This initiative provides general guidelines that are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
Name in original language
National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
Initiative overview
Research on human participants pertains to a broad range of scientific enquiry aimed at developing generalizable knowledge that improves health, increases understanding of disease and is ethically justified by its social value. Every research has some inherent risks and probabilities of harm or inconvenience to participants/communities. Therefore, protection of participants should be built into the design of the study. Do no harm (non-maleficence) has been the underlying universal principle guiding health care in all systems of medicine around the world. While conducting biomedical and health research, the four basic ethical principles namely; respect for persons (autonomy), beneficence, non-maleficence and justice have been enunciated for protecting the dignity, rights, safety and well-being of research participants. These four basic principles have been expanded into 12 general principles described in the guidance document, and those are to be applied to all biomedical, social and behavioural science research for health involving human participants, their biological material and data.The purpose of such research should be:i. directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian cultural, social and natural environment;ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; andiii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
Name of responsible organisation (in English)
ICMR
