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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules human fetal tissue was not obtained or transferred for valuable consideration and that federal funds were not used to acquire or otherwise obtain the human fetal tissue; and Provide that expenses associated with the acquisition of human fetal tissue for use in research are not allowable expenses under Federal awards from an HHS awarding agency.
Alternatives Considered HHS carefully considered several alternatives, but rejected the potential alternatives for a number of reasons:
Alternative 1: Not taking any action.
HHS concluded that this alternative was unacceptable because of the serious regulatory, moral and ethical considerations involved with respect to research involving human fetal tissue from elective abortions.
Alternative 2: Making no changes to 45 CFR part 46, subpart B or to part Part 75, but issuing guidance on 1 best practices for and the elements that should be included in informed consent for the donation of human fetal tissue for research, 2 the documentation that should be maintained with respect to compliance with the statutory bar on valuable consideration for the transfer of human fetal tissue, and 3 encouraging the practice of obtaining human fetal tissue by donation or non-cost material transfer agreement. HHS concluded that this alternative would be inadequate because the guidance mechanism 1 did not seem commensurate with the nature and seriousness of the issue and 2 may not be sufficient to permit HHS to conduct appropriate oversight and ensure compliance with/enforce the identified informed consent standards and the bar on valuable consideration.
Alternative 3: Make more limited changes to 45 CFR part 46, subpart B
and Part 75, such as by 1 requiring that, with respect to research involving human fetal tissue from elective abortions, HHS-funded projects obtain informed consent for the donation of human fetal tissue from elective abortion, without specifying any required content of the informed consent document; or 2 clarifying recordkeeping and access requirements.
HHS concluded that this alternative would be inadequate because, among other reasons, it would not ensure that the informed consent process included measures and statements to ensure that the informed consent was truly voluntary and truly informed and that no consideration or inducements had been provided for the human fetal tissue.

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Expected Benefits and Costs of the Proposed Rule HHS expects several benefits from this proposed rule. The proposed rule would provide better assurance of compliance with federal statutory requirements with respect to the acquisition and use of human fetal tissue in research. It would better align federal and state law with respect to informed consent for the use of fetal tissue in research, and ensure the uniformity across HHS/NIH grants with respect to the elements of informed consent for the donation of human fetal tissue for research. It would strengthen the informed consent process. It would also strengthen HHSs ability to conduct oversight of, and monitor compliance on, these issues informed consent, bar on valuable consideration. While maintaining, consistent with the Public Health Service Act, the ability of NIH to fund research involving human fetal tissue from abortion, this proposed rule would also ensure thatin light of the serious moral and ethical issues involvedthe costs associated with such human fetal tissue would not be borne by the federal taxpayer.
HHS believes that the costs associated with the proposed rule will be de minimis. In the main, the costs would consist of the administrative costs to the relevant recipients to 1 become familiar with the requirements of the final rule; 2 update their informed consent documents; and 3 update their grant policies and procedures or compliance manuals on grant record retention to reflect certain information retention requirements, practices concerning treatment and disposal of human fetal tissue, the bar on valuable consideration, and the unallowability of costs associated with the acquisition of human fetal tissue from abortion.
Familiarization Costs. NIH is the only HHS component that funds grants, cooperative agreements, or R&D
contracts for research involving human fetal tissue. Between FY 2015 and FY
2019, NIH funded between approximately 120 and 178 research projects involving the use of human fetal tissue from abortions each year, including between 15 and 55 new research projects per year; with NIHfunded projects usually having a five year project period, most such annually funded research projects represented renewals, revisions, extensions, or continuations. The entities that hold the NIH awards for such research projects include major colleges and universities, medical schools, academic medical centers, major hospitals and childrens hospitals, biomedical research
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institutions and several corporations.
Many of these entities hold multiple NIH grants, cooperative agreements, or R&D contracts for research involving the use of human fetal tissue. In FY 2019, there were a total of 71 unique institutions with active NIH awards for research involving human fetal tissue.
Thus, to ensure that costs are not underestimated, for purposes of estimating the costs associated with this rulemaking, HHS will use 80 as the number of organizations that would be affected by this proposed rule. Given the size and sophistication of these entities, the task of familiarization would likely fall to the equivalent of a lawyer in the entities law departments. According to the U.S. Bureau of Labor Statistics,51
lawyers have a mean hourly rate of $69.86. HHS assumes that the total dollar value of labor, which includes wages, benefits, and overhead, is equal to 200% of the wage rate, or $139.72.
The changes proposed in the proposed rule are straightforward and easy to understand. Accordingly, HHS
estimates that it would take a recipient approximately an hour to become familiar with the requirements if the proposed rule is finalized as proposed.
HHS, thus, concludes that the total cost for recipient familiarization with such a final rule would total $11,177.60
$139.72 80.
Informed Consent and Informed Consent Forms. As noted above, since not later than 2016, NIH has conveyed to researchers working with human fetal tissue that receive NIH grants for such research that 1 NIH-funded research involving human fetal tissue must be conducted in compliance with all applicable federal, state, and local laws and regulations; 52 2 most states require informed consent for the use of fetal tissue in research; and 3 NIH
expects informed consent to have been obtained from the donor for any NIHfunded research using human fetal tissue. See NOTOD16033; NIH
Grants Policy Statement, Sec. 4.1.14.
Recently, NIH informed grantees, contractors, and applicants that it expects such informed consent forms to contain certain statements that are consistent with the statements proposed in this proposed rule. See NOTOD19
128. In addition, the AMA has indicated, through its 2016 Code of Ethics Opinion, that physicians who are involved in research that uses human fetal tissue should, in all instances, 51 U.S. Bureau of Labor Statistics, May 2019
National Occupational Employment and Wage Estimates United States, available at https
www.bls.gov/oes/current/oes_nat.htm.
52 See 45 CFR 46.206a.

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