LAUSR

This article pertains to the governance of biomedical and health research after the publication of the New Drugs and Clinical Trial Rules, 2019. The new regulations cover all types of research. However, those concerning biomedical and health research may fall short on certain counts regarding: reviewing studies with vulnerable populations, undertaking risk benefit analysis, finding relatedness in case of serious adverse events, and providing compensation. The challenges faced by ethics committees from the inception of a study to its completion are discussed. There is a need for rigorous training of all members involved in the ethics committee's functioning.