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Institutional Ethics Committee Regulations and Current Updates in India

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DOI: 10.5005/jp-journals-10024-2117

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Amit V Mahuli et al 10.5005/jp-journals-10024-2117
Review article

Institutional Ethics Committee Regulations and

Current Updates in India
1
Amit V Mahuli, 2Simpy A Mahuli, 3Shankargouda Patil, 4Shilpa Bhandi

ABSTRACT INTRODUCTION
Aim: The aim of the review is to provide current updates on Ethical dilemmas in research since time immemorial
regulations for ethics committees and researchers in India.
have been a major concern for researchers worldwide.
Background: Ethical dilemmas in research since time immemo- The question “what makes clinical research ethical” is
rial have been a major concern for researchers worldwide. The significant and difficult to answer as multiple factors
question “what makes clinical research ethical” is significant and
difficult to answer as multiple factors are involved. are involved. With the enormous amount of literature
and guidelines available online, it becomes very tricky
Review results: The research involving human participants
to follow the right ones. The basic ethical principles are
in clinical trials should follow the required rules, regulations,
and guidelines in one’s own country. It is a dynamic process, autonomy, justice, beneficence, and nonmalfeasance
and updates have to be learned by researcher and committee for research. The current ethical principles assess the
members. The review highlights the ethical regulation from the risk–benefit ratio of the clinical trial so that the results
Drug Controller General of India, Clinical Trial Registry of India,
can be generalized and extrapolated to the population
and Indian Council of Medical Research guidelines.
as a whole.1
Conclusion: In this article, the updates on Indian scenario of The regulations unique to the country of research are
the Ethical Committee and guidelines are compiled.
mandatory to follow. Table 1 lists few important ethical
Clinical significance: The review comes handy for clinical guidelines that a researcher and ethics committee member
researchers and ethics committee members in academic insti-
should be aware of.2-7 The Indian Council of Medical
tutions to check on the current updates and keep abreast with
the knowledge on regulations of ethics in India. Research7 has proposed ethical guidelines for Biomedical
Research in India. The majority of the guidelines explicitly
Keywords: Audiovisual consent, Biomedical research, Ethics
and informed consent. mention about the clinical trial using the newly found
drug for human participants and any intervention, such
How to cite this article: Mahuli AV, Mahuli SA, Patil S, Bhandi S.
as drugs, surgical procedures, preventive measures, life-
Institutional Ethics Committee Regulations and Current Updates
in India. J Contemp Dent Pract 2017;18(8):738-741. style modifications, devices, educational or behavioral
treatment, and rehabilitation strategies. In academic
Source of support: Nil
institutions, the protocol has to meet various screening
Conflict of interest: None stages as shown in Flow Chart 1 before assessment of
ethics committee.
1,2
Department of Public Health Dentistry, NIMS Dental College
Jaipur, Rajasthan, India
REGULATIONS IN INDIAN PERSPECTIVE
3
Division of Oral Pathology, Department of Maxillofacial Surgery In India, it is mandatory to take ethical clearance for a
and Diagnostic Sciences, College of Dentistry, Jazan University clinical trial on human participants from a registered
Jazan, Kingdom of Saudi Arabia
ethical committee under Rule 122DD and informed
4
Department of Restorative Dental Sciences, College of consent according to Appendix VIII of Schedule Y of
Dentistry, Jazan University, Kingdom of Saudi Arabia
Drugs and Cosmetics Act, 1940 and Rules 1945 regulated
Corresponding Author: Amit V Mahuli, Department of Public by the Central Drug Standard Control Organization
Health Dentistry, NIMS Dental College, Jaipur, Rajasthan, India
(CDSCO), Office of Drug Controller General India (DCGI),
Phone: +918107960145, e-mail: [email protected]
Directorate General of Health Services, and Ministry of
738
 JCDP

Institutional Ethics Committee Regulations and Current Updates in India

Table 1: List of applicable ethical guidelines for research in human participants

Guidelines Source Year with update
Nuremberg code Nuremberg military tribunal decision in the United 1947
States v Brandt
Belmont report National commission for the protection of human 1979
subjects of biomedical and behavioral research
Guidelines for good clinical practice The WHO technical report series 1995
Standards and operational guidance for ethics review World Health Organization 2011
of health-related research with human participants
Ethical principles of medical research involving human World Medical Association: Declaration of Helsinki 64th meet 2013
participants
Ethical guidelines for biomedical research on human Indian Council of Medical Research 2006
participants

Flow Chart 1: Functioning of institutional review boards • Ethics committee shall review the research protocol as
(IRBs)/ethics committees in academic setup
per Schedule Y and Good Clinical Practice Guidelines
for Clinical Trials in India to safeguard the right, well-
being, and safety of the trial participants.
• In the case of any adverse event during the clinical
trial, the ethics committee shall analyze and forward
its opinion as per schedule Y.
• Ethics committee shall cooperate with the inspectors
and officials authorized by the Central Drugs Standard
Control Organization to enter its premises to inspect
any record, data, or any document related to clinical
trial and provide adequate replies to any query.
• The committee shall maintain all the information
regarding the clinical trial for at least 5 years after the
completion of the trial.
• The ethics committee registration is valid for 3 years.
The committee should inform in writing to the licens-
Health and Family Welfare, Central Government, India. As ing authority in case of any changes in the ethics
per Schedule Y, a freely given written, informed consent committee. Licensing authority has the right to issue
of individuals participating in the research trial is manda- show cause notice in the event of any complaints and
tory. Audiovisual (AV) recording of the informed consent wrongdoing. The authority has the right to cancel the
process has been made mandatory for clinical trials, fol- registration of the committee.
lowing the Supreme Court decision dated October 21, 2013, • Ethics committee should have a minimum of 7 mem­
as per the DCGI office order dated November 19, 2013.8,9 bers and a maximum of 15 members, which includes a
Trial registration in the Clinical Trial Registry – India chairperson (independent of an institution or outside
(CTRI) is mandatory by the DCGI (www.cdsco.nic. the institution), one member secretary, clinicians
in). The CTRI was first launched on July 20, 2007; since (medical and scientific), legal expert, social scientist,
then, more than 3,300 trials have been registered until and layperson.
January 2013. The CTRI, in turn, is a part of the World • For clearing the protocol for a clinical trial, the ethics
Health Organization (WHO)’s International Clinical Trials committee should have the quorum of at least five
Registry Platform, so all the trials add to the global pool members: Basic scientist, legal expert, clinician, social
of data.10 scientist, and layperson.
• The principal investigator and the Ethical Committee
FUNCTIONS AND FORMATION OF THE ETHICS members are expected to have adequate knowledge
COMMITTEE IN INDIA on Good Clinical Practice guidelines for clinical trials
• The institutional ethics committee has to prepare a in India. Members representing ethics committee
constitution, standard operating procedures, condi- should have a postgraduate degree, possess sufficient
tions for member appointment, the offices, and the scientific knowledge, and should be aware of their
quorum requirements.11 roles and responsibilities as board members.
The Journal of Contemporary Dental Practice, August 2017;18(8):738-741 739
Amit V Mahuli et al

• There should be no conflict of interest while decision by CDSCO and Directorate General of Health Services,
making on the research protocol from any of the com- Government of India.9
mittee members. All members should declare their Honorable Supreme Court of India, CDSCO vide F.
conflict of interest. No. GCT/20/SC/Clin./2013 DCG1 dated November 19,
• The committee can invite specialist and experts in the 2013, has categorically stated that all clinical trials will
case of discussion related to the topic of their exper- have to follow AV consent in addition to the written
tise, but the invited experts will not have the right of informed consent. The statement should clearly explain
voting. the study participants about the purpose of research,
duration, the procedure/intervention involved, the pos-
RESPONSIBILITIES OF ETHICS COMMITTEE sible risk involved, benefit to the participant, referrals
• The novelty of research and social value: The study should in case of emergency, and compensation to the study
add to the existing knowledge or should help in inno- participants. The investigator should maintain confi-
vation for the new knowledge and should benefit the dentiality regarding the participants involved in the
society and humanity by enlarge. trial. The consent has to be explained in the language the
• Scientifically sound: The research should be scientifi- patient understands the best, in simple and not techni-
cally valid sound study design, appropriate statisti- cal words. The consent has to be understood, voluntary,
cal analysis, the feasibility of the study, and precise and the participant has the right to withdraw from the
scientific objective. study anytime.
• Fair selection of the study samples: Selection of the vul-
nerable group for research with risky outcomes is a METHOD OF RECORDING
major ethical problem. Appropriate selection of the
The investigator will identify the participant involved,
sample based on the merit of the study and justice to
the language they understand, and protocol of the study.
the sample is of most importance.
A study team member can help as interpreter if the
• Favorable risk–benefit ratio: Maximum benefit and
language is not known. The photo ID of the participant
minimum risk care should be taken to have minimal
is documented to identify the participant. The video
risk to the patient in comparison to the benefit. The
camera for the AV recording should be of adequate capa-
benefit is assessed on the total good from the research
bility to simultaneously capture the facial details of the
to the individual and the society. Patients should not
participant, impartial witness (if any), and investigator/
be exploited.
authorized person present during the consent process.
• Independent review of the research protocol: Review
The AV recording should be conducted in a room con-
of the protocol for possible conflict of interest, the
ducive to the recording of disturbance-free audio and
source of funding, and other financial details are to be
thoroughly assessed. There should also be review of video of the consent process. During the videography
research design of the trial and risk to the population process, care should also be taken not to include unre-
recruited in the trial. lated persons/patients at the hospital within the field
• Informed consent: It should be taken from every sample of vision. Poor video or audio quality may not sever
recruited in the study; it should be voluntary, legal, the purpose of consent; care should be taken to use the
and comprehending and should be recorded and camera with good resolution and mic with good quality.
maintained as per regulations of the country. The AV recordings of consent have to be preserved for
• Respect for potential and enrolled participants in the study: a minimum period of 5 years after the completion of
Autonomy of the participants involved in research is the study.
very crucial; the participants need to be informed of
the risk and benefits involved in the trial, and they LATEST UPDATES
have the right to withdraw from the study at any
• No permission for conduct of clinical trial intended
given time.
for academic purposes with respect to approved drug
formulation shall be required for any new indication
AUDIOVISUAL INFORMED CONSENT
or new route of administration or new dose or new
The clinical trials on new drugs have strict regulations in dosage form where the trial is approved by the ethics
India; Drug & Cosmetic Rule 1945 being amended from committee, the data generated are not intended for
time to time under Schedule Y of the rules. The clini- submission to the licensing authority. The ethics com-
cal trials are to be conducted with approved protocols, mittee, however, has to inform the licensing authority
and the Good Clinical Practice Guidelines published about the study updates.12,13
740
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Institutional Ethics Committee Regulations and Current Updates in India

• The participants have to be notified about the inter- 4. World Health Organization. Guidelines for good clinical
vention failure regarding therapeutic effect in the practice (GCP) for trials on pharmaceutical products. Vol. 850.
Geneva: WHO Technical Report Series; 1995. p. 97-137.
clinical trial involving new drugs.
5. World Health Organization. Standards and operational guid-
• The participants should be disclosed about placebo- ance for ethics review of health-related research with human
controlled trials that placebo administered will not participants. Geneva: World Health Organization; 2011.
have any therapeutic effect. 6. World Medical Association. World Medical Association
Declaration of Helsinki: ethical principles for medical research
CONCLUSION involving human subjects. Seoul: World Medical Association;
2008. [cited 2016 Aug 23]. Available from: http://www.wma.
In the current scenario, researchers and ethics committees net/en/30publications/10policies/b3.
have to keep track of the changes in the rules, regulations, 7. ICMR. Ethical guidelines for biomedical research on human par-
and amendments as this is a dynamic process. There can ticipants. New Delhi: ICMR; 2006. [cited 2016 Aug 26]. Available
be more seminars and workshops to discuss the updates from: http://www.icmr.nic.in/ethical_guidelines.pdf.
8. CDSCO. Drugs and Cosmetics Act, 1940. As Amended up
and latest guidelines. With the number of clinical trials
to the 30th June. India: CDSCO; 2005. [cited 2016 Aug 26].
increasing, there will be more complex ethical issues to Available from: http://www.cdsco.nic.in/forms/content-
handle and to learn from different situations. The CDSCO page1.aspx?lid=1888.
is providing with all updates on their website. 9. CDSCO. Draft Guidelines on Audio-Visual Recording of
Informed Consent Process in Clinical Trial. India: CDSCO;
CLINICAL SIGNIFICANCE 2014. [cited 2016 Aug 26]. Available from: http://www.cdsco.
nic.in/writereaddata/Guidance_for_AV%20Recording_09.
The review comes handy for clinical researchers and January.14.pdf.
ethics committee members in academic institutions to 10. Clinical Trial Registry India. [cited 2016 Aug 26]. Available
check on the current updates and keep abreast with the from: http://www.ctri.nic.in/Clinical-trials/login.php.
knowledge on regulations of ethics in India. 11. CDSCO. Indian GCP Guidelines. New Delhi: CDSCO; 2004.
[cited 2016 Aug 24]. Available from: http://www.cdsco.nic.
in/html/GCP1.html.
REFERENCES 12. Gazette Notification published on 6th January, 2016. G.S.R.
1. Emanuel EJ, Wendler D, Grady C. What makes clinical 611(E). 2016. [cited 2016 Aug 24]. Available from: http://www.
research ethical? JAMA 2000 May;283(20):2701-2711. cdsco.nic.in/writereaddata/GSR%2011(E)%20dated%20
2. Nuremberg Military Tribunal. The Nuremberg Code. J Am 06_01_2016.pdf.
Med Assoc 1996 Nov;276(20):1691. 13. Gazette Notification published on 31st July, 2015, G.S.R. 11(E).
3. National Commission for the Protection of Human Subjects 2015. [cited 2016 Aug 24]. Available from: http://www.cdsco.
of Biomedical and Behavioral Research. The Belmont Report. nic.in/writereaddata/Gazette%20Notification%2031%20
Washington (DC): US Government Printing Office; 1979. July%202015.pdf.

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