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Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

JAN 2.6 2021

ADMINISTRATIVE ORDER
No. 2021001)
-_

SUBJECT: Implementing Guidelines of Section 35 of the Republic Act No. 11223,


otherwise known as
the “Universal Health Care Act’, on Standards on Receipt,
Assessment, and Management of
Conflict of Interest

I. BACKGROUND AND RATIONALE

Section 15, Article I] of the 1987 Philippine Constitution provides that it


is the policy of
the State “to protect and promote the right to health of the people and instill health consciousness
among them.” To further this State Policy, in 2019, the Congress enacted R.A. 11223, or the
Universal Health Care (UHC) Act, which is an extensive reform of the health care system in the
country. It aims to progressively realize universal health care in the country through a systematic
approach and clear delineation of roles of key agencies and stakeholders towards better
performance in
the health system. Also, it ensures that all Filipinos are guaranteed equitable access
to quality and affordable health care goods and services and protected against financial risk.

Section 35 of the UHC Act mandates that the implementation of the law shall be
strengthened by commitment of all
stakeholders to abide by ethical principles in public health
practice. This shall be achieved through (1) a Conflict of Interest (COI) declaration and
management policy; (2) tracking of financial relationships between health and health-related
commodity manufacturers, healthcare providers and health professionals; and (3) the constitution
of a Public Health Ethics Committee.

Under the law’s IRR, all stakeholders involved in policy-determining activities at all levels
of policy-making are required to act in a manner that shall serve the public’s best interest and thus
are required to disclose and manage any real or perceived conflicts of interest. As such, Section
35.3 of the same directs the DOH
and management
to
issue guidelines that specify standards for receipt, assessment,
of declared COI.
Together with this Order, the following Orders are to be issued: (1) Creation of the Public
Health Ethics Committee (PHEC), and Guidelines on the Public Health Ethics Review, and (2)
Guidelines for the tracking of financial relationships between health and health-related commodity
manufacturers, healthcare providers, and health professionals.

In order to strengthen the implementation of the existing issuances and standardize the
procedures across the
all implementing agencies of the UHC Act, this Order is hereby promulgated
to provide the guidelines on the standards of disclosure, receipt, assessment and management of
{

4
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 Local 1113, 1108, 1135
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: [email protected]
COls, which shali be applicable to all persons involved in the policy-determining activities of the
said law.

Il. OBJECTIVE

To provide a clear, specific, and standard process in the declaration and management
COI of all persons involved in the policy-determining activities of the implementing agencies and
of
advisory bodies/committees of the UHC Law in order to ensure integrity and impartiality in
decisions, as well as to address potential graft and corruption practices.

Iii. SCOPE OF APPLICATION


This Order shall apply to all decision makers, policymakers, employees, personnel under
Contract of Service (COS), and consultants involved in the design, institutionalization, financing,
implementation and evaluation of public health policies, plans and programs in
all agencies and
advisory bodies/committees implementing the UHC Act, such as, but not limited to, the Health
Technology Assessment Council (HTAC), Price Negotiation Board (PNB), their secretariat, and
resource persons.

IV. DEFINITION OF TERMS

A. Conflict of Interest — refers to acts or omissions constituting a conflict of interest under


existing laws and civil service rules, including international treaties where Philippines is a
signatory. It is a situation created when persons or entities in the public and/or private
sectors involved in conducting research, making recommendations and decisions have
substantial interest — personal, financial or any other interest — that may influence their
policy-determining activities at all levels.

For the purpose of this Order, this shall mean either:


a. Financial Interest, such as, but not limited to, employment, consultancy, and shares
in a business that is being regulated by the DOH of persons covered under this
Order
or any
of their relatives as defined herein; OR
b. Affiliation/relationship/non-financial interest in a business or organization that can
reasonably affect or perceived to impair a person’s ability to be impartial and act in
the best interests of the government.

B. COI Management Plan - refers to a document describing the methods for mitigating or
eliminating identified actual or potential COI.

C. Covered Individuals — refers to the individuals as enumerated under Section III Scope
and Coverage of this Order.

D. Declaration of Conflict of Interest Form - the standard form that will be used for persons
covered under this Order to disclose any and all conflicts of interest. (Annex A)
4)
2 4
. Financial Interest - any monetary interests gained for the past 5 years; i.e. salary or other
payments for services or equity interests such as stocks, stock options, intellectual property
rights, among others.

. Full Participation - the extent of participation where a member will be


take part in all activities and decision-making processes.
allowed to actively
. Intellectual Interest - personal views or moral conviction on the importance of a particular
area or topic that can influence the scientific opinions of other people.

. Head of the Advisory Body — refers to the head/chair of the independent advisory body
created pursuant to the UHC Acct, such as, but not limited to the HTAC and PNB.

Head of Agency — refers to the Secretary of a Government Agency tasked to implement


any the provision of the UHC Act, such as, but not limited to the Department
of of
Science
and Technology (DOST), Department of Education (DepEd), and Professional Regulation
Commission (PRC). Itshall also refer to the head of a DOH-attached agency, hospital, or
health facilities, such as, but not limited to the Food and Drug Administration (FDA), and
PhilHealth.

. Head of Office — refers to the head of office in a Government Agency identified to


implement any of the provision of the UHC Act.

. Non-Financial Interest - refers to any non-monetary interest, e.g., career or personal


advancement that may be perceived as unduly influencing one’s judgment.

. Originating Office — refers to all agencies, bodies, or committees tasked to implement any
of the provisions in the UHC Act.

. Partial Participation - the extent of participation where a member will be allowed to


actively take part only certain parts of activities and decision-making process subject
in to
the approval of the members who have full participation.

. Policy-determining Activities refers to actions taken



in
aid of public policy development
leading to impartial decisions in adopting and implementing a policy option or policy
recommendation using the best available evidence. These include drafting, reviewing,
coordinating with stakeholders, documenting and other similar tasks that facilitate policy
development.

. Relatives - those related within the fourth civil degree of consanguinity (relationship by
blood) or affinity (relationship by marriage) as defined in RA No. 6173, otherwise known
as the “Code of Conduct and Ethical Standards for Public Officials and Employees.”

. Total Exclusion - refers to a situation where the member will not be allowed to take part
in the deliberation and decision-making processes.

\
Q. 201 File — refers to a set of documents containing a person’s comprehensive profile, which
is in the custody of the Personnel and Administrative Division (PAD) or the Human
Resource Office of the concerned Office.

V. GENERAL GUIDELINES

A. The covered agencies, offices, and advisory bodies/committees shall ensure the disclosure
and management of COIs in

all
its policy-determining activities to safeguard professional
integrity and preserve public trust while sustaining the collaboration with private
stakeholders.

B. Each covered agency, office, and advisory body/committee shall develop their guidelines
in receiving, evaluating and managing declared COIs according to the standards set forth
in this Order. They shal! each create their own COI Management Plan for all
identified
actual or potential COI according to the format prescribed by the PHEC.

C. All heads of covered offices shall ensure the disclosure and management ofactual or
potential COIs of persons under their supervision that are involved in any level of
policy-
making. They shall ensure that all covered persons under their offices shall fill-out a
Declaration of Conflict of Interest Form (Declaration Form) under Annex A.

D. The Heads of Agencies covered under this Order shall identify which offices in their
respective agency is tasked to implement any of the provisions of the UHC Act.

E. All persons covered under this Order shall accomplish a Declaration Form, and update such
form as may be necessary. They shal! report any financial, non-financial, or any other
interests relevant to their function in which they have been asked to participate, as well as
any interest that could be affected by the outcome of their function. A list of the reportable
financial and non-financial is provided herein under Annex B. The list provided is not an
exclusive list.
F. The Head of Office/Agency/Advisory Body shall be responsible in (1) preparing the COI
Management Plan of such office, (2) receiving the Declaration Form of all covered
individuals in such office, (3) ensuring completeness of the Declaration Form prior to
submission to the PHEC Secretariat, and (4) submission of COI documents to the PHEC
Secretariat. ~

G. Notwithstanding any declaration made, all individuals covered under this Order shall
promptly disclose any circumstance that could result in potential COI related to their
functions in which they will be engaged, and cooperate in the management such.of
H. Any doubt as to whether there exists a conflict or not shall be brought to the PHEC for
assessment.

4 4
I. The PHEC shall recommend the appropriate course of action based on their review of the
Declaration Forms, the corresponding COI Management Plan, and other supporting
documents.

J. This Order shall be reviewed every after two (2) years following its effectivity to determine
any need for revision.

VI. SPECIFIC GUIDELINES/IMPLEMENTING MECHANISMS

|
A. Declaration and Management of Conflict of Interest in the DOH

exci
CONCERNED HEADS
OFFICES
OF
|» PHEC
SECRETARIAT » PHEC

1. All covered individuals shall complete the Declaration Form where they must disclose any
financial, non-financial, or any other interests relevant to their function in which they have
been asked to participate, as well as any interest that could be affected by the outcome of
their function. Non-completion and non-disclosure of all relevant information from the
Declaration Form may be subject to administrative sanctions or a valid cause for pre-
termination of contract, as the case may be.
2. They shall also declare, to best of their knowledge, substantial interests (financial, non-
financial or any other interests) of their relatives up to the fourth (4") civil degree of
consanguinity or affinity as defined under this Order that may be perceived as unduly
influencing their judgment.

3. The Declaration Form shall be accomplished in three (3) copies. It shall! then be submitted
to their respective Heads of Office within ten (10) days from effectivity of this Order, or
from the date of the person’s employment or engagement of his/her services.

4. The Head of Office shall collect all the Declaration Forms and Summary Reports of all the
covered individuals in the respective office. He/She shall be responsible in transmitting the
same to the PHEC Secretariat.

5. The Head of Office shall ensure completeness of the Declaration Forms prior to submission
to the PHEC Secretariat.

6. The Head of Office shall also prepare a Summary Report in three (3) copies indicating any
personnel/employee with declared conflict and an initial assessment as to whether such
conflict is significant, generally permissible or not significant.

7. The Head of Office shall retain one (1) copy of the Declaration Forms and Summary Report
in their records. He/She shall transmit one (1) copy of the same to the Personnel
(
4I
Administrative Division (PAD, for inclusion in the 201 File of covered individuals, and
one (1) copy to the PHEC Secretariat.

8. Should the Head of Office himself/herself have COI, he/she must immediately report the
COIto the PHEC, through the PHEC Secretariat, for assessment and management such of
conflict.

9. Covered individuals with declared COIs shall promptly inform the PHEC Secretariat,
through the Head of Office, of any change of information prior to the course of carrying
out their functions.

B.Declaration and Management of Conflict of Interest in DOH Attached Agencies, Hospitals


and Health Facilities, and Agencies Outside DOH

CONCERNED
INDIVIDUAL |»| HEADS OF
OFFICES |»| HEADS OF
AGENCY
BD
PHEC
secretariat
| PHEC

1. The Head of Agency, which


offices within its Agency.
is the over-all officer-in-charge, shall determine the covered
2. All covered individuals shall complete the Declaration Form where they must disclose any
financial, non-financial, or any other interests relevant to their function in which they have
been asked to participate, as well as any interest that could be affected by the outcome of
their function. Non-completion and non-disclosure of all relevant information from the
Declaration Form may be subject to administrative sanctions or a valid cause for pre-
termination of contract, as the case may be.
3. All covered individuals shall also declare, to best of their knowledge, substantial interests
(financial, non-financial or any other interests) of their relatives up to the fourth (4") civil
degree of consanguinity or affinity as defined under this Order that may be perceived as
unduly influencing their judgment.

4. The Declaration Form shall be accomplished in three (3) copies. It shall then be submitted
to their respective Heads of Office within ten (10) days from effectivity of this Order, or
from the date of the person’s employment or engagement of his/her services.

5. The Head of Office shall collect all the Declaration Forms and Summary Reports of all the
covered individuals in the respective office. He/She shall be responsible in transmitting the
sameto the respective Head of Agency.

6. The Head of Office shall ensure completeness of the Declaration Forms prior to submission
to the Head of Agency.
7. The Head of Office shall also prepare a Summary Report in three (3) copies indicating any
personnel/employee with declared conflict and an initial assessment as to whether such
conflict is significant, generally permissible or not significant.

8. The Headof Office shall retain one (1) copy of the Declaration Forms and Summary Report
in their records. He/She shall transmit one (1) copy of the same to the personnel division
of the concerned office for inclusion in the 201 File of covered individuals, and one (1)
copy to the Head of Agency, which shall then be submitted to the PHEC Secretariat.

9. The Head of Agency shall collect all the Declaration Forms and Summary Reports from
the concerned Heads of Offices. He/she shall be responsible for the submission of the
Agency’s COI Summary Report and the attached Declaration Forms to the PHEC
Secretariat.

10. The Head of Agency shail report to the PHEC Secretariat all identified COIs under the
agency.

11. Should the Head of Office/A gency himself/herself have conflict of interest, he/she must be
immediately report the COI to the PHEC, through the PHEC Secretariat, for assessment
and management of such conflict.

C. Declaration and Management of Conflict of Interest in the Independent Advisory Bodies


HEADS OF
CONCERNED
INDIVIDUAL AOpY
PHEC
SECRETARIAT » PHEC

1. All covered individuals shall complete the Declaration Form where they must disclose any
financial, non-financial, or any other interests relevant to their function in which they have
been askedto participate, as well as any interest that could be affected by the outcome of
their function. Non-completion and non-disclosure of all relevant information from the
Declaration Form may be subject to administrative sanctions or a valid cause for pre-
termination of contract, as the case may be.

2. They shall also declare, to best of their knowledge, substantial interests (financial, non-
financial or any other interests) of their relatives up to the fourth (4) civil degree of
consanguinity or affinity as defined under this Order may be perceived as unduly
influencing their judgment.

3. The Declaration Form shall be accomplished in three (3) copies. It


shall then be submitted
to the Head of Advisory Body within ten (10) days from effectivity of this Order, or from
the date of the person’s employment or engagement of his/her services.

4
/
The Head of Advisory Body shall collect all the Declaration Forms and Summary Reports
of all the covered individuals in the respective office. He/She shall be responsible in
transmitting the same to the PHEC Secretariat.

The Head of Advisory Body shall ensure completeness of the Declaration Forms prior to
submission to the PHEC Secretariat.

The Head of Advisory Body shall also prepare a Summary Report in three (3) copies
indicating any personnel/employee with declared conflict and an initial assessment to as
whether such conflict issignificant, generally permissible or not significant.

The Head of Advisory Body shall retain one (1) copy of the Declaration Forms and
It
Summary Report in their records. shall transmit one (1) copy of the same to the Personnel
Division of such office for inclusion in the 201 File of covered individuals, and one (1)
copy to the PHEC Secretariat.

Should the Head of Advisory Body have conflict of interest, he/she must immediately
report the COI to the PHEC, through the PHEC Secretariat, for assessment and
management ofsuch conflict.

Covered individuals with declared COIs shall promptly inform the PHEC Secretariat,
through the Head of Advisory Body, of any change of information prior to the course of
carrying out their functions.

D. Management of Conflict of Interest


1. The management of COI shall apply to financial, non-financial, and all other interests of
all individuals or institutions involved in the design, implementation and evaluation of
public health policies and programs.

The deliberation or decision-making process shall follow the Public Health Ethics Review
Process set forth in the PHEC Guidelines.

. The covered individual’s participation in a deliberation or decision-making process shall


be categorized to: Full Participation, Partial Participation, or Total Exclusion.

The covered individual whose participation is categorized as full or partial participation


shall proceed with the deliberation or decision-making process. Meanwhile, those which
are categorized as total exclusion shall be prohibited to participate or be present in the
deliberation process.

. The covered individual with partial participation shall be allowed to be present during the
deliberation proceedings. However, only members with full participation shall vote to
make the final recommendations with respect to the issue/topic under deliberation.

14
“4
VII. Roles and Responsibilities

A. Head of Office or Advisory Body

Prepare a COI Management Plan for the respective Office;


Provide copies of the Declaration Forms to
the covered individuals;
Collect the Declaration Forms;
AwWPYWNS

Ensure completeness of the Declaration Forms submitted to them;


Prepare a Summary Report of all declared COIs;
Retain a copy of the Forms and Summary Report for safekeeping and future
reference;
7. Transmit 1 copy to PAD, or Personnel Division of the office, as the case may be,
for inclusion in the 201 File of covered individuals; and
8. Transmit 1 copy to the Head of Agency, in case of Agencies outside DOH, or the
PHEC Secretariat, in case of DOH Offices and Independent Advisory
Bodies/Committees outside DOH.

B. Head of Agency

Identify the covered offices under the agency;


Prepare a Summary Report of all declared actual or potential COIs of the Agency;
Report to the PHEC Secretariat all identified COIs under the agency;
ePwWN?r

Submit to the PHEC Secretariat the following:


a. COI Management Plan of the covered offices;
b. Declaration Forms; and
c. Summary Report.

C. PAD/ Personnel Division of the Office

The PAD or
the Personnel Division/Unit of the Office concerned shall retain a copy
of the Declaration Forms for inclusion in the 201 File of covered individuals.

Vil. PENALTY CLAUSE


The following acts/omissions may be sanctioned in accordance with any of the existing
laws and rules, such as but not limited to:

1. Any falsification made in the Declaration Form and/or Summary Report punishable under
the Revised Penal Code of the Philippines; and

Any
of theacts/omissions punishable under Revised Rules on Administrative Cases in the
Civil Service.

,/
VIII. REPEALING CLAUSE

Department Order No. 2017-0332 titled: “Guidelines on the Disclosure and Management
of Conflict of interest in Relation to the use of Pharmaceutical Products and Medical Devices” is
hereby repealed by this Order. Meanwhile, all other issuances whose provisions are inconsistent
with this Order are hereby repealed.

IX. EFFECTIVITY

This Administrative Order shall take effect after fifteen (15) days following the completion
of its publication in a newspaper of general circulation, and its submission in the Office of the
National Administrative Register (QNAR) of the UP Law Center.

QUE HI, MD, MSc


Secgetary of Health

10
ANNEX A

DECLARATION OF CONFLICT OF INTEREST


1. CURRENT FINANCIAL INTERESTS
To the best of your knowledge, do 1) you or any of your relative within the fourth (4") civil degree, by affinity or consanguinity, 2) organization in which you serve as an
officer, director, trustee, general partner, or employee and/or 3) entity with whom you are
negotiating or have any arrangement concerning prospective employment have
any current involvement or financial tink with any policy determining activity of the office/agency/advisory body/committee:

a. INVESTMENTS (e.g. stocks, bonds, retirement plans, trust, partnerships, sector O NONE
(/f “none”, skip to Item b.)
funds, etc.)
CHECK PERCENTAGE NET WORTH
OWNER
ESTABLISHMENT INVESTMENT OF SHARES CURRENT VALUE LESS MORE
if spouse, etc.)
(self, t THAN 5-15% THAN
5% 15%

b. EMPLOYMENT (Full or Part Time) (Current or Under Negotiation) O NONE


(if “none”, skip to Item c.)
DATE EMPLOYMENT OR
ESTABLISHMENT RELATIONSHIP POSITION IN FIRM
NEGOTIATIONS BEGAN

c. CONSULTANT/ADVISOR (Current or Under Negotiation) D NONE


(if “none”, skip to Item d.)
RELATED TO LISTED
DATE DATE PRODUCTS/
ESTABLISHMENT TOPIC/ISSUE AMOUNT RECEIVED
FROM To INDICATIONS/
ISSUES

d. CONTRACTS/GRANTS (Current or Under Negotiation) O NONE


(If “none”, skip to Item e.)
AMOUNT OF RELATED TO
TYPE OF PRODUCT UNDER REMUNERATION TO LISTED
TIME YOUR
AGREEMENT STUDY AND SPONSOR* AWARDEE PRODUCTS/
INSTITU PERIOD ROLE**
(contract, grant) INDICATIONS YOU INDICATIONS/
TION
ISSUES
O YES
ONO
Yes
Ono
O YES

ONo
O YES

ONo

* Establishment, Institution, individual


Government,
** Site Investigator, Principal Investigator, Co-Investigator, Employee, Partner, No Involvement, or Other

1F MORE SPACE {S NEEDED, PLEASE ATTACH ADDITIONAL PAGES


1. CURRENT FINANCIAL INTERESTS (Continued)

e. INTELLECTUAL PROPERTY (PATENTS/ROYALTIES/TRADEMARKS) O NONE


(If “none”, skip to Item f.)

RELATED TO LISTED IF “YES”, EXPLAIN BELOW AND


FOR ESTABLISHMENT PRODUCTS/ INDICATE INCOME RECEIVED
INDICATIONS/ ISSUES

Oyves ONO

Oyes ONO

Oves ONO

f, EXPERT WITNESS (Last 12 Months or under negotiation) O NONE


(if “none”, skip to Item g.)
|
appeared for or against the following listed establishment(s) and issue(s)

RELATED TO LISTED

FIRM AND ISSUE AMOUNT RECEIVED PRODUCTS/ IF “YES”, EXPLAIN BELOW


INDICATIONS/ ISSUES

Oyves ONO

Oyves ONO

Oyves ONO

g- SPEAKING/WRITING (Last 12 Months or under negotiation) C1 NONE


(If “none”, skip to Item g.)
AMOUNT RECEIVED RELATED TO LISTED
FIRM TOPIC/ISSUE HONORAR- DATES PRODUCTS/
TRAVEL
(UM INDICATIONS/ ISSUES

Qyes ONO

Oyes ONO

Oyves ONO
2. PAST FINANCIAL INTERESTS
a. To the best of your knowledge, do 1) you or any of your relative within the fourth (4) civil degree, by affinity or consanguinity, 2) organization in which you serve as an
officer, director, trustee, general partner, or employee have any past involvement with any policy determining activity of the office/agency/advisory body/committee:

O YES ONo 0 NOT TO MY KNOWLEDGE

b. If “Yes.” describe involvement.


RELATED TO LISTED
FINANCIAL INVOLVEMENT PRODUCTS/
FIRM/PRODUCT ROLE DATES
(e.g. contract/consultant) INDICATIONS/
ISSUES

Oyves ONO

Oyves Ono

Oyes ONO

Oyes Ono

IF MORE SPACE IS NEEDED, PLEASE ATTACH ADDITIONAL PAGES


3. OTHER INVOLVEMENTS (Other Kinds of
Relationships) OC NONE
(If
“none”, skip to item 4.)
Using the list of products/firms/issues, identify anything that would give an “appearance” of a conflict which has not been disclosed above (e.g. involvement in a lawsuit,
researcher initiated study, gift of research materials, etc.).

4. CERTIFICATION STATEMENT
L designated as of the ,
of Agency, Office, Bureau,
|
(First Nome, Mi, Family Name) (Position/Designation, when applicable) (Name Service, Hospital, or Unit}
do hereby declare on my honor that the above information is true and complete, to the best of my knowledge. !f
there are any changes, will promptly notify you. This
includes any change that occurs before or during the meeting or work itself and through the period up to the publication of the final results or completion of the activity
concerned.

My response contains pages.

NAME AND SIGNATURE OF DECLARANT DATE

CONFIDENTIALITY STATEMENT
The primary use
of this information is for review of the Public Health Ethics Committee (PHEC) to determine compliance with applicable conflict of interest with laws and
regulations.

This confidential report will not be disclosed to any requesting person, unless authorized by law.

Falsification of information or failure to file or report of information required to be reported is subject to disciplinary action by the OOH.
FOR PHEC USE ONLY
NAME AND SIGNATURE OF REVIEWING OFFICIAL DATE

COMMENTS OF REVIEWING OFFICIAL

IF MORE SPACE IS NEEDED, PLEASE ATTACH ADDITIONAL PAGES


ANNEX B

Financial and Non-Financial Conflict of Interest


The following shall constitute as actual or potential conflict of interest that should be
disclosed:

1. Financial interest irrespective of amount:

a. Employment and consulting of the investigator within twelve (12) months


precedingthe disclosure, such as being employed by a commercial sponsor
of clinical research and/or engagement to paid speaking engagements, and
holding position on marketing and medical advisory boards;
Employment and consulting of relatives up to the fourth (4") civil degree
of consanguinity or affinity;
Research support for the expert’s own research and that of his or her unit,
including supplies and equipment;
Financial interest in the form of bonuses or increase in payments after
fulfillment of specified number of participants enrolled in clinical trials;
Financial interest such as ownership of stock and equity, other securities,
business interests, receipt of honoraria;
Financial interest from intellectual property (e.g., patents, publications,
licenses and royalty rights);
Travel and attendance to trainings and continuing education (e.g., CME,
oe CPD) or other instructional sponsorships;

a
Financial agreements linked to the outcome of clinical trial;
Any proprietary interest in the investigational product; and
So
Any other financial interests relevant to the declarant’s function in which
he/she has been asked to participate, as well as any interest that could be
affected by the outcome of his/her function/s.

Significant financial interest exists if the value of any outstanding equity


(e.g., stock, securities, or other ownership/business interest) or remuneration
received in twelve (12) months preceding the disclosure, exceeds aggregate value
of Two Hundred Fifty Thousand Pesos (Php 250,000.00).

2. Non-financial relationship that may be perceived as unduly influencing one’s


judgment, such as, but not limited to:

a. Personal and professional relationship that includes but not limited to:
i. Family relationships
ii. Friends or adversaries
iii. Volunteer commitments;
Conflict of commitment with other institutions and/or activities and
programs;
Involvement in institutional decisions or consulting positions concerning
the purchase or approval of medications or equipment, or the negotiation of

1
se

other contractual relationships over the investigational product or result of


the study;
d. Any proprietary interest in the investigational product.

3. Other forms of compensation/ incentives:


a. Recruitment incentives i.e., referral system, finders’ fee;
b. Financial or non-financial augmentation of salary;
c. Non-research travel and other gifts.

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