title: The protectors and the protected: what regulators and researchers can learn from IRB members and subjects.
abstract: Clinical research is increasingly conducted in settings that include private physicians' offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non-academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community-based IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule.
authors.forename: Ann Freeman
authors.initials: AF
authors.lastname: Cook
authors.forename: Helena
authors.initials: H
authors.lastname: Hoas
authors.forename: Jane Clare
authors.initials: JC
authors.lastname: Joyner
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D016265:Conflict of Interest; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D012108:Research Personnel; D035842:Research Subjects