NIH Issues New DHHS Policy Regarding Use of Fetal Tissue in Extramural Research

Legislative Update
July 29, 2019

On July 26, 2019, the National Institutes of Health (NIH) released a notice outlining the new Department of Health and Human Services (DHHS) requirements for Extramural Research that proposes the use of human fetal tissue obtained from elective abortions (HFT). Following the June 5 announcement from the White House, competitive applications for grants and cooperative agreements submitted for due dates on or after September 25, 2019 and R&D contract proposals submitted to solicitations issued after September 25, 2019 involving HFT may now be assessed by an Ethics Advisory Board.

According to the full notice, NIH is implementing requirements regarding the documentation of the use of HFT in research, as NIH does with other research materials and models, to ensure that it is utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes. NIH will require applicants and contract offerors to provide detailed information addressing the use of HFT in applications/proposals and reports. These requirements are designed to enable NIH to assess whether extramural research applicants/contract offerors and recipients/awardees/contractors are adequately assuring compliance with all applicable laws and HHS/NIH policies concerning the acquisition and use of HFT obtained from elective abortion.”

In the June announcement, the White House stated that DHHS would eliminate any federal funding for NIH Intramural Research that uses HFT, as well as to impose a new Ethics Advisory Board review on NIH research grant applications or current research in the competitive renewal process (Extramural Research) that propose to use HFT.

H.R. 2740, the four-bill [Defense, Energy and Water, State-Foreign Operations, and Labor, Health and Human Services (LHHS)] Fiscal Year (FY) 2020 spending package, includes language sponsored by Cong. Mark Pocan (D-WI) that prohibits any funds made available by the bill to convene an Ethics Advisory Board to review proposed/ongoing Extramural Research using HFT. At this time, it is uncertain whether complementary language will appear in the Senate version of the LHHS spending bill, as the Senate has yet to begin its markups for the twelve FY2020 spending bills pending approval of the two-year budget deal in the Bipartisan Budget Act of 2019, which it is expected to pass this week.