Ethics committees in India: Facing the challenges!

Abstract

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

“…[14] A joint network of ECs is required, first at a local level and then at the regional and national levels, which would serve as forums to discuss issues of importance to them. A study conducted in 2009, to study the profile and roles of EC members in Pune, noted that even with an appropriate EC constitution, the members had suboptimal understanding of the ethical issues and principles.…”

A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition

“…[15] Some of the other issues that have been raised often are the inappropriate manner, inefficient, or professionally biased in the constitution of an IEC. [12161718] The IEC should be free from conflict of interest; however it has been observed that the composition of an IEC among health institutes is often influenced by the professional specialty of the college. The ethical review process must be free from institutional bias, but data showed that majority of members in the IEC of various institutes were professionally biased by including IEC members of their own institute specialties.…”

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

“…Literature review enlisted challenges which included improper knowledge of appointment of committee members, availability/scarcity of trained legal expert and layperson in the quorum and very few consultant having the research background with no formal training in GCP. [45] Most of the challenges faced during IEC set up remained same however few well trained and experienced IEC external members guided in selection of quorum. Major hurdle of training of new members in SOP and IEC review procedure was accomplished with help of experienced external members.…”