Clinical trials are paramount for the development of medical science and advancement in therapeutics. Mankind has made great strides in medical science, thanks to the ever curious scientific acumen of researchers. But since clinical trials involve human ‘participants’, their safety, and policies to protect their rights justly take precedence over scientific advancement.
In India, the regulatory agency overseeing and approving clinical trials is the CDSCO, ‘Central Drugs Standard Control Organization’ (1). The CDSCO considers and approves only those trials that have been approved by the Ethics Committees, thereby, making the Ethics Committees (EC) the most important link in safeguarding ...view middle of the document...
Also, another important step would be introducing a mandatory ethics checklist and a scoring system, for example, from 1 to 5 (1 – adequately addressed to 5 – grossly neglected). The ethical concerns that could be incorporated in such a list could include - scientific rationale of the study, equitable and fair selection of subjects, favorable risk benefit ratio, the informed consent process, factors likely to affect the voluntariness, post trial access, subject insurance and compensation, financial inducement, vulnerable population and so on (4,7). This will ensure adequate consideration of all ethical concerns and the scoring system will ensure an objective decision making as against the current system of voting where the majority decides the fate of a trial.
Reviewing a trial protocol and awarding approval doesn’t end the task of the EC. Just as the investigator has to provide regular study updates to the EC, the EC should also take initiative in regular on-site monitoring of ongoing clinical trials to affirm the approval granted on a periodic basis (8). This is something, although mandatory by law, is lacking (3,9–11). The recent amendment (2013) in the Drugs and Cosmetics act of 1940 has made it mandatory for the ECs to submit periodic reports of ongoing trials to the CDSCO but to what extent this has been implemented remains doubtful (8).
Another concern that needs to be addressed is the non-disclosure of conflict of interest by the EC members and the so called, ‘private hospital-investigator-EC’ nexus (4,5,12,13). To obviate this it has recently been made mandatory to include at least 50% of government sites for clinical trials (2). Even the law doesn’t make it mandatory for the EC members to declare conflict of interest and hence it is seldom done. We have come a long way in regulating clinical trials and improving the functioning of ECs but there still exist gaps that need to be filled. To summarize, we need to train EC members in bioethics, mandate accreditation of ECs and a check list based scoring system to review protocols, regular on-site monitoring and declaration of conflict of interest by the EC members.
1. Central Drugs Standard Control Organization [Internet]. Director General Of Health Services, Ministry of Health And Family Welfare, Government Of India. Available from: http://www.cdsco.nic.in/forms/Default.aspx
2. Suvarnapathaki K. Indian regulatory update 2013. Perspect Clin Res [Internet]. 2013 Oct [cited 2014 Apr 27];4(4):237–8. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3835969&tool=pmcentrez&rendertype=abstract
3. Nadig P, Joshi M, Uthappa A. Competence of ethics committees in patient protection in clinical research. Indian J Med Ethics [Internet]. [cited 2014 Apr 27];8(3):151–4. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22106640
4. Pandiya A. Quality of independent review board/ethics committee oversight in clinical trials in India. Perspect Clin Res...