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On June 5, 2019, the Department of Health and Human Services issued a statement in which it announced the Administration’s policies with respect to research conducted or funded by the Department involving human fetal tissue derived from elective abortion.  Consistent with that announcement, the Department will propose changes to human subject protection regulations and its grants regulations in order to adopt and strengthen safeguards and program integrity requirements applicable to extramural research involving the use of human fetal tissue.

Statement of Need:

As a result of the comprehensive review that HHS undertook of all HHS research involving human fetal tissue from elective abortion to ensure consistency with the statutes and regulations governing such research and to ensure the adequacy of procedures and oversight of such research in light of the serious regulatory, moral, and ethical considerations involved, the Administration and HHS determined that it would be appropriate to undertake changes to its regulations (and certain policies) to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue. See Statement from the Department of Health and Human Services of June 5, 2019. The proposal would also better align federal and state law on informed consent requirements.

Summary of the Legal Basis:

The legal basis for the rulemaking includes 5 U.S.C. 301; 31 U.S.C. 503(b)(2)(2); 41 U.S.C. Chapter 13; and 42 U.S.C. 216(b), 289, 289g-1, and 289g-2.

Alternatives:

Alternatives considered by the Department include making no changes to the 45 CFR part 46 Subpart B and part 75, or making more limited changes. It has determined that a rulemaking is necessary to, among other things, to adopt, clarify, or strengthen safeguards and program integrity requirements and, thus, to ensure compliance with the federal statutes and policies addressing the use of human fetal tissue in HHS-funded research.

Anticipated Costs and Benefits:

HHS anticipates that the proposed adoption or strengthening of the safeguards and program integrity requirements may involve some additional costs for recipients of HHS funds that engage in research involving human fetal tissue. However, given state law requirements and current federal requirements imposed on recipients of federal funds, those costs should be minimal. Benefits would include better assurance of compliance with federal statutory requirements with respect to the use of human fetal tissue in research.

Risks:

The contemplated rulemaking would adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue. In the absence of such a rulemaking, there is a risk that recipients of federal research funds may not fully comply with federal safeguards and program integrity requirements applicable to extramural research involving human fetal tissue. Failure to conduct the rulemaking would also be inconsistent with announced Administration policy.