U.S. issues new guidelines for fetal-tissue study funds

The National Institutes of Health issued instructions Friday for how scientists seeking grants for research using fetal tissue must comply with recent restrictions on federal funding of such studies. The new requirements triggered an immediate outcry from leaders in the field.

In a notice spelling out the rule changes, the National Institutes of Health says that all grant applications and renewals for research relying on tissue collected from elective abortions must provide a detailed justification, documenting why no alternative methods could accomplish the same research goals. This and other changes for scientists at universities and other institutions take effect in two months.

The instructions also impose stringent requirements for how grant applicants must prove that women had given permission for their aborted fetuses to be donated for research.

And for the first time, the rules forbid graduate and postdoctoral students who receive training funds from proposing fetal tissue research.

The instructions represent the first explanation of how the nation’s largest sponsor of biomedical research is setting in motion a decision announced in early June — made by President Donald Trump over the objection of his top health and science advisers — to limit funding of research using fetal tissue.

The administration’s restrictions already forbid any new fetal tissue studies by scientists who work directly for the National Institutes of Health. For outside researchers, the administration is not outright ending such research but has created a new layer of ethics review for grant applications that qualify for funding based on the institutes’ usual scientific reviews. Friday’s notice provides details, though not complete information, about how the additional review will work.

Scientists say that fetal tissue research has proved crucial to help understand and develop therapies for diseases including HIV, cancers, Zika and Parkinson’s disease.

National Institutes of Health spokesman Renate Myles said the instructions were developed jointly by the institutes and the Department of Health and Human Services and that the date when the rule changes go into effect — Sept. 25 — matches the institutes’ next grant cycle.

She said the ethics advisory boards, which will carry out the new layer of review, are in the process of being formed.