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Evaluating research risk requires understanding a variety of potential harms and their nuanced impact. IRBs might find it useful to have a matrix to help explore each potential harm.
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Even as multicenter studies with central IRB reviews gain traction, some IRBs are still hesitant to join in. However, coordinating a multisite study among several IRBs within the same university system can be a time and paperwork hassle for both principal investigators and IRBs and could make previously reluctant IRBs consider a new central reliance agreement.
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The Presidential Commission for the Study of Bioethical Issues May 2014 report, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, includes recommendations for institutions and individuals engaged in neuroscience research.
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Technology advances have driven increased interest in molecular studies involving tissue analyses. As a result, biotech firms increasingly are asking scientists to sell human tissues for study by outside enterprises.
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The IRB at Grand Valley State University in Allendale, MI, uses a matrix that clarifies how IRB members and staff might describe various potential harms at four levels, from no more than minimal risk to high risk.
