ICMR releases fresh guidelines on biomedical and health research

The Indian Council of Medical Research (ICMR) has released two national guidelines addressing newer emerging ethical challenges in the country and to improve public trust in research. Those are solely aimed at better understanding of ethical issues around research involving human participants (adults and children). These guidelines which are included in ‘National Guidelines for Biomedical and Health Research Involving Human Participants – 2017’ are targeted to protect and safeguard the interests of individuals, communities and society as a whole in all types of biomedical and health research.

There is no denying the fact that the benefit of research carried out in adult cannot be applied to children. Certainly several issues such as the doses and duration of therapy, pharmacodynamics, and adverse effects of drugs vary in children. Side by side, children are susceptible to a greater risk of harm during research. Thus there is indeed need to have regulations and guidelines in case of research exclusively on children. This is in fact true for neonates or adolescents also. Here in lies the importance of ICMR guidelines which not only aim to improve the quality of research but alsosafeguard participants involved in research. No doubt, transparency is a key aspect in this case and thus the concerned guidelines will also support regulatory agencies and all other stakeholders involved in research enterprise and enable better protection of our population.

The guidelines thus categorically calls for specific needs - one or more members of the team should be a pediatrician and/or have prior experience of conducting research involving children; also, research involving children should take into consideration the unique physiology, anatomy, psychology, pharmacology, social situation and special needs and their families. Most importantly, research involving children has to be conducted in a child-friendly environment. In this case let us not forget those case studies where studies involving children would be needed without prior adult studies, for example, surfactant use in premature babies with respiratory distress syndrome.

In this regard, the domain of biomedical research involving children cannot be ignored either. In case of promote health, hygiene and preventing and treating diseases that affect children, there is certainly no alternative to experimentation. In all such cases, to achieve best possible outcome of clinical care, thorough understanding of research outcome is needed, which definitely highlights the need of adhering to ICMR guidelines. Thus in case of both health and biomedical research, the advanced ICMR guidelines are to be followed, ensuring the care and safety of the participants.