ICMR issues “National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016”

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The Indian Council of Medical Research (ICMR) has issued the draft “National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016” which will make specific provisions to meet ethical challenges posed by newer scientific advances. The guidelines are divided in various sections to cover a range of topics and attempts to address the emerging ethical concerns related to biomedical and health research.   

The guidelines have been drafted by Expert Subcommittees working under the dynamic leadership of an Advisory Committee chaired by Dr Vasantha Muthuswamy.  The ICMR has invited suggestions/feedback from all interested stakeholders till 15th September, 2016.

These guidelines are applicable to all biomedical, socio-behavioural and health research conducted in India involving human participants, their biological material and data. The purpose of such research should be directed towards enhancing knowledge about the human condition in relation to its social and natural environment.  It should be conducted under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subjected to any medical 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.  It must be subjected to a regime of evaluation at all stages of the proposal i.e.,  research design and conduct with the objectives in mind, the means by which they are sought to be achieved, the anticipated benefits and harms, declaration of results and use of the results thereof.

As per the new guidelines, research pertains to a broad range of scientific enquiry on human participants for developing generalisable knowledge that improves health, increases understanding of disease and is justified ethically by its social value. Every research has some inherent risk and probabilities of harm to participants/community. Therefore, protection of participants should be built in to the design of study. Do no harm (non maleficence) has been the underlying universal principle in all systems of medicine around the world for guiding healthcare. While conducting biomedical and health research, the four basic principles namely; Respect for Persons (Autonomy), Beneficence, Non Maleficence and Justice have been enunciated to govern research. These four basic principles have been expanded into 12 general principles, which are to be applied to all biomedical and health research involving human participants or research using their biological material or data.

The 12 general principles include principle of biomedical and health research, principle of essentiality, principle of voluntariness,  principle of non-exploitation, principle of ensuring privacy and confidentiality,  principle of risk minimization, principle of professional competence, principle of accountability, principle of the maximization of benefit, principle of institutional arrangements, principle of transparency and principle of totality of responsibility.  

The new guidelines have adapted important guidance points from some of the International guidelines in accordance with the socio-cultural milieu of our country.  The socio-cultural ethos in India and its varying standards of health care today pose unique challenges to the application of universal ethical principles to biomedical and health research. The last decade has seen emerging ethical issues necessitating further revision as ‘National Ethical Guidelines for Biomedical and Health Research on Human Participants 2016’. These guidelines have covered some newer areas like social and behavioural sciences, responsible conduct of research and new technologies, while a few other specialised areas like informed consent process, biological materials and data sets, vulnerability, international collaboration, research during humanitarian emergencies and disasters have been expanded.

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