ALTERNATIVE IRB MODELS National Conference on Alternative IRB Models: Optimizing Human Subject Protection AHP summarized the findings of a landmark national conference held in Washington, D.C. on November 19-21, 2006: “National Conference on Alternative IRB Models: Optimizing Human Subject Protection.” Its purpose was to enhance the protection of human subjects of research by encouraging the use of alternative Institutional Review Boards (IRB) models under appropriate circumstances. Planners shared a belief that the changing nature of research involving human subjects, particularly investigations involving multi-institutional trials, has created an opportunity to be more innovative in selecting IRB models. The many sponsors of the conference included the HHS Office of Human Research Protections (OHRP), the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC), the American Society of Clinical Oncology (ASCO), and the Department of Veterans Affairs (VA). The widely disseminated report captured the findings and recommendations of stakeholder groups on key issues, as well as the edited remarks of speakers in plenary sessions and breakout groups. Workshop on Alternative Models of IRB Review Issues explored in the conference were identified by participants in a preceding workshop, “Alternative Models of IRB Review,” held in Washington, D.C. on November 17-18, 2005. The workshop and the associated summary report prepared by AHP laid the groundwork for the conference by identifying key issues involved in the use of alternative models. Participants in both the workshop and the conference included IRB chairs, academic investigators, community-based researchers, attorneys, patients, ethicists, industry officials, and senior university and medical school research administrators.
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