Protection of human research subjects--HHS. Notice of proposed rulemaking.

The Department of Health and Human Services (HHS) is proposing to amend its human subjects protection regulations applicable to research conducted or supported by HHS, by replacing the existing Subpart B of the regulations entitled "Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization" with new regulations entitled "Additional DHHS Protections for Pregnant Women, Human Fetuses, and Newborns Involved as Subjects in Research, and Pertaining to Human In Vitro Fertilization." This revision continues the Department's recognition of the need to provide special protections for the human fetus and newborn in research, while eliminating unnecessary barriers to consent to research that can benefit fetuses or newborns. Additionally, consistent with recent practices and statutory changes, this proposed regulation provides a mechanism for special ethical reviews on an ad hoc basis as may be deemed appropriate by the Secretary, HHS.