|Year : 2012 | Volume
| Issue : 6 | Page : 663-664
Ethics committee: Critical issues and challenges
Department of Pharmacology, B. J. Medical College, Ahmedabad - 380016, Gujarat, India
|Date of Web Publication||8-Nov-2012|
Department of Pharmacology, B. J. Medical College, Ahmedabad - 380016, Gujarat
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Desai M. Ethics committee: Critical issues and challenges. Indian J Pharmacol 2012;44:663-4
Clinical research is a systematic study of medicines in human subjects. Since 2005, there has been a phenomenal increase in outsourcing of clinical research to India. We have now become a preferred destination for conducting clinical trials due to the large pool of treatment-naive patients, highly skilled investigators, excellent technological infrastructure, and lower drug development costs.  Unfortunately, clinical trials have continued to be in news for all the wrong reasons. Although sensationalized out of proportion, much of the information in public domain cannot be ignored. The recent reports of conducting drug trial on 'mentally challenged' and 'illiterate patients' have brought up several irregularities to our notice. It has also brought the Ethics Committees (ECs) in spotlight and questions are being raised about their functioning across the country.
Recently the national drug regulatory body, Central Drug Standard Control Organization (CDSCO) has empowered ECs as an important and primary ethical regulator of clinical research. For starting a clinical trial, the approval of EC is required in the first place and without this the Drugs Controller General of India (DCGI) does not sanction the study. Secondly, the official guidelines for formation of ECs are periodically updated by Indian Council of Medical Research (ICMR). However, ECs in India are still struggling with some basic requirements and are generally viewed as signing authorities only. The prime responsibility of an EC is to protect and safeguard the rights and well being of research participants. This can be achieved by scientific and technical review of the research proposal along with the inspection of the facilities from participants' perspective. However, studies report that several ECs do not comply with the Schedule Y recommendations. A study conducted by ICMR observed that there were no legal experts on most of the ECs and there was a lack of clarity in the appointment procedure of EC members along with poor record keeping and questionable independence.  Another contentious issue is the competence of EC members. A study of knowledge, attitude, and practice conducted on 11 ECs across the country was an eye opener. It observed that EC members lacked the knowledge of Schedule Y along with inadequate training in Good Clinical Practice (GCP), they were unable to enlist the essential documents for EC review, and failed to state the role of EC approval in clinical research. The composition of EC members includes clinicians, medical scientists, and experienced representatives from nonscientific communities. It has been observed that the nonscientific members are ambiguous about their role during the review process and remain silent.  The objective of having nonscientific members in ECs is to review and critically analyze the research protocol from a community and cultural perspective, especially complex proposals involving 'mentally challenged', illiterate, and vulnerable groups. More often than not, their involvement is lacking. Further, it is commonly believed that the responsibilities of the EC members is limited to provide approval to research proposals submitted for review. They are, usually, unaware or ignore the need for a continuous and periodic review of ongoing research projects, scrutinize the informed consent process, and conduct the periodic inspection of the study sites. An approval of the research proposal by an EC based at other station has also been questioned and criticised.
Surprisingly, the institutions and hospitals that claim to undertake clinical trials and promote their research facilities tend to ignore the basic requirements of an EC. Besides having competent and qualified members, the essential requirements of a functional EC include appropriate standard operating procedures (SOPs), an adequate space for EC operations, record keeping and documentation, administrative support, experienced manpower, trained personnel, and reasonable remuneration for its members. However, most of the institutions are insensitive toward these requirements. Often the venue used for EC meetings is not neutral and it may influence the proceedings and the opinion of the members. Moreover, the increased participation of private/corporate hospitals in clinical research (many of them are owned by pharmaceutical companies) has also raised ethical concerns. The presence of members with conflicting interests is likely to restrict an impartial review and generates a biased opinion.  Participation of principal investigators in multiple clinical trials simultaneously has also raised doubts on their ability to handle the workload and do justice to the research.
To date, ECs in India have been functioning in isolation with no alliance with a central regulatory body. Further, there is no collaboration between the ECs to share and exchange the experiences. Although the EC proceedings are confidential, the communication is especially necessary in complex situation like multicentric clinical trials (when the decision of two ECs may differ), research proposals with special characteristics like use of illiterate patients or placebo, reporting of the serious adverse events, etc. In addition, there is no system in place to monitor the EC operations.
Thus, the boom of clinical research in India has stood out sourly with ethical concerns and brought out several deficiencies in the functioning of ECs. In order to overcome these gaps, one needs to look for solutions to ensure ethical operations of ECs.
A mandatory registration of ECs has been proposed at par with clinical trial registry by Drugs Technical Advisory Board, the highest decision making body under Union Health Ministry. This comes in the wake of widespread complaints that ECs at most places are neither independent nor active about the monitoring of trials. It is expected that registration of ECs will bring uniformity and control over them. The ECs will be accountable to respond to the enquiries and ensure that the clinical trials are monitored and they comply with Indian and International GCP. However, the proposal is yet to be implemented. Accreditation of ECs can also be an important step in this direction. Approval by an accreditated EC should be considered valid for conducting global clinical trials and publishing data. Teaching and training in bioethics at local and national level will help in capacity building. Bioethics may be integrated into medical, paramedical, pharmacy, and life sciences course curriculum to sensitize the prospective researchers.
To ensure the desired competence in its members the individual EC should take up several proactive steps. A compulsory training in principles of bioethics, GCP and regulatory guidelines should be introduced before appointment as an EC member. Sponsors or Contract research organizations can also organize regular GCP training programs for EC members. A periodic audit by the quality assurance department can also help overcome the deficiencies and improve the quality of the EC functioning. There is also a need to educate as well as empower the research participants (and patients) to enhance their understanding of ethics and science. Involving the public in training program would be of long-term help to clinical research industry to survive and flourish. Initiatives have been taken by the Government and ICMR to regulate Indian ECs, albeit at a slow pace. A bill on 'Biomedical Research on Human Participants (Promotion and Regulation)' has been planned. ICMR has revised and released comprehensive guidelines that give clear directions to biomedical research in India. ICMR has also collaborated with regional Forum for Ethics Review Committees of Asia Pacific (FERCAP) to facilitate research and organize education programs for ECs and other stakeholders in health research. Under FERCAP, the Forum for Ethics Committee Review in India (FERCI) has been set up to improve the functioning of ECs in India by capacity building and imparting accreditation to them.
Thus, ECs continue to play an important role in the ethical conduct of clinical research. However, ECs as a system are facing challenges with paucity of trained experts and lack of supervising national body. This calls for a strong need to focus on capacity building and establishment of an efficient central body to include all ECs under its umbrella to bring transparency and accountability in their functioning. Combined efforts by DCGI, ICMR, and individual ECs will definitely promote a sound culture of clinical research and restore the credibility in this regard in India.
| » References|| |
|1.||Rana JA. Strengthening clinical research in India. Lancet 2007;369:1233. |
|2.||Kumar N. Bioethics Activities in India under ICMR. Available from: http://icmr.nic.in/bioethics/cc_biothics/presentations/haryana/activity.pdf. [Accessed in 2012 Sep]. |
|3.||Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol 2004;36:207-8. |
|4.||Nadig P, Joshi M, Uthappa A. Competence of ethics committees in patient protection in clinical trials. Indian J Med Ethics 2011:8;151-4. |