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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules there are other sources from which researchers can and do obtain human fetal tissue, the organization at issue also provides human fetal tissue to a number of NIH-funded extramural researchers. As a result, HHS also became concerned that grantees, or those from whom fetal tissue had been obtained by grantees, may not always have readily available documentation of informed consents for fetal tissue research, or documentation that valuable consideration was not provided in exchange for human fetal tissue in connection with HHS-funded research, notwithstanding NIHs policy requirements and section 498B of the Public Health Service Act 42 U.S.C.
289g2a, which prohibits acquiring, receiving, or otherwise transferring human fetal tissue for valuable consideration if the transfer affects interstate commerce.
Building on these developments, in June 2019, HHS announced the Administrations new policy with respect to human fetal tissue research.
That announcement included a commitment to undertake changes to HHS regulations and to NIHs grants policy to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue.
NIH began implementing the Administrations policy with the issuance of Changes to NIH
Requirements Regarding Proposed Human Fetal Tissue Research, NOT
OD19128.38 In that notice, NIH
outlined for its extramural research community the new requirements and review considerations with respect to research supported by NIH that involves the proposed use of human fetal tissue obtained from abortions in extramural applications for grants, cooperative agreements, and research and development R&D contracts. It reminded the community of expectations to obtain informed consent from the donor for any NIH-funded research using human fetal tissue. 39
The notice included requirements for a justification for the use of human fetal tissue for the proposed research; for planned written, voluntary, informed consent process for cell/tissue donation;
and for budget information and justification for the quantity, type, and source of human fetal tissue, as well as a certification that valuable consideration has not been provided for
the acquisition of such tissue. The notice outlined NIHs expectations for the contents of the informed consents and related assurances: Language that the informed consent for donation of human fetal tissue was obtained by someone other than the person who obtained the informed consent for abortion, occurred after the informed consent for abortion, and would not affect the method of abortion; no enticements, benefits, or financial incentives were used at any level of the process to incentivize abortion or the donation of human fetal tissue; and the informed consent was signed by both the woman and the person who obtained the informed consent. NIH also indicated that the NIH award recipient should have documentation from the human fetal tissue donating organization assuring adherence to the requirements of the informed consent process and documentation that human fetal tissue was not obtained or acquired for valuable consideration; the awardee would be expected to provide such assurance for each year of the award such research is conducted for the life of the award and to maintain this documentation in accordance with the NIH Record Retention and Access policy.40
As the next step in this process, HHS
now proposes to make modifications to 45 CFR part 46 Subpart B, which provides additional protections for pregnant women, human fetuses and neonates involved in research, and 45
CFR part 75, which implements standard requirements for administrative and financial management of Federal awards. The decision to amend HHSs regulations was the result of HHSs comprehensive review of HHS research involving human fetal tissue from elective abortions. Given the serious regulatory, moral, and ethical considerations involved, HHS concluded that it is appropriate to 1 clearly identify, in regulation, the minimum requirements for informed consent for the donation and use of human fetal tissue in research, especially when the fetal tissue is obtained from elective abortions; 2 impose certain requirements to help ensure compliance with the statutory bar on the provision of valuable consideration for human fetal tissue. These conclusions also follow from consideration of the authorities described above, the views
38 See Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research, NOTOD
19128 July 26, 2019, available at https
grants.nih.gov/grants/guide/notice-files/NOT-OD19-128.html.
39 Id. citing NOTOD16033.

40 Id. The notice also required that the application describe plans for the treatment of human fetal tissue and its disposal when the research was complete, as well as assurances that such treatment and disposal would be consistent with such plans.
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of the medical community, State laws, and a comprehensive review of the use of human fetal tissue in research by HHS. HHS recognizes that, with respect to informed consent, this proposal goes beyond the approach taken by the Common Rule in subpart A with respect to biospecimens. However, HHS
has long recognized the need for additional research protections for certain vulnerable populations or certain types of researchhence, the existence of Subparts B, C, and Dand believes that the additional protections proposed here are warranted to protect the interests of pregnant women and the integrity of science, as well as the serious moral and ethical considerations noted above. With respect to research involving human fetal tissue, this proposed rule would also align Subpart B more expressly with NIH policy and the AMAs Code of Ethics Opinion on the need for informed consent. HHS
considered making no changes to 45
CFR part 46 subpart B and part 75, or making more limited changes. However, HHS has determined that a rulemaking is necessary to, among other things, 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 HHSfunded research.
III. Summary of the Notice of Proposed Rulemaking HHS proposes to amend 45 CFR part 46, subpart B, Protection of Human Subjects, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, and 45
CFR part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, in the following ways:
A. Definitions, 46.202
HHS is proposing to add a paragraph i to 46.202. Paragraph i would provide that, for purposes of Subpart B
of 45 CFR part 46, human fetal tissue shall have the definition ascribed to it in 42 U.S.C. 289g1g, namely tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
While HHS proposes to define the term consistent with the statutory definition applicable to fetal tissue transplantation research and the prohibition on valuable consideration, many of the provisions proposed below would only apply to human fetal tissue derived from elective abortions and to HHS-funded research involving such tissue.
For the purpose of implementing the June 2019 policy through NOTOD19

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