Ethics in Biomedical Research and General Principles of Indian Council for Medical Research National Ethical Guidelines for Biomedical and Health Research involving Human Participants 2016

Knowing what constitutes ethical research is important for those who conduct research and the researcher should be familiar with the basic ethical principles and policies designed to ensure the safety of the research subjects. Research must be ethically conducted, trustworthy, and socially responsible for the results to be valuable. Ignorance of policies designed to protect research subjects is not considered a viable excuse and the researcher needs to fully understand the ethical code and guidelines to guarantee upstanding research practices. In the last decade medical research in India saw emergence of difficult ethical issues and intervention from the Supreme Court of India. The different socio-cultural ethos and the varying standards of health care in India pose unique challenges to the application of the universally prevailing ethical principles and guidelines. This necessitated the Indian Council of Medical Research (ICMR) to revise their 2006 ethical guidelines for biomedical research as ‘National Ethical Guidelines for Biomedical and Health Research on Human Participants 2016’. These guidelines are applicable to all biomedical, socio-behavioral and health research conducted in India which involves human subjects. This article gives an overview of the evolution and principles of research bioethics, and helps to understand and disseminate the general principles of the Declaration of Helsinki 2013 of World Medical Association and the National Ethical Guidelines 2016 of ICMR