Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and expedited categories, approval periods, ceding review, Quality Improvement/Quality Assessment activities, and some requirements for pregnant women, prisoners, and children. This case study may assist other institutions in responding to the Final Common Rule.

For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, 4) ethics committees (...) apply inappropriate principles, 5) ethics review harms the innocent, and 6) better options exist. (shrink)

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...) the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)

As international collaborative health research activities increase, building research ethics committees infrastructure and capacity in lowand middle-income countries for efficient and thorough review of research protocols becomes more critical, especially in sub-Saharan Africa. International investigators may face multiple challenges when conducting research in these settings, an important one being the length of time involved in securing REC review and approval. We discuss an approach to the problem that involved organisation of ‘rapid review’ REC sub-committees who met via video-conference for collaborative (...) review of research protocols. (shrink)