Guidelines National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic-April (2020)

The Indian Council of Medical Research (ICMR) has published a document titled "Ethical Guidelines for Biomedical and Health Research Involving Human Participants during COVID-19 Pandemic" to provide guidance on conducting research during this unprecedented situation. The document is compiled by Dr. Roli Mathur, Scientist F & Head, ICMR Bioethics Unit, NCDIR, Bengaluru, and published by the ICMR-National Centre for Disease Informatics & Research, Bengaluru.

The guidelines emphasize the importance of respecting human dignity, rights, safety, and well-being while conducting biomedical and health research. They highlight 12 general principles that must guide research, including respect for persons (autonomy), beneficence, non-maleficence, and justice. The guidelines also address various ethical issues related to COVID-19 research, such as benefit-risk assessment, privacy and confidentiality, distributive justice, payment for participation, compensation for research-related harm, conflict of interest, community engagement, post-research access and benefit sharing, storage of biological material/datasets, collaboration in research, public health and socio-behavioral research, role of agencies/sponsors & governance of research, and biosafety in laboratories and hospitals.

The document also provides guidelines on ethical review procedures, including the categories of research that may require ethics review (new research directly related to COVID-19, ongoing non-COVID research, and new non-COVID research). It emphasizes the importance of ensuring a thorough scientific and ethical review of research as per national guidelines and regulations to safeguard the dignity, rights, safety, and well-being of research participants.

The guidelines also address special situations, such as institutions having multiple ethics committees or utilizing services of another institution with mutual agreement. They emphasize the need for transparency and accountability in research and provide guidance on informed consent, benefit-risk assessment, selection and recruitment of participants, qualification & adequacy of study sites, payment for participation, disclosure of conflict of interest, plans for medical management and compensation for study-related injury, community considerations, protection of privacy and confidentiality, and other related issues.

The document also provides guidelines on the role of agencies/sponsors & governance of research, including humanitarian emergencies leading to fragile political environments, disruption of health systems, challenging social situations, resource constraints for fast track conduct of research. It emphasizes the need for ensuring appropriate safety, funds, care, and compensation, including insurance coverage as well as training at individual, societal, and/or community levels for patients, healthcare workers, and others engaged in COVID-19 research.

Overall, the guidelines aim to provide a framework for conducting biomedical and health research during the COVID-19 pandemic while protecting the rights, safety, and well-being of research participants.