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What To Know About New FDA Informed Consent Guidance

Law360, New York (August 11, 2017, 1:00 PM EDT) -- On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document[1] announcing its intention not to object to an institutional review board’s (IRB) waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections. The guidance, which takes effect immediately, will align the FDA’s policy on waiving informed consent with the “Federal Policy for the Protection of Human Subjects” (the Common Rule) (45 C.F.R. part 46, subpart A), which since 1991 has permitted an IRB to waive informed consent requirements for minimal-risk research...

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