Ethical Guidelines for Biomedical Research on Human Participants (2006)

The Indian Council of Medical Research (ICMR) has published revised Ethical Guidelines for Biomedical Research on Human Subjects in 2006. The guidelines aim to ensure that medical and related research using human beings as participants is conducted with the highest ethical standards, taking into account the unique cultural context of India. The guidelines outline principles for biomedical research involving human participants, including informed consent, non-exploitation, privacy and confidentiality, precaution and risk minimization, professional competence, accountability and transparency, maximization of public interest, distributive justice, institutional arrangements, public domain, totality of responsibility, and compliance. These principles are designed to protect the rights and welfare of research participants, particularly vulnerable populations such as women, children, and those with disabilities. The guidelines also emphasize the importance of ethics committees in reviewing research proposals, monitoring ongoing research, and providing feedback on ethical issues related to biomedical research. Additionally, the guidelines address specific areas of biomedical research, including clinical trials, epidemiology, human genetics and genomics, transplantation research, and assisted reproductive technologies.