National Ethical Guidelines for Bio-Medical Research Involving Children (2017)

The National Ethical Guidelines for Biomedical Research Involving Children, published by the Indian Council of Medical Research (ICMR) in 2017, provide a framework for conducting research on children. The guidelines emphasize that biomedical research involving children is necessary to advance child health and must be conducted with utmost care and consideration.

Children are considered vulnerable participants who cannot give informed consent due to their age, and therefore, researchers must take additional precautions to protect them from harm. The guidelines outline the importance of assessing benefit and risk in research involving children and provide definitions for minimal risk, low risk, moderate risk, high risk, and more than minimal risk.

The guidelines also stress the need for informed consent and assent from children's parents or legal guardians. They recommend that children's assent should be obtained if they are capable of understanding the research procedure and its risks. The guidelines further outline the requirements for ethics committees to review research proposals involving children, including the need for a detailed protocol, informed consent forms, and procedures for monitoring data safety.

The document also discusses special situations such as research in neonates, HIV-positive children, vaccine studies, genetic research, and research involving adolescents. It provides guidance on compensation for participation and accidental injury, as well as safeguard systems, including ethics committees, data and safety monitoring boards, and bio-banking of samples.

The guidelines are intended to be used in conjunction with the National Ethical Guidelines for Biomedical Research Involving Human Participants, ICMR Government of India. They aim to provide a comprehensive framework for conducting research on children while protecting their rights and interests.