Abstract
Background/Aims Institutional Review Boards (IRBs) are charged with protecting human subjects, balancing experimental risks against potential benefits. IRB members sometimes raise concerns that project findings may create risks for an organization. Even if the concerns are legitimate, IRBs have neither the responsibility nor the appropriate expertise to address them. These concerns arise not from research processes potentially addressable by changing the study methods, but from potential findings. Ex ante reviews are speculative; ensuring low probability scenarios never occur means avoiding most delivery system research. Ex post review and approval allows projects to begin, but are generally unacceptable to researchers, funders, and journals. A two-phase process incorporating ex post reviews, but not approvals, offers a solution.
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