Burris and Davis (2009) raise questions regarding the potential for institutional review boards (IRBs) to require empirical assessment of risk prior to the initiation of research, as a form of “due diligence” (48). They are rightly cautious about the possibility of undue burden on investigators and unproductive use of scarce research resources. Concerns about IRBmission creep and the exaggeration of risk are also valid. However, in framing the discussion so narrowly, the authors fail to address a larger issue, that is, the need for systematically developed knowledge derived from evidence-based approaches to solving ethical problems in human research.
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