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Editorial policy for biomedical journals increasingly calls on authors to affirm that approval was received from an Institutional Review Board (IRB) (or equivalent) prior to initiating any human subjects research presented in a manuscript submitted for publication. For most investigations and investigators this does not present any problem. However, when research is carried out in a setting where there is no IRB, should editors consider a report of such a study based on the merits alone? There is no simple answer to this question. This commentary explores aspects of the question and presents issues to be considered in developing an answer.