Role of institutional review boards in the regulation of ethical Guidelines for clinical research in india

Recently, the increasing area of attention is the Research funding in the developing countries. The
Global Forum for Health Research has pointed out that less than 10% of the world’s research
resources are earmarked for 90% of the health problems. Over the last decade, Indian clinical research
environment has witnessed two forces pulling in opposite directions. The regulatory changes – Indian
Good Clinical Practice(GCP) guidelines, Amended Schedule Y, Indian Council of Clinical
Research’s Ethical Guidelines for Biomedical Research on Human Participants, Clinical Trial
Registry of India – all, together with focus on education and training of clinical research professionals
in academia and industry, promoted the growth of clinical research and clinical trials. In parallel,
frequent media stories of commercialization of clinical research and exploitation of subjects have
impeded the growth of clinical research. The Independent Ethics Committee (IEC) also referred to as
Institutional Review Board (IRB) in many countries, serves as an independent representative and
competent body to review, evaluate and decide on the scientific and ethical merits of research
proposals. As per the Bulletin report of the World Health Organization (WHO) there are less than 40
ECs/IRBs in India, which are properly constituted and functioning. This brief review and summary
seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) in
India to contribute to the future evolution of ethics in clinical research as we advance forward.