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ICMR Releases Guidelines on Biomedical & Health Research Involving Human Participants

The Indian Council of Medical Research (ICMR) has released national guidelines for biomedical research involving human participants. These guidelines are aimed to protect and safeguard the interests of individuals, communities and society as a whole.

Two separate set of guidelines for adults and children respectively would help in understanding the complexities of ethical issues around research involving human participants. 

The ‘National Guidelines for Biomedical and Health Research Involving Human Participants – 2017’ and the ‘National Ethical Guidelines for Biomedical Research Involving Children’ are aimed to help strengthen the protection of rights, well-being and safety of research participants involved in all types of biomedical and health research. The revised ethical guidelines have been expanded to address newer emerging ethical challenges being faced in the country and to improve public trust in research.

The guidelines will ensure that the biomedical and health research is carried out in an ethical manner to maintain and improve the public trust towards medical research.

Research ethics is a dynamic subject and over the last decade many new concerns and issues have evolved over the ethical dilemmas faced by the scientific and ethics committees in the conduct and review of biomedical research. The ICMR undertook an extensive exercise by engaging with experts and diverse stakeholders such as patient groups, civil society, lawyers, clinicians, scientists, members of ethics committees and others through regional, national as well as public consultations in the process of preparing these guidelines.

According to Dr Soumya Swaminathan, Director General of ICMR, medical research is the need of the hour and therefore it ’s important to not only be responsive to emerging issues, but to also build greater trust towards research. It is thus important that every stakeholder, whether a researcher or a member of an ethics committee, or a sponsor, is aware of the provisions made in the revised ethical guidelines, which would help improve the conduct of biomedical research in India, she said.

The revised National Guidelines for Biomedical and Health Research Involving Human Participants, 2017 includes additions such as detailed guidance to help ethics committees in the process of review, guidance to researchers in conducting research, responsible conduct of research, obtaining informed consent, multicentre research, clinical trials of drugs and other interventions, public health research, socio behavioural research, genetics, bio-banking and datasets, research during humanitarian emergencies and disasters, etc. The document also highlights the needs for additional safeguards in the conduct and review of research carried out on vulnerable population including children, lower socioeconomic group, those with mental illness, or with rare disorders.

The National Ethical Guidelines for Biomedical Research Involving Children have been developed specifically to address ethical issues of conducting research in children. Benefit of research carried out in adult cannot be applied to children, as the doses and duration of therapy, pharmacodynamics, adverse effects of drugs in children vary from adults. Children are potentially vulnerable and carry a greater risk of harm during research. The guideline was prepared after extensive literature review and expert consensus, and also covers the ethical and legal dimensions. Other special scenarios like school based research, research using internet, research involving HIV positive children, children in emergency situations and research in neonates or adolescents are also covered.

These ICMR guidelines aim to improve the research quality as well as safeguard participants involved in research. Both the guidelines will also support regulatory agencies and all other stakeholders involved in research enterprise, in imparting better protection of our population.

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