Washington Update

HHS Proposes Additional Changes to Human Fetal Tissue Research

By: Yvette Seger
Wednesday, January 27, 2021

On January 13, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking regarding the “Establishment of Safeguards and Program Integrity Requirements for HHS-funded Extramural Research Involving Human Fetal Tissue.” In June 2019, the Trump Administration announced significant changes to HHS policies overseeing human fetal tissue research. The current Notice represents a follow-up to those policy changes, with an emphasis on informed consent policies.

Key elements of the proposed rule include:

  • A definition of human fetal tissue
  • Requirement that the pregnant mother provide informed consent before human fetal tissue obtained through elective abortion is used in HHS-funded research
  • Additional administrative and financial parameters regarding acquisition and use of human fetal tissue for research

The Department is accepting comments on the proposed rule through February 12.