Biomedical and health research: ICMR releases revised guidelines

New Delhi: The Indian Council of Medical Research (ICMR) has released revised guidelines aimed at strengthening the protection of rights, well-being and safety of research participants involved in all types of biomedical and health research.

The 'National Guidelines for Biomedical and Health Research Involving Human Participants 2017' and the 'National Ethical Guidelines for Biomedical Research Involving Children' have been drafted to address newer emerging ethical challenges being faced in the country and to improve public trust in research.

Union Health Minister J P Nadda lauded the efforts directed by ICMR to ensure that the biomedical and health research is carried out in an ethical manner to maintain and improve the public trust towards the medical research.

"I understand that the ICMR National Guidelines for Biomedical and Health Research Involving Human Participants 2017' have been prepared considering the moral, ethical, social values and ethos of our diverse population," he said.

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.

ICMR undertook an extensive exercise by engaging with stakeholders including 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, Nadda said.

Dr Soumya Swaminathan, DG-ICMR said medical research is the need of the hour and therefore it was 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 detailed guidance to help ethics committees in the process of review, guidance to researchers in conducting research, responsible conduct of research, obtaining informed consent, clinical-socio-behavioural research among others.

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 an adult cannot be applied to children, as the doses and duration of therapy, pharmacodynamics, adverse effects of drugs in children vary from adults, Dr Swaminathan said.

Here is the full guideline on National Ethical Guidelines for Biomedical Research Involving Children