Handbook on National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2018)

'The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2018, published by the Indian Council of Medical Research (ICMR), provides a comprehensive framework for conducting research involving human participants in India. The guidelines emphasize the importance of protecting the dignity, rights, safety, and well-being of research participants.

The guidelines outline general principles that researchers must follow, including respect for persons, beneficence, non-maleficence, and justice. They also address specific issues related to informed consent, vulnerability, clinical trials, public health research, social and behavioral sciences research, human genetics testing, and biological materials.

Researchers are required to obtain voluntary written informed consent from each participant before conducting research. The guidelines also outline procedures for handling vulnerable populations, such as children, pregnant women, and individuals with mental illness.

The guidelines emphasize the importance of community engagement and post-research access and benefit-sharing. They also provide guidance on responsible conduct of research (RCR), including conflict of interest policies, data management, and publication practices.

Overall, the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2018 provides a comprehensive framework for conducting research involving human participants in India, with a focus on protecting the rights and dignity of participants.'