HHS Reverses Trump Administration Restrictions on Fetal Tissue Research

Bass, Berry & Sims PLC

On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human fetal tissue obtained from elective abortions. Specifically, HHS reversed its 2019 decision that all applications for NIH grants, contracts, and cooperative agreements proposing to use human fetal tissue from elective abortions be reviewed by an NIH Human Fetal Tissue Research Ethics Advisory Board (EAB). Certain Trump-era NIH policies regarding fetal tissue research were left in place, however.

The scientific community has, by and large, advocated for policies that allow for the continued use of human fetal tissue in research. Many in the research community consider human fetal tissue research to be the gold standard for evaluating the accuracy of models of human fetal development and “an essential resource” for studying complex interactions between cells and for the generation of vaccines for infectious diseases such as polio, rubella, measles, chickenpox, and COVID-19. The Trump administration’s 2019 restrictions disrupted COVID-19 treatment research and caused some scientists to change their career paths.

The Trump Administration’s Policy Shift on Human Fetal Tissue Research

In June 2019, HHS announced, over the objection of then HHS Secretary Alex Azar, that NIH intramural research (i.e., research at NIH) that required the new acquisition of human fetal tissue from elective abortions would no longer be permitted. At the same time, HHS announced new requirements for documentation and review by the EAB of extramural applications (e.g., applications from researchers at universities and hospitals outside the NIH campus) for NIH grants, cooperative agreements, and contracts proposing the use of human fetal tissue obtained from elective abortions.

The revised documentation and reporting requirements for research proposing the use of human fetal tissue obtained from elective abortions were outlined in an NIH notice to the extramural research community and applied to competitive applications for grants and cooperative agreements submitted for due dates on or after September 25, 2019, and contract proposals submitted to solicitations issued after September 25, 2019.

The EAB was constituted in February 2020 to advise, consult with, and make recommendations to the Secretary of HHS regarding whether NIH should fund proposed research projects involving human fetal tissue obtained from elective abortions. The EAB considered a total of 14 research proposals and voted to recommend that the Secretary withhold funding from 13 of them, over the strenuous objections of leading scientific organizations, industry groups, and leading research institutions.

Then, in January 2021, HHS issued a Notice of Proposed Rulemaking (NPRM) that would codify safeguards and program integrity requirements applicable to extramural research involving human fetal tissue from elective abortions and disallow HHS coverage of tissue acquisition expenses, among other things.

The Biden Administration’s Reversal

In an update to the extramural research community issued on April 16, 2021, NIH announced that HHS is reversing the 2019 policy requiring all research applications for NIH grants and contracts proposing the use of human fetal tissue from elective abortions be reviewed by the EAB. Accordingly, HHS/NIH will not convene another EAB. A separate notice emailed internally notified NIH investigators that NIH will permit the acquisition and use of human fetal tissue on the NIH campus to resume as well.

However, the 2019 rules regarding documentation of the use of human fetal tissue for applications and contract proposals remain in place, in addition to the clarifying FAQs that were issued alongside those rules, and rules regarding informed consent from donors of human fetal tissue. The April 16 announcement did not mention the NPRM, but the Biden administration may elect not to finalize it.

The April 16 announcement does not change other pre-existing rules regarding the acquisition and use of fetal tissue in research, including federal prohibitions on the payment of valuable consideration for such tissue at 42 U.S.C. §§ 289g-1 and 289g-2, and the requirements regarding the use of women and fetuses in research at 45 C.F.R. Part 46 Subparts A and B. Grantee responsibilities for the conduct of human fetal tissue research are further described in the NIH Grants Policy Statement Part 4.1.14. State laws may also apply to the acquisition and use of fetal tissue in research.

If you have questions regarding the new HHS/NIH policy or about human fetal tissue research, please contact one of the authors.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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