What's the Big Deal? Protecting Participants in Minimal Risk Research

Although Institutional Review Boards (IRB) are mandated to assess the risk of harm associated with participation in a research study, current regulations for the protection of human participants in research, do not define “risk.” They do, however, define “minimal risk,” and as such “minimal risk” has become the threshold for judging acceptable levels of participant risk. But the definition is intentionally vague and ambiguous; this is an asset since it allows the IRB to judge the merits of protocols on a case-by-case basis, but on the other hand, may contribute to overestimation of risks in behavioral and psychological research. This may be detrimental to the conduct of such research.

From a practical perspective, it is important to correctly identify minimal risk in research for at least two reasons: (1) A basic requisite for using the expedited review mechanism requires the research to entail no more than minimal risk. Consequently, a systematic approach to identifying minimal risk protocols may significantly reduce IRB workload by accurately identifying a greater number of protocols eligible for expedited review, and; (2) Waiver or alteration of informed consent also require that the research entail no more than minimal risk. This flexibility in the consent process is often important to the investigator. Further, expedited review suggests less time will elapse between protocol submission and the start of research. These issues are of increasing importance in social and behavioral science research of the sort social workers conduct. In April 2005, the Fordham University Center for Ethics Education and the APA Science Directorate, sponsored a working meeting where participants focused on operationalizing the definition of “minimal risk” in the context of behavioral and psychological research; the outcome of this meeting was a tool to enable the IRB to more accurately identify and classify minimal risk research protocols. This decision-making model, based on the regulatory definition of minimal risk, supplemented by additional information and examples of standard behavioral and psychological research methodologies, population characteristics, risks of daily life, and risk reducing procedures, will be shared with participants using examples from social work research.

This workshop will also identify current “guidance” from the Office of Human Research Protections, standards, practice and key flexibilities that IRB's may choose to employ. Our goal is to increase investigators' awareness of and ability to reference important concepts used by IRBs in discussing research participation within a “risk” framework.

Workshop leaders bring over 25 years combined IRB expertise and 50 years research experience in both minimal and higher risk social work research. Exercises in identifying and determining “minimal risk” in social work research will improve skills at providing salient information to IRBs more succinctly and efficiently, decreasing IRB returns and requests for additional information.