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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
provisions that would comply with the proposed informed consent requirements. This proposal would provide certainty to the regulated entities that they have sufficiently obtained informed consent and met the requirements of this proposed rule.
However, the use of the sample provisions would not be required, and relevant parties would be free to use their own language in a form for informed consent for the donation of human fetal tissue as long as the form meets the proposed requirements. HHS
seeks comment on the contents of sample informed consent form provisions.
C. Research Involving Pregnant Women or Fetuses, 46.206
HHS proposes to add paragraphs c, d, e, f, g, h, and i to 46.206.
Paragraph c would require that, at all stages in the process to acquire or otherwise obtain human fetal tissue for use in research, there would be no enticements, benefits, or financial incentives provided to the pregnant woman or attending physician to incentivize the occurrence of an abortion or the donation or acquisition of human fetal tissue. HHS proposes to add this paragraph for the same reasons that it proposes to add paragraph k1B to 46.204. Paragraph c would help implement 42 U.S.C. 289g 2 and specify what is required by that provision in the context of research involving pregnant women, fetuses, or human fetal tissue.
Paragraph d would require that no person who solicits or knowingly acquires, receives, or accepts a donation of human fetal tissue for use in research shall provide valuable consideration for the costs associated with the acquisition of the fetal tissue or with any abortion that may be the source of the human fetal tissue used or to be used in the research. HHS proposes to add paragraph d for some of the same reasons that it proposes to add paragraph k1B to 46.204.
Permitting a person to provide valuable consideration for costs associated with the abortion that is the source of the human fetal tissue could impact the decision whether to donate human fetal tissue which should be independent of the decision whether to have an abortion. Moreover, permitting a person to provide valuable consideration for such costs could enable the person, by claiming they are merely paying for the costs of the abortion and not the human fetal tissue, to circumvent the prohibition on providing valuable consideration for human fetal tissue. If a person could provide valuable
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consideration for the abortion, enforcement actions arising out of payments for human fetal tissue would frequently face evidentiary questions about whether the payment was for the costs associated with the abortion, rather than the human fetal tissue.
Paragraph e would require that no person who solicits or knowingly acquires, receives, or accepts a donation of human fetal tissue for use in research shall provide valuable consideration for the costs associated with the donation or acquisition of human fetal tissue.
HHS proposes to add paragraph e for some of the same reasons that it proposes to add paragraph k1B to 46.204. Furthermore, paragraph e would 1 eliminate any uncertainty about whether 42 U.S.C. 289g2s prohibition on providing valuable consideration for the acquisition, receipt, or transfer of human fetal tissue applies to human fetal tissue research, and 2 specify what is required to comply with that provision in the human fetal tissue research context.
Paragraph f would define valuable consideration for purposes of paragraphs d and e as all payments other than payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
Paragraph f is in accord with 42 U.S.C.
289g2e3, which provides that valuable consideration does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
Paragraph f would also provide certainty to those involved in human fetal tissue research, by making clear that the enumerated costs are the only ones that do not constitute valuable consideration for purposes of 46.206.
Paragraph g would emphasize that human fetal tissue may be used in research only if an informed consent that meets the applicable requirements of 46.204k has been obtained with respect to the tissue donation. HHS
proposes that the requirement would apply with respect to donations of fetal tissue by women where the initial donation occurs after the effective date of the final rule.
Paragraph h would provide that human fetal tissue from elective abortions can only be used in research conducted or funded by HHS if the human fetal tissue is acquired or otherwise obtained from Federal or State Governments, Federal or State Government-owned entities, universities, colleges, accredited degreegranting institutions of higher education, or university hospitals or
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other academic medical centers. In this context that implicates serious moral and ethical considerations, HHS is committed to ensuring that research conducted using human fetal tissue has been obtained through appropriate procedures, including that the informed consent associated with the donation of fetal tissue is truly voluntary and not performed on an ad hoc basis or by those who are not sufficiently qualified.
Thus, this proposed requirement would establish additional safeguards to ensure that the procurement of human fetal tissue is conducted by organizations or institutions that are familiar with, and accustomed to complying with, informed consent requirements and that are regularly subject to oversight by HHSand is not obtained by organizations or individuals that are not qualified to implement such requirements, that are not otherwise subject to regulation and oversight by HHS, and that accordingly may not respond to requests for access to records. HHS also believes that paragraph h strengthens program integrity by making sure that the entities obtaining human fetal tissue for research are substantially more likely to comply with these requirements, especially in a manner that complies with the concerns expressed by Congress when it placed limits on the use of human fetal tissue in the Public Health Service Act.
Paragraph i requires that, once human fetal tissue is no longer to be used in research, it shall be treated respectfully and disposed of reasonably and in compliance with any additional laws or regulations imposed by applicable state law. By its statutory enactments, Congress has expressed that members of the public should proceed carefully when their actions involve human fetal tissue. HHS believes that paragraph i would further implement this concern at minimal burden. Many states and accredited academic institutions have already adopted statutes or policies with similar requirements.47 HHS asks for comment on this proposed regulatory requirement and the contours of such proposed requirement.
D. Access to Records, 75.364
HHSs grants regulations, at 75.364a, provide that, among others, the HHS awarding agency, HHS
47 See, e.g., AR Code 2017801; GA ST 16
12141.1 2017; IN ST 163434 2016; SD ST
342532.4; University of Minnesota Policy Statement Regarding Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Transplantation Research, available at https
policy.umn.edu/research/fetalresearch.

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