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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
using the fetal tissue for research purposes.
Decisions regarding the technique used to induce abortion and the timing of the abortion in relation to the gestational age of the fetus are based on concern for the safety of the pregnant woman.
Ensure that health care personnel involved in the termination of a pregnancy do not benefit from their participation in the termination. 27
HHS research and human research protection components have also adopted policies and provided guidance on research involving human fetal tissue. Subpart B requires that such research be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities; the regulations further direct that no inducements, monetary or otherwise, will be offered to terminate a pregnancy and that individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy. 45 CFR
46.206a, 46.204hi. Following enactment of the NIH Revitalization Act of 1993which amended the Public Health Service Act to add among other provisions section 498A 42 U.S.C.
289g1, establishing certain requirements for research on fetal tissue transplantation, and section 498B 42
U.S.C. 289g2, barring valuable consideration in connection with the acquisition, receipt, or transfer of human fetal tissuethe Office for Human Research Protections issued guidance on fetal tissue transplantation research.28 In the January 2007 HHS
Grants Policy Statement,29 HHS
included specific provisions on research on human fetal tissue and transplantation of human fetal tissue. In the Grants Policy Statement, HHS noted that the scientific and ethical challenges associated with research utilizing human fetal tissue make it imperative that researchers and their organizations be fully aware of and in compliance with the Federal requirements, noting particularly section 498B of the Public Health Service Act.30 It also noted the 27 Id. The Code of Ethics Opinion also addresses the use of fetal tissue in transplantation research or clinical care.
28 See, e.g., Fetal Tissue Transplantation Research Guidance 2003, available at https www.hhs.gov/
ohrp/regulations-and-policy/guidance/fetal-tissuetransplanation/index.html.
29 HHS Grants Policy Statement Jan. 1, 2007, available at https www.hhs.gov/sites/default/files/
grants/grants/policies-regulations/hhsgps107.pdf.
30 See HHS Grants Policy Statement Jan. 1, 2007
at II16, available at https www.hhs.gov/sites/

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additional requirements of section 498A
with respect to research on human fetal tissue transplantation.31 Given its preeminent role in conducting and funding biomedical research, NIH has also issued guidance on human fetal tissue in research. For example, on August 14, 2015, it released Reminder of Legal Requirements Regarding the Acquisition and Use of Human Fetal Tissue for Research Purposes, NOTOD15143.
In that notice, NIH reminded its grantees and contractors that research involving human fetal tissue must be conducted in accordance with applicable Federal, State and local laws, regulations, and policies, including the NIH Grants Policy Statement, making specific reference to the Public Health Service Act provisions and to 45 CFR
46.204hj and 46.206.32 Early the following year, in 2016, NIH released its policy, applicable to both NIH
intramural research investigators and extramural researchers, NIH Policy on Informed Consent for Human Fetal Tissue Research. 33 In that notice, NIH, which is committed to ensuring that research involving human fetal tissue is conducted responsibly and meets the highest ethical standards, stated that NIH-funded research involving human fetal tissue must be conducted in compliance with all applicable federal, state, and local laws and regulations. . . . 34 NIH further noted that current federal laws and regulations require informed consent for research involving the transplantation of human fetal tissue and for research with human fetal material associated with information that can identify a living individual and that most states require informed consent for the use of fetal tissue in research. Accordingly, NIH expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue.35 NIH further noted that when obtaining primary human fetal tissue for research purposes, NIH expects grantees and contractors to maintain appropriate documentation, such as an attestation from the health care provider or a third party supplier, that informed consent was obtained at the time of tissue default/files/grants/grants/policies-regulations/
hhsgps107.pdf.
31 Id. at II17II18.
32 See Reminder of Legal Requirements Regarding the Acquisition and Use of Huma Fetal Tissue for Research Purposes, NOT=OD15.143 Aug. 14, 2015, available at https grants.nih.gov/grants/
guide/notice-files/NOT-OD-15-143.html.
33 See NIH Policy on Informed Consent for Human Fetal Tissue Research, NOTOD16033
Feb. 11, 2016, available at https grants.nih.gov/
grants/guide/notice-files/not-od-16-033.html.
34 Id.
35 Id. emphasis added.

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collection. 36 In October 2018, these expectations and requirements became part of NIHs Grants Policy Statement.37
As noted above, in September 2018, HHS initiated a comprehensive review of all HHS research involving human fetal tissue from elective abortions to ensure consistency with statutory and regulatory requirements and to ensure the adequacy of procedures and oversight of such research in light of the serious regulatory, moral, and ethical considerations involved. As part of this audit and review, HHS personnel reviewed the contracts or purchase orders, as applicable executed by personnel at NIH for the acquisition of human fetal tissue from elective abortions, and sought to obtain, from the organizations that supplied such tissue to the NIH researchers, copies of the required informed consents for the donation of the fetal tissue for research purposes, as well as documentation that valuable consideration was not sought or given in connection with the transfers of fetal tissue. One tissue procurement organization, which procured human fetal tissue for a number of NIH
intramural research projects, provided its template informed consent document. It, however, refused to produce any executed informed consents or documentation of its compliance with laws and NIH policies on the informed consent of the mother to donate the fetal tissue for research, and would not make any representations to HHS that such informed consents had been obtained.
The organization also declined to provide HHS with financial documentation for HHS to assess compliance with federal prohibitions on valuable consideration. Informed consents were obtained from two other organizations, an academic institution that maintains a tissue bank and another private tissue procurement organization, which provided fetal tissue for two intramural research projects. While HHSs inability to obtain information from one tissue procurement organization to confirm compliance with informed consent requirements and the bar on valuable consideration occurred in the context of HHSs audit of intramural research involving human fetal tissue from elective abortions, and 36 Id. FDAs Staff Manual Guides also contains guidance for FDAfunded or conducted research involving human fetal tissue. See FDA Staff Manual Guides, Volume IVAgency Program Directive, General or Multidiscipline, Research Involving Human Fetal Tissue, SMG 9001.3 Feb. 11, 2016.
37 October 2018 NIH Grants Policy Statement, Section 4.1.14, available at https grants.nih.gov/
grants/policy/nihgps/html5/section_4/4.1.14_
human_fetal_tissue_research.htm.

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