The board sent its advice in a report to HHS on Tuesday, less than three weeks after the announcement of its members, two-thirds of whom are outspoken opponents of abortion, fetal tissue research or both. The group has operated in secrecy, with even its own members unaware of who else was in it until the end of July, when it held a single, day-long virtual meeting, most of it closed to the public. Members were required to sign nondisclosure agreements about their deliberations.
The 15-page report does not name any of the researchers or their projects. But it shows that the board’s votes were splintered to varying degrees, with four of the proposals receiving a 14-to-1 vote against. The most common reason cited for recommending against funding a project was the contention that the researcher had not provided adequate ethical justification for using fetal tissue. Two proposals were rejected unanimously, with board members saying they were weak.
The only proposal the board recommended to be funded, on a 9-to-6 vote, is a study that will use fetal tissue to try to validate whether an alternative model works as well. The administration has been encouraging the development of such alternatives.
“If successful, the research will obviate the need for HFT [human fetal tissue] in future models,” the report said. It also noted that the researchers involved said they planned to use existing fetal tissue in storage, rather than acquiring any more.
At least four researchers with grant or contract applications reviewed by the board have already received invitations from NIH to revise their proposals, excluding any mention of fetal tissue, according to two individuals familiar with some of the scientists, speaking on the condition of anonymity to describe private communications. At least one of those also is trying to validate an alternative model to fetal tissue.
Scientists who use fetal tissue in their work, as well as their advocacy organizations, were infuriated by the report, regarding it as a worst-case scenario that they had predicted for months.
“The evaluation process for research should be insulated from ideology and special interests,” said a statement swiftly issued by the International Society for Stem Cell Research. “It is disheartening to see an ethics review perverted by an administration seeking to achieve a policy goal, a near ban on research with human fetal tissue.”
The one board member who has used fetal tissue in his own research, Lawrence Goldstein, a senior faculty member at the University of California at San Diego, denounced the process late Tuesday. “I think the whole thing is a travesty,” he said shortly after the report’s release. “They handpicked a board that wouldn’t approve very much, if anything. And they got the outcome that they wanted.”
Goldstein recalled that when the administration announced plans to create an ethics review board, he “went out of my way to defend” to skeptical colleagues that it could be fair. “I tried to keep an open mind, let’s see what we get. And this is what we get. I was clearly wrong to defend the administration.”
The report was sent to the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee. Rep. Frank Pallone Jr. (D-N.J.), the Energyand Commerce Committee chairman, said in a statement that its conclusions were “predetermined when the Trump administration stacked the advisory board that prepared it with ideological opponents of fetal tissue research. . . . We should be pursuing new cures and treatments based on science, not ideology.”
Supporters of the administration’s fetal tissue policy had no immediate public response.
The board’s recommendations are not binding. And Azar has not indicated what he will do. If he were to delay acting until after the November presidential election — or take no action — the practical effect would be the same as denying funding. Putting the HHS secretary in charge is a marked departure from the usual way the government, by far the largest source of money for biomedical research in the United States, determines which studies to support. Typically, NIH oversees such decisions, and fellow scientists assess the scientific merits of proposed grants and contracts.
All 14 proposals reviewed by the ethics board already had been judged worthy of NIH support through the institutes’ normal review process.
Many scientists consider fetal tissue an invaluable research tool that has led to advances in understanding and treatment of several major diseases and could be useful in developing cures and vaccines for the novel coronavirus. Social conservatives aligned with Trump regard such research as unethical because it hinges on small amounts of tissue from aborted fetuses, and they have long argued against using taxpayer money to support it.
In June 2019, Trump rewrote the rules for federal funding of such research, over the objections of some of his health advisers. The most immediate change was that scientists who work directly for NIH could no longer receive funding for research that involves fetal tissue. But for researchers at universities and other outside labs who rely on NIH support, the rules said grants and contracts could continue, as long as applications, approved on their scientific merits, then went through a new ethics screening.
The rules said an ethics advisory board would be formed, but the administration took no action for months, leaving in limbo researchers eager for grants or contracts to be renewed or funded for the first time. In February, a Federal Register notice called for nominations to a board that Azar would convene. The notice said the board must meet in time to submit a report within a half-year. That set the Tuesday deadline.
The board’s chair is Paige Comstock Cunningham, the interim president of an evangelical Christian college, Taylor University, who used to be president of Americans United for Life, an antiabortion group. Five other board members are affiliated with the Charlotte Lozier Institute, the research arm of the antiabortion Susan B. Anthony List. Four others also have publicly opposed abortion or fetal tissue research.
The Lozier-affiliated board members include David Prentice, the organization’s research director. The others are Maureen Condic, of the University of Utah who belongs to the Pontifical Academy for Life; G. Kevin Donovan, director of a Georgetown University bioethics center; Kathleen Schmainda, a professor at the Medical College of Wisconsin who is a faculty mentor for a medical student antiabortion group, and Ingrid Skop, a Texas obstetrician-gynecologist who has testified before that state’s legislature in favor of abortion restrictions.