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AAMC, Stakeholders Urge Withdrawal of Proposal to Restrict Fetal Tissue Research

February 19, 2021

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CONTACTS
Christa Wagner, Senior Legislative Analyst

The AAMC submitted a comment letter and also joined nearly 100 scientific, medical, and patient organizations in a Feb. 12 letter urging Acting Secretary of Health and Human Services (HHS) Norris Cochran to withdraw a proposed rule that would restrict NIH-funded research using human fetal tissue.

The proposed rule, “Establishment of Safeguards and Program Integrity Requirements for Health and Human Services-Funded Extramural Research Involving Human Fetal Tissue,” was issued on Jan. 13 by the Trump administration with comments due Feb. 12 [see Washington Highlights, Jan. 15].

The AAMC letter asserted that the changes proposed by HHS ranged from “unnecessary or redundant with existing rules to harmful restrictions on the available sources of tissue for researchers.” The primary objections the AAMC raised were that the rule prohibited the use of federal grant funds to acquire the tissue for research, unjustifiably restricted the types of entities from which the tissue could be obtained, and conflated the “procedures for ensuring that research subjects are informed about the purpose and process of research with those ensuring that biospecimen donors are informed about donating tissue for later research.”

The joint stakeholder letter reiterated the important contribution of fetal tissue and cells derived from fetal tissue in developing new treatments and vaccines to combat human disease. The letter also warned that the proposed rule, if finalized, could delay scientific advances, increase institutional research costs, and impose “unnecessary procedural barriers” to obtaining tissue for research.

“The longstanding oversight process for [human fetal tissue] research ensures that [the] research was scientifically meritorious, legal, and ethically sound. This ethical and legal framework remains the standard. … It already requires robust informed consent and prohibits individuals from profiting from the acquisition, receipt, or transfer of [human fetal tissue] for research. Therefore, we encourage you to withdraw the proposed rule and immediately revoke the other 2019 policy changes for [human fetal tissue] research,” the group letter stated.

The AAMC previously joined these organizations in a Jan. 7 letter to then-President-elect Joe Biden urging the administration to swiftly rescind the HHS policy issued in 2019 that restricted the availability and use of fetal tissue in the NIH’s intramural research and newly proposed extramural research projects. [see Washington Highlights, Jan. 8].

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