On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
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