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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
IV. Request for Comment HHS seeks comment on all aspects of this proposed rule and the model informed consent form provisions, including the likely impacts of the proposed rule, as compared to the status quo. HHS also seeks comment on its regulatory impact analysis.
V. Regulatory Impact Analysis HHS has examined the impacts of this proposed rule as required under Executive Order 12866 on Regulatory Planning and Review, 58 FR 51,735
Oct. 4, 1993; Executive Order 13563 on Improving Regulation and Regulatory Review, 76 FR 3821 Jan. 21, 2011;
Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs, 82 FR 9339 Feb. 3, 2017; the Regulatory Flexibility Act Pub. L. 96
354 Sept. 19, 1980 codified as amended at 5 U.S.C. 601612 and Executive Order 13272 on Proper Consideration of Small Entities in Agency Rulemaking, 67 FR 53461 Aug.
16, 2002; section 202 of the Unfunded Mandates Reform Act of 1995 Pub. L.
10404, 109 Stat. 48 Mar. 22, 1995;
Executive Order 13132 on Federalism, 64 FR 43255 Aug. 4, 1999, Subtitle E
of the Small Business Regulatory Enforcement Fairness Act of 1996 Pub.
L. 104121, 110 Stat. 847 Mar. 29, 1996 codified as amended at 5 U.S.C.
801808 commonly known as the Congressional Review Act; section 654
of the Treasury and General Government Appropriations Act of 1999
the Assessment of Federal Regulation and Policies on Families; and the Paperwork Reduction Act of 1995, 44
U.S.C. 3501 et seq.
Executive Orders 12866 and 13563
Determination Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects; distributive impacts;
and equity. Executive Order 13563 is supplemental to Executive Order 12866
and reaffirms the principles, structures, and definitions governing regulatory review established there. For significant regulatory actions, Executive Order 12866 requires an assessment, including the underlying analysis, of benefits and costs anticipated from the regulatory action. Executive Order 12866, 6a3C, 3f1.
The Office of Management and Budget OMB has determined this proposed rule is a significant regulatory action
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under Executive Order 12866, 3f4, in as much as it raises novel legal or policy issues that arise out of legal mandates, the Presidents priorities, or the principles set forth in an Executive Order, but that it is not economically significant in that it will not have an annual effect on the economy of greater than $100 million in one year. Thus, the Office of Management and Budget has reviewed it. Under Executive Order 13563, in proposing this rule, HHS has attempted to promote coordination, simplification, and harmonization; has sought to identify means to achieve regulatory goals that are designed to promote innovation; and has ensured the objectivity of any scientific and technological information and processes used to support this proposed rule.
Summary of and Need for Proposed Rule HHS recognizes that conducting and funding research involving human fetal tissue from abortions presents serious regulatory, moral, and ethical considerations. The principle of informed consent is central to the practice of medicine, as well as to human subjects research. Federal and state laws and policies recognize the importance of informed consent, not only for research involving human subjects, but also for the donation of human tissue and cells for research purposes. This informed consent is especially important when the tissue being donated is human fetal tissue and the source of such tissue is elective abortions. Congress has similarly recognized the moral and ethical issues implicated by the acquisition of human fetal tissue and the use of human fetal tissue in research: It amended the Public Health Service Act to, among other things, make it unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration which does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissueif the transfer affects interstate commerce.
As a result of a comprehensive review of HHS research involving human fetal tissue from elective abortion and in light of the serious regulatory, moral and ethical considerations involved, HHS
determined that it would be appropriate to undertake changes to its regulations to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue. These safeguards and program integrity
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requirements relate to the informed consent process and the statutory bar on the provision of valuable consideration in connection with the transfer of human fetal tissue. HHS believes that additional informed consent statements and procedures are needed to ensure that 1 the informed consent to the donation of human fetal tissue from abortion is in fact voluntary and informed, and not motivated by any enticements, benefits, or financial considerations, and 2 there is separation between the decision and consent for abortion and the decision on the donation of fetal tissue, such that the abortion decision is not influenced by considerations relating to the research, including the potential contribution to biomedical research that could cure disease, advance understanding of diseases, and the like.
Similarly, HHS desires to strengthen recipients understanding of, and compliance with, the informed consent requirements and the statutory bar on the provision and receipt of valuable consideration for human fetal tissue by ensuring access to records relating to such issues for oversight purposes.
Accordingly, the proposed rule would:
Require, prior to conducting research on human fetal tissue, that informed consent, including certain statements, be obtained from the pregnant woman;
Prohibit providing enticements, benefits, or financial incentives to the pregnant woman or attending physician to incentivize the occurrence of an abortion or human fetal tissue donation;
Prohibit providing valuable consideration for costs associated with obtaining human fetal tissue or the abortion if any that is the source of the human fetal tissue;
Mandate that research involving human fetal tissue from elective abortions can only use human fetal tissue that is acquired or otherwise obtained from a Government, Government-owned entities, university, college, accredited degree-granting institution of higher education, university hospital, or academic medical center;
Require that human fetal tissue be treated respectfully and disposed of reasonably when no longer to be used in research;
Require HHS recipients that engage in human fetal tissue research to provide HHS, inspectors general, and the Comptroller General with a right of access to all informed consent forms obtained for human fetal tissue research, and documents, papers, or other records as are necessary to establish that the
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