Streamlining Review by Accepting Equivalence
In their target article, Barchi, Singleton, and Merz (2014) identify several challenges to the review of international research, including regulatory frameworks and review criteria that may overlap or compete across research sites. They articulate a variety of mechanisms by which institutional review boards (IRBs) can collaborate internationally to streamline review and avoid unnecessary burden while continuing to protect subjects, but one important mechanism for achieving these goals goes beyond the IRB's purview: the regulatory authority offered under 45 CFR 46.101h to accept equivalent protections of human subjects enrolled in research abroad. [...]
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bioethics health law policy holly fernandez lynch human subjects research i. glenn cohen