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Conference on “Minimal Risk” in Behavioral Science Research: A Decisional Framework for Investigators and IRBs

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 IRBs and researchers in the responsible evaluation of risk in behavioral science research.

By Sangeeta Panicker, PhD

The APA Science Directorate in collaboration with the Center for Ethics Education at Fordham University will sponsor a conference entitled "Minimal Risk" in Behavioral Science Research: A Decisional Framework for investigators and IRBs, in April 2005. 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 IRBs and researchers in the responsible evaluation of risk in behavioral science research.

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.

Consequently, the specific goals of this conference 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."

To ensure that the myriad settings, methodologies, and the accompanying unique perspectives that characterize minimal risk behavioral research are adequately represented at the conference, nominations were solicited from APA divisions. The deadline for divisions to submit nominations was November 30, 2004. The conference organizers will make every effort to ensure that the breadth of the field is appropriately represented on the conference-working group. However, since the size of the conference-working group has to, by necessity, be limited to a manageable size (20-25 individuals), divisions whose nominees are not selected to serve on the conference-working group are welcome to send representatives to attend the conference. The format of 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.