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Oct-Dec2004-12(4)
VIEWPOINT
Concerns about ethical review
of health research in India
V Mohanan Nair, Douglas
K Martin
This essay presents a brief discussion on ethical
review of biomedical research in India, and problems that need to be addressed.
Given the paucity of published material on this subject, it depends on informal
exchanges with researchers, academicians and members of ethics committees during
various training sessions on research ethics.
Limitations of ethical review in
India
The Indian Council of Medical Research (ICMR), the apex agency guiding biomedical research involving human participants in India, has published detailed guidelines on the composition and responsibilities of Institutional Ethics Committees or IECs (1). Despite these guidelines, more than 50% of institutions conducting research in India reportedly lack formal IECs (2). It is apparently difficult to get external members to volunteer, especially from among trained legal scholars and ethicists. Most medical schools do not offer bioethics courses. Typically, well-known people are nominated as IEC members. Finally, in the Indian context, 'lay persons' can be intimidated by the presence of more powerful scientific members.
The Indian Council of Medical Research (ICMR), the apex agency guiding biomedical research involving human participants in India, has published detailed guidelines on the composition and responsibilities of Institutional Ethics Committees or IECs (1). Despite these guidelines, more than 50% of institutions conducting research in India reportedly lack formal IECs (2). It is apparently difficult to get external members to volunteer, especially from among trained legal scholars and ethicists. Most medical schools do not offer bioethics courses. Typically, well-known people are nominated as IEC members. Finally, in the Indian context, 'lay persons' can be intimidated by the presence of more powerful scientific members.
Institutional budgets seldom allocate resources for
IECs. Many IECs do not have sufficient office space. There have been instances
of protocols disappearing after the project's approval. The IEC secretary can be
a middle or lower level staff or faculty member for whom this responsibility is
in addition to a full workload. There are no post-approval monitoring systems in
place, and IECs' responsibilities tend to end with approval. Without standard
operating procedures, the IECs may follow different methods for submission,
approval and follow up of research.
The politics of research
For medical researchers the world over, publishing research in peer-reviewed journals is a vehicle for career advancement. When ethical review and monitoring are weak, researchers may be under pressure to cut corners. Pharmaceutical companies hire practising doctors as researchers for their prescribing potentials. Hyder, Kass and Dawson note that 'the majority of developing country researchers were middle-aged males who were physicians employed by educational institutions, carrying out research on a part-time basis' (3). Gulhati observes that 'many investigators who conduct clinical trials are, or have been, beneficiaries of largesse from the pharmaceutical manufacturers (4).' Institutional members in the IEC may be junior to these researchers. Since no overt conflict of interest is apparent to IECs, the indirect benefits and mutual arrangements between companies and doctors often go unnoticed. Institutions' need for resources may also put subtle pressure on IECs to approve research.
For medical researchers the world over, publishing research in peer-reviewed journals is a vehicle for career advancement. When ethical review and monitoring are weak, researchers may be under pressure to cut corners. Pharmaceutical companies hire practising doctors as researchers for their prescribing potentials. Hyder, Kass and Dawson note that 'the majority of developing country researchers were middle-aged males who were physicians employed by educational institutions, carrying out research on a part-time basis' (3). Gulhati observes that 'many investigators who conduct clinical trials are, or have been, beneficiaries of largesse from the pharmaceutical manufacturers (4).' Institutional members in the IEC may be junior to these researchers. Since no overt conflict of interest is apparent to IECs, the indirect benefits and mutual arrangements between companies and doctors often go unnoticed. Institutions' need for resources may also put subtle pressure on IECs to approve research.
Moreover, the ICMR lacks the authority to take
action against unethical IECs. There exists no mechanism for accreditation of
IECs and quality control of ethics review is practically impossible. There is no
comprehensive database on either IECs or research participants.
India is also witnessing the birth of unaffiliated
Ethics Committees to review protocols for institutions with no IECs, supported
by fees from the pharmaceutical industry. In the West, there is an 'uneasy
alliance' between such bodies and the industry (5). The problem is likely to be
worse in India.
The Indian Council of Medical
Research
The ICMR has implemented several interventions in
the past few decades to improve the ethical review of research. In addition to
developing general research guidelines, it has started work on guidelines for
specific areas of research. It has constituted a 'Bioethics Cell' under senior
staff trained in bioethics. It hosts a website with links to leading bioethics
journals (6). It is preparing standard operating procedures for IECs and
standard formats for ethics review across IECs. It has supported the formation
of a forum for ethics review committees in India, is working with similar bodies
in the Asia-Pacific region, and is putting together a database on IECs in the
country. To enhance ethics capacity, the ICMR identifies mid-career
professionals to be trained in bioethics through fellowships. It also conducts
training sessions for researchers, academicians, IEC members and students within
India.
Future directions
Various initiatives are on to strengthen the capacity of bioethics in India, with the help of the US National Institutes of Health and global bodies such as the World Health Organization and UNESCO. However, current efforts may be limited, given the number of research institutions and the volume of research. The following suggestions may be considered:
Various initiatives are on to strengthen the capacity of bioethics in India, with the help of the US National Institutes of Health and global bodies such as the World Health Organization and UNESCO. However, current efforts may be limited, given the number of research institutions and the volume of research. The following suggestions may be considered:
India needs more professionals trained in
bioethics. Bioethics training should figure strongly in the medical curriculum,
and researchers need to be trained in research ethics. When professionals such
as lawyers cannot be attracted to work voluntarily for IECs, their time may need
to be compensated for adequately. IEC member secretaries must be compensated
fairly for their additional work. A portion of every research institute's budget
should be earmarked for IECs. Databases on IECs and trial participants will have
to be created. State-level IECs should be created to monitor IECs and review
protocols of institutions without IECs. Standards must be prepared and made
available to all IECs. The ICMR must be given more legal authority.
Institutional mechanisms for ethical reviewing of
research involving human participants in India are weak and vulnerable. A
concerted effort is required to strengthen them to fulfil their stated missions.
References
1. Indian Council of Medical Research. Ethical Review Procedures in Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research 2000; pp 9-16.
2. Ahmad K. Developing countries need effective ethics review committees. Lancet 2003;362:627.
3. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Ethics 2004;30:68-72.
4. Gulhati CM. Needed: closer scrutiny of clinical trials. Indian Journal of Medical Ethics 2004;12:4-5.
5. Bodenheimer T. Uneasy alliance-clinical investigators and the pharmaceutical industry. N Engl J Med 2000;342:1539-44.
6. Available from URL:http://www.icmr.nic.inbioethics.htm(accessed on May 6, 2004).
1. Indian Council of Medical Research. Ethical Review Procedures in Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research 2000; pp 9-16.
2. Ahmad K. Developing countries need effective ethics review committees. Lancet 2003;362:627.
3. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Ethics 2004;30:68-72.
4. Gulhati CM. Needed: closer scrutiny of clinical trials. Indian Journal of Medical Ethics 2004;12:4-5.
5. Bodenheimer T. Uneasy alliance-clinical investigators and the pharmaceutical industry. N Engl J Med 2000;342:1539-44.
6. Available from URL:http://www.icmr.nic.inbioethics.htm(accessed on May 6, 2004).
Acknowledgements
We gratefully acknowledge the editorial comments provided by Dr Amar Jesani to the first draft of this paper and the valuable comments provided by Dr Peter A Singer, Dr Martin McKneally, Ms Maria McDonald, Mr Mark Handelman and other colleagues at the Joint Centre for Bioethics. We are also grateful to an unknown reviewer whose comments helped to rewrite the paper in its present form.
We gratefully acknowledge the editorial comments provided by Dr Amar Jesani to the first draft of this paper and the valuable comments provided by Dr Peter A Singer, Dr Martin McKneally, Ms Maria McDonald, Mr Mark Handelman and other colleagues at the Joint Centre for Bioethics. We are also grateful to an unknown reviewer whose comments helped to rewrite the paper in its present form.
Dr Mohanan Nair was supported by a Fogarty
International grant for his MHSc Programme at the Joint Centre for Bioethics,
University of Toronto. Dr Martin is supported by a Career Scientist Award from
the Ontario Ministry of Health and Long-Term Care.
V Mohanan Nair*, Douglas K Martin**Civil Surgeon, General Hospital, Thiruvananthapuram, Kerala 695011, India. e-mail:v.mohanannair@utoronto.ca; **Assistant Professor, Department of Health Policy, Management and Evaluation and the Joint Centre for Bioethics, University of Toronto, Canada.
V Mohanan Nair*, Douglas K Martin**Civil Surgeon, General Hospital, Thiruvananthapuram, Kerala 695011, India. e-mail:v.mohanannair@utoronto.ca; **Assistant Professor, Department of Health Policy, Management and Evaluation and the Joint Centre for Bioethics, University of Toronto, Canada.