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Trump Administration Ethics Board to Review Fetal Tissue Studies (2)

Dec. 23, 2019, 3:51 PMUpdated: Dec. 23, 2019, 8:26 PM

A new fetal tissue research ethics review board will get underway early next year as part of the Trump administration’s plan to place restrictions on an area of research abortion opponents have protested.

The Department of Health and Human Services will formally announce the intention to convene the National Institutes of Health Human Fetal Tissue Research Ethics Advisory Board in early 2020, and the board will start reviewing studies later in the year, according to a Dec. 23 NIH grants notice. A request for board nominees also will go out in early 2020, the notice said.

The notice follows up on a policy change announced by the Trump administration in June that bars direct NIH employees from fetal tissue research. Extramural 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—must then undergo an additional layer of review by the new ethics board. Such a board currently doesn’t exist and the announcement indicates the first concrete steps to set up the board.

All federally funded extramural studies using fetal tissue have been on hold since the new policy went into effect because there’s no ethics board in place to approve them, NIH Director Francis S. Collins said in September.

The NIH said it is issuing the grants notice to provide additional time to consider nominations.

Groups such as the Association of American Medical Colleges and the International Society for Stem Cell Research oppose President Donald Trump’s fetal tissue research restrictions on the grounds they stifle an area of biomedical research that has been critical to the development of treatments ranging from the polio vaccine to Gilead’s HIV pre-exposure prophylaxis pill Truvada. Abortion opponents embraced the White House decision as a change they say is necessary to stop an unethical and outdated form of research. The NIH funded about $115 million in research using fetal tissue in fiscal year 2018.

The board will primarily be made up of scientists with “substantial accomplishments in biomedical or behavioral research,” along with at least one attorney, ethicist, practicing physician, and theologian, according to the notice.

“It will be important for the board to be comprised of scientists and people who are also very aware of all of the issues, including the history and importance of fetal tissue research,” Heather H. Pierce, the AAMC’s senior director and regulatory counsel, said Dec. 23.

Annual Assessments Planned

The notice said that the board will likely meet once a year, as opposed to convening each time there’s a grant application that scores high enough to receive grant funding under the initial peer review process.

“This could be more efficient,” Pierce said. But it could also lead to funding delays if the board only meets very late in the year, for scientists who become eligible for funding earlier in the year.

The new ethics review should be coordinated with the scientific peer review, Deepak Srivastava, president of the international stem cell group, told Bloomberg Law.

“Promising biomedical research that has cleared the scientific peer review process shouldn’t have to wait for a once-a-year review by an ethics board,” he said. “This is an unnecessarily cumbersome and bureaucratic process that will likely deter applicants from pursuing important research that will benefit human health and the development of new therapies to treat devastating diseases.”

A similar ethics board was formed in the late 1970s to add a layer of oversight for NIH-funded extramural research on human embryos, University of Wisconsin-Madison bioethicist R. Alta Charo told Bloomberg Law last summer. The Reagan administration instituted a policy that required the ethics board review, but Charo said no one was appointed to it.

“Applications for [human embryo] research that had passed scientific review were, metaphorically, slipped under the door of a locked and empty room, where they sat for over a decade under Reagan and [George H.W.] Bush,” Charo said. The human embryo research ethics board policy ultimately was withdrawn by the Clinton administration.

The Dec. 23 grants notice indicates the Trump administration indeed plans to go forward with its policy on fetal tissue research.

(Updates with comments from president of the International Society for Stem Cell Research in the 11th and 12th paragraphs.)

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

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Randy Kubetin at rkubetin@bloomberglaw.com

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