or data collection methods proposed.
Describe expected degree and frequency of
such risks, discomfort, side effects of drug
etc.
If the procedures in the trial are invasive or
potentially harmful, describe what
arrangements have been made for treatment
of the complications arising from the trial?
Who will bear the cost of treating the
complications arising from this trial?
Does your study involve testing of drug/s, Yes [ ] No [ ]
device/s and/or biologics?

SOP 03/V2
Are they already approved by the regulatory Already approved [ ] New one [ ]
authorities and available in the market or
are they new ones?
Who has prepared and /or is manufacturing
the drug/s, device/s and biologics under
investigation?
Who holds the patent or IND/IDE of the
drug/s, device/s and biologics under
investigation?
What are the reasonable possibilities of the
availability after the study of the
investigational drug(s), device(s) and
biologics for the study participants/subjects
if it is found to be effective?
Does your study require permission from Yes [ ] No [ ]
regulatory authorities?
If yes,
(i) from DCGI Yes [ ] No [ ]
(ii) from the ICMR Yes [ ] No [ ]
(iii) From other govt. departments Yes [ ] No [ ]
If yes, specify the department Whether Yes [ ] No [ ]
permission is obtained
Does your study require you to send human Yes [ ] No [ ]
biological material outside India?
If yes, have you obtained permission of the Yes [ ] No [ ]
director, TMH & DGFT?
Has TMH and the foreign party signed Yes [ ] No [ ]
agreement/MOU for that?
If yes, attach a copy of agreement/MOU
If study will be conducted fully or partially
outside the TMH, please describe the need
for permission from institution(s), health
centre(s), local government/administrative
bodies, etc.
Describe how you define adverse events in
your study, how and to whom you propose
to report them, and what rules you will use
for stopping the study due to adverse events.
In what way will you ensure the
confidentiality and privacy of the subjects?
If some procedures in this trial are
emotionally upsetting describe what
arrangements have been made for
psychological counseling?

SOP 03/V2
Describe (i) How, where, when and by

whom the Informed Consent will be
obtained. (ii) how much time the subject/
participant will be given to consider
participation and decide, (iii) describe
additional plans/needs for informed
consent in case the study involves special
population such as minors, pregnant
mothers, neonates, etc. (iv) Describe how
you will assess that information is correctly
understood by the participant.
Who will be maintaining the trial records
and where?
For how long will the data be stored? Give
details of where they will be stored, who
will access
Describe briefly, if any, the financial and
other interests of any of the investigators
and /or close relative/s, with the sponsor/s
and outcome of the study.
Have you made provision for insuring
yourself, and TMC against any legal action
that may arise out of this project?
Have you made provision for insuring trial
subjects for any accidental unforeseen trial
related injury?
How is it intended the results of the study - Peer reviewed scientific journals
will be reported and disseminated? - Other publication
- Conference presentation
- Internal report
- Submission to regulatory authorities
- Access to raw data and right to publish freely by
all the investigators in study or by independent
steering committee on behalf of all investigators
- Other ………………..
Name of PI: Signature: Date:

SOP 03/V2
1 Title of the Project:

2 Principal Investigator
3 Designation and address of the PI
4 Co-investigators
5 Source of funding
Government Central [ ], State [ ], Local [ ]
Intramural
Private Foundation Indian [ ], Foreign [ ]
Industry Private [ ], Public [ ], Other [ ]
Other
No funding required
Address, phone, fax. E-mail of sponsor
with the name of the contact person
6 Total Budget for the entire project
7 Duration of the Project
8 Proposed date of starting the project
9 Direct payments to investigators, if any
10 Any other benefits to the investigators
11 Conflict of Interests, if any
12 Type of project funding
Intramural from TMC
Non profit agency / trust funded
Pharma / industry sponsored
Others – specify

SOP 03/V2
Detailed Budget for the Proposed Study
1. Source of funding
Items 1st Year 2nd Year 3rd Year Total
2. Salaries-personnel (Numbers)
Research Nurse
Doctor ( Research Fellow)
Data operator
Any other specify
3. Equipment and Hardware
-
-
-
-
4. Drugs and Consumables
-
-
-
-
5. Clinical Investigations
-
-
-
-
6. Hospitalization
-
-
-
7. Travel expenditure for investigators
-
-

SOP 03/V2
8. Travel expenditure for trial subject

and one attendant
9. Honorarium to doctors/technicians
10. Insurance
i. for investigators
ii. any unforeseen, accidental trial
related injury
11. Any other expenditures
12. Miscellaneous (<5% of budget)
13. Total
14. TMC Service Charge (10% of total)
(TMC, DAE, ICMR, DBT, DST, IAEA,
WHO, IARC etc. funded project
are exempted)
15. Estimated Investigator fees
(15% at the end of the study
on actuals)
Grand Total
Note:
PI should devise incremental budget whenever necessary.
Please provide the complete break-up of item nos. 3, 4 & 5 on separate sheet.
Instructions:
This form must be printed and not handwritten.
Fill the form completely (If there are any questions/queries, please contact the IRB office
022-24177262).
Make sure to include the e-mail address and contact numbers of the PI, Co-investigators.
Please submit the documents as per the checklist (AX2-V1/SOP03/V2) to ensure all
requirements for submission are fulfilled so that the IRB review is not delayed.
Submit this application (submission form) and appendices along with the supporting
documentation to the IRB office.

SOP 03/V2
AX2-V1/SOP03/V2
Checklist of Documents
Item No. Mandatory Documents Yes No NA
1 IRB processing fee (applicable for sponsored trials)
2 Project Submission Form (both hard and soft copies)
duly signed by the Principal Investigator
Conflict of Interest Statement
3 Study Protocol
4 Participant Information Sheet & Informed consent forms
(ICFs) in English, Marathi & Hindi
(and if required any other language)
5 Back translations of ICFs
(not mandatory for Hindi and Marathi)
8 Case Record Form
9 Investigator Brochure
10 Insurance policy
11 DCGI approval letter / DCGI submission letter
12 NOC from DCGI / DGFT/ICMR
13 Appendix VII (Schedule Y)
Undertaking by the Investigator
14 Clinical Trial Agreement (CTA) / Memorandum of
Understanding (MOU) / Material Transfer Agreement
(MTA) if applicable
15 Brief resume of PI and Co-investigators (1 Page each)

SOP 03/V2
AX3-V1/SOP 03/V2
Institutional Review Board

Document Receipt Form
TMH Study Number :

Submitted date:
Type of Initial Review

Submission: Continuing Review of Approved Protocols
Protocol Title:
Principal Investigator:
Mode of submission: Post E-submission in Person
Type of document:
Checklist to assess the projects before they are submitted to SRC & HEC review
Item No. Mandatory Documents Yes No NA

1 IRB processing fee (applicable for sponsored trials)
2 Project Submission Form (both hard and soft copies)
duly signed by the Principal Investigator

SOP 03/V2

3 Study Protocol
4 Participant Information Sheet & Informed consent forms
(ICFs) in English, Marathi & Hindi (and if required any
other languages)
5 Back translations of ICFs (not mandatory for Hindi and
Marathi)
8 Case Record Form
9 Investigators Brochure
10 Insurance policy
11 DCGI approval letter / DCGI submission letter
12 DGFT approval letter / DGFT submission letter
13 Appendix VII (Schedule Y) Undertaking by the
Investigator
14 Clinical Trial Agreement (CTA) / Memorandum of
Understanding (MOU) / Material Transfer Agreement (MTA)
if applicable
15 Brief resume of Principal Investigators and Co-investigators
(1 Page each)
Documents submitted:
Complete
Incomplete; will submit on…………...

Comments:
Receiver Name, Sign & Date Secretary, SRC

(IRB Secretariat) Sign & Date
Project submitted by Name & Sign

(Project or study team member)

SOP 03/V2
AX4-V1/SOP03/V2
Guidelines for devising ICF and Sample format of an Informed Consent Document.
Guideline for preparation of the informed consent form

While submitting your project report to the Human Ethics Committee, ensure that you have
included an informed consent form that is prepared as per the guidelines for ICH – GCP,
ICMR ethical guidelines 2006, and the Declaration of Helsinki. The consent form must necessarily
include the following points listed below. Any further information you wish to add, is your
choice.
The following are instructions for devising Informed Consent Form:
- Informed consent forms in English, Marathi, and Hindi
- Font: Arial
- Size: 12
- All the consent forms must have Version No, Date, Page no in the footer
- Separate forms should be prepared when minors (children) are study participants; assent
form for the mature minors (teenagers) and consent form for the parents
The consent form must necessarily include the following points listed below and any further
information you wish to add.
Template for devising an “Informed Consent Form”

(Include or exclude information, as applicable)
Informed Consent Form

[The title of the project here exactly as it is in the project design with names of Principal Investigator
and all other investigators.]
Introduction:
You are invited to participate in a study/research/experiment. This document gives you a
description of the study/trial in which you are being asked to participate. Your participation
in this study is voluntary, and you can enquire about all details before giving your written
consent to participate in the study.
Purpose:
The purpose of this study is to …………………………………………………………………

SOP 03/V2
Information:
List all procedures, which will be employed in the study. Point out any that are considered
experimental/or otherwise, and explain technical and medical terminology in simple,
non-technical & direct language.
Graphics could be used if helpful in making the text meaningful to the research subject.
If this is a randomized trial, details of both arms of the trial must be explained in writing to the
subject being enrolled.
State the amount of time required of the subject per session, for the total duration of study
and the expected duration of the study.
If applicable to your study, list:
i. The number of participants who will be participating in the research.
ii. Information concerning taping or filming.
iii. If tissues or biological samples are being retained for research, describe what will be
done to the tissues in simple lay person’s terms.
Alternative treatments:
Disclose appropriate alternative treatments available, if any.
Risks:
List the foreseeable risks, if any, of each of the procedures to be used in the study, and any
measures which will be used to minimize the risks, or treat them should they occur. Explanation
of anticipated side effects, and even rare side effects, or known idiosyncratic reactions.
Costs:
Describe the cost for participating in the study to the subject/participant. The information
must be written in clear terms regarding the cost which will be borne by sponsors/Principal
Investigator/s of the project, and study participant.
Reimbursement for Participation:

Describe plan to reimburse or compensate participant for the inconvenience, time spent and
for expenses incurred. If yes, the amount of payment proposed. Discuss travel details for trial
subjects &/or attendant who need to come for follow-up, and spell out methodology for the
reimbursement for travel.
Emergency Medical Treatment:

(If applicable, add here)
If physical injury is suffered in the course of research, or for more information, please notify
the investigator in charge (list PI name and phone number).
Describe available medical treatment in case of complications.

SOP 03/V2
Benefits:
List the benefits you anticipate will be achieved from this research, either to the participants,
others, or the body of knowledge.
Also mention that the many of the most effective treatments used today are the result of
clinical trials done in the past.
Confidentiality:
The information in the study records will be kept confidential and the clinical charts will be
housed in the TMH/CRS. Data will be stored securely and will be made available only to
persons conducting the study and to the regulatory authorities. The data will not be made
available to another individual unless you specifically give permission in writing. No reference
will be made in oral or written reports which could link you to the study. Result of the project
will not be communicated to the subject unless deemed necessary.
Compensation for protocol Related Injury:

Describe the details of compensation or insurance for protocol related injury to the trial
subject. Explain who will bear the cost in case of trial related injury?
Contact:
If you have questions at any time about the study or the procedures, (or you experience
adverse effects as a result of participating in this study,) you may contact the researcher,
[Name], at [Office Address], and [Office Phone Number]. If you have questions about your
rights as a participant, contact the member secretary, HEC [Name], at [Office Address], and
[Office Phone Number].
Participation:
Your participation in this study is voluntary; you may decline to participate at anytime without
penalty and without loss of benefits to which you are otherwise entitled.
If you withdraw from the study prior to its completion, you will receive the usual standard of
care for your disease, and your non participation will not have any adverse effects on your
subsequent medical treatment or relationship with the treating physician
If you withdraw from the study before data collection is completed, your data will not be
entered in the project report. Your legal rights will not be affected by signing this documents.

SOP 03/V2
Consent
I have read the above information and agree to participate in this study. I have received a copy
of this form.
Participant’s name (print):
Participant’s signature:
Address (capital letters):
Phone Nos.:
Legal Representative name:
Legal Representative signature & date:
Witness’s name (Print):
Witness’s signature & date:
Name of PI or the person administering

the consent (Print):
PI or person’s Signature & date:
Note to Investigators Regarding the Process of Administoring Informed and

Understood Consent
(The templates for Participant Information Sheet have been provided herewith):
The prospective participant should be given Participant Information Sheet first.
The participant should then be encouraged to read the Information Sheet and think over,
preferably for a period of 24 hours. Following which, the participant should be served a
questionnaire to ensure that he/she is aware of his/her own rights as a participant in the
clinical trial. The informed consent form should be served to the participant only after ensuring
that the participant is now prepared for informed decision making.
The PIs are urged by the HEC to download and use the wording in the glossary available on
the TMC website and follow the sample format of Informed Consent Form, unless the PI
support reasons for alternative wording.
Use of alternative wording or different format may slow down the review process. The form
should be written in second person (“You are invited...”). Use of first person (“I”) can be
interpreted as suggestive and coercive.
The study participant should be explained all the details in a language she/he understands.

SOP 03/V2
The Informed Consent Form must have the name and Telephone No. of the Principal Investigator
or of any other co-investigator, as the subject must know who to contact in case of an emergency,
or even to seek answers to their queries.
The consent form must be dated.
If the prospective participant so desires, a Xerox copy of the Informed Consent Form must be
given to him/her.
Copies of the consent form must be available in English, Marathi and Hindi.
Please tailor your ICF to suit the needs of our Indian population, and if this is a multinational
Pharma based project, an additional ICF specifically designed for us may be used.
Separate forms should be prepared when minors are used; one for the mature minors (teenagers)
and one for the parents.
If your form is more than one page, there should be a line at the bottom of each page for the
subject’s initials, except for the last page where the signature is obtained.
Be sure to include any elements of informed consent that are appropriate to your study. If
they apply to your study, they must be included.
If informed consent form requires more than one page, print the informed consent form front
to back.
Please make provision for the assent of the child to the extent of the child’s capabilities such
as in the case of mature minors and adolescents.
Please make provision on the form for signatures/thumb impression of the participant/parent
or legal guardian, if minor and of the investigator, or person administrating the consent form,
and of a witness.

SOP 03/V2
AX5-V1/SOP 03/V2
Child Information Sheet and Assent Form
Study title: “……………………………………………………………………”
Introduction
You have come to meet the doctor as you are suffering from ……... You may be having
symptoms……………………….
Describe briefly the purpose of this study
If this is a randomized trial, details of both arms of the trial must be explained in writing to the
subject being enrolled.
Disclose appropriate alternative treatments available, if any.
We invite you to participate in this study.
What will you have to do?
To participate in this research study, you will be examined by your doctor and if found to
fulfill pre-specified criteria, you will be eligible to be enrolled in this research study.
Since you are in the age group of 8-12 years we ask you to sign this assent form if you agree
to participate. The assent form describes the research study and states that you have been
explained the purpose and the nature of the study to your satisfaction by the attending doctor
and you are ready to abide by the trial procedures. Your accompanying parent / guardian
will also sign a similar form called as the Parent Informed Consent Form.
List all procedures, which will be employed in the study. Point out any that are considered
experimental/or otherwise, and explain technical and medical terminology in simple, non-
technical & direct language.
In addition, to record the same parameters daily your parent / guardian will also be provided
with a diary where they will enter the same findings accordingly. You will have to tell them
about your symptom and they will mark accordingly in the diary
Side effects
All medicines/procedures produce some side effects – the medicine you will take/the procedure
you will undergo can produce (Describe the side effects). Your Physician will take due
precautions so that you do not experience these side-effects. If you experience any of these
listed effects or any other unlisted effects do contact your study doctor immediately. The
study doctor will treat you accordingly.
Your parents will not have to bear the cost of the medical treatment / hospitalization as a
result of these side effects.

SOP 03/V2
In addition, during the trial period if you suffer from any other diseases, if you consider some
of the side effects as serious or you undergo hospitalization during the study period, please
immediately contact the study doctor:
Dr. Phone:
The occurrence of any of the side effects (known / unknown) and concomitant diseases will
be noted by the physician at every visit. The assessment of acceptability of the formulation/
procedure will be performed by the treating physician at the end of the study.
Risks and discomforts
There is no foreseen significant risk / hazard to your health, if you wish to participate in the
study. You will not bear the expenses regarding the therapy. If you follow the directions of
the doctors in charge of this study and you are injured due to any substance or procedure
given under the study plan, the Sponsor will pay for the medical expenses for the treatment
of that injury.
Benefits
If you participate in the study you will receive ………………If you appear to have any acute
illness ……………you will be offered free treatment for those visits in accordance with local
standard medical care. You will not be offered free treatment for chronic diseases or conditions
not related to study procedures.
Your participation in the study may help others, because this participation will help us
determine if the study drug/procedure is safe.
Confidentiality
Your existing medical records may be accessed; personal health information about you may
be collected and processed by study investigators for the purpose of performing the study.
Information about you will be collected and stored in files with an assigned number, and not
directly with your name. All documents related to the study will only be accessed by the
study investigator, sponsor, the Ethics Committee and the Regulatory authority.
Your parent / guardian will have the right to access personal information about you at any
time with the study doctor and the right to correct this personal information. Your parent /
guardian can take away your authorization to collect process and disclose data about you at
any time.
Right to refuse or withdraw
You do not have to take part in this research if you do not wish to do so. Refusing to
participate will not affect your treatment. You will still have all the benefits that you would
otherwise have got at this clinic/hospital. You may stop participating in the research at any
time you wish without losing any of your rights. Your treatment will not be affected in any
way.

SOP 03/V2
The study doctor may decide to withdraw you from the study if he/she considers it is in your
best interest
You will be informed of important new findings developed during the course of the study so
you will be able to consider your participation in the study in light of new information
Whom to contact
If you have any questions, please ask them now. You may also ask questions later. If you
wish to ask questions later, contact
Dr. Phone:
If you have any queries regarding your rights as a study participant, you may contact, the
Chairperson of the Institutional Ethics committee
Dr. Phone:
Your responsibilities
It is the responsibility of your parent / guardian to come along with you to the hospital during
the study period for all the visits unless you withdraw or are prematurely discontinued from
the study. It is also your responsibility and your parent / guardian to report any expected or
unexpected reactions (side effects) that you notice during the study period.
It is also the responsibility of your parent / guardian to inform the doctor if you consume any
other medication apart from the study treatment.
We expect your co-operation throughout the study.

SOP 03/V2
Child Assent Form
I________________________________________________, exercising my free power of choice,

hereby give my consent for participation in the study entitled:
“………………………………………………………………………………”
I have been informed, to my satisfaction, by the attending physician, about the purpose of
the study and the nature of the procedure to be done. I am aware that my parents/guardians
do not have to bear the expenses of the treatment if I suffer from any trial related injury,
which has causal relationship with the said trial drug
I am also aware of right to opt out of the trial, at any time during the course of the trial,
without having to give reasons for doing so
Name and Signature of the study participant Date:
Name and Signature of the attending Physician Date:

SOP 03/V2

SOP 04a/V2
Title: Initial Review of Submitted Protocol
SOP Code: SOP 04a/V2 Date :01/09/2009 Pages: 16
Initial Review of Submitted Protocol Page 77

SOP 04a/V2
4a.1 Purpose
The HEC should review every research proposal on human participants and must approve the
proposal before the research is initiated. HEC should ensure that scientific evaluation has been
completed and approved by SRC before ethical review is taken up. The committee should
evaluate the possible risks to the participants with proper justification, the expected benefits to
participants/community and adequacy of documentation for ensuring privacy & confidentiality.
The purpose of this Standard Operating Procedure (SOP) is to describe how the HEC members
will review an initially submitted protocol for approval using the Assessment Form for initial
review. The Assessment Form AX1-V1/SOP04a/V2 is designed to standardize the review process
and to facilitate reporting, recommendations, and comments offered to each individual protocol.
4a.2 Scope
This SOP applies to the review and assessment of all protocols submitted for initial review and
approval from the HEC. The specific points in the guidelines attached to the Assessment Form
for initial review must be adequately addressed in the protocol itself and/or protocol-related
documents under review. Relevant comments made during discussion and deliberation about a
specific protocol should be recorded in the minutes of the meeting. The decision reached by
the HEC will be communicated to the PI.
4a.3 Categorization of protocols
The Member Secretary, HEC or secretariat shall screen the proposals for their completeness and
depending on the risk involved in the research proposals categorise them into three types, viz.
Exemption from review, Expedited review, and Initial review. An investigator cannot categorize
his/her protocol in to the above three types. This SOP describes the process of initial review.
4a.4 Initial Review
All research presenting with more than minimal risk, research protocols which do not qualify
for exemption or expedited review and projects that involve vulnerable population and special
groups should be subjected to full review by all the members.
While reviewing the research protocols, the following situations should be carefully assessed
against the existing facilities at the research site for risk/benefit analysis:
a. Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture
from (Refer APP6/V1) :-
i. Healthy adults and non-pregnant women who weigh normal for their age and
not more than 500 ml blood is drawn in an 8 week period and frequency of
collection is not more than 2 times per week
ii. From other adults and children, where the age, weight, and health of the
participants, the collection procedure, the amount of blood to be collected,
and the frequency with which it will be collected has been considered and not
SOP 04a/V2
more than 50 ml or 3 ml per kg whichever is lesser, is drawn in an 8 week
period and not more than 2 times per week
iii. From neonates depending on the haemodynamics, body weight of the baby
and other purposes not more than 10% of blood is drawn within 48 – 72
hours. If more than this amount is to be drawn it becomes a risky condition
requiring infusion/blood transfusion
iv. Prospective collection of biological specimens for research purposes by
noninvasive means.
For instance:
skin appendages like hair and nail clippings in a non-disfiguring manner
dental procedures - deciduous teeth at time of exfoliation or if routine
patient care indicates a need for extraction of permanent teeth; supra
and subgingival dental plaque and calculus, provided the collection
procedure is not more invasive than routine prophylactic scaling of the
teeth
excreta and external secretions (including sweat)
uncannulated saliva collected either in an unstimulated fashion or
stimulated by chewing gum or by applying a dilute citric solution to the
tongue
mucosal and skin cells collected by buccal scraping or swab, skin swab,
or mouth washings
sputum collected after saline mist nebulization and bronchial lavages
b. Collection of data through noninvasive procedures routinely employed in clinical

practice. Where medical devices are employed, they must be cleared/ approved for
marketing, for instance –
Physical sensors that are applied either to the surface of the body or at a
distance and do not involve input of significant amounts of energy into
the participant or an invasion of the participant’s privacy
Weighing or Testing Sensory Acuity
Magnetic Resonance Imaging
Electrocardiography, Echocardiography Electroencephalography,
Thermography, detection of naturally occurring radioactivity,
Electroretinography, Ultrasound, Diagnostic Infrared Imaging, Doppler
Blood Flow and such alike
Moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age, weight,
and health of the individual
c. Research involving clinical materials (data, documents, records, or specimens) that

will be collected solely for non-research (clinical) purposes
d. Collection of data from voice, video, digital, or image recordings made for research
purposes
e. Research on individual or group characteristics or behaviour not limited to research
on perception, cognition, motivation, identity, language, communication, cultural

SOP 04a/V2
beliefs or practices, and social behaviour or research employing survey, interview,
oral history, focus group, program evaluation, human factors evaluation, or quality
assurance methodologies
f. Research involving collection and storage of genetic materials (Refer APP10/V1)
g. Research involving gene therapy and gene transfer protocols (Refer APP11/V1)
4a.5 Elements of Review
The primary task of the HEC is to review of research proposals and their supporting documents
with special attention given to the informed consent process, documentation, and the suitability
and feasibility of the protocol. HEC will take into account prior scientific review by the SRC, and
the requirements of applicable laws and regulations.
The following will be considered, as applicable:
4a.5.1 Scientific Design and Conduct of the Study
The appropriateness of the study design in relation to the objectives of the study
The statistical methodology (including sample size calculation), and the potential for
reaching sound conclusions with the smallest number of research participants
The justification of predictable risks and inconveniences weighed against the anticipated
benefits for the research participants and the concerned communities
The justification for the use of control arms; criteria for prematurely withdrawing
research participants
Criteria for suspending or terminating the research as a whole
The adequacy of provisions made for monitoring and auditing the conduct of the
research, including the constitution of a DSMB, the adequacy of the site, including
the supporting staff, available facilities, and emergency procedures
The manner in which the results of the research will be reported and published
4a.5.2 Care and Protection of Research Participants
Suitability of the investigators’ qualifications and experience for the proposed study
Any plans to withdraw or withhold standard therapies for the purpose of the research,
and the justification for such action
Medical care to be provided to research participants during and after the course of
the research
Adequacy of medical supervision and psycho-social support for the research
participants
Steps to be taken if research participants voluntarily withdraw during the course of
the research
Criteria for extended access to, the emergency use of, and/or the compassionate use
of study products
Arrangements, if appropriate, for informing the research participant’s general
practitioner or family doctor, including procedures for seeking the participant’s consent
to do so
SOP 04a/V2
Description of any plans to make the study product available to the research participants
following the research; a description of any financial costs to research participants
(Refer APP3/V1)
Rewards and compensations for research participants (including money, services,
and/or gifts)
Provisions for compensation/treatment in the case of the injury/disability/death of a
research participant attributable to participation in the research (Refer APP4/V3, See
Also ICMR website for Draft Guidelines on compensation)
Insurance and indemnity arrangements
4a.5.3 Protection of Research Participant Confidentiality
A description of the persons who will have access to personal data of the research
participants, including medical records and biological samples
The measures taken to ensure the confidentiality and security of personal information
concerning research participants
4a.5.4 Informed Consent Process
A full description of the process for obtaining informed consent, including the
identification of those responsible for obtaining consent (Refer APP7/V1 & APP8/
V1)
Adequacy, completeness, and comprehension of written and oral information to be
given to the research participants, and, when appropriate, their Legally Acceptable
Representative(s) (LAR) (Refer APP5/V1)
Clear justification for the intention to include research participants who cannot consent,
and a full account of arrangements made to obtain their consent /authorisation
Assurances that research participants will receive information that becomes available
during the course of the research relevant to their participation including their rights,
safety, and well-being
Provisions made for receiving and responding to queries and complaints from research
participants or their representatives during the course of a research project
4a.5.5 Community Considerations
Impact and relevance of the research on the local community and on the concerned
communities from which the research participants are drawn
Steps taken to consult with the concerned communities during the course of designing
the research
Influence of the community on the consent of individuals
Proposed community consultation during the course of the research
Extent to which the research contributes to capacity building, such as the enhancement
of local healthcare, research, and the ability to respond to public health needs
A description of the availability and affordability of any successful study product to
the concerned communities following the research

SOP 04a/V2
The manner in which the results of the research will be made available to the research
participants and the concerned communities
4a.5.6 Recruitment of Research Participants
The characteristics of the population from which the research participants will be
drawn (including gender, age, literacy, culture, economic status, and ethnicity) (Refer
APP2/V1)
The means by which initial contact and recruitment is to be conducted
The means by which full information is to be conveyed to potential research participants
or their representatives
Inclusion criteria for research participants
Exclusion criteria for research participants
Students or staff recruitment in research (Ref. APP1/V1)
4a.6 Responsibility
The IRB Secretariat is responsible for receiving, verifying, and managing the hard copies of the
received packages. In addition, the Secretariat should create a protocol specific file, distribute
the packages to the HEC members for review by HEC and communicate the review results to
the investigators
HEC members are responsible for receiving, verifying, and reviewing the research protocols.
4a.7 Detailed instructions
Distribution of the project documents

The distribution of the project documents for HEC review will be as follows:
Chairperson, Member Secretary, and the lead discussant/s will get complete project
proposal while all other members should be given only the duly filled TMC Project
Submission form and informed consent forms.
Assigning Lead discussants

Member Secretary, HEC assigns 1 or 2 lead discussants to each research protocol. A
lead discussant is the member of HEC responsible for a detailed review of the
assigned protocol
o The lead discussant is informed preferably 10 days prior to the meeting through
the agenda. In case, the lead discussant is not in a position to review due to
some reason; he/she should inform the Member Secretary, HEC at the earliest,
so that the research protocols can be assigned to other member.
o In the event of his/her absence, a lead discussant can send written comments
on the research protocols to the Member Secretary, which will be tabled and
discussed during meeting. However, a final decision on the research protocol
will be arrived at, by a broad consensus at the end of discussion among
attending members and not solely based on written comments.

SOP 04a/V2
o It is the responsibility of the assigned lead discussant/s to review the research
protocols assigned to them thoroughly, offer their observations, comments,
and decisions to the HEC during the meeting and return all research protocols
to the secretariat on the day of the meeting
Responsibilities of HEC members

Check the contents of the package
Sign and date an acknowledgement form / receipt upon receiving the package
Return the acknowledgement form/ receipt back to the delivery person /IRB Secretariat
Check the meeting date to see if he/she is available to attend the meeting.
Identify the project assigned for review
Notify the IRB Secretariat 3 days prior to the convened HEC meeting regarding the
missing documents, if any
The members must return the packages to the IRB Secretariat on the day of the
scheduled meeting. In case, HEC member is not in a position to attend the scheduled
meeting, the responsibility of returning of packages would that be of the respective
HEC member.
4a.8 Review the Protocol:
Review all elements as per section 4.3. The protocol will be reviewed by each member as per
guidelines to review a study protocol described in AX1-V1/SOP04/V2
4a.9 Use of study assessment forms
It is the responsibility of the HEC members to use assessment form as a checklist while reviewing
each research protocol. The duly filled, signed and dated assessment forms should be returned
along with the research protocols to the Secretariat at the end of the meeting. The assessment
form is designed to standardize the review process. The study assessment form helps to ensure
that all elements of research protocol are reviewed and are accordingly documented during the
discussion / meeting Study Assessment Form Template (AX1-V1/SOP04aV2)
Note: The completed assessment form is the official record of the decision reached by
the HEC for the specific protocol
4a.9.1 Gather the assessment reports
The HEC Secretariat will collect the Assessment Forms AX1-V1/SOP04a/V2, the comments from
each reviewer and file in the original set of the study file.
4a.10 HEC meeting
The details of review procedures and communication of decision is described in detail in

SOP05/V2

SOP 04a/V2
References
Biomedical Research, 2000) Retrieved from- www.who.int/tdr/publications/publications/
accessed 14th September 2008
GCP) 1996 Retrieved from- http://www.ich.org/LOB/media/MEDIA482.pdf accessed 14th
September 2008
3. Cavazos N., Forster D., and Bowen A.J., Ethical Concerns in Placebo-controlled studies: An
Analytical Approach, Drug Information Journal 36(2) 2002: pgs 249- 259, via WIRB
documents
4. Draft Guidelines for Compensation to Participants for Research Related Injury in India.
http://icmr.nic.in/guidelines.htm
Glossary
Document: Document may be of any forms, e.g., paper, electronic mail (e-mail), faxes, audio or
video tape, etc.
Expedited review/meeting: A review process by only member secretaries of both the HECs or
HEC subcommittee, who then report the decision to the full board in a formal meeting. An
expedited review is an accelerated review for minor changes to the approved protocol, for
research proposal with minimal risk and documents of minor nature.
Full Board/ Regular Review: Review of initial, resubmitted, continuing review, amendments
of protocols and or ICFs and any other documents which are tabled in a formally convened
meeting of the full HEC committee for detailed discussion and decisions.
Initial Review: The first time review of the protocol done by one or two individual reviewers/
lead discussants (HEC members) during the formally convened full board HEC meeting.
Pre-clinical study: Animal and in vitro studies provide information on possible toxicities and
mechanisms of action, and starting doses for human studies.
Phase I studies: Initial introduction of an investigational new drug (IND) into humans, studies
designed to determine the metabolism and pharmacological actions of drugs in humans, and
studies designed to assess the side effects associated with increasing doses.
Phase II study: A study of drug metabolism, structure-activity relationships, and mechanism of

action in humans, as well as studies in which investigational drugs are used as research tools to
explore biological phenomena or disease processes.
Phase III study: A study expands controlled and uncontrolled trials performed after preliminary
evidence suggesting effectiveness of the drug has been obtained. They are intended to gather

SOP 04a/V2
the additional information about effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
Phase IV study: A study that seeks to expand an approved medication’s use into a new population,
new indication, or new dose.
Study Assessment Form: An official record that documents the protocol review process.
Vulnerable subjects: A vulnerable category of subjects includes children, prisoners, pregnant

women, handicapped or mentally disabled persons, refugees, displaced persons and economically
or educationally disadvantaged persons, who are likely to be vulnerable to coercion or undue
influence.

SOP 04a/V2
AX1-V1/SOP04a/V2
Study Assessment Form to be used at the HEC meeting.

Page 1 of 5
Study Assessment Form
Protocol Number : Date (DD/MM/YY):
Protocol Title :
Principal Investigators: MMC Registration No.
Institute: Contact No.
Co – investigator(s): Contact No.
Delineation of
responsibilities of
investigators:
Total No. of Participants: No. of Study site/s:
Funding Agency: Contact No.
Duration of the Study: Status: New Revised Amended
Reviewer’s name : Contact No.
Type of the Study : Intervention Epidemiology
Document based Individual based Genetic
Social Survey Others, specify……
Review Status: Regular Expedited Emergency
Description of the Study in brief: Mark whatever applied to the study.
Randomized Stratified Randomized Open-labeled
Double blinded Placebo controlled Treatment controlled
Cross-over Parallel Interim Analysis
Multicenter study Screening Descriptive
Use of Tissue samples Use of Blood samples Use of genetic materials
Brief the study design and the statistic used:
Study Objectives:
Please see my attached comments in a separate sheet
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

SOP 04a/V2
Mark and comment on whatever items applicable to the study
1 Objectives of the Study What should be improved?

clear unclear
2 Need for Human Participants Comment:

Yes No
3 Methodology: What should be improved?

clear unclear
4 Background Information and Data Comment:

sufficient insufficient
5 Risks and Benefits Assessment Comment:

acceptable unacceptable
6 Inclusion Criteria Comment:

appropriate inappropriate
7 Exclusion Criteria Comment:

8 Discontinuation and Withdrawal Criteria Comment:

9 Involvement of Vulnerable Participants Comment:

Yes No
10 Voluntary, Non-Coercive Recruitment Comment:

of Participants
Yes No
11 Sufficient number of participants? Comment:

Yes No
12 Control Arms (placebo, if any) Comment:

Yes No

SOP 04a/V2
13 Are qualification and experience of the

Participating Investigators appropriate? Comment:
Yes No
14 Disclosure or Declaration of Potential Comment:

Conflicts of Interest
Yes No
15 Facilities and infrastructure of Comment:

Participating Sites
Appropriate Inappropriate
16 Community Consultation Comment:

Yes No
17 Involvement of Local Researchers and Comment:

Institution in the Protocol Design,
Analysis and Publication of Results
Yes No
18 Contribution to Development of Comment:

Local Capacity for Research
and Treatment
Yes No
19 Benefit to Local Communities Comment:

Yes No
20 Availability of similar Study / Results Comment:

Yes No
21 Are blood/tissue samples sent abroad? Comment:

Yes No
22 Are procedures for obtaining Informed Comment:

Consent appropriate?
Yes No

SOP 04a/V2
23 Contents of the Informed Comment:

Consent Document
clear unclear
24 Language of the InformedComment:

Consent Document
clear unclear
25 Contact Persons for Participants Comment:

Yes No
26 Privacy & Confidentiality Comment:

Yes No
27 Inducement for Participation Comment:

Unlikely Likely
28 Provision for Medical / Comment:

Psychosocial Support
29 Provision for Treatment of Comment:

Study-Related Injuries
30 Provision for Compensation Comment:

31 Provision for post-trial access Comment:


SOP 04a/V2
Assessment Report
Review Date (DD/MM/YYYY): Protocol number:
Protocol Title :
Elements Reviewed Attached Not attached
Review of Revised Application Date of Previous review:

Yes No
DECISION : Approved Approved with Recommendation

Resubmission Disapproved
Comment:
Signature : Date:

SOP 04a/V2

SOP 04b/V2
Title: Expedited Review of Submitted Protocol
SOP Code: SOP 04b/V2 Date :01/09/2009 Pages: 6
Expedited Review of Submitted Protocol Page 93

SOP 04b/V2
4b.1 Purpose
The purpose of this SOP is to provide criteria for categorisation of research protocols which can
be reviewed through expedited process as well as instructions on management, review, and
decision of the expedited review.
4b.2 Categorization of protocols
depending on the risk involved in the research proposals categorise them into three types, viz.,
Exemption from review, Expedited review, and Initial review. An investigator cannot categorize
his/her protocol in to the above three types. This SOP describes expedited review in detail.
4b.3 Expedited Review
The proposals involving no more than minimal risk to research participants may be subjected to
expedited review
An expedited review may be conducted, only if the protocols involve -
1. Revised proposal previously approved through full review by the HEC or continuing
review of approved proposals where there is no additional risk or activity is limited
to data analysis or health record research (Refer APP9/V1)
2. Anonymous surveys and retrospective chart reviews
3. Analysis of discarded pathological specimens / stored paraffin blocks without personal
identifiers
4. Proposals involving previously banked materials and/or tissues as per policies of
respective authorities like – tumour tissue repository, following scientific approval
by SRC
5. Research activities that involve only procedures listed in one or more of the following
categories:
a. Clinical studies of drugs and medical devices only when -
i. Research is on already approved drugs except when,
a. Study of drug interaction
b. Conducting trial on vulnerable population
OR
ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of
minor nature is reported
b. Research involving clinical materials (data, documents, records, or specimens)
that have been collected for non-research (clinical) purposes
6. Other documents which would be considered for expedited review are as follows but
may not restrict to:
i. Minor deviations from originally approved research during the period of approval
(usually of one year duration
ii. Change in the name, address of sponsor

SOP 04b/V2
iii. Change in contact details of PI and HEC
iv. Change in PI or hand over of trials or projects
v. Inclusion or deletion of name/s of co-investigator/s
vi. Request for change in PI , Co-I, change in any member involved in the research
vii. Minor amendments in the protocol, CRF
viii. Minor corrections in budget
ix. Other administrative changes in the IB, ICF, etc.
4b.4 Scope
This SOP applies to the review and approval of research protocols and documents with not
more than minimal risk to participants
4b.5 Responsibility
It is the responsibility of the Member Secretary to identify (as per section 4b.3) which research
protocols or documents should be reviewed through expedited process.
4b.6 Detailed instructions to the IRB secretariat:
4b.6.1 Receive the submitted documents

Receive the application documents submitted by investigators as per the check list
Acknowledge the submitted documents
Hand over the received documents to the Member Secretary, HEC
4b.6.2 Expedited Process

The subcommittee comprising of Member Secretaries of both the HECs will review the
documents which qualify for expedited review (refer section no. 4b.3-point 6).
After determining that the Protocol/ Project or documents qualify for an expedited review,
Member Secretary informs the Chairperson and Chairperson nominates one or two HEC
members to review the protocol. In this case, the subcommittee comprising of Members
Secretaries of both the HECs, an external HEC member from any one of the committee
and a HEC member from the institution will be formed. The external member will chair
the meeting.
Review may be made either by circulation of comments, telephone discussion, or meeting
The expedited review should not take longer than 2 weeks, from the date of receipt of
the research protocol approved by SRC.
The minutes of the expedited review subcommittee meeting should be ratified in the
next regular full board meeting.
If consensus cannot be reached, the Chairperson will revert the proposal or the documents
back to the HEC for a full board review.

SOP 04b/V2
4b.6.3 Communication between the HEC and the investigator
The decision of subcommittee, HEC, will be communicated to the PI immediately after
minutes of subcommittee are finalized.
If project is disapproved or requires resubmission after certain modifications, this will be
informed to the PI in writing. The reasons for disapproval of a project will be specified
in the letter sent to PI.
References
1. ICMR Ethical Guidelines for Biomedical research on Human Participants, ICMR (2006) -
http://www.icmr.nic.in/ethical_guidelines.pdf (accessed 9th June 2009)
GCP) 1996- http://www.ich.org/LOB/media/MEDIA482.pdf
(last accessed 14th September 2008)
3. WHO Operational Guidelines for Ethical Review Committee that Review Biomedical
Research (Geneva 2000) - www.who.int/tdr/publications/publications/ (accessed 14th
September 2008)
Glossary
Document: Document may be of any forms, e.g., paper, electronic mail (e-mail), faxes, audio
or video tape, etc.
Expedited review/meeting: A review process by only member secretaries of both the HECs
and HEC subcommittee, who then report the decision to the full board in a formal meeting. An
expedited review is an accelerated review for minor changes to the approved protocol, for
research proposal with minimal risk and documents of minor nature.

SOP 04b/V2

SOP 04c/V2
Title: Exemption from the Ethical Review for Research Projects
SOP Code: SOP 04c/V2 Date : 01/09/2009 Pages: 10
Exemption from the Ethical Review for Research Projects Page 99

SOP 04c/V2
4c.1 Purpose
The purpose of this Standard Operating Procedure (SOP) is to describe which research projects
can be exempted from ethics review and do not require the approval of the HEC. The Exemption
Form AX1-V1/SOP04c/V2 is designed to standardize the process of exemption.
4c.2 Categorization of protocols
depending on the risk involved in the research proposals categorise them into three types, viz.,
Exemption from review, Expedited review, and Full review. An investigator cannot categorize
his/her protocol in to the above three types. This SOP describes exemption from ethics review
in detail.
4c.3 Exemption from review
Proposals which involve less than minimal risk fall under this category.
Minimal risk would be defined as one which may be anticipated as harm or discomfort not
greater than that encountered in routine daily life activities of general population or during the
performance of routine physical or psychological examinations or tests. However, in some
cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the
treatment itself, but this may be within the range of minimal risk for the research participant
undergoing these interventions since it would be undertaken as part of current every day life
(ICMR 2006).
The exemption from review may be seen in following situations:

i. Research on educational practices such as instructional strategies or effectiveness of or
the comparison among instructional techniques, curricula, or classroom management
methods
Exceptions:
1. When research on use of educational tests, survey or interview procedures, or
observation of public behaviour can identify the human participant directly or through
identifiers, and the disclosure of information outside research could subject the
participant to the risk of civil or criminal or financial liability or psychosocial harm
2. When interviews involve direct approach or access to private papers
ii. The research proposals which do not involve live human participants or data derived from
them are exempt from ethics review. For example,
Audits of educational practices
Research on microbes cultured in the laboratory
Research on immortalized cell lines
Research on cadavers or death certificates provided such research reveals no identifying
personal data
Analysis of data freely available in public domain
SOP 04c/V2
In some circumstances research which appears to meet low risk criteria may need to be reviewed
by the HEC. This might be because of requirements of:
The publisher of the research
An organization which is providing funding resources, existing data, access to participants
etc.
4c.4 Scope
This SOP applies to the all protocols submitted for exemption from review by the HEC. The
specific points in the Exemption Form should guide the Member Secretary to determine whether
the protocol qualifies for exemption from review. The decision should be taken by the Member
Secretary in consultation with the Chairperson and should be informed to the members in the
forthcoming HEC meeting.
4c.5 Responsibility
It is the responsibility of the Member Secretary to record the decision in the Exemption Form
with reasons. The HEC Secretariat is responsible for recording and filing the decision including
the reasons for that decision. The Chairperson must sign and date letter conveying the decision
AX1-V1/SOP04c/V2.
4c.6 Detailed instructions to the IRB Secretariat:
4c.6.1 Receive the submitted documents

The Secretariat will receive the Exemption from review Application Form AX1- V1/
SOP04c/V2, Protocol and other documents submitted by the investigators.
Acknowledge the submitted documents
Hand over the received documents to the Member Secretary, HEC
4c.6.2 Determine protocols eligible for exemption from review

The Member Secretary, HEC will determine whether a protocol qualifies for exemption from
review based on criteria explained in (section 4c.3).
4c.6.3 Exemption Process

If the protocol and related documents satisfy the criteria as listed in 4c.3, the Member
Secretary in consultation with the Chairperson will review the brief summary of the
project and the Exemption Form.
The Member Secretary records the decision on the Exemption Form.
The Secretariat communicates the decision to the investigator.
The Member Secretary informs the HEC members about the decision at the next full
board meeting.
In case the protocol does not fit in any of the above stated criteria, the Member
Secretary / Chairperson may keep the application for review and discussion at the
full board meeting.
SOP 04c/V2
4c.6.4 Communication between the HEC and the investigator
The decision regarding request for Exemption from review, signed by the HEC
Chairperson, will be forwarded by the Secretariat to the PI within 14 days after the
decision regarding the exemption is taken.
The Member Secretary will inform the HEC members of the decision at the forthcoming
regular meeting and minute it in the meeting notes.
References
1. ICMR’s Ethical Guidelines for Biomedical research on Human Participants, ICMR

(2006) - http://www.icmr.nic.in/ethicalguidelines.pdf (accessed 20 April 2009)
2. WHO Operational Guidelines for Ethical Review Committee that Review Biomedical
Research (Geneva 2000) - www.who.int/tdr/publications/publications/ (accessed 14th
September 2008)
Glossary
Exemption from review: A research study is said to be exempt from review when it does not
require the Ethics Committee approval for its conduct
SOP 04c/V2
AX1-V1/SOP04c/V2
Review Exemption Application Form
TMC Project No. : _____________________ (To be filled by HEC Secretariat)
1 Principal Investigator’s Name: _____________________________________________________
2 Department: _________________________________________________________________________
Title of Project: _______________________________________________________________________
____________________________________________________________________________________
4 Names of other participating staff and students:
5 Brief description of the project:
Please give a brief summary (approx. 300 words) of the nature of the proposal, including the
aims/objectives/hypotheses of the project, rationale, participants’ description, and procedures/
methods to be used in the project:-
6 State reasons why exemption from ethics review is requested?
Audits of educational practices

Research on microbes cultured in the laboratory
Research on immortalized cell lines
Research on cadavers or death certificates provided such research reveals no identifying
personal data
Analysis of data freely available in public domain
Any other
(This should include justification for exemption e.g. study does not involve human
participants. If exemption is being requested on the basis of low risk involved in the study
please refer to Note on Page Nos. 97-98 of this annexure. )
7 IND APPLICATION EXEMPTION CHECKLIST
This checklist is intended to be used by the investigator as a preliminary test of whether an IND
application needs to be submitted to the DCGI for studies involving DCGI/RA-approved drugs.
If any question is answered “yes”, an IND application must be submitted to the DCGI. If the
answers to all questions are “no”, then the study may meet the criteria for an exemption from
an IND.
SOP 04c/V2
1. Name of drug
Dosage
Route
2. Does the study involve a different route of administration of the marketed drug than already
approved?
YES NO
3. Does the study involve the administration of different drug dosage levels that significantly
increase risk or decrease the acceptability of risk to study subjects?
YES NO
4. Does the study involve the administration of the drug to a different patient population for
whom there may be increased risk or decreased acceptability of risk?
YES NO
5. Does the study entail any other factor that significantly increases the risk or decreases the
acceptability of risk to study subjects?
YES NO
6. Are the results of the study intended to be reported to the DCGI/RA in support of any
significant change in labeling or advertising for the drug (only for corporate sponsored studies)?
YES NO
Signature of Investigator: Date:
Principal Investigator’s signature: ________________ Date ________________
Forwarded by the Head of the department:

Name:________________________________
Signature:________________________________
Date ________________________________
Recommendations by the HEC Member Secretary:
Exemption
Can not be exempted, Reasons ______________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
___________________________________________________
Discussion at full board
Signature of the Member Secretary: ________________ Date ________________
SOP 04c/V2
Final Decision:
Exemption
Cannot be exempted,
Reasons ____________________________________________________________________
____________________________________________________________________________
Discussion at full board
Signature of the Chairperson: ____________________ Date _______________

Final Decision at Full Board meeting held on _____________________________
Signature of the Chairperson: ______________________ Date ______________________
NOTE:
No research can be counted as low risk if it involves:
(i) Invasive physical procedures or potential for physical harm

(ii) Procedures which might cause mental/emotional stress or distress, moral or cultural
offence
(iii) Personal or sensitive issues
(iv) Vulnerable groups
(v) Cross cultural research
(vi) Investigation of illegal behaviour(s)
(vii) Invasion of privacy
(viii) Collection of information that might be disadvantageous to the participant
(ix) Use of information already collected that is not in the public arena which might be
disadvantageous to the participant
(x) Use of information already collected which was collected under agreement of
confidentiality
(xi) Participants who are unable to give informed consent
(xii) Conflict of interest e.g. the researcher is also the lecturer, teacher, treatment-provider,
colleague or employer of the research participants, or there is any other power
relationship between the researcher and the research participants.
(xiii) Deception
(xiv) Audio or visual recording without consent
(xv) Withholding benefits from “control” groups
(xvi) Inducements
(xvii) Risks to the researcher
SOP 04c/V2
This list is not definitive but is intended to sensitize the researcher to the types of issues
to be considered. Low risk research would involve the same risk as might be encountered
in normal daily life.
Please check that your application / summary has discussed:
Procedures for voluntary, informed consent

Privacy & confidentiality
Risk to participants
Needs of dependent persons
Conflict of interest
Permission for access to participants from other institutions or bodies
Inducements
In some circumstances research which appears to meet low risk criteria may need to
be reviewed by the HEC. This might be because of requirements of:
The publisher of the research
An organisation which is providing funding resources, existing data, access to participants
etc.
SOP 04c/V2
SOP 05 /V2
Effective Date: 01.09.2009 HEC TMC
Title: Agenda Preparation, Meeting Procedures and Recording of Minutes
Agenda Preparation, Meeting Procedures and Recording of Minutes Page 109

SOP 05 /V2
5.1 Purpose
The purpose of this procedure is to elaborate administrative process and provide instructions for
preparation, review, approval, and distribution of meeting agenda, minutes, and notification
letters of HEC, TMC meetings.
The day, time, and venue of HEC meetings for both committees are specified as follows:
HEC- I meets at 8.30 am on the last Friday of every month unless otherwise specified
HEC- II meets at 8.00 am on the third Friday of every month unless otherwise specified
Maximum interval between 2 regular meetings will be not more than 3 months.
Venue: Meeting room, 3rd Floor, IRB office, Main Hospital Building, TMH, Parel, Mumbai 400012.
5.2 Scope
This SOP applies to administrative processes concerning the conduct of the meeting.
5.3 Responsibility
It is the responsibility of the Secretary, HEC of each committee and IRB staff to prepare for the
respective HEC meeting.
5.4.1 Before full board HEC meeting
Prepare the agenda of the HEC meeting (AX1-V1/SOP05/V2)

Schedule protocols on the agenda on a first come first serve basis. TMC has constituted
two HECs, so the protocols are assigned randomly to the committees. However, in case
PI is a member of one of the HECs, the protocol is referred to the other HEC to avoid
conflict of interest.
5.4.2 Distribution of Protocol/Documents Packages to the HEC Members
Distribute copies of the protocols to the HEC members by either electronic mail (in case
of electronic submission of protocols) or by courier preferably 10 days in advance of the
scheduled meeting
Verify (verbally, by e-mail, by fax or by mail) with the members whether the protocol
packages are received
It is the responsibility of the HEC member to verify items of the parcel on receipt and in
the event of any missing items, intimate the IRB office immediately so that the relevant
documents could be made available to the members before the meeting.

SOP 05 /V2
5.4.3 Preparation for the meeting
Reserve the IRB meeting room on the scheduled meeting date and time. The meeting will
be held in the meeting room of IRB, unless otherwise specified.
Ensure that the room, equipment (projectors, recorder, etc) and facilities are available in
good housekeeping conditions on the day of the meeting.
On the previous day of the meeting keep all original files of protocols on the agenda in
the meeting room for ready reference during the meeting.
5.4.4 Conduct of Meeting
The members should gather in IRB meeting room on scheduled time.

o The Chairperson should determine that the quorum (SOP 02/V2 section no. 2.9)
requirements are met.
o The Chairperson should ask for declaration of conflict of interest either verbally or
written on any protocol for discussion.
o If a HEC member has conflict of interest involving a project then he / she should
declare the same, before the meeting commences and leave the meeting room
before the discussion on the same. This should be recorded in the minutes
The Member Secretary should table the minutes of the previous meeting and present the
agenda for discussion
The HEC may invite investigators to attend the full board meeting related to their studies,
and clarify doubts, if any
The meeting proceeds in the sequential order of the agenda; however the Chairperson
may change the order, if the situation so demands
The Member Secretary will request the lead discussant to discuss the research protocol.
The lead discussant will submit the duly filled study assessment form at the end of the
discussion or at the conclusion of HEC meeting.
Amendment will be reviewed by previously assigned lead scientific discussant.
In case the lead discussant cannot attend the meeting, secretary, HEC or any other HEC
member may brief the HEC about the research protocol and also discuss the written
comments/duly filled study assessment form, if provided by the lead discussant.
The Member Secretary, HEC / IRB administrative officer minutes/records the proceedings
of the HEC meeting.
5.4.5 Decision Making Process
HECs provide complete and adequate review of the research proposals submitted to them. The
committees will review new project proposals, amendments, annual progress of ongoing projects,
SAE reports, and assess final reports of all research activities through a scheduled agenda.
A HEC member will withdraw from the meeting for the decision procedure concerning
an application where a conflict of interest exists.
If HEC member has her/his own proposal for HEC review he/she will not participate in
the HEC discussion on that particular project.

SOP 05 /V2
Decision may only be taken when sufficient time has been allowed for review and
discussion of an application in the absence of non-members (e.g., the investigator,
representatives of the sponsor, independent consultants) from the meeting, with the
exception of IRB staff.
Decisions will only be made at meetings where a quorum (SOP 02/V2 section no. 2.9) is
present.
The documents required for a full review of the application should be complete and the
relevant elements considered before a decision is made.
Only HEC members who attend the meeting will participate in the decision.
Decisions will be arrived at through consensus. When a consensus is not possible, the
HEC will vote.
If the full board approves a research proposal in principle subject to minor modifications,
the revised project proposal submitted by the PI will be reviewed and approved by the
Member Secretary, HEC or in some cases by the primary reviewer on behalf of the full
board. Such revised proposals will not be taken up for the full board review. However,
in case of major changes, the revised documents will be discussed in full board meeting.
An HEC may decide to reverse its positive decision on a study if it receives information
that may adversely affect the risk/ benefit ratio.
Any advice that is non-binding will be appended to the decision.
In cases of conditional decisions, clear suggestions for revision and the procedure for
having the application re-reviewed will be specified.
A negative decision on an application will be supported by clearly stated reasons. If the
investigator wishes to appeal to the decision, he/she may do so by contacting the IRB
Secretariat.
The discontinuation of a trial will be recommended if the HEC finds that the goals of the
trial have already been achieved midway or unequivocal results are obtained.
If necessary, the investigator may be invited to present the protocol or offer clarifications
in the meeting. Representative of the patient groups or community can be invited during
deliberations to offer their viewpoint.
Subject expert/s may be invited to offer their views, but expert/s should not participate
in the decision making process. However, his / her opinion must be recorded.
The proceedings of the HEC meetings will be documented and signed by the Member Secretary.
5.4.6 After the HEC meeting
5.4.6.a Preparing the minutes and the decision letters
The Member Secretary will compile the proceedings of HEC meeting in a concise and
easy-to-read style and will check spelling, grammar and context of the written minutes.
The minutes of the meeting will be compiled within a week.
5.4.6.b Approval of the minutes and the decision
The minutes of the HEC meeting will be signed by Member Secretary, HEC.

SOP 05 /V2
The minutes of the HEC meeting will be ratified in the subsequent HEC meeting.
The HEC decisions will be communicated to the PIs.
5.4.6.c Filing of the minutes of the meeting
Place the original version of the minutes in the minutes file and copy of the minutes are
filed in the corresponding research protocol file.
5.4.7 Communicating Decision
The decision will be communicated in writing to the PI, preferably within a period of 10 days
of the HEC meeting at which the decision was made.
The communication of the decision will include, but is not limited to, the following,
TMC Project No. and title of the research proposal reviewed

The clear identification of the protocol of the proposed research or amendment, date
and version number (if applicable).
The names and specific identification number version numbers/dates of the documents
reviewed, including the potential research participant information sheet/material and
informed consent form
The name and title of the Principal Investigator
The name of the site(s)
The date and place of the decision
A clear statement of the decision reached
Validity of approval usually will be yearly for multiyear projects, however may change
on case to case basis.
Any suggestions by the HEC
A conditional decision (i.e. approval with recommendations or modifications, suggestions
for revision and the procedure, any other requirements by the HEC), will be valid only
for six months from the date of issue of letter. If the PI does not comply with the HEC
suggestions during these three months, a reminder will be issued. The modifications will
be re-reviewed by Member Secretary, HEC or primary reviewer/s and /or may be referred
for full board review (AX3-V1/SOP05/V2).
In the case of a positive decision, the PI is notified of the following requirements through
an approval letter (AX2-V1/SOP05/V2)
o a statement of the responsibilities of the PI; for example, confirmation of the
acceptance of any requirements recommended by the HEC
o submission of progress report(s) decided on case to case basis, usually yearly.
o the need to notify the HEC in cases of protocol amendments (other than amendments
involving only logistical or administrative aspects of the study)
o the need to notify the HEC in the case of amendments to the recruitment material
like the potential research participant information, or the informed consent form
o the need to report serious and unexpected adverse events related to the conduct of
the study

SOP 05 /V2
o the need to report unforeseen circumstances, the termination of the study, or significant
decisions by other HEC
o the information the HEC expects to receive in order to perform ongoing review
o the final summary or final report
o the schedule/plan of ongoing review by the DSMB of sponsored trials
In the case of a negative decision, the reasons should be clearly stated in the communication
to the PI
The PI will also be notified of the duration of the approval, which will not exceed one
year
All decision and approval letters will be signed by the Member Secretary, HEC
Every page of consent forms (English, Hindi, Marathi) of investigator initiated trials and
first page of ICFs of sponsored trials (English, Hindi, Marathi) will be signed and dated
by Member Secretary, HEC. These approved ICFs will be sent to the PI along with the
approval letter.
The Chairperson / Member Secretary, HEC, will sign and date the approval letter and
approval certificate in the original research protocol.
References

GCP) 1996 Retrieved from- http://www.ich.org/LOB/media/MEDIA482.pdf accessed 24
March 2008
Biomedical Research, (Geneva 2000)- Retrieved from- www.who.int/tdr/publications/
publications/ accessed 24 March 2008
Glossary
Agenda: A list of things to be done; a program of business for the meeting
Minutes: An official record of proceedings at a meeting
Quorum: Number of HEC members required to act on any proposal presented to the committee
for action.

SOP 05 /V2
AX1 –V1/SOP05/V2
Agenda format
I) Minutes
II) Projects for Initial Review
III) Amendments
IV) Letters
V) Minutes of DSMSC & SAEs

SOP 05 /V2
AX2 –V1/SOP05/V2
FORMAT FOR APPROVAL LETTER OF ETHICS COMMITTEE
To,
Dr.____________________
Principal Investigator,
Tata Memorial Hospital.
Ref: Project No.
Dear Dr.
Human Ethics Committee reviewed and discussed your application (dated) to conduct the
research study entitled “___________” during the HEC meeting held on (date).
The following documents were reviewed and approved:

1. Project Submission form.
2. Study protocol (including protocol amendments), dated_________, version no(s).
3. TMC-Scientific Review Committee approval letter dated ________
4. Patient information sheet and informed consent form (including updates if any) in English
and/Vernacular language.
5. Investigator’s brochure, dated________, version no.______
6. Proposed methods for patient accrual including advertisement(s) etc. proposed to be used
for the purpose.
7. Current CVs of Principal investigator, Co-investigators
8. Package inserts
9. Insurance policy/compensation for participation and for serious adverse events occurring
during the study participation.
10. Investigator’s Agreement with the sponsor
11. Investigator’s undertaking
12. DCGI/DGFT approval
13. Clinical Trial Agreement (CTA)/Memorandum of Understanding (MOU)/Material Transfer
Agreement (MTA), if applicable

SOP 05 /V2
The following members of the Human Ethics committee (HEC) were present at the meeting held
on Date __________ Place ___________
Name of member/Position on HEC/Affiliation/Gender
_______________ Chairman of the Ethics committee
_______________ Member secretary of the ethics committee
_______________ Name of each member with designation
The trial is approved in its presented form. The approval is valid until one year from the
date of sanction. You may make a written request for renewal / extension of the validity,
along with the submission of annual status report.
Following points must be noted:

1. HEC should be informed of the yearly progress of the study.
2. HEC has approved recruitment of ____ patients on this study.
3. PI and other investigators should co-operate fully with DSMSC, who will monitor the trial
from time to time.
4. The decision was arrived at through consensus. Neither PI nor any of proposed study team
members was present during the decision making of the HEC.
5. At the time of PI’s retirement/intention to leave the institute, study responsibility should be
transferred to colleague after obtaining clearance from HOD, Status report, including accounts
details should be submitted to HOD, DSMSC and extramural sponsors.
6. The HEC functions in accordance with the ICH-GCP/ICMR/Schedule Y guidelines.
7. In case of any new information or any SAE, which could affect any study, must be informed
to HEC, DSMSC and sponsors. The PI should report SAEs occurred for HEC approved
studies within 7 days of the occurrence of the SAE. If the SAE is ‘Death’, the IRB Secretariat
will receive the SAE reporting form within 24 hours of the occurrence.
8. In the events of any protocol amendments, HEC must be informed and the amendments
should be highlighted in clear terms as follows:
a. The exact alteration/amendment should be specified and indicated where the amendment
occurred in the original project. (Page no. Clause no. etc.)
b. Alteration in the budgetary status should be clearly indicated and the revised budget
form should be submitted
c. If the amendments require a change in the consent form, the copy of revised Consent
Form should be submitted to Ethics Committee for approval.
d. If the amendment demands a re-look at the toxicity or side effects to patients, the same
should be documented.

SOP 05 /V2
e. If there are any amendments in the trial design, these must be incorporated in the protocol,
and other study documents. These revised documents should be submitted for approval of
the SRC and HEC, only then can they be implemented.
f. Approval for amendment changes must be obtained prior to implementation of changes.
Without including all the above points, the amendment is unlikely to be approved by the
Ethics committee.
g. Any deviation/violation/waiver in the protocol must be informed to the HEC.
Thanking You,
Yours Sincerely,
Member Secretary,

SOP 05 /V2
AX3 –V1/SOP05/V2
FORMAT FOR CONDITIONAL APPROVAL FOR PROJECT/AMENDMENTS
Conditional approval.
Dr…
Principal Investigator,
TMH/TMC.
Ref: Project No.
Dear Dr…
The above referenced project was tabled, reviewed and discussed during the Human Ethics
Committee meeting held on date/time/place
List of documents reviewed.
The following members attended the meeting.
The committee suggested the following:

a.
b.
c.
The approval will be granted subject to the compliance with all the above suggestions of the
HEC.
Kindly resubmit the two copies of revised proposal or documents within three months for
re-review.
This conditional approval is valid only for six months from the date of issue of letter.
Thanking you,
Yours sincerely,
Secretary, HEC

SOP 05 /V2

SOP 06/V2
Title: Review of Amended protocol/ Protocol related documents
Review of Amended protocol/ Protocol related documents Page 123

SOP 06/V2
6.1 Purpose
The purpose of this procedure is to describe how protocol amendments or any other amendments/
letters are reviewed by the HEC.
6.2 Scope
This SOP applies to amended study protocols/ documents and letters that are submitted for
HEC approval. Amendments made to protocols or any other amendments related to the study
may not be implemented until reviewed and approved by the HEC.
6.3 Responsibility
It is the responsibility of the HEC secretariat to manage protocol amendments, documents and
letters.
Receipt of the Amendment Package

The amendment package forwarded by the PI is received by the secretariat. The
amendment package along with the covering letter should be accompanied by Amendment
Reporting Form (AX2-V1/SOP06/V2).
The secretariat of the HEC should follow the procedures as in SOP03/V2 (Procedures for
Management of protocol submission).
Upon receipt of the amendment package the IRB, Secretariat should follow the following
procedure
The Member Secretary, HEC, classifies the amendments into minor or major and tables the
major amendments on the agenda of the subsequent scheduled meeting (for Minor amendments
refer to 6.4.3). The amendments and other documents which need full board review are processed
as per the SOP 04a/V2
6.4. Review amended protocols/documents/letters: Review as per Section 4.3

SOP 04a/V2
6.4.1 Decision
If the HEC approves the amendments, the secretariat staff communicates this decision to
the PI (AX1-V1/SOP06/V2).
If the HEC does not approve the amendments, the secretary should immediately notify
the investigator in writing of the decision and the reason for not approving the amendment.
If the HEC recommends or suggests modifications to any of the documents, or the
amendments, the secretariat sends a written communication to the investigator about the
specific changes asking him or her to make the necessary changes and resubmit the
documents to HEC.

SOP 06/V2
6.4.2 Storage of Documents:
File the amendments in the corresponding research protocol file, as per the SOP 10/01 on
documentation and archival.
6.4.3 Minor amendments and notifications
Minor amendments (those that do not increase the risk or decrease the potential benefit to
subjects) may be approved by the Member Secretaries, HEC in the expedited review subcommittee
meeting (Refer SOP no. 04b/V2.)
Minor notifications may be noted by the Member Secretary, HEC and not tabled in HEC
meeting
This may include but may not restrict to:
Renewed insurance policy
DCGI and DGFT approvals
Administrative notes
References
Biomedical Research (Geneva 2000) Retrieved from-www.who.int/tdr/publications/
publications/ accessed 14th September 2008
GCP) 1996 Retrieved from-http://www.ich.org/LOB/media/MEDIA482.pdf accessed 14th
September 2008
3. Code of Federal Regulation (CFR), 21 §56.110, The United States of America, 1998
Glossary
Amendment protocol package: A package of the amended parts and related documents of
the protocol, previously approved by the HEC/IRB, TMC. In the course of the study, the PI may
decide to make changes in the protocol

SOP 06/V2
AX1-V1/SOP06/V2
Format for Project Amendment/Document Amendment Approval letter
To
XXXXX(PI)
Department
Ref: - Project title
Dear Dr. ——
We have received the following document/s on (date)
1.
At the HEC meeting held on ——date/time/place, the above mentioned documents were reviewed.
After deliberation, the committee has decided to approve the aforementioned study-related
documents.
The members who attended this meeting held on —— date and place of meeting—— at which
the above mentioned document was discussed, are listed below.
1.
2.
3.
It is to be noted that neither you nor any of your proposed study team members were present
during the decision-making procedures of the HEC.
Yours truly,
Signature with Date

Member
Secretary,
HEC

SOP 06/V2
AX2-V1/SOP06/V2
IRB Secretariat
Amendment Reporting Form
Project No. :
Title :
Principal Investigator :
Have you highlighted the amended portion in the document or tabulated details of changes?
Does this amendment entail any Yes / No

changes in ICFs
If yes, whether amended ICFs are

submitted pl. specify Version
No. & Date.
Please mention version no. and

date of amended Protocol /
Investigators brochure / Addendum.
No. of active trial participants
Signature of the Principal Investigator & Date:

SOP 06/V2

SOP 07/V2
Title: Continuing review of study Protocols
Continuing review of study Protocols Page 131

SOP 07/V2
7.1 Purpose
The purpose of continuing review is to monitor the progress of the entire study which was
previously approved; not just the changes in it but to ensure continued protection of the rights
and welfare of research subjects.
Continuing review of the study may not be conducted through an expedited review procedure,
unless 1) the study was eligible for, and initially reviewed by, an expedited review procedure;
or 2) the study has changed such that the activities remaining are eligible for expedited review.
7.2 Scope
This SOP applies to conducting continuing review of study protocols involving human subjects at
intervals appropriate to the degree of risk but not less than once a year. Depending upon the
degree of risk to the participants, the nature of the studies and the vulnerability of the study
participants and duration of the study, the HEC may choose to review the studies more frequently.
7.3 Responsibility
It is the responsibility of the secretary, HEC to determine the date of continuing review and to
remind the HEC and the PIs.
All the approved protocols will be reviewed annually. The Chairperson is responsible for
determining the date of continuing review if the project will be reviewed more frequently in the
year. This decision is taken during the HEC meeting wherein the project is finally approved.
The HEC is responsible for reviewing the progress made in the protocol, the occurrence of
unexpected events or problems, and the rate of accrual of participants. The protocol, informed
consent documents and assent documents are examined to ensure that the information remains
accurate.
The HEC has the same options for decision making on a continuing review package as for an
initial review package. The decision is made as, approval to continue the study; approval with
recommendations; or disapproval. All Principal Investigators along with the submission of the
annual project progress report will also apply for extension of approval of the project.
7.4 Detailed Instructions
7.4.1 Determine the date of continuing review
The Secretariat will look through the master file of projects approved by the HEC for the
due date of continuing reviews.
The Secretariat will plan for continuing review of annual progress reports to be reviewed
at least one month ahead and as close as possible to the due date (i.e. one year after the
date of original approval) of the protocol.

SOP 07/V2
The Member Secretary will consult the Chairperson whether to include the annual project
report/s in the forthcoming HEC meeting for discussion or to review by Member Secretary/
Chairperson and inform the members at the full board meeting or to send to two HEC
members nominated by Chairperson for review.
7.4.2 Notify the PI or the study team
The Secretariat will inform the PI at least two months of the due date for the continuing
review in writing, (AX2-V1/SOP 07/V2) requesting for 2 copies of the annual / periodic
progress report to allow the Study Team sufficient time to collate the information and to
prepare a report package required for the continuing review.
The Secretariat will provide a Continuing Review Application Form (AX1-V1/SOP 07/V2)
(available at the IRB Secretariat) to the Study Team and file the acknowledgement in the
master file of the research protocol.
Any PI who fails to submit the report for review within the stipulated time, will have to
clarify the delay in writing, this will be forwarded to the Chairperson, HEC.
7.4.3 Manage continuing review package upon receipt
The Secretariat will receive a package submitted by the Study Team of continuing review
for each approved protocol.
Upon receipt of the package, the Secretariat of the HEC will perform the following (as
per instructions in SOP03/V2 for procedures on receipt of submitted packages).
7.4.4 Verify the contents of the package
The Secretariat will verify that the contents of the package include the following documents:
1. Continuing Review Application Form (AX1-V1/SOP 07/V2)
2. The Progress Report with:
Information about the number of participants enrolled to date and since the time of the last
review, an explanation for any “yes” (ticked on the Continuing Review Application Form
AX1-V1/SOP 07/V2) answers on the application form and a discussion of scientific
development, either through the conduct of this study or similar research that may alter
risks to research participants.
The progress report summary of the protocol since the time of the last review (1 copy).
1. Request letter for extension of approval of the project, if the project is ongoing.
The Secretariat will check for complete information and for the presence of the required
signatures of the Principal Investigator in the Continuing Review Application Form.
7.4.5 Filing the continuing review package
The Administrative Officer will file the continuing review package in master file of the research
protocol.

SOP 07/V2
7.4.6 Notify the Members of the HEC
The Secretariat will distribute the protocol progress report to HEC members prior to the
meeting.
7.4.7 Prepare meeting agenda

The Secretariat will follow for procedures on the preparation of meeting agenda and place
the forwarded Annual Progress Report on the agenda for the meeting of the HEC, if
deemed necessary by the Chairperson/ Member Secretary, on the date which is as close as
possible to the due date (i.e. one year after the date of original approval) of the protocol.
7.4.8 Protocol Review Process

The HEC Chairperson/ Member Secretary/ members will use the Continuing Review
Application Form (AX1-V1/SOP07/V2) to guide the review and deliberation process. The
HEC members could arrive at any one of the following decisions at the HEC meeting:
1. Noted and the project can be continued without any modifications

2. Modifications recommended - Protocols for which modifications have been suggested
by the HEC may not proceed until the conditions set by the HEC in the decision have
been met. Protocols should be amended and submitted to the HEC within one month
for re-review. Protocols that have been approved with recommendations by the HEC
may not proceed until the conditions set by the HEC in the decision have been met.
Protocols should be amended and submitted to the HEC within one month for re-
review
3. Disapproved.
This decision is recorded by the Member Secretary on AX3-V1/SOP07/V2
The HEC Chairperson will sign and date the HEC decision on Continuing Review Report
after a decision has been reached.
The completed HEC decision on Continuing Review Report is the official record of the
decision reached by the HEC for the protocol.
The HEC Secretariat will maintain and keep the HEC decision forms and minutes of the
meeting relevant to the continuing review as part of the official record of the review
process.
7.4.9 Store original documents

Place the original completed documents with the other documents in the Continuing Review
Package in the protocol file.
7.4.10 Communicate the HEC Decision to the PI

The Secretariat will notify the PI of the decision (AX4-V1/SOP 07/V2). If the decision is to
recommend modifications, the recommendations will be notified to the PI and he/she will be
requested to resubmit the protocol/protocol related documents as amendment within 1 month for
approval. Till then the project is suspended. These letters must be sent to the PI within 14 days.

SOP 07/V2
References
Biomedical Research, (Geneva 2000) www.who.int/tdr/publications/publications /(accessed
24th September 2008)
2. International Conference on Harmonization, Guidance on Good Clinical Practice (ICH GCP)

1996- http://www.ich.org/LOB/media/MEDIA482.pdf (accessed 24th September 2008)

SOP 07/V2
AX1-V1/SOP 07/V2
Continuing Review Application Form
TMH STUDY No.:
PROTOCOL TITLE:
PI :
Institute:
Date of HEC approval :
Start Date of study:
Duration of study:
HAVE THERE BEEN ANY AMENDMENTS WERE THE ICD AMENDMENTS

SINCE THE LAST REVIEW? APPROVED BY HEC
NO NO
YES YES
(Describe briefly in attached narrative)
WERE THESE PROTOCOL If no mention the amendments not

AMENDMENTS APPROVED BY HEC approved
NO __________________________________________
YES __________________________________________
If no mention the amendments not Which ICF amendment is the site
approved following at this date
Which protocol amendment is the site __________________________________________

following at this date
SUMMARY OF PROTOCOL Has any information appeared in the

PARTICIPANTS: literature, or Evolved from this or
Accrual ceiling set by HEC similar research that might affect the
New participants accrued since last review hec evaluation of the Risk/Benefit
Total participants accrued since analysis of human subjects involved in
protocol began this protocol?
_____ Number of active patients

SOP 07/V2
_____ Number of patients who have NO

completed the study
IMPAIRED PARTICIPANTS YES (Discuss in the attached narrative)
None Have any unexpected complications, AEs

Or
Physically
SAE been noted since last review at our
Cognitively site?
Both NO
HAVE THERE BEEN ANY CHANGES YES (Discuss in the attached narrative-
IN THE PARTICIPANT POPULATION, no. of patients at our site who had SAEs,
RECRUITMENT OR SELECTION whether reports of SAEs at our site have
CRITERIA SINCE THE LAST REVIEW? been submitted to the HEC, whether
reports of SAEs at other sites have been
NO submitted to the HEC, types of adverse
events. This should be tabulated with
YES complete details)
(Explain changes in attached narrative)
IS REPORT OF THE DATA SAFETY AND
HAVE ANY PARTICIPANTS WITHDRAWN MONITORING BOARD AVAILABLE?
FROM THIS STUDY DURING THE LAST
ONE YEAR?
NO
NO
YES (submit as an attachment)
YES (Discuss in the attached narrative,
state reasons for drop-outs)
When was study last monitored?
HAVE ANY PARTICIPATING ___________________________________________________
INVESTIGATORS BEEN ADDED OR
DELETED SINCE LAST REVIEW? Did the monitoring team have any
adverse comments regarding the study?
NO
(If, Yes, please attach a copy of their
YES (Identify all changes in the comments)
attached narrative)
Attach a copy of current statement from
HAVE ANY NEW COLLABORATING SITES accounts showing utilization of funds.
(INSTITUTIONS) BEEN ADDED OR
DELETED SINCE THE LAST REVIEW?
IS REPORT OF INTERIM DATA
ANALYSIS AVAILABLE?

SOP 07/V2
NO Status of project
Ongoing
YES (submit as an attachment) Not started/Not initiated -
If not started, state reasons-
________________________________________
Completed Accrual
completed Follow-up
Suspended
Terminated
Closed
HAVE ANY INVESTIGATORS DEVELOPED AN EQUITY OR CONSULTATIVE RELATIONSHIP

WITH A SOURCE RELATED TO THIS PROTOCOL WHICH MIGHT BE CONSIDERED AS
CONFLICT OF INTEREST?
CONFLICT Of INTEREST
NO
YES (Append a statement of disclosure)
SIGNATURES:
Date: ……………….
Principal Investigator

SOP 07/V2
AX2-V1/SOP 07/V2
Reminder letter by the HEC to PI
Name of Principal Investigator:-

Address of Principal Investigator:-
Ref: - Project Title: XXXXXX
The above referenced project was approved by the HEC on XXXXXXX and is due for continuing
annual review by the HEC. You are requested to submit an annual status report in the prescribed
format AX1-V1/SOP 07/V2 on or before XXXXX.
Signature with date

Secretary

SOP 07/V2
AX3-V1/SOP 07/V2
HEC Decision on Continuing Review Report
Project Title :
PI :
Review a) Annual Progress Report
b) Other
Date of HEC meeting :
Further the review and approval of resubmitted protocol is subjected to:
Reviewed by Chairperson / Member Secretary only. HEC members were informed at Full
Board/ Expedited meeting.
Reviewed in Full Board
Reviewed by any 2 HEC members in Full Board /Expedited meeting
1. Name of HEC member: _________________________
Sign: ____________________________________________
2. Name of HEC member: _________________________
Sign: ____________________________________________
Decision
Noted and the project can be continued without any modifications

Modifications recommended, requiring protocol resubmission
Protocol discontinued
State the recommendations:

Member - Secretary
Signature with date
Chairperson
signature with date

SOP 07/V2
AX4-V1/SOP 07/V2
Project Report Approval Letter
PI Name :
PI address :
Ref : Project Title
This is with reference to your letter dated ______________ regarding the annual status report of
the above mentioned project. The Annual Study Status Report was discussed and noted in the
HEC meeting held on ______________. The HEC has noted the progress report. The following
recommendations are suggested (wherever applicable)
Signature with date

Member Secretary
HEC

SOP 07/V2

SOP 08/V2
Title: Reporting of Protocol Deviation/Non-Compliance/Violation/Waiver
Reporting of Protocol Deviation/Non-Compliance/Violation/Waiver Page 145

SOP 08/V2
8.1 Purpose
To provide instructions for taking action and maintaining records, when investigators/ trial
sites, fail to -
follow the procedures written in the approved protocol

comply with national / international guidelines for the conduct of human research,
including those
who fail to respond to the HEC requests
8.2 Scope
This SOP applies to all HEC approved research protocols involving human subjects.
8.3 Responsibility
1. HEC secretariat is responsible for receiving deviations /violations/waiver reports as per

(AX1–V1/SOP08/V2) submitted by the PI and placing it on agenda of the meeting. Reporting
of deviation/ non-compliance/violation/waiver in any other reporting format will not be
accepted.
2. HEC members should review and take action on such reports.
8.4 Detailed instruction
8.4.1 Detection of Protocol deviation/ non-compliance/ violation/waiver
8.4.1.a The HEC members performing monitoring of the project at trial site can detect
protocol deviation/non-compliance / violation, if the project is –
not conducted as per protocol / national / international regulations
when scrutinizing annual / periodic reports / SAE reports
any other communication received from the Investigator / trial site / sponsor /
study monitor / CRO
8.4.1.b The Secretariat can detect protocol deviation / non-compliance / violation from
failure to
comply with statutory requirements
respond to requests from HEC within reasonable time limit
respond to communication made by HEC
8.4.1.c The PI himself / herself may forward protocol deviation / non- compliance /
violation / waiver reports to inform the HEC.
Protocol Waiver is analogous to a Protocol Deviation, except that prior IRB
approval must be obtained before implementing the necessary departures
from the protocol. Therefore, Protocol Waivers are anticipatory, while Protocol
Deviations are not.
SOP 08/V2
e.g. Protocol Waiver means a prospective decision by a sponsor or investigator
to permit accrual of a subject who does not satisfy the approved inclusion /
exclusion criteria for enrollment.
8.4.1.d Communication / complaint / information received from research participant

who has been enrolled or any individual who has been approached for
enrollment
8.4.1.e Any report / communication brought to the notice of member secretary /

Chairperson of HEC
8.4.1.f Communication received from the Director, TMC informing HEC about an
alleged protocol violation / non-compliance / protocol deviation
8.4.2 Noting protocol deviation / non-compliance / violation / waiver by the Secretariat
The HEC members who have performed monitoring of a particular trial site and detect
protocol deviation / non-compliance / violation will inform the Secretariat in writing
within 24 hours [one working day].
Whenever protocol deviation / non-compliance / violation has been observed, the Secretariat
will ensure that the issues as well as the details of non-compliance involving research
investigators are included in the agenda of the HEC meeting.
The deviations / violations will be scrutinized for gravity and implications in the formal full board
HEC meeting. The HEC decision will be communicated to PI.
8.4.3 Board discussion, Decision and Action
If the protocol deviation / non-compliance / violation is detected by HEC member

during monitoring visit he/she will present the protocol deviation / noncompliance /
violation information.
If detected by Secretariat / forwarded by PI, the Secretary will present the protocol
deviation / non-compliance / violation / waiver information.
The Chairperson / HEC members will review the information available and take a decision
depending on the seriousness of the violation.
The decision will be taken to ensure that the safety and rights of the research participants
are safeguarded. The decision will be taken by consensus and if no consensus is arrived
at, voting will be conducted.
The actions taken by HEC could include one or more of the following:
Inform the PI that HEC has noted the violation / noncompliance / deviation and inform the
PI to ensure that deviations / noncompliance / violations do not occur in future and follow
HEC recommendations.
Enlist measures that the PI would undertake to ensure that deviations / noncompliance /
violations do not occur in future.
SOP 08/V2
Reprimand the PI
Call for additional information
Suspend the study till additional information is made available and is scrutinized
Suspend the study till recommendations made by the HEC are implemented by the PI
and found to be satisfactory by the HEC
Suspend the study for a fixed duration of time
Inform the Director, TMC
Revoke approval of the current study
Inform DCGI / Other relevant regulatory authorities
Keep other research proposals from the PI/ Co-PI under abeyance
Review and / or inspect other studies undertaken by PI/Co-PI
8.4.4 Notify the investigator
The IRB secretariat records the HEC decision Drafts and types a notification letter.
The Chairperson / Secretary signs and dates the letter.
The IRB Secretariat makes four copies of the notification letter.
The IRB Secretariat sends the original copy of the notification to the investigator.
The IRB Secretariat sends a copy of the notification to the relevant national authorities and
other trial sites, in case of multi-centric trial.
The IRB Secretariat sends the fourth copy to the sponsor or the CRO of the study.
8.4.5 Records and follow up to be kept by IRB Secretariat
Keeps the last copy of the notification letter in the “non-compliance’ file.
Stores the file on the shelf with an appropriate label.
Follows up the action after a reasonable time.
Maintains a file that identifies investigators who are found to be non-compliant with
national / international regulations or who fail to follow protocol approval stipulations or
fail to respond to the HEC request for information/action
References
Biomedical Research, (Geneva 2000) www.who.int/tdr/publications/publications / (accessed
24 September 2008)
2. International Conference on Harmonization, Guidance on Good Clinical Practice (ICH GCP)

1996- http://www.ich.org/LOB/media/MEDIA482.pdf (accessed 24 September 2008)

SOP 08/V2
Glossary
Deviation / on-compliance / Violation: The HEC monitors whether investigators do not perform
the study in compliance with the approved protocol, ICH GCP, FDA regulations and/or fail to
respond to the HEC request for information/action.
Waiver: Protocol Waiver is analogous to a Protocol Deviation, except that prior IRB approval
must be obtained before implementing the necessary departures from the protocol

SOP 08/V2
AX 1-V1/SOP08/V2
Deviation (D)/Waiver (W)/Violation (V)

Reporting Form
Specify if D/W/V-
Nature: Minor Major Other

(Tick whichever applicable)
If other, please specify:
Date of occurrence: dd/mm/yyyy (Not applicable incase of Waiver)
No of similar D/W/V occurred for the same trial:
Patient No.
IRB Project No:

Project Title:
Complete Details of D/W/V:
Action taken by PI/Co-PI/Co-I : (Not applicable in case of Waiver)
Impact on trial subject (if any) : (Not applicable inc ase of Waiver)
Name of PI:
Sign of PI:
Date:

SOP 08/V2

SOP 09/V2
Title: Review of Serious Adverse Events (SAE) Reports
Review of Serious Adverse Events (SAE) Reports Page 153

SOP 09/V2
9.1 Purpose
The purpose of this SOP is to provide instructions on the review and follow-up reports of
serious adverse events (SAEs) and unexpected events for any active study approved by the
HEC.
Unanticipated risks are sometimes discovered during the course of studies. Information that
may impact on the risk/benefit ratio should be promptly reported to and reviewed by the HEC
to ensure adequate protection of the welfare of the study participants. The unanticipated risks
may as well include any event that in the investigator’s opinion, may adversely affect the rights,
welfare or safety of subjects in the study.
9.2 Scope
This SOP applies to the HEC review of SAE and unexpected events reports, both on site and off
site, including follow up reports submitted by investigators. The detailed instructions regarding
on site and off site SAE review are described in the following section 9.4
9.3 Responsibility
The primary responsibility of the HEC is to review and address SAE and unexpected events
involving risks to research participants. In addition, the committee is authorized to offer mediation
under appropriate circumstances.
HEC should also make sure that researchers are made aware of the policies and procedures
concerning reporting and continuing review requirements.
The IRB Secretariat is responsible for receiving the complete SAE / unexpected events reports
and directing them to DSMSC for detailed review as described in the DSMSC - Policy and
Procedures manual (2003). Following the DSMSC meeting, the Secretary, DSMSC will then
submit the report to the Member Secretary, HEC. The Member Secretary, HEC will then table the
DSMSC minutes in the subsequent HEC meeting.
Notifying the IRB Secretariat, DSMSC, or Secretary, HEC does not relieve the PI from his/her
responsibility to notify the sponsor and regulatory authorities.
9.4. Detailed instructions
A. On site SAEs
9.4.1 SAE related activities before HEC meeting

The IRB Secretariat will verify that the reports are complete, signed and dated by the
PI. In case the IRB Secretariat notes that the report is incomplete, it will be forwarded
to Member Secretary, HEC for decision and also revert back to PI.

SOP 09/V2
The IRB secretariat should receive the reports of SAEs occurred for HEC approved
studies within 7 days of the occurrence of the SAE.
If the SAE is ‘Death’, the IRB Secretariat should receive the SAE reporting form (AX1-
V1/SOP 09/V2) within 24 hours of the occurrence.
If the PI has not adhered to the above stipulated time period, the IRB Secretariat will
notify the discrepancies in the reporting time and time of occurrence of SAE to the
PI.
9.4.2 Actions to be taken by Member Secretary, HEC

The Member Secretary will review the SAE Report, write comments and forward it to
the Secretary, DSMSC, immediately.
If the SAE reported is ‘death’, the Member Secretary, HEC, will review the SAE report
and forward it to member Secretary, DSMSC within 1 working day for immediate
action. If deemed necessary, Member Secretaries of HEC I and II and Member
Secretary, DSMSC will review the SAE, death, either in person, by e-mail or telephone
and inform the Chairperson, HEC.
The Member Secretary will table the DSMSC minutes which includes SAE review, at
the next scheduled HEC full board meeting.
9.4.3 Actions to be taken by Chairperson

The Chairperson, HEC on basis of the information and comments received from the
Member Secretary, HEC and DSMSC, and applying his/ her judgment will direct the IRB Secretariat
to any one or more actions listed below, but are not limited to.
suspending enrolment of new research participants till further review by the HEC
suspending all trial related procedures (except those intended for safety and well-
being of the participant) till further review by the HEC
suspend some trial-related procedures (listed by the secretariat).
calling for an emergency review by full board.
o This review should be initiated within 48 working hours (2 working days) of
receipt of information.
o This review could be done through a meeting, teleconference, email or
telephonic conversation.
o The IRB Secretariat will take appropriate steps to ensure that HEC members
are informed about this full board meeting.
o Depending upon the complexity of the issue(s) involved, the chairperson
could direct the Member Secretary, HEC, to invite one or more experts whose
opinion would be valuable. These experts could participate after they agree to
the confidentiality clause and abide by the rules and regulations of HEC.
soliciting opinion of one or more expert in writing. The information can be provided
to expert after he/ she/ they agree(s) to the confidentiality clause and abide by the
rules and regulations of HEC. The expert would be requested to provide an opinion
in writing within 2-14 working days, depending upon the gravity and seriousness of
the matter.

SOP 09/V2
B. Off Site SAEs
Off Site SAEs where adverse event reports that are serious, unexpected and related
(definitely, probably and possibly) to the drug need prompt reporting to the HEC.
The SAEs that are expected (if listed in the informed consent) or unexpected but
unrelated to the drug (classified as per the Off site Safety Report Classification form
– AX2-V1/SOP09/V2) have to be logged (AX3-V1/SOP09/V2) by the PI and to be
submitted every 3 months and/or submitted along with continuing review report. The
log has to be maintained continuously until the end of the study.
Those off site SAEs which qualify for prompt reporting, (classified as per the Off site
Safety Report Classification form – AX2-V1/SOP09/V1) will be reported to IRB
Secretariat, and forwarded to Member Secretary, HEC and Secretary, DSMSC for
further action.
If the HEC and DSMSC need to review the off site SAE reports, the committee will
request copies of SAE reports at any time, as and when necessary.
If a trend is observed in SAEs by PI, such a trend will be reported to IRB Secretariat,
action on such reports will be taken by the Member Secretary, HEC and Secretary
DSMSC, as per 9.3-9.4
The IRB Secretariat will not accept the complete set of “Off site Safety Reports” and/
or the log. However, the IRB will accept the log of (AX3-V1/SOP09/V2) the SAEs
every 3 months and/or at the time of continuing review/submission of annual status
report.
9.5 During the HEC meeting
On site SAEs
The Secretary, DSMSC will inform all the HEC members about the SAEs and actions
taken. The minutes of DSMSC meeting will be discussed.
If appropriate, specific action or combination of actions will be taken, based on the
consensus decision of the HEC discussion. Some of which are listed below:
o Terminate the study;
o Suspend the study till review is completed;
o Suspend the study till additional information is obtained;
o Suspend the study for a fixed duration of time;
o Suspend the study till amendments requested for by the HEC are accepted;
o Suspend enrolment of new research participants;
o Suspend certain activities under the protocol (while going on with activities
intended to protect the safety, well-being of participants who have already
been enrolled);
o Recommend an amendment to the protocol, the ICD, Participant information
sheet, investigator brochure and/ or any other document.
o Request additional details
o Request further follow up information
o Direct the PI to inform participants already enrolled in the study about the SAE
and obtain their consent regarding continuation in the research trial, if necessary.

SOP 09/V2
and request them to undertake additional visits, additional procedures, additional
investigations, etc. as prescribed in the amendment.
o Note the SAE report in the HEC records if information submitted is found to be
adequate
o Any other action
Off site SAEs
The Secretary, DSMSC will inform all the HEC members about those off site SAEs
which qualify for prompt reporting, (classified as per the Off site Safety Report
Classification form – AX2-V1/SOP09/V) and were reviewed in DSMSC meeting. The
minutes of DSMSC meeting will be discussed.
If appropriate, specific action or combination of actions will be taken, based on the
consensus decision of the HEC discussion. Some of which are listed below:
o Terminate the study;
o Suspend the study till review is completed;
o Suspend the study till additional information is obtained;
o Suspend the study for a fixed duration of time;
o Suspend the study till amendments requested for by the HEC are accepted;
o Suspend enrolment of new research participants;
o Suspend certain activities under the protocol (while going on with activities
intended to protect the safety, well-being of participants who have already
been enrolled);
o Recommend an amendment to the protocol, the ICD, Participant information
sheet, investigator brochure and/ or any other document.
o Request additional details;
o Request further follow up information;
and obtain their consent regarding continuation in the research trial, if necessary.
and request them to undertake additional visits, additional procedures, additional
investigations, etc. as prescribed in the amendment.
o Any other action
9.6 After the review of SAE
The IRB secretariat will send a formal letter to the investigator/s with instructions for
specific actions as per the HEC decision.
The HEC will instruct the PI to forward follow-up reports of the SAE to the IRB.
The HEC will instruct the PI regarding compliance to actions recommended by the
HEC within 14 days of receipt of the HEC letter.
In case a PI fails to respond to the HEC letter, the matter will be discussed at the
next full board meeting and a decision will be taken for specific action by simple
majority.

SOP 09/V2
The Member Secretary / Chairperson will sign and date the letter.

The IRB Secretariat will send the letter and file a copy of the letter in the master file
of the research protocol.
References
Biomedical Research, (Geneva 2000)- www.who.int/tdr/publications/publications/ (accessed
24 September 2008).
2. International Conference on Harmonization, Guidance on Good Clinical Practice, (ICH GCP)

1996 - http://www.ich.org/LOB/media/MEDIA482.pdf (accessed 24 September 2008)
3. Nationwide Children’s Hospital, Standard Operating Procedure: SAE Reporting and Review
http://etrac.ccri.net/CRI/Doc/0/2137HUSRMVKKFBHAT542EHDME8/011%20
Adverse%20Event.pdf (last accessed 24 September 2008)
4. Schedule Y (drugs of ecomitics Act 1940; amendment 20th January 2005) retrieved from
http://www.idsco.nic.in/html/schedule Y 20 (Amended 20 veesion-2005 assessed 24 March
2008)
Glossary
Adverse Event: Any untoward medical occurrence in a patient or clinical investigation participant
administered an investigational product and which does not necessarily have a causal relationship
with this treatment. The adverse event can therefore be any unfavorable or unintended sign or
experience associated with the use of the investigational product, whether or not related to the
product.
Adverse Drug Reaction: In the pre-clinical experience with a new medicinal product or its
new usages, particularly as the therapeutic dose(s) may not established all noxious or unintended
responses to the product related to any dose should be considered adverse drug reactions. The
phrase “responses to a medicinal product” means that a causal relationship between the product
and the adverse event is at least a reasonable possibility, i.e., the relationship can not be ruled
out. Regarding marketed products, a response to a product which is noxious and unintended
and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of
diseases or for modification of physiological function.
IND: Investigational New Drugs means substances with potential therapeutic actions during the
process of scientific studies in human in order to verify their potential effects and safety for
human use and to get approval for marketing.

SOP 09/V2
Annexe
AX1-V1/SOP09/V2
Serious Adverse Event Review Report for SAE
As per ICH-GCP:
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
Any untoward medical occurrence (due to the participation in the concerned trial) that
at any dose:
• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability / incapacity,
or
• is a congenital anomaly/birth defect
Investigator(s) shall report all SAE (as above) to the Sponsor within 24 hours and to the
Ethics Committee that accorded approval to the study protocol within 7 working days
of their occurrence and within 24 hours in the event of death.
Does the Principal Investigator feel this SAE is related to participation in the trial?
Yes No Possibly
Does the protocol have an inbuilt data monitoring plan? Yes No
1. Title of project and Project No:
2. Principal Investigator:
3. Report date
Report type initial follow up
4. Patient case no: 5 a. Age 5 b. Gender
6. Mention the total number of SAE (prior) occurred at our site___________ other site(s) ___________
7. Mention number of similar SAEs (prior) occurred for same study at our site___________
other site(s)___________

SOP 09/V2
Suspect drug /device/intervention information

8. Suspect drug ( include generic name )/device/intervention
9. Dose: 10. Route(s) of administration:
11. Therapy dates (from/to) 12. Therapy duration:
13. Did the reaction decline after stopping the drug/procedure
YES
NO
NA
Concomitant drugs and history
14. Concomitant drug(s) and date of administration
15. Patient relevant history (e.g. diagnosis, allergies)
Reaction information
16. Description of adverse event (indicate if this is follow-up report and if so, include follow-
up information only) Underline the adverse event
17.Tick whichever is applicable for specific adverse event

A] expected event unexpected event (this refers to trial being conducted and not
disease process)
B] hospitalization increased hospital stay death others (If others, please specify)
C] No permanent significant functional/ cosmetic impairment

Permanent significant functional/ cosmetic impairment
Not applicable
18. Describe the medical treatment provided( if any ) to the research subject:
19. Outcome was

resolved ongoing death
20. Was the research subject continued on the research protocol
yes no

SOP 09/V2
21. In your opinion, does this report require any alteration in trial protocol?
— yes — no
if yes then please specify.
Signature of Principal Investigator _________________________________ date: _______________
Upon receipt of this report , the HEC/DSMSC will decide whether additional information is
needed or whether further investigation of the incident is required
For HEC use only
I ____________ agree ____________ disagree with the assessment of the Principal Investigator.
DSMSC Reviewer _______________________________________________ date: ____________
Explanation:

SOP 09/V2
AX2-V1/SOP09/V2
Off site Safety Reports Classification Form
NOTE to PI:
The following questions will act as a guide for submission of the “Safety Reports”. This form is
merely providing guidance for reporting / logging of Off site Safety Reports.
If the answer to all three questions is “Yes”, prompt reporting is required and such off site
Safety Reports need to be reported to HEC along with the log.
If any one answer is “No”, it needs to be logged as prescribed format. (AX3-V1/SOP 09/V2).
This log should be submitted to the IRB Secretariat every 3 months and/or along with Continuing
Review report.
Project No.
Project Title :
Questions Yes No
Is adverse event serious?
Is adverse event related?
Is adverse event unexpected?
Date of reporting
Signature of PI
Name of PI

SOP 09/V2
AX3-V1/SOP09/V2
Off Site Safety Reports Log
NOTE to PI:
1. Please log in details of Off Site Safety Report.

2. The following log has to be maintained continuously until the end of the study.
3. This log should be submitted to the IRB Secretariat every 3 months and/or along with
Continuing Review report.
4. The log must be submitted to the IRB Secretariat immediately, if prompt reporting is required
and/or if a trend related to the occurrence of SAE is observed.
5. Please note the complete set of Off site Safety Reports need not be sent to IRB Secretariat
as and when received. If the IRB needs to review the reports, they can request copies at
any time.
Project No.:
Project Title:
No. of Participants already enrolled in TMC:
S. No. Country Date of Onset Adverse event Out Come Remarks
Name and Signature of PI: Date:

SOP 09/V2

SOP 09/V2

SOP 10/V2
Title: Maintenance of Active Project Files, Archival of Closed Files and

Retrieval of Documents
Maintainence of Active Project Files, Archival of closed files and Retrieval of documents Page 167
SOP 10/V2
10.1 Purpose
To provide instructions for preparation and maintenance of active study files and other related
documents approved by the HEC, TMC, and storing of closed files and retrieval of documents.
10.2 Scope
This SOP applies to all protocol/study files and their related documents that are maintained in the
IRB office and closed files.
10.3 Responsibility
It is the responsibility of IRB staff to ensure that all study files are prepared, maintained, and kept
securely for a period of three years after the closure of the project (under a proper system that
ensures confidentiality and facilitates retrieval at any time).
10.4 Maintain the active study files
Master file is the file comprising of all essential documents and correspondence related
to the study/protocol. Trial master files should be established at the beginning of the
trial, in the IRB secretariat.
The approved study files are assigned unique identifiers (serial project no.).
Gather, classify and combine all related documents together of the approved study files
appropriately.
Keep all active files in a secured file cabinet with controlled access. A log book of
authorized individuals accessing the files will be maintained.
Maintain the study files in an easily accessible and secure place for at least 3 years after
the study closure.
All closed study files will be separately archived.
Final disposal of study/master files on completion of archival period.
10.5 Disposal of closed files and copies of protocols and documents submitted for
HEC review.
The trial master file will be maintained in the IRB office for a period of three years following
closure of the study. After completion of archival period the closed files will be shredded and
disposed off. However, all the copies of research projects and documents submitted for HEC
review will be shredded off by the authorized IRB personnel after the HEC meeting without any
notification to PI. A log book of disposed documents will be maintained.
10.6 Accessibility / Retrieval
Master files will be made available for inspection and copying by authorized representatives of
regulatory authorities after receiving the request in writing.
SOP 10/V2
In case, any investigator needs a copy of any document from the master file, he/she should make
a written request. (AX1 –V1/SOP10/V2). The IRB staff will furnish a copy of the required
document within a week with HEC Secretary’s consent. The IRB will issue a copy of the following
documents on formal written request:
10.7 Final Disposal of Master files
The master files will be disposed off after archival period of 3 years. A formal written off register
(AX2- V1/SOP 10/V2) will be maintained, providing details of documents being written off /
disposed off.
Glossary
Active Study File: Any approved protocol, supporting documents, records containing
communications and reports that correspond to each currently approved study
Closed Study File: The study which is completed or terminated or discontinued or suspended
or not initiated is considered to be closed.
SOP 10/V2
AX1–V1/SOP10/V2
Document Request Form
Project No.: Project Title :
Name of PI: Requested by:
Documents requested:
Purpose of the request:
Principal Investigator’s Signature:
Signature of the requesting person:
Permission of Secretariat YES/NO
Member Secretary, HEC
SOP 10/V2
AX2 –V1/SOP10/V2
Format of written off register
Project Title PI No of EC Study Study Name &

No. files approval Initiation Closure Sign of
Date Date Authorized
Individual
SOP 10/V2
SOP 11/V2
Title: Documentation of the HEC activities
Documentation of the HEC activities Page 175

SOP 11/V2
11.1 Purpose
To describe the procedures for documenting the HEC activities.
11.2 Scope
This SOP will apply to all research activity involving human subjects, without regard to the source
type of funding.
11.3 Responsibility
It is the responsibility of IRB staff to maintain HEC files at IRB office.
11.4 Detailed Instructions
11.4.1 HEC records will include the following

1. HEC members’ records
a. Acceptance letters of each member
b. signed and dated recent Curriculum vitae and confidentiality agreement letters of
each member
c. Training records for each HEC member
d. Documentation of resignation/termination
2. HEC membership roster
3. HEC attendance roster
4. HEC meeting agenda and minutes
5. Standard Operating Procedures
6. Annual reports
11.4.2 Access to HEC records

HEC records will be made available for inspection by authorized representatives of regulatory
authorities after receiving the request in writing.

SOP 11/V2

SOP 12/V2
Title: Review of study completion reports
Review of study completion reports Page 179

SOP 12/V2
12.1 Purpose
The purpose of this SOP is to provide instructions on the review of Study Completion Report for
every study previously approved by the HEC.
12.2 Scope
This SOP applies to the review of the Study Completion Report which is an obligatory review of
each investigator’s activities presented to the HEC as a written report of study completed.
Although HEC provides a Study Completion Report Form (AX1-V1/SOP12/V2) to the investigator,
any mechanism (letter format, form provided by the Sponsor, etc.) may be used, provided that
the information submitted is sufficient.
12.3 Responsibility
It is the responsibility of the HEC members to review the study completion report and notify it
or request for further information, if necessary.
12.4.1 Before each board meeting

The secretariat will receive 15 copies / as per strength of HEC membership, of Study
Completion Reports from the PI.
The Secretariat will follow instructions as in SOP 03/V2 (Management of Protocol
Submission) for receiving and checking the report packages.
It is the responsibility of the IRB Secretariat to review the report for completeness before
submission for the Board meeting.
The IRB Secretariat should keep the study completion reports on the agenda for HEC
meeting. (Procedures for Agenda preparation, Meeting procedures and recording of
Minutes- SOP 05/V2)
12.4.2 Before and during board meeting

HEC member(s) should review a copy of the Final Report.
The members will discuss the report in the HEC meeting.
If appropriate to the discussions, the Chairperson may call for consensus to accept it or
request further information or take any other action as suggested by HEC.
12.4.3 After the board meeting

The Secretariat will note the decision in the meeting minutes and the study will be
considered as closed if the document is accepted.
The HEC decision is communicated to the investigator. In case further information /
action is requested, the same should be followed by the PI and communicated to the IRB
office within 30 days. This update will be tabled in the full board meeting of HEC.

SOP 12/V2
The Secretariat will accept and file the Final Report in the project master file.
The IRB secretariat will archive the entire study protocol and the report for a period of 3
years from the date of completion of the project, if the report is accepted.
References
24 September 2008)
GCP) 1996- http://www.ich.org/LOB/media/MEDIA482.pdf (accessed 24 September 2008)

SOP 12/V2
Annexure
AX1-V1/SOP 12/V2
Study Completion Report Form
(To be Filled by PI)

TMC Project No.
Protocol Title:
Principal Investigator:
Phone number, email address
Sponsor
Address
Phone, E mail
Total no. of study participants recruited
Study Initiation Date
Total no. of study participants
approved by the HEC for
recruitment
No. of study arms
Duration of the study
Objectives
Results (brief) (use extra blank sheets,
if more space is required)
SAEs at our center
(Total number and type)
Whether all SAEs intimated
to the HEC (Yes/No)
No. of patients withdrawn
Reasons for withdrawal
Protocol deviations/violations
(Number and nature)
Conclusion
Signature of PI
Date:

SOP 12/V2

SOP 13/V2
Title: Management of Premature Termination / Suspension /

Discontinuation of the Study
Management of Premature Termination/Suspension/Discontinuation of the Study Page 185

SOP 13/V2
13.1 Purpose
The purpose of this SOP is to describe how the HEC proceeds and manages the premature
termination / suspension / discontinuation of a research study. Protocols are usually terminated at
the recommendation of the HEC, DSMSC, PI, sponsor or other authorized bodies wherein
subject enrollment and subject follow-up are discontinued before the scheduled end of the
study.
13.2 Scope
This SOP applies to any study approved by HEC that is being recommended for termination/
suspension/discontinuation before its scheduled completion.
13.3 Responsibility
It is the responsibility of the Chairperson, HEC to terminate any study that the HEC has previously
approved when the safety or benefit of the study participants is doubtful or at risk. The Secretariat
is responsible for management of the premature termination / suspension /discontinuation process.
13.4.1 Receive recommendation for study Termination / Suspension / Discontinuation

The Secretariat will receive recommendation and comments from DSMSC, PI, Sponsor or
other authorized bodies for premature termination of study protocol.
The HEC members /Chairperson can prematurely terminate the study if protocol
non-compliance /violation is detected and HEC decision is to terminate the study.
SAE occurring at trial site may require the study to be prematurely terminated for the
safety of the patients.
The Secretariat will inform the PI to prepare and submit a protocol termination package
along with Premature Termination Report (available at IRB office)
The Secretariat will receive the study protocol termination package prepared and submitted
by the PI and verify the contents of the package for inclusion of:
o Premature Termination Report (AX1- V1/SOP13/V2) signed and dated by the PI
should contain a brief written summary of the protocol, its results, and accrual data.
o The Secretariat will check the completeness of the information, including accrual
data since the time of the last continuing review.
o The Secretariat will initial and date the package upon receipt.
13.4.2 Review and discuss the Termination / Suspension / Discontinuation Package

HEC will review the termination package at regular full board meeting to discuss about
the recommendation.
The Secretary in the meeting will inform of the premature termination of the project and
the HEC members will review the Premature Termination Report (AX1- V1/SOP13/V2)
If the Premature Termination Report is unclear/more information is required from the PI,
the Secretariat is instructed to send a query to the PI.

SOP 13/V2
13.4.3 Notify the PI
The Secretariat will make notification letter acknowledging the approval of termination or
query letter to request information regarding the premature termination.
The Secretariat will send the notification letter to the PI for their records within 14 days
after the meeting.
13.4.4 Store the protocol documents

The Secretariat will keep the original version of the Premature Termination Report in the
Protocol file and send the file to archive.
The protocol documents will be stored for a period of 3 years from the date of project
Termination.
If a query is sent to PI, on receipt of the reply letter, it is reviewed in the forthcoming full
board meeting and steps in 13.4.2 will be performed by the Secretariat.
References
24 March 2008).
GCP) 1996 - http://www.ich.org/LOB/media/MEDIA482.pdf (accessed 24 March 2008)

SOP 13/V2
(AX1- V1/SOP13/V2)
Premature Termination / Suspension / Discontinuation Report
TMH Project No.:

Protocol Title:
PI:
Phone : E-Mail:
Trial Site:
Sponsor:
HEC Approval Date: Date of Last Progress Report Submitted to HEC:
Starting Date: Termination Date:

No. of Participants Enrolled: No. of Participants Completed:
No. of Ongoing Participants: No. of Drop Outs:
SAE (Total No.): SAE Event:
Summary of Results:
Reason for Termination/Suspension/Discontinuation:
PI Signature: Date:

SOP 13/V2

SOP 14/V2
Title: Request for Waiver of Written Informed Consent
SOP Code: SOP 14/V2 Date :01/09/2009 Pages: 8
Request for Waiver of Written Informed Consent Page 191

SOP 14/V2
14.1 Purpose
The purpose of this SOP is to describe the type of research projects for which the HEC may grant
waiver for requirement of obtaining written informed consent and the format of the application
form to be used by the investigators for requesting waiver of consent. The Application Form AX1-
V1/SOP 14/V2 is designed to standardize the process of applying for consent waiver.
14.2 Scope
This SOP applies to the all protocols with a request of granting consent waiver submitted for
review by the HEC. The decision should be taken by the HEC members at the expedited
subcommittee meeting or in some cases during full board meeting.
14.3 Responsibility
It is the responsibility of the Member Secretary to table the request in the expedited subcommittee
meeting or in some cases, during full board meeting.
When a request for waiver of consent is submitted by the PI along with the study documents
to the HEC secretariat, in the given format AX1-V1/SOP 14/V2 stating the reasons for the
consent waiver; the following steps are taken:
The HEC Secretariat will check if the concerned documents are filled completely and
the required list of documents is enclosed.
The HEC members will review the request taking into consideration the types of
studies for which waiver of consent may be granted.
The HEC will ensure that there are adequate mechanisms described in the protocol for
protection of the identity of the research participants and maintaining confidentiality
of the study data. This is necessary as the participant cannot be assured directly about
confidentiality of health data through a formal informed consent process, when consent
waiver is granted.
The decision whether to grant the waiver is taken in expedited subcommittee meeting
or in some cases during full board meeting.
The decision regarding approval/disapproval of waiver is informed to the PI in writing.
If the waiver is not granted, the HEC will provide reasons for the same.
14.5 Type of research projects which may qualify for consent waiver:
A request to waive written informed consent must be accompanied by a detailed explanation.

The investigator is also required to provide assurance regarding protection of identity of research
participants and maintenance of confidentiality about the data of the research participants. The
following criteria (ICMR 2006 guidelines) must be met for a research project so that it can
qualify for granting a waiver of both written and verbal consent.

SOP 14/V2
1. The proposed research presents no more than minimal risk to subjects. (ICMR guidelines,
45CFR 46) e.g. a retrospective review of patient case records to determine the incidence of
disease/ recurrence of disease. [Minimal risk would be defined as that which may be anticipated
as harm or discomfort not greater than that encountered in routine daily life activities of
general population or during the performance of routine physical or psychological examinations
or tests. However, in some cases like surgery, chemotherapy or radiation therapy, great risk
would be inherent in the treatment itself, but this may be within the range of minimal risk for
the research participant undergoing these interventions since it would be undertaken as part
of current everyday life].
2. When it is impractical to conduct research since confidentiality of personally identifiable

information has to be maintained throughout research as may be required by the sensitivity
of the research objective. (ICMR 2006 guidelines)
e.g. conducting interviews with citizens about their religious beliefs/ people with HIV and
AIDS / conducting phone interviews with homosexuals.
The only record linking the participant and the research would be the consent document
and when there is a possible legal, social or economic risk to the participant entailed in
signing the consent form as they might be identified as such by signing the consent form,
the requirement for obtaining consent can be waived of by the HEC.
[In case of telephonic interviews, waiver of written informed consent may be requested but
this does not mean that verbal consent cannot be utilized].
The following points need to be considered.

a. The following documents need to be submitted for the HEC review
A script for verbal consent - a verbal consent script provides all of the elements of
consent in a more informal style. In addition, each subject should be provided
with an information sheet that describes the study and gives contact names and
numbers.
The interview schedule (questions to be asked???) will confirm that the interview
is a simple 5 minute call and that no questions are asked that compromise a
person’s confidentiality or position.
b. Normally, investigators will be asked to keep a log of those who were approached
about the study, and offered verbal consent. A simple chart can indicate the subjects as
participant 1, participant 2, and participant 3. A column can indicate that verbal consent
was given and a date. Since a specific number of study participants are to be recruited.
It is important that investigators keep some record to indicate that they are not enrolling
more subjects than they originally requested.
3. Research on publicly available information, documents, records, work performances, reviews,

quality assurance studies, archival materials or third party interviews, service programs for
benefit of public having a bearing on public health programs, and consumer acceptance
studies. (ICMR 2006 guidelines)

SOP 14/V2
4. Research on anonymised biological samples from deceased individuals, left over samples
after clinical investigation, cell lines or cell free derivatives like viral isolates, DNA or RNA
from recognized institutions or qualified investigators, samples or data from repositories or
registries etc. (ICMR 2006 guidelines)
5. In emergency situations when no surrogate consents can be taken. (ICMR 2006 guidelines)
when consent of person/ patient/ responsible relative or custodian/ team of designated
doctors for such an event is not possible, the HEC can allow waiver of consent for recruiting
participant in a research study. However, information about the intervention should be
given to the patients whenever he/she gains consciousness or to relative/ legal guardian
when available later.
References:
1. Ethical Guidelines for Biomedical research on Human Participants, ICMR (2006)

2. 45CFR Title 45 Public Welfare (45 CFR 46) Protection of human subjects, Department of
Health and Human Services, revised June 23, 2005. Retrieved From: http://www.hhs.gov/
ohrp/humansubjects/guidance/45 CFR 46.htm, paragraph 46.116

SOP 14/V2
AX1-V1/SOP 14/V2
Application form for requesting waiver of consent
1. Principal Investigator’s name:

2. Department:
3. Title of project:
4. Names of other participating staff and students:
5. Request for waiver of informed consent:

Please check the reason(s) for requesting waiver (Please refer the back of this annexure
for criteria that will be used by HEC to consider waiver of consent).
1. Research involves ‘not more than minimal risk’
2. There is no direct contact between the researcher and participant
3. Emergency situations as described in ICMR Guidelines (ICMR 2006
Guidelines- http://www.icmr.nic.in/ethical_guidelines.pdf)
4. Any other (please specify)
Statement assuring that the rights of the participants are not violated
State the measures described in the Protocol for protecting confidentiality of data and
privacy of research participant
Principal Investigator’s signature with date:

SOP 14/V2

SOP 15/V1
Title: Site Monitoring
Site Monitoring Page 199

SOP 15/V1
15.1 Purpose
The purpose of this SOP is to provide the procedures to select a site for monitoring and how the
site will be monitored.
15.2 Scope
This SOP applies to any visit and /or monitoring of any study sites of HEC approved study
protocols.
15.3 Responsibility
It is the responsibility of the HEC members to perform or designate some qualified agents to
perform on its behalf on-site inspection of selected study sites of relevant projects it has approved.
The HEC members or Secretariat in consultation with the Chairperson may initiate an on-site
evaluation of a study site for cause or for a routine audit.
15.4.1 Selection of study sites

Sites will be identified for routine monitoring at the time of approval of the project by the
Full Board which will be recorded in the minutes.
“For cause” monitoring will be performed at sites for reasons identified by any member of
HEC, approved by Chairperson. For cause monitoring could be initiated, in any of the
following conditions: for high number of protocol violations, large number of studies
carried out at the study sites, remarkable SAE reports, high recruitment rate, Non-compliance
or suspicious conduct and any other cause as decided by HEC.
15.4.2 Before the visit

If the site was identified for routine monitoring, the Secretariat will inform the HEC members
in the Full Board meeting, 1 month prior to the stipulated date of monitoring.
For cause / routine monitoring of the project, the HEC Chairperson will designate an HEC
member or appoint an independent monitor to perform the task of monitoring.
The Secretariat will inform the PI in writing about the date / time of monitoring visit and
request for confirmation letter from the PI to be available for the monitoring visit.
The HEC member / Independent monitor will also:
o Contact the site to notify them that they will be visiting them. At that time, the monitor
and the site will coordinate the time for the site evaluation visit.
o The Secretariat will make the appropriate travel arrangements for the HEC member /
Independent monitor.
o The HEC member / Independent monitor will review the HEC project files for the study
and site profile and make appropriate notes.

SOP 15/V1
o The HEC member / Independent monitor may copy some parts of the HEC project files
for comparison with the site files and collect the Site Monitoring Visit Report Form
(AX1-V1/SOP15/V1) from the Secretariat.
15.4.3 During the visit

The HEC member/Independent monitor will
Review the informed consent document to make sure that the site is using the most recent
version,
Review randomly the subject files to ensure that subjects are signing the correct informed
consent,
Observe the informed consent process, if possible,
Observe laboratory and other facilities necessary for the study at the site, if possible.
Review the project files for the study to ensure that documentation is filed appropriately.
Verifying that the investigator follows the approved protocol and all approved amendment(s),
if any.
Ensuring that the investigator and the investigator’s trial staff are adequately informed
about the trial
Verifying that the investigator and the investigator’s trial staff are performing the specified
trial functions, in accordance with the protocol and any other written agreement between
the sponsor and the investigator/institution, and have not delegated these functions to
unauthorized individuals.
Verifying that the investigator is enrolling only eligible subjects.
Verifying that source documents and other trial records are accurate, complete, kept up-to-
date and maintained.
Checking the accuracy and completeness of the CRF entries, source documents and other
trial-related records against each other.
Determining whether all adverse events (AEs) are appropriately reported within the time
periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable
regulatory requirement(s).
Collect views of the study participants, if possible.
Fill the Site Monitoring Visit Report Form AX1-V1/SOP15/V1and write the comments.
15.4.4 After the visit
The HEC member / Independent monitor will complete the report (use the form AX1-V1/
SOP15/V1) within 14 days describing the findings of the monitoring visit and during the
Full Board meeting present them. If the Independent monitor is unable to attend the HEC
meeting he / she can courier the Monitoring Visit Report with comments and the HEC
Secretary can present the same.
The Secretariat will place the report in the correct files.
Full board recommendations to change the study / premature termination / continuation of
the project will go to the PI in writing within 14 days of the meeting.

SOP 15/V1
Glossary
Independent Consultants
Many Ethics Committees rarely find time to perform monitoring visit themselves. They may ask
outside experts or the staff of Ethics Committees to perform the tasks on their behalf and later
report their findings to HEC.
Monitoring visit
An action that HEC or its representatives visit study sites to assess how well the selected
investigators and the institutes are conducting researches, taking care of subjects, recording
data and reporting their observations, especially SAEs found during the studies. Normally monitoring
visit will be arranged in advance with the PI.
Monitoring Report
Reports should include a summary of what the monitor reviewed and the monitor’s statements
concerning the significant findings / facts, deviations and deficiencies, conclusions, actions taken
or to be taken and / or actions recommended to secure compliance.

SOP 15/V1
Annexure
AX1-V1/SOP15/V1
Site Monitoring Visit Report
Site Monitoring Visit Report Date of the Visit:

HEC project-
Study Title:
Principal Investigators: Phone:
Institute: Site:
Sponsor:
Total number of subjects enrolled: Total subjects ongoing:
No. of subjects completed: No. of drop outs:
Are site facilities appropriate?
Yes No Comment:
Are Informed Consents of recent version Comment:
used?
Yes No
Is it approved by the HEC? Comment:

Yes No
Whether consent has been taken Comment:
from all patients?
Yes No
Whether appropriate vernacular Comment:

consent have been taken?
Yes No
Are Protocols of recent version used? Comment:

Yes No
Is it approved by the HEC? Comment:
Yes No
Any adverse events found? Comment:

Yes No
Any SAEs found? Comment:
Yes No

SOP 15/V1
Were the SAEs informed to HEC within Comment:

7 working days & SAE death within
24 hrs.?
Yes No
Any protocol non-compliance / violation? Comment:

Yes No
Are all Case Record Forms up to date? Comment:

Yes No
Are storage of data and investigating Comment:
products locked?
Yes No
How well are participants protected? Comment:

Good Fair Not good
Any outstanding tasks or results of visit? Give details:

Yes No
Duration of visit: …….hours Starting from: Finish:
Name of HEC/ representatives:

Completed by: Date:
Signature:
Name of study team member (PI/Co-I):
Sign & Date:

SOP 15/V1

SOP 16/VI
Title: Dealing with participants / patients requests and complaints
Dealing with Participants / patients requests and complaints Page 207

SOP 16/VI
16.1 Purpose
The HEC considers protection of the rights and welfare of the human subjects participating in a
clinical research approved by the HEC as its primary responsibility, Informed Consent documents
reviewed by the HEC contains the statement, “Questions regarding the queries regarding rights
of a participant/patient may be addressed to the HEC, Member secretary, with the HEC address
and phone number.
This procedure provides guidelines for dealing with and accommodating requests by participants/
patients regarding their rights as a participant or to resolve their complaints in any approved
research study.
16.2 Scope
This SOP applies to all requests concerning the rights and well-being of the research participants
participating in studies approved by the HEC.
16.3 Responsibility
It is the responsibility of the HEC Secretariat for providing required information to the research
participants in case of queries received from research participants.
It is the responsibility of the Chairperson to initiate a process to give information to the participants
or to identify and address any injustice that has occurred, if complaints are received from research
participants.
The HEC member/ administrative staff receive an inquiry or request from research participant
/ patient.
The request and information is recorded in the request record form (Form AX1- V1/SOP
16/V1)
The Secretariat will inform the Chairperson about the query / complaint received from the
research participant.
The Chairperson / Members designated by the Chairperson will provide information required
by the research participant.
In case of complaint received from a research participant, the Chairperson initiates a process
to identify and address any injustice that may have occurred.
The Chairperson will direct the Member Secretary to consider the matter for discussion at
a full board meeting or to call an emergency meeting of 2 or more HEC members for
discussion or to appoint a subcommittee of 2 or more HEC members for enquiry in order to
resolve the matter.
The Chairperson / Member Secretary / designated HEC members will assess the situation and
mediate a dialogue between the research participant and the investigator in an attempt to
resolve the matter.

SOP 16/VI
The HEC will insist on factual details to determine reality between truth and individual
perception.
The final decision will be informed to the research participant by the Secretariat.
The information including any action taken or follow-up will be recorded in the form AX1- V1/
SOP 16/V1 and the form is signed and dated.
The HEC members are informed about the action taken and the outcomes in the forthcoming
HEC meeting.
16.5 Filing the request document
The record form is filed in the “response” file by the Member Secretary / administrative staff.
A copy of the same is kept in the study file.
The file is stored in a secured place.
Reference
1. Kathleen J. Motil, Janet Allen and Addison Taylor, “When a Research Subject Calls with a
Complaint, What Will the Institutional Review Board do?” IRB: Ethics and Human Research
26, no.1(January –February 2004 ):9-13

SOP 16/VI
AX1- V1/SOP 16/V1
Request Record Form
Date Received:
Received by :
Request from :
Telephone call No
Fax No
letter / Date
E-mail / Date
Walk-in: Date / Time
Other, specify
Participant’s Name:
Contact Address:
Phone:
Title of the Participating Study
Starting date of participation :
What is requested?
Action taken:
Outcome:
Name of the Chairperson / Member Secretary _________________________________________________________
Signature of the Chairperson / Member Secretary ___________________ Date- ___________________

SOP 16/VI

SOP 12/V2
APPENDICES
APP1/V1 Policy on Recruitment of TMC Students and Staff

APP2/V1 Policy on the Recruitment of Research Subjects
APP3/V1 Policy on Research Costs to Subjects
APP4/V1 Guidelines on Compensation for Research Subjects
APP5/V1 Policy on the Use of Third Party/Surrogate Consent in Research at TMC
APP6/V1 Policy on Blood Withdrawal for Research Purposes
APP7/V1 Guidelines and Policy on Informed Consent
APP8/V1 Policy for Documentation of Informed Consent
APP9/V1 Health Record Research
APP10/V1 Guidelines for Research Protocols That Require Collection
and /or Storage of Genetic Materials
APP11/V1 Guidelines for Submission and EC Review of
Gene Therapy / Gene Transfer Protocols
APP12/V1 Recommended Terms for Use in Consent Forms
Appendices Page 213

SOP 12/V2
APP1/V1
Policy on Recruitment of
TMC Students and Staff for Research
DEFINITIONS
“Student” means any individual who is enrolled at TMC and those individuals who are in training
as, Residents, Fellows, or Postdoctoral trainees, including individuals enrolled at a training facility
other than TMC training or work program.
“Staff” mean all other TMC employees, including faculty.
POLICY GUIDELINES
TMC students and staff have the same rights as any other potential subject to participate in
research project, irrespective of the degree of risk, provided all of the following conditions
exist:
The research must not bestow upon participating TMC subjects any competitive academic
or occupational advantage over other TMC students or staff who do not volunteer, and the
researchers must not impose any academic or occupational penalty on those TMC students
or staff who do not volunteer.
TMC students and staff must not be systematically treated differently from non-TMC subjects
as part of the project.
Due to the potential for perceived or real coercion to participate, TMC students and staff
who desire to participate in the research (especially those under the direct supervision of
the PI or listed research collaborators) must be reviewed by Director TMC.
Appendix 1: Policy on Recruitment of TMC Students and Staff for Research Page 215
SOP 12/V2
APP2/V1
Policy on the Recruitment of Research Subjects
SPECIFIC RECRUITMENT GUIDELINES

(1) In addition to its review for scientific merit and protection of subjects from unnecessary
research risks, the HEC will evaluate all protocols for subject recruitment especially with
respect to women with childbearing potential, minority groups and children. Exclusion of
minorities, women or children will be recommended or approved when inclusion is
inappropriate with respect to the health of the subjects or the purpose of the research.
(2) TMC PATIENTS - Patients may be identified as potential research subjects through direct
contact of the PI with his or her patients, collaboration with physicians of other medical
specialties, contact with individual attending physicians, posted written notices, radio
announcements, or other HEC approved methods.
a. Inpatients - May be recruited by the investigator or other member of the research team
only after consultation with the patient’s attending physician.
b. Outpatients -
(i) For minimal risk research which does not bear directly upon a specific continuing
therapeutic relationship between the individual and a TMC physician, outpatients
may be recruited* without prior notification of their personal physicians. However,
when possible, each subject’s personal physician should be notified of the study
and informed that the patient has been entered into a minimal risk study.
(ii) For more than minimal risk research or any research bearing directly upon a
specific diagnosis or treatment, the subject’s personal physician should be notified
before enrolling* the subject.
* If the potential research subject is a minor, then contact must be via a parent or legal guardian.
Appendix 2: Policy on the recruitment of research subjects Page 216

SOP 12/V2
APP3/V1
Policy on Research Costs to Subjects
If a research participant may have to bear any costs, which would be unnecessary if the subject
had declined to participate in the research, all potential subjects must be fully informed of the
nature and estimated extent of these costs when obtaining consent. Examples of additional
research costs include:
1) Prolongation of treatment or hospitalization.

2) Extra diagnostic tests necessary for the research.
3) Extra clinical or laboratory assessments to evaluate research treatment outcome.
4) A research treatment (whether randomly assigned or not) which may be more costly than a
standard treatment.
5) Other substantial costs associated with extra visits to TMC.
Appendix 3: Policy on research costs to subjects Page 217

SOP 12/V2
APP4/V1
Guidelines on Compensation for Research Subjects
COMPENSATION FOR PARTICIPATION (ICMR Code 2000)

Subjects may be paid for the inconvenience and time spent, and should be reimbursed for
expenses incurred, in connection with their participation in research. They may also receive
free medical services. However, payments should not be so large or the medical services so
extensive as to induce prospective subjects to consent to participate in research against their
better judgement (inducement). All payments, reimbursement and medical services to be provided
to research subjects should be approved by the HEC.
Care should be taken:
1) when a guardian is asked to give consent on behalf of an incompetent person, no

remuneration should be offered except a refund of out of pocket expenses;
2) when a subject is withdrawn from research for medical reasons related to the study the
subject should get the benefit for full participation;
3) when a subject withdraws for any other reasons he/she should be compensated in proportion
to the amount of participation.
Prospective participants in research should also be informed of the sponsorship of research, so
that they can be aware of the potential for conflicts of interest and commercial aspects of the
research.
During the initial review of a research protocol, the HEC is required to review both the amount
of compensation proposed and the method and timing of disbursement to assure that neither
are coercive or present undue influence. The following are some additional guidelines:
1) Any compensation should not be contingent upon the subject completing the study, but
should accrue as the study progresses.
2) Unless it creates undue inconvenience or a coercive practice, compensation to subjects
who withdraw from the study should be made at the time they would have completed the
study, had they not withdrawn.
3) Compensation given as a “bonus” or incentive for completing the study is acceptable,
providing that the amount is not coercive. The HEC is responsible for determining if the
incentive amount is not so large as to be coercive or represent undue influence.
4) The amount of compensation should be clearly set forth in the informed consent document.
Appendix 4: Guidelines on Compensation for Research Subjects Page 218

SOP 12/V2
Reference: ICMR Code 2006
APP5/V1
Policy on the Use of Third Party / Surrogate Consent in Research at TMC
APPLICABILITY
When a TMC investigator proposes to conduct a research project utilizing adult subjects who by
virtue of age, physical impairment, mental impairment, language barrier or any other reason
may not be able to personally execute legally effective informed consent, the HEC shall review
the project on the basis of “risk” and “benefit” and shall determine that each project be assigned
to one of the categories below. This policy does not mean to imply that the requirement for
written documentation of consent is waived. Rather, it applies to those studies in which
third party/surrogate consent is obtained from a legally authorized representative.
Investigators must complete and submit an HEC Form for review and approval of inclusion of
subjects who are decisionally impaired.
Category I - Risks to subjects are minimal, direct benefits may or will accrue to subjects.
Category II - Risks to subjects are minimal, direct benefits will not, or are unlikely, to accrue to
subjects but potential societal benefits are inherent in research.
Category III - Risks to subject are greater than minimal, direct benefits may or will accrue to
subjects.
Category IV - Risks to subjects are greater than minimal, direct benefits will not, or are unlikely,
to accrue to subjects but potential societal benefits are inherent in the research.
HEC RECOMMENDATIONS TO THE ADMINISTRATION

When categorization has been accomplished, the HEC will recommend to the TMC Administration
to consider implementation or non-implementation of the project based upon the level of
benefit to be gained by the individual or society from this project as compared to the level of
risk involved.
It is the intent of the HEC to cause to recommend Category I projects to be initiated.
It is the intent of the HEC not to recommend initiation of any Category IV projects.
Appendix 5: Policy on the Use of Third Party / Surrogate Consent in Research at TMC Page 219
SOP 12/V2
APP6/V1
Policy on Blood Withdrawal for Research Purposes
APPLICABILITY
For many studies where the only research intervention is the collection of blood for analysis, the
HEC categorizes the following procedures for obtaining blood from children and adults as minimal
risk:
A. General Requirements
1. There are no special health reasons (e.g., anemia) to contraindicate blood withdrawal.
2. In patients from whom blood is already being drawn for clinical purposes, there are no other
health reasons to preclude additional blood collection.
3. In subjects from whom blood is not already being drawn for clinical purposes, the withdrawal
method is by cutaneous sticks (e.g., heel or finger) or by standard venipuncture in a reasonably
accessible peripheral vein, and the frequency of punctures does not exceed two per week.
4. The volume of blood drawn from lactating or known pregnant subjects does not exceed 20
ml per week.
5. All blood withdrawals and collections are carried out by experienced professional or technical
personnel.
B. Additional Requirements for Adults (Subjects over 18 years of age)
1. If less than 50 ml is being collected, there are no additional restrictions with regard to
hemoglobin or hematocrit.
2. If a volume greater than 50 but less than 200 ml is being collected for “no-benefit” studies,
hemoglobin levels should be >11.0 g/dl for males and >9.5 g/dl for females with MCVs >85
fl (These restrictions would not apply if iron deficiency anemia or other forms of anemia
were critical for inclusion in the study.).
3. The cumulative volume withdrawn or collected may not exceed 450 ml per twelve-week
period (this maximum includes blood being drawn for clinical purposes) from patients 18
years of age or older in good health and not pregnant.
C. Additional Requirements for Children (Subjects under 18 years of age
1. No more than three (3) skin punctures are to be made in any single attempt to draw blood,
and the frequency of punctures does not exceed twice per week.
2. The volume of blood withdrawn, including blood for clinical purposes, does not exceed the
lesser of 50 ml or 3 ml/kg in an eight week period and collection may not occur more
frequently than 2 times per week.
3. The cumulative volume of clinical and research blood withdrawn per eight-week period
does not exceed six per cent (6.0%) of the child’s total blood volume.
Appendix 6: Policy on Blood Withdrawal for Research Purposes Page 220

SOP 12/V2
4. In patients from whom blood is already being drawn for clinical purposes and when the
research is directly related to the child’s condition, there is no maximum number of extra
volume specimens which can be collected as long as the preceding requirements are met.
5. In subjects from whom blood is not already being drawn for clinical purposes, the maximum
number of allowable separate specimens (again, within the limits of the preceding restrictions)
depends upon the child’s age and whether the research is directly related to the child’s
condition.
D. Cord Blood
Cord blood from newborns can be used without restrictions when blood is extracted from the
placental side of the cord, after it has been clamped and severed.
E. Consent
Oral consent is generally sufficient to collect additional volume (within the limits specified above
for minimal risk) from patients in whom blood is being drawn for clinical purposes.
Appendix 6: Policy on Blood Withdrawal for Research Purposes Page 221

SOP 12/V2
APP7/V1
Guidelines and Policy on Informed Consent
A General Requirements
Except as described below, investigators may not enroll human subjects in research unless
they have obtained the legally effective, written, informed consent of the subject or the
subject’s legally authorized representative, prior to enrollment of the subject in the research.
Investigators are responsible for ensuring that subjects, or their representatives, are given
sufficient opportunity to consider whether or not to participate and must seek to avoid
coercion or undue influence. Information given to potential subjects or their representatives
must be in language that is understandable to the subject or representative. No process of
obtaining consent may include language through which the subject waives any of their
legal rights or releases or appears to release the investigator, sponsor, or institution or its
agents from liability for negligence.
B Elements of Informed Consent

A current sample informed consent document with required phraseology may be found in
Appendix B-2. The sample consent form contains all the required elements of consent. The
HEC requires that all consent forms be written in the first person, e.g., “I understand
that…”. The following are the basic required elements:
1. A statement that the study involves research, an explanation of the purpose of the
proposed research, the duration of the subject’s participation, a description of the
procedures, and which procedures are experimental;
2. The number of subjects that will be involved with the study, totally and at TMC;
3. A description of reasonably foreseeable risks or discomforts that the subjects may
encounter, and, if appropriate, a statement that some risks are currently unforeseeable;
4. A description of possible benefits, if any, to the subject and others which may be
reasonably expected. It should be stated that since it is an experimental treatment or
procedure, no benefits can be guaranteed;
5. A discussion of possible alternative procedures or treatments, if any, which are available
to the subject. One alternative might be to choose not to participate in the research
and this will not affect the usual standard of care;
6. A discussion of how confidentiality of records associated with the subject will be maintained;
7. A description of any compensation or reimbursement for time, inconvenience, travel,
parking, and other similar costs to the subject;
8. A description of any provisions for treatment of or compensation for research related
injury;
9. A statement of whom to contact for answers about the research and in the event there is
a research related injury. (This is generally the PI or another staff member closely
Appendix 7: Guidelines and Policy on Informed Consent Page 222

SOP 12/V2
associated with the study.) A separate contact must be named for questions concerning
the subject’s rights;
10. A statement that the subjects’ participation is voluntary, that refusal to participate will not
involve penalty or loss of benefits to which the subject is entitled, and that the subject
may discontinue participation at any time without penalty or loss of benefits;
11. If appropriate, any circumstances under which the subjects participation may be
terminated, with or without the subjects consent; and
12. A description of additional costs for which the subject will be responsible, that are likely
to result from participation in the research study.
C WAIVER OF INFORMED CONSENT

The HEC may waive the requirements for obtaining informed consent or approve a consent
procedure which does not include, or which alters, some or all of the elements of informed
consent listed above, provided that:
1. The research involves no more than minimal risk to the subjects
2. The waiver or alteration will not adversely effect the rights and welfare of the subjects
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information
after participation.
D DOCUMENTATION OF INFORMED CONSENT

Informed consent must be documented by the use of a written consent form reviewed and
approved by the HEC and signed by the subject or subject’s legally authorized representative.
A copy must be given to the subject or person signing the form. For TMC patients, a copy
of the signed consent form should also be placed in the subject’s medical record. It is
assumed that the consent form is only part of the total consent process in which the
investigator, perhaps using the written consent form as an outline, describes all facets of
the study and answers the subject’s questions. The investigator is responsible for ensuring
that research subjects understand the research procedures and risks. Failure of the
subjects to ask questions should not be construed as understanding on the part of
the subject.
E RECORD RETENTION REQUIREMENTS FOR SUBJECT CONSENT FORMS

1. The PI or project director shall maintain, in a designated location, all executed subject
consents. These consent forms are to be available for inspection by authorized officials of
the HEC, DSMSC, regulatory agencies and sponsors. For DCGI/RA regulated test article
studies, all signed subject consent forms shall be retained by the principal investigator for the
appropriate period(s) specified below.
Drugs: Two (2) years following the date a marketing application is approved or the study is
discontinued.
Devices: Two (2) years after a study is terminated or completed and the records are needed to
support DCGI/ RA approval.
Appendix 7: Guidelines and Policy on Informed Consent Page 223
SOP 12/V2
APP8/V1
Policy for Documentation of Informed Consent
I. INFORMED CONSENT PROCESS

1. Informed Consent of Subject : For all biomedical research involving human subjects, the
investigator must obtain the informed consent of the prospective subject or in the case of
an individual who is not capable of giving informed consent, the consent of a legal guardian.
Informed consent is based on the principle that competent individuals are entitled to
choose freely whether to participate in research or not. Informed consent protects the
individual’s freedom of choice and respect for individual’s autonomy.
When research design involves not more than minimal risk (for example, where the research
involves only collecting data from subject’s records) the HEC may waive off some of the
elements of informed consent.
Waiver of informed consent could also be considered during conditions of emergency.
However, this would be permissible only if HEC has already approved the study or use of
drug. However, the patient or the legal guardian should be informed after she/he regains
consciousness or is able to understand the study.
2. Obligations of investigators regarding informed consent : The investigator has the

duty to –
i. Communicate to prospective subjects all the information necessary for informed consent.
There should not be any restriction on subject’s right to ask any questions related to
the study as any restriction on this undermines the validity of informed consent.
ii. Exclude the possibility of unjustified deception, undue influence and intimidation.
Deception of the subject is not permissible. However, sometimes information can be
withheld till the completion of study, if such information would jeopardize the validity
of research.
iii. Seek consent only after the prospective subject is adequately informed. Investigator
should not give any unjustifiable assurances to prospective subject, which may influence
the subject’s decision to participate in the study.
iv. As a general rule obtain from each prospective subject a signed form as an evidence of
informed consent (written informed consent) preferably witnessed by a person not
related to the trial, and in case of incompetence to do so, a legal guardian or other
duly authorised representative.
v. Renew the informed consent of each subject, if there are material changes in the
conditions or procedures of the research or new information becomes available during
the ongoing trial.
Appendix 8: Policy for Documentation of Informed Consent Page 224

SOP 12/V2
vi. Not use intimidation in any form which invalidates informed consent. The investigator
must assure prospective subjects that their decision to participate or not will not affect
the patient - clinician relationship or any other benefits to which they are entitled.
3. Essential information for prospective research subjects: Before requesting an individual’s
consent to participate in research, the investigator must provide the individual with the
following information in the language he or she is able to understand which should not only
be scientifically accurate but should also be sensitive to their social and cultural context :
i. the aims and methods of the research;
ii. the expected duration of the subject participation;
iii. the benefits that might reasonably be expected as an outcome of research to the subject
or to others;
iv. any alternative procedures or courses of treatment that might be as advantageous to the
subject as the procedure or treatment to which she / he is being subjected;
v. any foreseeable risk or discomfort to the subject resulting from participation in the
study;
vi. right to prevent use of his / her biological sample (DNA, cell-line, etc.) at any time
during the conduct of the research;
vii. the extent to which confidentiality of records could be maintained ie., the limits to
which the investigator would be able to safeguard confidentiality and the anticipated
consequences of breach of confidentiality;
viii. responsibility of investigators;
ix. free treatment for research related injury by the investigator / institution;
x. compensation of subjects for disability or death resulting from such injury;
xi. freedom of individual / family to participate and to withdraw from research anytime
without penalty or loss of benefits which the subject would otherwise be entitled to;
xii. the identity of the research teams and contact persons with address and phone numbers;
xiii. foreseeable extent of information on possible current and future uses of the biological
material and of the data to be generated from the research and if the material is likely
to be used for secondary purposes or would be shared with others, clear mention of
the same;
xiv. risk of discovery of biologically sensitive information;
xv. publication, if any, including photographs and pedigree charts.
The quality of the consent of certain social groups requires careful consideration as their agreement
to volunteer may be unduly influenced by the Investigator.
This is accomplished as part of the total consent process by using a consent form that has been
reviewed and approved by the HEC. Confusion sometimes arises as to who can obtain consent
and who can be designated to sign the consent form. The following are the acceptable methods
for documentation of informed consent of human research subjects at TMC:

SOP 12/V2
1. The HEC must be made aware of the person (s) who will be conducting the consent interviews.
These faculty/staff members should be the only personnel allowed to obtain consent unless
indicated otherwise. The HEC requires that the person obtaining consent is medically trained.
2. Each subject (or their legally authorized representative) must be provided adequate time to
read and review the consent form, in addition to being advised of the procedures, risks,
potential benefit, alternatives to participation, etc. This is frequently accomplished using
the consent form as an outline for the interview process.
3. After completing the consent interview and assuring that the subject (or their representative)
has no further questions and agrees to participate in the research activity, the interviewer
should instruct the subject to sign and date the consent form in the appropriate spaces.
4. A witness must sign and date in the appropriate spaces. The witness cannot be the person
conducting the consent interview, but is not further restricted.
5. The person conducting the consent interview must then sign and date the consent form in
the appropriate spaces (PI or designee). It is assumed that in most cases, all persons
signing the consent form will do so at the conclusion of the consent interview.
6. Each subject (or their representative) must be given a copy of the signed consent form. The
original consent form should be filed in such a manner as to insure immediate retrieval
when required by auditing entities, HEC, or sponsor monitors.
7. The regulations are clear that written documentation informed consent is required. Therefore,
obtaining consent from an authorized third party via the telephone is not acceptable.
8. The regulations also include provisions for approval of a waiver or alteration of part or all
of the consent process. The HEC will consider written requests for waiver or alteration of
the process when accompanied by sufficient justification.
9. Obtaining informed consent from subjects must be accomplished prior to performing the
research activity and using only an HEC approved consent form. Written requests for
amendments to an existing consent form must be approved by the HEC prior to
implementation.
10. Upon receipt of an HEC approved consent form, all old versions should be discarded to
prevent inadvertent use of an outdated consent form. Copies of the most recently approved
consent form may be made and should be used until superceded by an amended consent
form. The consent form must be reviewed at least annually as part of the continuing review
process.

SOP 12/V2
APP9/V1
Health Record Research
The following is the HEC policy concerning research involving the study of medical records or
other forms of health information.
Research projects may involve the study of Patient case files with the stipulations described
below. Such studies raise issues of confidentiality that must be carefully addressed by the
investigator and the official custodian of the records. If it is anticipated that an individual’s
records or specimens will likely be used for research purposes, the potential subject should be
informed of the potential use of such materials upon entry into the institution or program in
which the materials will be developed or collected and be given an opportunity to either
provide or refuse consent to such research. Patient case files may always be used or disclosed
for research purposes if it has been de-identified and linkage back to a specific patient would
not be possible.
To use or disclose identifiable Patient case files without authorization of the research participant,
the investigator must accomplish one of the following:
1) complete and submit an HEC Form to request waiver of the requirements for obtaining
informed consent;
2) provide written documentation that the use of disclosure of patient case files is solely used
to design a research protocol or to assess feasibility of conducting a study, or;
3) Document that the use or disclosure is solely for research on the patient case files of
decedents.
Investigators must maintain in their files a letter from the HEC identifying the date on which the
waiver or alteration of the requirements to obtain informed consent was approved by the HEC,
and a statement that the HEC has determined that the waiver or alteration satisfies the following
criteria:
1) The use or disclosure of patient case files involves no more than minimal risk to the
research participants;
2) The alteration or waiver will not adversely affect the privacy rights and welfare of the
subjects;
3) The research cannot practicably be conducted without the alteration or waiver;
4) The research could not practicably be conducted without access to or the use of the patient
case files;
5) The privacy risks to individuals whose Patient case files is to be used or disclosed are
reasonable in relation to the anticipated benefits, if any, to the individuals, and the importance
of the knowledge that may reasonable be expected to result from the research;
6) There is an adequate plan to protect the identifiers from improper use and disclosure;
Appendix 9: Health Record Research Page 227

SOP 12/V2
7) There is an adequate plan to destroy the identifiers at the earliest possible opportunity
consistent with the conduct of the research, unless there is a health or research justification
for retaining the identifiers, and;
8) There are adequate written assurances that the Patient case files will not be reused or
disclosed to any other person or entity, except as required by law, for authorized oversight
of the research project, or for other research for which the use or disclosure of Patient case
files would be permitted by this policy.
The HEC letter should also contain a brief description of the Patient case files for which use or
access has been determined by the HEC to be necessary, a statement that the waiver or alteration
was approved by Expedited Review or at a convened meeting, and the letter should be signed
by the HEC Chair or the Chair’s designee.
Research use or disclosure of identifiable Patient case files with authorization of the research
participant is permitted providing that use or disclosure is for only the Patient case files that was
originally authorized. In order to use or disclose additional information, the investigator would
either have to obtain consent or request a waiver of the requirements to obtain consent.
Appendix 9: Health Record Research Page 228

SOP 12/V2
APP10/V1
Guidelines for Research Protocols which require

Collection and Storage of Genetics Materials
For the purpose of these guidelines, “Genetic Materials” are defined as human tissue samples
(blood, serum, tumor, etc.) on which genetic related research, such as biochemical studies of
inherited human traits or identification of DNA mutations, may be performed.
A. Previously acquired samples

i. Previously acquired genetic material may be used if identifiers are stripped irrevocably from
samples.
ii. If identifiers are present, experiments not described in present protocols must be submitted
for HEC review.
B. Prospectively acquired samples

1. Anonymous samples (further identification made impossible)
i. Ownership of genetic material will generally remain with the institution. This must be
stated in the consent form.
ii. The general scope of the investigations must be explained in the consent form, but
new avenues of investigation in the future are permissible if this possibility is explained
in the consent form.
iii. Whether the genetic material will be shared by other investigators should be explicit in
the consent form.
iv. The consent form should make clear that no specific information relative to the individual
donor will be forthcoming; however, information that accrues from the study that is
valuable to society may be shared with the individual.
2. Identified samples
i. If genetic material is linked to the donor by specific identifiers, ownership of the
material will generally remain with the institution. If a commercial use is anticipated
for the genetic material, the individual must be notified. The general policy of ownership
should be stated in the consent form using the following wording:
“I understand that additional or “leftover” (blood, serum, tumor, etc.) tissue may be
used for future research which may result in financial gain for TMC and the researchers.
I also understand that my donated tissue will be one of many that are used in the
research and it will be virtually impossible to attribute findings to any one sample. I
understand, however, that I am not otherwise waiving any of my legal rights by
participating in this study.”
Appendix 10: Guidelines for Research Protocols which require Collection and Storage of Genetics Materials Page 229
SOP 12/V2
ii. If identifiers are present, new experiments must be reviewed by the EC and new
consent obtained from the research participant regardless of the details of ownership.
iii. The investigator may include a provision in the consent form for new experiments not
requiring new consent if identifiers are irrevocably removed from the samples. If the
investigator anticipates future experiments without identifiers, this possibility should be
present in the original consent form. The methods for removal of identifiers must be
approved by the EC. Removal of identifiers must not be employed as a method of
avoiding ownership issues.
iv. A satisfactory method for sharing or withholding information gained by the research
must be in the research protocol and clearly indicated in the consent form.
v. Details for sharing or not sharing the genetic material with other investigators must be
present in the protocol and clearly indicated in the consent form.
vi. The length of time the genetic material will be maintained must be indicated in the
consent form.
C. Donation of genetic material as a requirement for participation in a research protocol.
i. Donation of genetic material may be required for participation in a protocol only if the
presence of the genetic material is necessary to satisfy the central question of the
research.
ii. The investigator will be required to make a clear case in the research protocol for the
necessity of the genetic material, if donation of genetic material is mandatory.
iii. This policy applies to genetic material with or without identifiers.APP11/V1
Appendix 10: Guidelines for Research Protocols which require Collection and Storage of Genetics Materials Page 230
SOP 12/V2
APP11/V1
Guidelines for Submission and HEC review of Gene Therapy /

Gene Transfer Protocols
As of October 10, 2000 the ICMR formulated Ethical Guidelines for Biomedical Research on
Human Subjects. ICMRs goal is to insure that no research participant is enrolled in a human
gene therapy/gene transfer research protocol before the local HEC have the benefit of the broad
perspective and experience in protocol review and risk assessment.
In November 2001, the Department of Biotechnology also finalised the Ethical Policies on the
Human Genome, Genetic Research and Services.
Guidelines are available at the Office of Biotechnology Activities Internet site http://dbtindia.nic.in/
ethical.html
The following items are required to be addressed in the protocol to provide the necessary
information for HEC review:
A. Background and justification

i Why is this disease a good candidate for gene transfer or gene therapy?
ii What previous work has been done, including studies of animals and cultured cell models?
Does the work demonstrate effective gene delivery? How does the proposed study relate to
previous work?
iii Is the disease course sufficiently predictable to allow for meaningful assessment of the
results of the treatment proposed?
iv What level of gene expression is presumed to be required to achieve the desired effect?
v Given responses to the above questions, is there a sufficient justification for the investigator
to proceed at this point to a clinical trial?
B. Research design
i What are the objectives of the proposed study (e.g., establishing feasibility or relative safety
of the gene transfer, determining therapeutic effectiveness, establishing a safe dose range,
demonstrating proof of principle, etc.)?
ii Is the goal of the study to ameliorate or cure disease or to enhance healthy individuals?
iii What is the target tissue for gene transfer (e.g., bone marrow cells, skeletal muscle cells,
respiratory epithelial cells, central nervous system tissue, etc.)?
iv What method(s) (e.g., direct injection, inhalation, ex vivo genetic modification with injection
of modified cells) and reagent(s) (e.g., vectors based on retroviruses, adenoviruses, adeno-
associated viruses, herpes viruses) will be employed for gene delivery? What is the rationale
Appendix 11: Guidelines for Submission and EC review of Gene Therapy / Gene Transfer Protocols Page 231
SOP 12/V2
for their use? Are other methods or reagents known that are more appropriate with regard to
efficacy, safety, and stability?
v How will the investigator determine the proportion of cells that acquires and expresses the
added DNA?
vi How will the investigator determine if the product is biologically active?
vii Is the planned statistical treatment appropriate: i.e., is it likely to provide valid answers to
the study question?
viii Is it reasonable to expect that the research design proposed will meet the investigator’s
objectives?
C. Procedures
i What research-specific procedures and research-specific investigations are required by the
study over and above those that would be required for patients receiving standard clinical
care (e.g., physical examinations, venous or arterial blood tests, collection of target cells,
imaging procedures, irradiation, chemotherapy, direct injection of vector, re-injection of
genetically modified cells, organ or tissue transplantation, surgery, tissue/tumor donation,
questionnaires, interviews)?
ii Is long term follow-up appropriate or essential for this protocol? If long term follow-up is
proposed, is there justification for the number of visits and the length of time required? Is
such follow-up feasible in the case of this protocol (e.g., have provisions been made for
subjects who move? Is adequate funding available for such follow-up?)?
iii What are the procedures for obtaining or maintaining information in a data/DNA bank (e.g.,
use of identifiers, limitation on access, need for consent, sharing with other investigators,
duration of storage, future subject contact)?
iv Are all of the research-specific procedures necessary? In combination with data collected in
the course of clinical care, is it reasonable to expect that the information produced by this
study will be sufficient to answer the research question?
D. Confidentiality
i Are the practical steps for maintaining confidentiality of data/records/database information
clearly specified and adequate (e.g., encryption, use of unique identifiers, sequestering of
records, security measures)?
E. Subject selection
i How has the study population been defined?
ii Has an adequate rationale been provided for each eligibility criterion (e.g., safety considerations,
definition of disease, avoidance of additional concurrent therapies, administrative
considerations)? Do they strike a defensible balance between scientific validity and
generalizability (i.e., is the study population sufficiently, but not unduly, restricted so as to
yield interpretable results)?
iii How will subjects be recruited? If a cohort of eligible patients exists, how will selection be
made amongst them? If several trials exist for which the same patients are eligible, how will
this be presented to prospective subjects?
SOP 12/V2
iv Does the definition of the research population reflect appropriate scientific, clinical, and
ethical norms? In recruiting and negotiating with potential subjects, have the norms of
nondiscrimination been respected?
F. Risks, discomforts, and benefits

i What risks and discomforts are associated with the research-specific procedures and
investigations (e.g., surgery, chemotherapy, radiation, bone marrow transplantation)? Have
they been minimized?
ii If a virus-mediated gene transfer is proposed, what is the potential for the presence of a
replication-competent or pathological virus or other form of contaminants? How sensitive
are the tests to detect such viruses or contaminants? What level of viral presence or other
form of contamination would be tolerable in this protocol?
iii Has the possibility of vertical transmission (i.e., gene insertion into germ cells or a fetus) or
horizontal transmission (e.g., to family members or health care staff) been considered?
What measures have been taken to minimize the risks of transmission? Are other measures
possible? If transmission were to occur, what would be the consequences?
iv What are the risks for the vector to activate an oncogene or inactivate a tumor suppressor
gene leading to vector-related malignancy?
v Are the risks and discomforts of the study justified given the potential benefit to subjects and
the scientific importance of the research?
G. Information to subjects
Have prospective participants been adequately informed of the following:
1. What is being studied and why, giving details about study procedures, known or potential
risks, discomforts and benefits, and alternatives to participation;
2. Their rights: (a) to information on an ongoing basis, confidentiality with regard to their
participation and handling of their data, and the right to consult with others before
making a decision whether to participate; and (b) to withdraw from the study without
penalty or loss of benefits, as well as of any health consequences of withdrawal for
themselves or their immediate contacts, or limitations on withdrawal, if any;
3. Any special issues related to this gene therapy trial, such as uncertainty associated with
short and long term risks and benefits or the possibility of media attention; and
4. Any commercial or financial interests in the research.
Have prospective participants been provided this information in simple language, using
translation where necessary, with answers to their questions, referral to other sources of
information, and adequate time to make up their minds whether to participate?
If there is no individual benefit from participation in the research, has this been appropriately
disclosed?
Will the general study results be made available to subjects?
Do all of the elements of the consent process combine to allow subjects a full opportunity
to make an informed choice?
Reference: Ethical Guidelines for Biomedical Research on Human Subjects ICMR 2000
SOP 12/V2
APP12/V1
Recommended Terms for use in Consent Forms
To facilitate understanding of consent forms by the subject, it is recommended that the language
used is at a reading level of an 12 year old. The following lay terms, definitions and suggestions
are recommended to help investigators in this process.
abdominal the body cavity containing the stomach, intestines, liver, and other
organs
acute new; recent; sudden
adjuvant helpful; assisting; aiding
adverse effect bad side effect
agitation Upset
allergic reaction itching and swelling; rash; trouble breathing
ambulate (-ation –ory) walk; able to walk; ability to walk
Ameliorate make smaller or less, reduce
analgesia pain relief
anaphylactic reaction a severe and sometimes dangerous reaction which may cause problems
breathing, fainting, itching and skin rash
anemia low red blood cell count
anesthetic (local) a drug used to decrease the feeling of pain by numbing an area of the
body, without putting you to sleep
anesthetic (general) a drug used to decrease the feeling of pain or eliminate the feeling of
pain by putting you to sleep.
anorexia lack of appetite
arrhythmia abnormal heartbeat
aspiration removal by using a sucking machine; fluid entering the lungs
asymptomatic without symptoms; having no symptoms
barrier method diaphragm and condom (with spermicide), cervical cap, or sponge
benign not malignant; usually without serious consequences
bolus an amount given all at once
bradycardia slow heartbeat
carcinogenic capable of causing cancer
carcinoma a type of cancer
cardiac heart
catheter a tube in a vein for withdrawing or putting fluids into my blood
central nervous system the brain and spinal cord
cerebral the brain; of the brain
cessation stopping
Appendix 12: Recommended Terms for use in Consent Forms Page 234
SOP 12/V2
CHD coronary heart disease; heart disease
chemotherapy treatment of a disease, usually cancer, with chemical agents
chronic continuing for a long time
clinical status state of health, how you are doing and feeling
Clinical trial an experiment in patients
completed Done
congenital Occurring prior to birth, due to parent’s genetic input
conjunctivitis irritation and redness of the thin covering of the eye
Consequences result or effects
controlled trial study in which the experimental treatment is compared to a standard
treatment
conventional therapy standard treatment
coronary pertaining to the blood vessels that supply the heart
CT (CAT) scan computerized series of x-rays
cutaneous relating to the skin
Culture take a sample of blood, fluid, or tissue to see if bacteria or viruses can
be found in it
dehydration loss of fluids
dermatologic pertaining to the skin
diastolic the lower number in a blood pressure reading
dilation expansion or stretching
discomfort pain; uncomfortable feeling
disseminated widely-spread, all through the body
distal toward the end; away from the center of the body
diuretic water pill; drug that causes an increase in urination
double-blind neither the subject nor physician can know what is beinggiven
dysfunction improper function
dysplasia abnormal cells
echocardiogram sound wave test of the heart
edema fluid in the tissues; puffiness; swelling
efficacy producing a positive result
electrocardiogram heart test; tracing of heartbeat or heart rhythm
emesis vomiting
endoscopic examination of the inside of the body with a lighted tube
epidural outside the spinal cord
eradicate get rid of
Erythrocyte red blood cell
FDA Food and Drug Administration; the branch of the government that
approves new drugs
fibrillation irregular heartbeat
fibrous like scar tissue
SOP 12/V2
gastrointestinal stomach and intestines
granulocyte white blood cell
hematocrit number of red blood cells
hematoma bruise; black and blue mark
holter monitor portable machine for recording heartbeats
hormonal therapy treatment with hormones
hypertension high blood pressure
hypotension low blood pressure
hypoxia low oxygen level in the blood
immunosuppressive a drug or therapy that reduces the body’s ability to fight infection;
helps prevent rejection of a transplanted organ
incidence number of times it happens
infarct death of tissue due to loss of blood flow
infectious occurrences infections
inflammation swelling which is usually painful, red and warm
infusion putting a substance into the body, usually into the blood
intravenous putting it into the vein
intubate the placement of a tube into the airway
ischemia decrease in oxygen in a tissue, usually because of decreased blood
flow
lactating producing milk
laparotomy a procedure where an incision is made in the abdominal wall to
enable a physician to look at the organs
lethargy sleepiness; lack of energy
lumen cavity of an organ; inside a blood vessel
lymphocyte a type of white blood cell important for defense against infections
Malaise feeling bad; a feeling of bodily discomfort
malignancy cancer which usually spreads and may be fatal if not successfully
treated
marrow suppression decreased growth of the bone marrow
metastasis spread of cancer cells from one part of the body to another
monoclonal antibody very specific, purified antibody
morbidity sickness/illness
mortality death
motility the ability to move
MRI pictures of the body created using magnetic rather than x-ray energy
murine obtained from mice
myalgia muscle aches
myocardial infarction heart attack
nasogastric tube a tube from the nose to the stomach
necrosis death of tissue
SOP 12/V2
neoplasia a tumor that may be cancerous or non-cancerous
neural brain or nerves
neutropenia decrease in white blood cells
non-invasive not breaking, cutting or entering the skin
obviate to prevent
occlusion closing; obstruction
occult blood test testing a stool sample for trace amounts of blood
Oncology the study of tumors or cancer
Ophthalmic pertaining to the eye
orthopedic pertaining to bones
osteoporosis bone disorder resulting from loss of bone leading to increased risk of
fracture
ovaries female sex glands that release the egg cells
pancytopenia low number of blood cells
percutaneous through the skin
perforation puncture, tear or hole
phlebitis irritation or inflammation of a vein
placebo inactive medication; dummy pill; sugar tablet; containing no medication
platelets blood cells that help the blood clot normally
post- after
prenatal before birth
probability chance
prognosis outlook, probably outcomes
prophylaxis A drug given to prevent disease or infection
prosthesis artificial body parts, such as arms, legs, hips
proximal closer to the center of the body, away from the end
psychosis major psychiatric problem
pulmonary pertaining to the lungs
QID four times a day
Radiotherapy treatment with radiation
randomly assigned similar to the toss of a coin; assignment to a treatment group by
chance
recur happen again
refractory not responding to treatment
regimen pattern of giving treatment
relapse return or reappearance of a disease
remission disappearance of evidence of cancer or other disease
renal kidney
resect remove or cut out surgically
respiratory failure lung failure; stop breathing
SOP 12/V2
somnolence sleepiness
staging a determination of the extent of the disease
stenosis narrowing of a duct, tube, or blood vessel
stratify arrange in groups by age, sex, etc., for analysis
subcutaneous under the skin
subsequent another, next
supine lying on the back
symptomatic having symptoms
syndrome a condition with a certain set of symptoms
systolic the top number in blood pressure
tachycardia fast heart beat
taper decrease; reduce
therapy treatment
thrombosis to get or have a blood clot in a blood vessel
titration gradual alteration of a drug dose to get the desired effect
topical applied to the skin
toxicity harm; problem; poisoning; unwanted side effect
transdermal through the skin
transient short-term; brief
trauma injury; wound
trial study
uptake taking a substance into the body and the cells
uremia kidney failure
varices enlarged veins, usually in the legs or lining of the tube connecting the
mouth to the stomach
vasodilation widening of the blood vessels
vasospasm narrowing of blood vessels due to a spasm of the vessel walls
vehicle preparation placebo cream; inactive preparation
venipuncture taking blood from the vein
via by
waive give up

SOP

Uploaded by

Copyright:

Available Formats

SOP

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

SOP

Uploaded by

Copyright:

Available Formats

Standard Operating Procedures

Human Ethics Committee

Tata Memorial Centre

S. No. Title Pg. Nos.

1. List of Acronyms xiv-xv

Chapter 1 Preparing Standard Operating Procedures (SOPs): 5

Contents Page iii

AX 3 V1/SOP01/V1 Document History of the SOP 15

Chapter 2 Constitution of Human Ethics Committee, TMC 21

Chapter 3 Management of Protocol Submissions 41

Chapter 4 Initial Review of Submitted Protocol 77

4a.3 Categorization of protocols 79

Chapter 4b Expedited Review of Submitted Protocol 93

Chapter 4c Exemption from the Ethical Review for Research Projects 99

Chapter 5 Agenda Preparation, Meeting Procedures and 109

Contents Page vii

Chapter 6 Review of Amended protocol / Protocol related documents 123

Chapter 7 Continuing review of study Protocols 131

Contents Page viii

7.4.7 Prepare meeting agenda 135

Chapter 8 Reporting of Protocol Deviation / Non-Compliance / Violation / 145

Chapter 9 Review of Serious Adverse Events (SAE) Reports 153

9.4 Detailed Instructions 155

Chapter 10 Maintenance of Active Project Files, Archival of Closed Files 167

Chapter 11 Documentation of the HEC activities 175

Chapter 12 Review of study completion reports 179

Chapter 13 Management of Premature Termination / Suspension / 185

Chapter 14 Request for Waiver of Written Informed Consent 191

Chapter 15 Site Monitoring 199

Contents Page xii

Chapter 16 Dealing with participants / patients requests and complaints 207

Contents Page xiii

Acronym Full Title/Description

AAHRPP Association for the Accreditation of Human Research Protection Programs

List of Acronyms Page xiv

List of Acronyms Page xv

Dr. Medha Joshi (Member Secretary HEC-II)

Dr. Sangeeta Desai (Member Secretary HEC-I)

Ms. Abhidnya Kandalkar (IRB Jr. Administrator)

Ms. Shirin Bharucha (Chairperson HEC I)

Dr. Urmila Thatte (Chairperson HEC-II)

Dr. R. A. Badwe, Director, TMC

Dr. Geeta Koppikar, Co Chairperson

Dr. R.C. Mistry, Member

Dr. Nithya Gogtay, Member

Mr. Gul Kripalani, Member

Ms. Viji Venkatesh, Member

Ms. Mrunal Marathe, Member

Dr. Pradnya Talawadekar, Member

Dr. S. K. Shrivastava, Member

Dr. S. D. Banavali, Member

Dr H.K.V. Narayan, Member

Dr. Parul J. Shukla, Member &

Dr. A. Gajiwala, Member

Dr. Vikram Gota, Alternate Member

Dr. R. F. Chinoy, Co-Chairperson

Dr. V.R. Joshi, Member

Dr. R. Munagekar, Member

Mr. P.K. Rao, Member