The IRB is familiar with a large array of research risks, those which are physical, psychological, medical, and risks to reputation. Some of these risks are intrinsic to the research methodology and/or the discipline. For instance, in certain kinds of social research there is a risk that the subject will become severely embarrassed by certain kinds of questions or in the face of certain kinds of evidence or illustrations. Sexually explicit material is often the source of this kind of risk, for example.
At the same time the IRB is not necessarily completely familiar with all lines of research in all disciplines, yet to determine "beneficence" the IRB must examine scientific premises and procedures, including statistical inferences. Applications for permission to use human subjects in research must explicate the research methodology to permit a rigorous analysis for risk and benefit. If problems occur later, both the IRB and the researcher will be criticized.
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