An analysis of India’s 2017 national Ethical guidelines for biomedical and health research involving Human participants: The social and behavioral sciences aspect

Abstract

In this commentary on Section 9 (Social and Behavioural Sciences Research for Health) of the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) by the Indian Council of Medical Research (ICMR), we appreciate that the guidelines clarify that human beings are “research participants” and not merely “subjects”. Further, we appreciate and commend the ICMR for: i) contextualising the guidelines to India’s unique sociocultural and economic situation and ii) affirming the multidisciplinary nature of health research and the wide scope of social and behavioural research. However, we question the prominence given to the difference between biomedical research and other aspects of health research and the description of social and psychological risks and discomforts as minor risks. Finally, we suggest that the guidelines would express greater value and diversity of the social aspects of health if they recommended wider representation of these aspects in the composition of research ethics committees.