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Fetal Tissue Scientists Need to Submit New Justifications (2)

July 26, 2019, 6:49 PMUpdated: July 26, 2019, 9:34 PM

Scientists working with fetal tissue will automatically have their grant applications pulled from consideration if they don’t justify why they need to use it, the NIH said.

The July 26 notice marks the first insight into the National Institutes of Health’s plan for implementing restrictions on fetal tissue research the Trump administration announced June 5. It lays out additional requirements researchers must meet if they want to use fetal tissue, including the need to justify the research along with details about cost and the source of the fetal tissue. Applications that fail to include all of that information “will be administratively withdrawn and not reviewed,” the NIH said.

“It’s important to ensure that all research is conducted ethically. The worry is that singling out this specific material for research may have a chilling effect on applications or on a willingness to use this avenue for exploration,” Heather H. Pierce, senior director of science policy for the Association of American Medical Colleges, said in an interview.

The AAMC and other science groups oppose President Donald Trump’s fetal tissue research ban on the grounds it stifles 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 Abortion opponents embraced the White House decision as a change they say is necessary to stop an unethical and outdated form of research.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 NIH notice applies to scientists who rely on the agency’s money but work at universities and other outside institutions. These outside researchers account for more than 80 percent of the NIH’s $39 billion annual budget, and Pierce’s organization accounts for more than half of those of those extramural funds.

The notice also specifies what counts as human fetal tissue, which includes umbilical cord tissue, cord blood, placenta, and amniotic fluid that came from an abortion. “It’s quite broad,” Pierce said. “It includes any derivative products like protein and not just the tissue.”

The NIH also provided more detail on ethics advisory board announced during last month’s rollout of the policy. Grant applications that passed scientific review will have to undergo the additional step of a new ethics board for fetal tissue, and the NIH clarified that reviewers will be looking to see if the applications meet the requirements of the July 26 notice.

“It’s good to see NIH moving ahead on these details,” David Prentice of the Charlotte Lozier Institute, the Susan B. Anthony List’s research division, said in an emailed statement. “Another step forward to replace antiquated fetal tissue research with modern, ethical science.”

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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; Andrew Childers at achilders@bloomberglaw.com

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