Conference on “Minimal Risk” in Behavioral Science Research: A Decisional Framework for Investigators and IRBs
Fordham University (Lincoln Center Campus)
33 West 60th Street
New York, NY 10023
April 29 – 30, 2005
Sponsored by
American Psychological Association, Science Directorate, and
Center for Ethics Education at Fordham University
Registration has reached capacity for the conference venue and is now closed.
The broad goal of this conference is to bring together stakeholders in behavioral science minimal risk research to create a consensus document that can guide the responsible evaluation of risk in behavioral science research. Specific goals are to develop: (1) a decision-making framework that can be applied to the broad spectrum of populations and methodologies characteristic of behavioral science research; (2) a set of cases illustrating how the framework can be applied; and (3) a list of specific exemplar methodologies that can be considered “minimal risk.”
The federal regulation defining “minimal risk” (§45 CFR 46.102) plays a pivotal role in Institutional Review Board (IRB) decisions regarding the application of federal policy for the protection of human subjects to classification and evaluation of behavioral science research protocols. However, anecdotal evidence points to the conviction in the behavioral science and IRB communities that “psychological” and “social” risks of research are often over-estimated, resulting in failure to appropriately classify protocols as “minimal risk.” Such overestimation of risk subjects psychological science protocols to unnecessary, more costly, and time-consuming full panel IRB review. In addition, a conservative approach to research risk can lead to implementation of participant protections that may be inappropriate or even harmful, dilute the scientific validity of the research, or discourage behavioral research involving under-studied populations.
Thus, there is a pressing need for specific guidance on the appropriate classification of minimal risk behavioral science research procedures. Such guidance is needed by all stakeholders in the responsible conduct of research, including investigators, IRBs, federal agencies, IRB accreditation bodies, university administrators, and research participants. Such guidance must provide a clear and cohesive decision-making framework that meets the goals of participant protection and classificatory consistency without sacrificing the flexibility needed for decisions regarding different populations and research contexts.
To ensure wide acceptance of the consensus document, conference participants will include not only psychological researchers and/or IRB members but also representatives from other entities involved in the application of federal regulations to minimal risk research in psychology, such as relevant federal agencies, organizations involved in IRB administration, scientific societies, etc. Conference participants will broadly represent the breadth of the field. In addition, the conference will include a period for open comments from the attendees, which will ensure that all perspectives are considered in the development of a consensus document.
Read information about Fordham University Lincoln Center campus.
Read the conference agenda.
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