Moral reasoning and the review of research involving human subjects.

The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research.