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Health and Human Services Secretary Alex Azar (foregound) is carrying out the new fetal tissue policy developed by President Donald Trumps administration.

AP Photo/Patrick Semansky

New U.S. ethics board rejects most human fetal tissue research proposals

An ethics board convened by the Trump administration today recommended that the United States refuse to fund all but one in a group of applications to do medical research using human fetal tissue donated after elective abortions. The applications, made to the U.S. National Institutes of Health (NIH), had already been recommended for funding by scientific reviewers and had met existing legal requirements for ethical use of the tissue.

The Human Fetal Tissue Research Ethics Advisory Board, appointed by Health and Human Services (HHS) Secretary Alex Azar, reviewed the 14 proposals last month. Its recommendations that 13 of them be rejected, delivered to Azar and Congress today, were the first under a new regime implemented last year by the Trump administration, in which projects by extramural, NIH-funded scientists using human fetal tissue need to pass an extra layer of ethics review.

Azar, who will make the final decision about whether to fund each proposal, made no comment this evening. HHS could not say when he would have decisions on the 14 proposals, which included both grants and contracts.

At least 10 of the board’s 15 members have publicly opposed abortion, fetal tissue research, human embryonic stem cell research, contraception, or a combination of these. Only one board member, Lawrence Goldstein, a neuroscientist at the University of California, San Diego, has been an outspoken advocate of fetal tissue use. “I am obviously disappointed by the obvious bias in the membership of the so-called ethics board and the obvious biased consequences for the outcome,” he tells ScienceInsider. “Excellent disease-relevant research will likely not be funded and it will not be possible to reduce the need for human fetal tissue in disease research.”

Paige Comstock Cunningham, the board’s chair and interim president of Taylor University, an evangelical Christian university in Upland, Indiana, could not immediately be reached for comment.

But groups that oppose abortion praised the board’s recommendations. “This was a serious review of the ethical considerations surrounding use of human fetal tissue in research by highly credentialed and distinguished professionals, following the process set out in federal law,” said Mallory Quigley, vice president of communications for the antiabortion group the Susan B. Anthony List. “We hope to see Secretary Azar adopt these recommendations.”

Scientists use human fetal tissue to study and develop therapies for diseases and conditions from diabetes to congenital heart defects to blindness. They also use the tissue to develop mice with humanlike immune systems to conduct research on infectious diseases, particularly HIV. Such mice could also be useful in the fight against the new coronavirus, proponents argue. In 2018, scientists at an NIH meeting attended by HHS leaders argued that human fetal tissue remains the “gold standard” for developing such mice. In 2019, NIH spent $109 million on about 175 projects that used human fetal tissue; this year, it expects to spend $116 million.

The report did not provide any details identifying the researchers whose proposals were before the board. Its decisions ranged from two unanimous votes against proposals to an eight-to-seven split on another. Overall, most votes were heavily lopsided against funding. According to the report, the unanimous votes went against one proposal that justified its need for human fetal tissue by stating only that a mouse made with the tissue “was the only one that would work” and another where board members complained that the researchers had essentially offloaded the task of complying with ethical requirements including informed consent to a company supplying the fetal tissue.

Under the law constituting the board, members could use only “ethical considerations” in deciding to vote against a proposal. The committee refused funding on grounds including scientists’ insufficient justifications for the use of the tissue; failure to rationalize the amount of tissue sought; purported inadequacies in informed consent forms for people donating the fetal tissue (even though institutional ethics committees had to have already approved the consents); and, in the proposal that was voted down eight to seven, the complaint that the human fetal tissue “was being used only to make the comparison” to an alternative to fetal tissue.

The one proposal that passed muster with the board, on a nine-to-six vote, was another attempt to develop an alternative to human fetal tissue, using as a comparator fetal tissue that has already been obtained and stored in a biorepository.

NIH last year launched a $20 million research program seeking alternatives to the use of human fetal tissue in research. But in announcing the program, NIH Director Francis Collins said that to validate such alternatives, “You’re going to have to compare it to the current standard, which is using fetal tissue.”

“Some of the proposals were constrained by the NIH requirement that [human fetal tissue] be used as a comparator,” the report states.

The near-blanket rejection of the proposals has upset scientists who support research with fetal tissue. “Crucial advances in biomedical research will be slowed because of the American restrictions on research using human fetal tissue,” Christine Mummery, president of the International Society for Stem Cell Research and a stem cell scientist at Leiden University Medical Center, says in response to the report. “People may die unnecessarily because the administration has allowed an ideological special interest group to hijack biomedical research.”

Some also attacked the composition of the committee. “This is a ban disguised as an ethics committee,” says Carolyn Coyne, a virologist at the University of Pittsburgh. She also noted that the board had just two nonwhite members. “So, the ‘ethics’ of research was decided by a largely Christian/Catholic, white panel.” Coyne is using placentas from elective terminations of pregnancies to study how the maternal immune system defends the fetus against viral invasion.

Multiyear grants that are in their early years won’t come under scrutiny by the board, which was convened for a one-time meeting to judge new grant proposals, or those competing for renewal after several years of funding. If President Donald Trump is reelected, a new board will be reconstituted to judge new and competing proposals in coming years.

The Trump policy, announced in June 2019, has already shut down studies by NIH staff scientists that use human fetal tissue. The board’s decisions announced today concerned proposals by extramural investigators.

The administration’s fetal tissue research restrictions are not law and could be reversed by a different presidential administration.