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HHS Releases Proposed Rule on Fetal Tissue Research

January 15, 2021

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

The Department of Health and Human Services (HHS) issued a proposed rule on Jan. 13 titled, “Establishment of Safeguards and Program Integrity Requirements for Health and Human Services-Funded Extramural Research Involving Human Fetal Tissue.” The proposed rule would amend Subpart B of the Federal Protections for Human Subjects and the federal grant regulations.

The proposed rule would:

  • Add a definition of “human fetal tissue” to the regulations.
  • Codify requirements for informed consent language and procedures for the donation of fetal tissue for research purposes.
  • Grant federal officials a right of access to all such informed consent documents.
  • Prohibit the use of federal grant funds for expenses “associated with the acquisition of human fetal tissue from elective abortions for use in research.”
  • Prohibit such research from using human fetal tissue from “elective abortions” if the tissue was acquired from an entity other than a federal or state government or academic institution or medical center.

The AAMC has opposed the actions the Trump Administration has taken to restrict the availability and use of fetal tissue for research. The association joined nearly 100 organizations in a Jan. 7 letter to President-elect Joe Biden urging the incoming administration to swiftly rescind the HHS policy issued in 2019 [see Washington Highlights, Jan. 8]. That policy ended intramural research involving fetal tissue and placed additional process steps before an extramural researcher could be funded to conduct research with human fetal tissue.

Comments on the proposed rule are due by Feb. 12.

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