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The Federal Policy for the Protection of Human Subjects (the “Common Rule”) is codified in separate regulations by seventeen federal departments and agencies, including the Department of Health and Human Services (HHS). HHS’s version of the Common Rule currently contains a basic policy for the protection of all human subjects, codified at Subpart A of the Common Rule, as well as special provisions governing human subjects research involving three sets of vulnerable populations, including pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). This Article proposes that HHS amend the Common Rule to add a new Subpart E governing human subjects research involving adults with impaired decision-making capacity.

Publication Citation

50 Houston L. Rev. 787 (2013).