Scientists worry over new requirements for human fetal tissue research

The National Institutes of Health issued new requirements Friday for scientists seeking government funding for research that uses human fetal tissue, and the changes are raising concern among some researchers.

The latest instructions require scientists to justify why they need to use human fetal tissue in research, including explanations of why alternatives can’t be used and how they were ruled out. Researchers must include information to show that they received consent from women who had abortions and plans for treatment and disposal of fetal tissue once research is complete.

The new funding requirements do not allow scientists in training to propose research that uses fetal tissue.

The requirements apply to grant applications and contract proposals submitted starting September 25.

An ethics advisory board “comprised of scientists, bio-ethicists and others” will assess proposals involving fetal tissue, according to the institutes. It said it is still in the process of assembling that board and does not have additional information about who will be on it.

‘Yet another set of barriers’

Some researchers are critical of the new funding requirements.

“This decision is all about the politics, not about the science, and it has unfortunately allowed the abortion debate to creep into what should be a research issue,” said Lawrence Goldstein, a University of California, San Diego professor of cellular and molecular medicine.

In June, the US Department of Health and Human Services announced that it would discontinue research conducted by National Institutes of Health scientists that involved human fetal tissue from elective abortions, a move applauded by anti-abortion advocates.

In July, 93 medical associations and universities responded with a letter to Health and Human Services Secretary Alex Azar to “express our collective and strong opposition” to the new policies.

“These policies would impose substantial barriers to and limit the use of an essential biomedical research resource that has led to many advances in human health and remains critical for the development of new treatments for a wide range of serious diseases,” the letter said. “Human fetal tissue research advances science, improves human health, and saves lives.”

The Association of American Medical Colleges is among the organizations that signed the protest letter. Heather Pierce, the senior director for science policy and regulatory counsel at the association, said the latest news is discouraging.

“This adds to yet another set of barriers beyond the ones we are already faced with,” Pierce said. “These new hoops to jump through, making this far more difficult to get funding, may leave some scientists wondering if it is really worth the effort to apply for these grants or to do the work at all.

“That may mean that we are not going to get this important research on terrible diseases like Alzheimer’s and macular degeneration and Zika.”

How fetal tissue is used in research

Fetal tissue has been used since the 1930s for research. It has played a part in research on vaccines and infectious diseases such as HIV/AIDS, and more recently, it’s been used to advance stem cell research and treatments for degenerative diseases.

Goldstein said fetal tissue has unique properties and often can’t be replaced with other tissue types. Human fetal cells are more flexible and can be more easily grown in a culture than adult tissue.

Some who oppose the use of fetal tissues argue that scientists should use stem cells instead, Goldstein said. However, scientists would still need fetal cells at some point to have as a comparison, he said.

One use at the moment is in the creation of lab-grown organs for transplantation. With a shortage of organs such as kidneys, “this is vital work.”

When scientists try to make these organs, they need to know whether they’re making the right sorts of cells.

“You can’t just look through a microscope and see what it is; you need a fetal-type precursor to those organ tissues,” Goldstein said. “You really can’t make sure you are on the right path without it.”

He said some of his colleagues worry that the criteria are set up so that no grant will be funded if it uses fetal tissue.

“I’m a little more optimistic, or if not optimistic, I have feasible doubts about the draconian nature of such things and see some real problems with the rules as they are written,” Goldstein said. “But we will have to see how this plays out.”