Benefit sharing in the revised Indian National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

Though not an ethical principle per se, benefit sharing is still an important tool to achieve justice in international research. It comes back as a transversal issue through the revised Indian Ethical Guidelines for Biomedical and Health Research Involving Human Participants (hereafter referred to as "the Guidelines"). The Guidelines invoke this principle with reference to the responsible conduct of research, ownership of biobanks and data repositories, informed consent process, community engagement, international collaborative research, and research in emergency or disasters, while using the phrase "maximization of benefit" instead of "benefit sharing". This approach may be seen as quite innovative, in that it sees benefit sharing (ie, maximisation of benefit) as a key ethical requirement. Unfortunately, it does not explicitly state that the principle is relevant to all research involving human participants, not only to specific situations such as biobanks, research in emergencies and international collaborations; rather it appears to consider the risk of lack of benefit sharing as mainly related to international collaborations. Another important drawback is the frequent use of noncommittal language such as "could be considered" and "may be offered". This suggests that the provisions with respect to benefit sharing are not mandatory and thus open to the discretion of different Ethics Committees. Therefore, for the Guidelines to become a positive model for other countries and ethics bodies, further elaboration of the principle and mode of implementation is needed.