DOI: 10.21276/aimdr.2016.2.6.

PC1

Section: Pharmacology
Original Article ISSN (O):2395-2822; ISSN (P):2395-2814

Awareness among Teaching Faculty about Ethics

Committees in a Medical College of Kolkata: An
Observational Study
Suvajit Das1, Kaushik Mukhopadhyay1, Richeek Pradhan2, Sonali Mukherjee3, Chandan
Chatterjee4
1
Assistant Professor, Department of Pharmacology, ESI-PGIMSR ESIC Medical College & Hospital, Kolkata – 7000104.
2
Tutor, Department of Pharmacology, ESI-PGIMSR ESIC Medical College & Hospital, Kolkata – 7000104.
3
Professor, Department of Pharmacology, ESI-PGIMSR ESIC Medical College & Hospital, Kolkata – 7000104.
4
Associate Professor, Department of Pharmacology, ESI-PGIMSR ESIC Medical College & Hospital, Kolkata – 7000104.

Received: August 2016

Accepted: August 2016

Copyright: © the author(s), publisher. Annals of International Medical and Dental Research (AIMDR) is an
Official Publication of “Society for Health Care & Research Development”. It is an open-access article distributed
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ABSTRACT
Background: An observational cross sectional study was performed to assess the overall knowledge of the respondent
about both clinical and animal research ethics committees. Objective: To study the perceptions amongst the medical
teaching faculty regarding types, composition, roles and responsibilities of both institutional clinical and animal research
ethics committees. Methods: After prior approval from the Institutional Ethics Committee (IEC), a standardized audit-based
pre-validated close-ended questionnaire was supplied to the willing faculty within the Medical College premises, who
instantaneously filled-up the questionnaire and returned it to the investigator. The questionnaire consisted of 20 close-
ended questions, 10 each regarding animal and clinical research ECs. The results were statistically analyzed to assess the
awareness and knowledge of medical teaching faculty about institutional ethics committees. Results: 87 faculty were
approached of whom, 70 consented to participate. Out of a total of 20 questions, mean of questions answered correctly
was 11.87 ± 2.32 (Mean and Standard deviation). When the faculty were grouped as per their designation, the mean
scores were (11.33 ± 2.33) for the Assistant Professors, (12.86 ± 2.41) for the Associate Professors, (11.0 ± 02.6) for
Professors, (13.17 ± 1.94) for Senior residents and (12.35 ± 2) for Tutors. The difference between the groups were not
statistically significant.Conclusion: The overall quality of knowledge and awareness regarding details pertaining to the
structure and functioning of IECs were sub-par when compared to results of similar studies done elsewhere.

Keywords: Ethics committee, teaching, faculty, awareness, medical college.

INTRODUCTION necessary information arising from the study. The

purpose, composition and responsibilities of clinical
research ECs are different from that of animal ECs.
In India, Ethics Committees (ECs) are established in The former is guided mostly by Schedule Y whereas
different medical institutions to protect the rights, the later is guided as per the Prevention of Cruelty to
safety and confidentiality of the participating Animals (PCA) Act and Schedule Y, under
subjects in a research study. It has now been made supervision by the Committee for the Purpose of
mandatory legally that all research protocols in Control and Supervision of Experiments on Animals
India, involving human subjects or studies involving (CPCSEA), the acts being amended from time to
experimental animals receive prior approval from time as per situations demand.
registered institutional or independent ethics Though research involving human subjects as well
committees before undertaking the study. as experimental animals are an integral part of the
Indian medical curriculum in undergraduate and
Name & Address of Corresponding Author
Dr. Chandan Chatterjee postgraduate education, to what extent faculty are
Associate Professor, actually involved in formal training of students
Department of Pharmacology, regarding ethical principles, research ethics and
ESI-PGIMSR ESIC Medical College & Hospital,
ethics committees - is grossly unexplored.[1] Despite
Kolkata – 7000104.
a diligent literature search, a very few previous
Indian studies were found reflecting knowledge and
During the course of the study, the researcher is perceptions of teaching faculty regarding functioning
supposed to update the concerned ECs with all of ECs.[2] In those studies, considerable fraction of
the faculty members were found to have a dearth of

Annals of International Medical and Dental Research, Vol (2), Issue (6) Page 1
 Section: Pharmacology
Das et al; Awareness among Teaching Faculty about Ethics Committees

relevant knowledge regarding ECs. Only few existence, composition, responsibilities and
persons who were actively involved in conduct of functioning of the institutional clinical research EC
clinical trials or institutional research projects were and institutional animal EC, amongst the
well informed. undergraduate and postgraduate medical teachers
To the best of our knowledge, there has been no who had been associated with the medical college or
published study reflecting awareness of medical hospital at least since the past six months.
teachers about ethics committees in the eastern part
of India. This study was designed to be conducted in MATERIALS AND METHODS
a Government-run Medical College and Hospital in
Kolkata to assess the awareness of medical teaching
faculty regarding a few important aspects of clinical Accordingly, a questionnaire-based observational
research ethics committees and animal ethics cross sectional study commenced after due approval
committees. from the institutional Clinical Research EC.A pre-
tested and pre-validated questionnaire consisting of
Aim and Objectives 20 close-ended dichotomous questions was used
The study site which is a Government-run Medical [Table 1]. The questions consisted of knowledge
College and Hospital, consists its own about the composition of both institutional clinical
Clinical research EC as well as an Animal Ethics research and animal ECs and their functioning, in
Committee, both being fully functional. This study general.
was planned to assess the knowledge regarding the

Table 1: Questionnaire to assess awareness among the faculty about Ethics committees.
Time allotted: 10 minutes
Please answer and return the questionnaire immediately
Please answer in exact order, avoiding over-writing
Answers once answered cannot be changed later
Please answer without any assistance
Particulars of the Study Participant

Name (optional): Age:

Department: Designation:
No of Years in this institution: Total Teaching experience: _____ years PG Teacher: Yes / No Past experience as PG
Teacher: Yes / No
Experience as Member of Institutional Ethics Committee: Yes / No
Questionnaire (to be filled by the participant) Yes No Don't know
1. Research projects in our institution are reviewed by Independent (non-institutional) Ethics
Committees.
2. Ideally, a clinical ethics committee should have 12-16 members as per ICMR guidelines.
3. A minimum of three non-scientific members are required to be present in a meeting of the clinical
research ethics committee, to form a quorum.
4. In the clinical ethics committee, eight members are required to form a quorum while conducting a
meeting.
5. Dean is the chairperson of our institutional clinical ethics committee.
6. Member Secretary of an institutional clinical ethics committee in a medical college should be a
faculty of the institution.
7. Is it necessary to take permission from ethics committee before starting a non-interventional study
and/or observational study?
8. It is mandatory to include scientific member/s from outside the institution while constituting the
institutional ethics committee.
9. A clinical ethics committee should ensure that in a new drug trial, audio-visual recording of
informed consent procedure on trial participants is mandatorily performed.
10. Legal expert is mandatory for any clinical research ethics committee.
11. Clinical ethics committee plays a major role in taking decisions regarding compensation issues
owing to adverse events during a clinical drug trial.
12. Institutional animal ethics committee should be separate from institutional clinical ethics committee
13. All animal ethics committee members are selected by the institution.
14. Veterinary surgeon is an essential person in the animal ethics committee.
15. Ideally, an animal ethics committee should have 7 members as per CPCSEA guidelines
16. Dean is the chairperson of our animal ethics committee.
17. In the animal ethics committee, it is absolutely necessary to include scientific member from outside
the institution.
18. A minimum of two non-scientific members are required in an animal ethics committee.
19. A researcher has the right to continue his/her project without prior approval from clinical or animal
ethics committee.
20. Ethics committees are to be mandatorily constituted in every Medical College.
Total number of correct responses:

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 Section: Pharmacology
Das et al; Awareness among Teaching Faculty about Ethics Committees

The questionnaire form was supplied to the medical disciplines participated in this study for 1
institutional faculty including Professors, Associate month.
Professors, Assistant Professors, Senior Residents Among a total of 20 questions, each correct response
and Tutors belonging to different medical disciplines was given a score of 'one'. The summation of correct
who had duly consented to participate in the study responses to the questions were scored numerically
by signing the informed consent form. Data were against a total score of 20. Numerical parameters so
collected only from Medical Faculty within the obtained were entered and analyzed using SPSS
premises of ESI, PGIMSR, ESIC Medical College, (version 20). Between group comparisons was done
Joka. Only those who were assigned with teaching in addition to descriptive statistical analysis.
designations for at least 6 months were included. All
Faculty members of the department of RESULTS
Pharmacology, ESI PGIMSR and ESIC Medical
College Joka were excluded as some of them were The data was analyzed by using SPSS (version 20)
contributing to the design and conduct of this study. software. 70 faculty out of 87 consented to
The respondents were required to fill in the participate in the study. Awareness of faculty
questionnaire in front of the investigator or the members regarding clinical and animal ethics
designated person, and return it immediately. A committees were estimated by analyzing the
maximum time of ten minutes was allotted for the questionnaire [Table 1]. Mean correct score to
participants to complete the questionnaire and he responses given by all participants was 11.87 ±2.32
/she was not allowed to converse during the (Mean and Standard deviation) out of a total score of
procedure. Questionnaire forms which were not 20. When grouped according to their designations,
filled and returned immediately were rejected from mean scores were 11.33 + 2.33 for Assistant
the analysis. Confidentiality and privacy of the Professors (Group 1), 12.86 + 2.41 for Associate
respondents were strictly maintained throughout the Professors (Group 2), 11.00 + 2.6 for Professors
procedure. 70 faculty members from different (Group 3), 13.17+ 1.94 for Senior residents (Group
4) and 12.35 + 2 for Tutors (Group 5).

Table 2: Percentage of Correct Responses to Individual Questions.

Total Number of Percentage of
Questions Number of Correct Participants
Responses Responses Answering
Correctly
1. Research projects in our institution are reviewed by Independent (non-institutional)
70 15 21.43 %
Ethics Committees.
2. Ideally, a clinical ethics committee should have 12-16 members as per ICMR
70 15 21.43 %
guidelines.
3. A minimum of three non-scientific members are required to be present in a meeting of
70 51 72.86 %
the clinical research ethics committee, to form a quorum.
4. In the clinical ethics committee, eight members are required to form a quorum while
70 40 57.14 %
conducting a meeting.
5. Dean is the chairperson of our institutional clinical ethics committee. 70 22 31.43 %
6. Member Secretary of an institutional clinical ethics committee in a medical college
70 50 71.43 %
should be a faculty of the institution.
7. Is it necessary to take permission from ethics committee before starting a non-
70 59 84.29 %
interventional study and/or observational study.
8. It is mandatory to include scientific member/s from outside the institution while
70 51 72.86 %
constituting the institutional ethics committee.
9. A clinical ethics committee should ensure that in a new drug trial, audio-visual
70 51 72.86 %
recording of informed consent procedure on trial participants is mandatorily performed.
10. Legal expert is mandatory for any clinical research ethics committee. 70 17 24.29 %
11. Clinical ethics committee plays a major role in taking decisions regarding
70 46 65.71 %
compensation issues owing to adverse events during a clinical drug trial.
12. Institutional animal ethics committee should be separate from institutional clinical
70 50 71.43 %
ethics committee
13. All animal ethics committee members are selected by the institution. 70 41 58.57 %
14. Veterinary surgeon is an essential person in the animal ethics committee. 70 57 81.43 %
15. Ideally, an animal ethics committee should have 7 members as per CPCSEA
70 37 52.86 %
guidelines
16. Dean is the chairperson of our animal ethics committee. 70 33 47.14 %
17. In the animal ethics committee, it is absolutely necessary to include scientific
70 50 71.43 %
member from outside the institution.
18. A minimum of two non-scientific members are required in an animal ethics
70 23 32.86 %
committee.
19. A researcher has the right to continue his/her project without prior approval from
70 61 87.14 %
clinical or animal ethics committee.
20. Ethics committees are to be mandatorily constituted in every Medical College. 70 62 88.57 %

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Das et al; Awareness among Teaching Faculty about Ethics Committees

On between group comparisons, the difference

between the groups were not statistically significant
(p = 0.127).
When percentage of correct responses to each
question was analyzed [Table 2], question number
20 (regarding whether Ethics committees are to be
mandatorily constituted in every Medical College)
was correctly answered by most (88.57%) of the
faculty. The first two questions (regarding review
process of research projects in our institution and
constitution of clinical research ethics committee,
respectively) were incorrectly answered by most.
Only 21.43% of faculty answered each of them
correctly. Figure 3: Percent score in clinical ethics questionnaire
When analyzed based on the duration of teaching and Percent score in animal ethics questionnaire.
experience, mean score of teaching faculty who have
been in this profession for more than 5 years was DISCUSSION
11.41 (with an SD of 2.67), whereas that for faculty
working less than 5 years was 12.03 (SD of 2.04), We conducted a cross-sectional questionnaire based
with no significant difference between the two study among consenting teaching faculty of a post-
groups (p = 0.289). Also, no significant difference in graduate government medical college in Kolkata to
the knowledge scores of participants who were post- assess their knowledge and awareness in general,
graduate medical teachers, as compared to under- regarding clinical research ECs and animal ECs.
graduate medical teachers, though the numbers of Similar studies conducted in the past are extremely
post-graduate teachers in our institution were very scanty in number. A recent similar study conducted
few in number. in Nair Hospital, Mumbai,[2] aimed to assess the
A considerably large portion of the participants awareness about the composition and functioning of
(68.43%) wrongly considered the Dean of our EC amongst the medical teachers. The overall scores
institution as chairperson of clinical ethics reflecting the relevant knowledge were found to be
committee. sub-par. Only 44.4% of the faculty was found to be
satisfactorily informed about the composition of EC
in general. In our study, mean correct score to
responses given by all participants was 11.87 ±2. 32
(Mean and Standard Deviation) out of a total score
of 20, and an overall 52% of the questions being
correctly answered, which was pretty acceptable
when compared to similar studies.
In the Mumbai-based study, as the years of teaching
experience increased among the faculty, the
knowledge about the composition of ECs were
found to increase but the information about the
functioning of IEC did not improve significantly.
The awareness about EC was also significantly
higher amongst the postgraduate teachers versus the
Figure 1: Mean of total score in different departments. undergraduate teachers. The findings in our study,
however were different. Though the mean correct
score of all faculty was satisfactory, the mean
performance of the Professors (score of 11±2.55 out
of 20) were lesser than the average performance of
all respondents (11.87 ±2.32), the difference with
other groups being statistically insignificant.
The most common misconception in the Mumbai-
based study was that "Dean" was the Chairperson of
EC. In our study, the greatest misconception among
the faculty members was regarding whether an
institutional EC ever existed in our institution (only
21.43% of participants answered correctly) and
regarding the composition of the clinical EC
(21.43% of participants answered correctly). 68.43%
Figure 2: Mean total score according to designation. of respondents wrongly considered Dean of the

Annals of International Medical and Dental Research, Vol (2), Issue (6) Page 4
 Section: Pharmacology
Das et al; Awareness among Teaching Faculty about Ethics Committees

institution as chairperson of clinical ethics There have been several limitations to our study.
committee. Firstly, since our study was based on convenience
Though no other similar studies were found among sampling, professionals reluctant about clinical
medical teachers, a few studies have been found to research may have opted out of the survey, thus the
assess the awareness among medical and para- findings may not have reflected the awareness and
medical students. In a descriptive, cross-sectional knowledge of the faculty of the entire institution.
study conducted to assess the knowledge of and Secondly, attitude and practice of participants could
attitudes towards medical ethics among not be simultaneously assessed due to logistic
undergraduate medical students in West Bengal[3], constraints. Thirdly, since the total number faculty in
340 medical students of a medical college in West our institutional is relatively less, the sample size for
Bengal were given a semi-structured questionnaire this study could not be increased further. Lastly, time
that included questions regarding their awareness of constraints prevented us from designing a
ethics, their attitudes towards various issues in prospective study where in addition to the present
clinical ethics, and their knowledge of the code of study, we could have assessed the effects of subtle
medical ethics. Only 10.9 % were aware of the interventions to increase awareness regarding ethics
existence of an institutional ethics committee and committees and ethical issues in clinical research.
42.8% did not know its exact role. No increase in Studies like this emphasize the need to develop
relevant knowledge was found among those with methods to create awareness among faculty
additional years of medical education. members to promote quality research. Measures
A cross-sectional questionnaire-based study among such as regular workshops on Bioethics or
final year undergraduates of paramedical sciences in distributing relevant educational materials about the
a teaching hospital in Coimbatore assessed how roles and responsibility of research ethics
respondents felt about the need for ethical approval committees to the institutional teaching faculty have
before the start of the study and other aspects of been suggested, but to what extent these are actually
clinical research, including participant's autonomy, beneficial, need to be further investigated. We
monitoring of study, studies requiring ethical contemplate to explore different ways to enhance
clearance, members of ethical committee and roles awareness among faculty of our institution, through
of ethics committee.[4] Among a total of 161 future research studies.
paramedical undergraduate participants, a statistically
significant difference was found between researchers CONCLUSION
and non-researchers regarding awareness about ethics
committees. This study emphasised the need for
introducing medical ethics in course curriculum and The overall quality of knowledge and awareness
conducting period workshops or seminars to increase among teaching faculty regarding details pertaining
their awareness on ethical approval process in to the structure and functioning of IECs were sub-
research. par when compared to results of similar studies done
In another study done in the Middle East on dental elsewhere.
faculty the researchers found that many of the
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Annals of International Medical and Dental Research, Vol (2), Issue (6) Page 5
 Section: Pharmacology
Das et al; Awareness among Teaching Faculty about Ethics Committees

How to cite this article: Das S, Mukhopadhyay K,

Pradhan R, Mukherjee S, Chatterjee C. Awareness among
Teaching Faculty about Ethics committees in a Medical
College of Kolkata: An Observational Study. Ann. Int. Med.
Den. Res. 2016; 2(6):PC01-PC06.

Source of Support: Nil, Conflict of Interest: None declared

Annals of International Medical and Dental Research, Vol (2), Issue (6) Page 6