Highlights of Indian Council of Medical Research National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

Advancements in the field of biomedical and health research pose new ethical challenges warranting the need for constant updation in the existing ethics guidance. Realizing this, revision of “Ethical Guidelines for Biomedical Research on Human Participants (2006)” was initiated in the year 2015. The preparation of guidelines was a participatory process involving large number of stakeholders from various backgrounds in order to get a variety of perspectives. The initial draft went through an extensive process of consultation at both regional and national level, with experts and stakeholders from academia, govt. agencies, departments and ministries, public and private institutions, pharmaceutical industry, non-governmental organizations, patient organizations, regulators, international agencies as well as with public. The revised “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017” were released on October 12, 2017, and address ethical concerns, in accordance to the sociocultural milieu of our country. New sections have been added on informed consent process, vulnerability, biological materials, biobanking and datasets, responsible conduct of research, sociobehavioral research, research in emergencies or disasters. The revised guidelines must be followed by all stakeholders who are engaged in biomedical and health research including sponsors, institutions, ethics committees, and researchers. It is expected that the implementation of these guidelines would help to protect the dignity, rights, safety and well-being of research participants and also to improve the quality of biomedical and health research.