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Trump-Era Fetal Tissue Research Restrictions Reversed by HHS (1)

April 16, 2021, 8:07 PM; Updated: April 16, 2021, 8:34 PM

NIH-funded scientists who want to use fetal tissue in their studies will no longer face Trump-era restrictions favored by abortion opponents.

The Department of Health and Human Services is reversing a 2019 policy that effectively stopped the National Institutes of Health from funding research using tissue from aborted fetuses, according to a guide notice the NIH issued Friday.

“Because the HHS Secretary has determined there are no new ethical issues that require special review, 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 be reviewed by an Ethics Advisory Board,” the NIH said in a statement.

“NIH will manage and oversee research using human fetal tissue according to policies and procedures that were in place prior to the publication of the June 5, 2019, HHS Statement,” it said.

HHS Secretary Xavier Becerra told a House spending panel Thursday that the change was coming.

The NIH said it reminds the research community of expectations, regulations, and applicable laws for the conduct of research using human fetal tissue, including those that require informed consent from the donor and prohibit people from profiting from such tissue.

The agency funded about $120 million in research using fetal tissue in fiscal 2019.

‘Scientific and Ethical Merit’

President Joe Biden has said repeatedly he wants to lead with science. The White House put a slew of Trump-era midnight health-related rules and policies on hold as it reviews them. The administration has already dropped three Medicare proposed rules and withdrawn appointments to a panel for disputing drug discounts.

Christine Mummery, president of the International Society for Stem Cell Research, applauded what she described as a return to evidence-based policymaking.

“Research grants should be based on the scientific and ethical merit of each proposal,” she said. The ISSCR was one of the leading groups looking to undo the Trump administration’s policy.

Fetal tissue “was critical for the development of vaccines for polio, rubella, measles, chickenpox, and rabies. It remains essential for creating models of the human immune system for studying viral infections from HIV, Zika, coronavirus, and other viruses,” Mummery said.

But Tara Sander Lee, senior fellow and director of life sciences at Charlotte Lozier Institute, said the decision defies both the best ethics and most promising science. The Lozier institute is the research and education arm of the anti-abortion group Susan B. Anthony List.

“There are superior and ethical alternatives available,” Sander Lee said in a statement. “All scientists should reject the administration’s attempts to prey on fears related to the pandemic to advance the practice of harvesting fetal tissue.”

The Biden administration restores key ethical safeguards that have been in place for decades, R. Alta Charo, a bioethicist who’s worked on human embryo research and regenerative medicine policies since the Clinton administration, said in an email.

Those safeguards include: separating a woman’s decision to terminate a pregnancy from any decision about how to manage the fetal remains; removing financial incentives for donation or collection; and requirements for voluntary and informed consent by the donor. Researchers will still have to explain the need for fetal tissue, and why other kinds of tissue cannot suffice.

“Reversing the Trump Administration’s policy is a welcome return to a socially responsible approach to the use of fetal tissue in medical research,” Charo, who’s a professor emerita of bioethics and law at the University of Wisconsin, said.

Ethics Board Nixed

The Trump administration in June 2019 prohibited direct employees of the NIH from conducting fetal tissue research. Under the new grants guide, the NIH intramural research program may resume new acquisition and use of human fetal tissue, but it must still follow NIH policy and state and federal law.

Outside scientists who propose to use fetal tissue from abortions—and whose studies have passed the scientific peer review that all studies need to get funded—had to undergo an additional layer of review by an ethics board under the 2019 policy. That board rejected all but one grant application—a study on alternatives to fetal tissue research.

The NIH said it will not convene another board, according to the grants guide.

A group of Democrats who called on Biden last week to make the change said the decision prioritizes science.

“During a time when our country necessitates recovery that prioritizes science over politics, this is an integral step towards protecting the advancements of our scientific community,” Reps. Suzan DelBene (Wash.), Mark Pocan (Wis.), and Jan Schakowsky (Ill.) said in a joint statement. Pocan offered an amendment to a fiscal 2020 spending bill that would have undone the policy.

(Updated with additional reporting throughout)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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