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Risks to participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result from the research.
In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits that may result from therapies or other interventions participants would receive even if not participating in the research). The IRB will not consider long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
The IRB will examine study design or scientific merit of a proposed study within the context of its risk/benefit analysis.