National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017)

The Indian Council of Medical Research (ICMR) has released new National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017. These guidelines are a result of in-depth discussions and debates involving diverse stakeholders and the public. The ICMR ethical guidelines are well-respected not only in India but also in several other countries.

The revised guidelines have addressed newer emerging ethical issues, keeping in view the social, cultural, economic, legal, and religious aspects of India. They have covered some newer areas like public health research, social and behavioral sciences research for health, and responsible conduct of research. The guidelines have expanded into separate sections, including informed consent process, vulnerability, biological materials, biobanking, and datasets.

The ICMR ethical guidelines are based on the four basic principles of respect for persons (autonomy), beneficence, non-maleficence, and justice. These principles have been enunciated to protect the dignity, rights, safety, and well-being of research participants. The guidelines also emphasize the importance of ensuring privacy and confidentiality, minimizing risks, and maximizing benefits.

The researcher and the team are responsible for protecting the dignity, rights, safety, and well-being of the participants enrolled in the study. They should have the appropriate qualifications and competence in research methodology and be aware of and comply with the scientific, medical, ethical, legal, and social requirements of the research proposal.

The ECs are responsible for ensuring that the research is conducted in accordance with the aforementioned principles. The guidelines also outline the importance of informed consent, benefit-risk assessment, and minimizing risks to participants.

Overall, these revised guidelines aim to promote good governance and high-quality biomedical and health research, which will ultimately contribute to improving human health outcomes in India.