Updating protections for human subjects involved in research

For decades, all federally funded research involving human subjects has bee n subject to regulations that require the informed consent of the subject a nd oversight by the local institution. These regulations last underwent maj or revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research suppo rt, and the institutional environment in which clinical research is conduct ed. In the intervening years, doubt has evolved as to whether the regulatio ns currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, i n terms of time, bureaucracy, and delay, are justified by the level of prot ection afforded. The Human Research Ethics Group, administered by the Cente r for Bioethics at the University of Pennsylvania Health System, extensivel y reviewed the status of existing human subjects protections with the aim o f making recommendations to improve and reform the regulations. Here, we pr esent recommendations constituting a consensus of the group members for ref orm in 3 key areas: protecting subject populations with special needs and v ulnerabilities, oversight by institutional review boards, and regulatory po licy.