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Restrictions on NIH-Funded Fetal Tissue Research Reversed

April 30, 2021

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CONTACTS
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel

A 2019 policy from the Department of Health and Human Services (HHS) that required all proposed research involving human fetal tissue (HFT) to undergo independent review by an ethics advisory board before it could be funded by the National Institutes of Health (NIH) was reversed through an NIH guide notice issued on April 16.

Through the notice, the NIH “informs the extramural research community that HHS is reversing its 2019 decision that all research applications for NIH grants and contracts proposing the use of human fetal tissue from elective abortions will be reviewed by an Ethics Advisory Board. Accordingly, HHS/NIH will not convene another NIH Human Fetal Tissue Research Ethics Advisory Board.”

The 2019 HHS policy had also halted all intramural research using fetal tissue and imposed additional barriers to the funding of extramural research using fetal tissue supported by the NIH [refer to Washington Highlights, June 7, 2019]. The recent NIH guide notice reminds applicants that all other requirements described in guide notices from July 26, 2019, and Aug. 23, 2019, “remain unchanged.” These requirements include the addition of a “justification” section to research grant proposals to justify the use of human fetal tissue for the research and the inclusion of the template consent form used for the donation of the tissue.

The AAMC had previously joined nearly 100 organizations in a Jan. 7 letter to President-elect Biden urging the administration to revoke the 2019 HHS policy [refer to Washington Highlights, Jan. 8]. In that letter, the organizations wrote that “as a result of the flawed 2019 policy, highly worthy, scientifically meritorious research was not funded, creating a chilling effect on the broader scientific community. The NIH guide notices that implemented the HHS policy (NOT-OD-19-128 and NOT-OD-19-137) must be revoked to restore the integrity of the peer review process and lift the unnecessary barriers to promising biomedical research using HFT.”

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