alexa The Python's Embrace: Clinical Research Regulation by Institutional Review Boards
Clinical Research

Clinical Research

Journal of Clinical Research & Bioethics

Author(s): Simon N Whitney

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Subject consent and its waiver are critical topics in contemporary research. Institutional review boards (IRBs), acting under the wary eye of the Office for Human Research Protections (OHRP), typically may waive consent when research involves no more than minimal risk, waiver would not harm the subjects, and the research would be impracticable without the waiver.1 IRBs constrict research when they cautiously interpret “impracticable” to mean “impossible” and insist on consent. And, in an ironic twist, IRBs can thus injure the vulnerable groups they imagine they are protecting.

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This article was published in Pediatrics and referenced in Journal of Clinical Research & Bioethics

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