What HHS Wants To Know About Revising The "Common Rule"
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Informed Consent Guidance Focuses On Children And Non-English Speaking Subjects
FDA’s draft guidance urges consideration of ethical ramifications of enrolling or excluding potential subjects from clinical trials when there may be a language barrier.
Central IRBs, Data Security Standards Feature In Overhaul Of "Common Rule"
Clinical trials that take place at multiple U.S. sites and are covered by the "Common Rule" of federal regulations relating to human subject protection could soon be required to use a single institutional review board of record, under a proposed revision.
Central IRBs, Data Security Standards Feature In Overhaul Of "Common Rule"
Clinical trials that take place at multiple U.S. sites and are covered by the "Common Rule" of federal regulations relating to human subject protection could soon be required to use a single institutional review board of record, under a proposed revision.