An outside investigation paid for by the University of Pittsburgh has found the institution is “fully compliant with federal and state regulatory requirements” regarding its use of fetal tissue in scientific research. The investigation came after the university was criticized by right-wing media for its research practices.
In September, Pitt hired a Washington, D.C.-based law firm to conduct the review of its use of fetal specimens in biomedical research – including work on treatments for HIV and liver failure.
The firm, Hyman, Phelps & McNamara, specializes in health care law. According to its website, the firm has expertise in internal investigations and supply chain integrity.
When Pitt hired the firm, the university said that though it had nothing wrong and adheres to a robust compliance regime, it decided to take this “proactive step to ensure that it is positioned to continue leading the way — scientifically, legally and ethically — in practicing and advancing lifesaving research.”
One of the report’s three authors, Michael S. Heesters, is a 2004 graduate of Pitt’s pharmacy school. Heesters later attended law school before becoming an assistant U.S. Attorney; during that time he prosecuted several cases of health care fraud.
When asked if his role as an investigator presented a conflict of interest, Pitt replied that such a notion was completely devoid of merit, noting that Heesters graduated nearly two decades ago.
Quashing unfounded claims
Pitt research scientists are far from unique in their use of fetal tissue. Still, last year a group of right-wing pundits became fixated on the university’s use of these materials. What seems to have kicked off the maelstrom was, at least in part, incendiary conservative coverage of a 2020 study, in which scientists altered rodents’ immune systems with fetal tissue and stem cells to further the study of skin infections in people.
One blog post even alleged that Pitt has “an illegal Quid-Pro-Quo” arrangement with Planned Parenthood of Western Pennsylvania clinics in order to obtain specimens. Planned Parenthood has also been targeted for its role in providing fetal tissue for research.
The Hyman, Phelps & McNamara investigation found that since 2001 none of the 31 Pitt studies that used fetal tissue worked with specimens that came from Planned Parenthood of Western Pennsylvania patients. In fact, the report notes this branch of the health care nonprofit doesn’t collect fetal tissue for research purposes.
Another accusation conservative pundits put forth last year was that Pitt leveraged its access to fetal tissue to obtain federal funding for research from the National Institutes of Health. Investigators noted that, “NIH grant money is not tied to the source of human fetal tissue.”
Findings
The 27-page report lays out how Pitt acquires fetal tissue, explaining the chain of custody of these materials from surgery suite to research bench.
Primarily, specimens are donated to Pitt by UPMC patients who had an abortion, or experienced a stillbirth or miscarriage.
In instances of abortion, patients are only asked if they’d like to donate after they decide to terminate their pregnancies. This is in accordance with the Pennsylvania Abortion Control Act of 1989.
The report explains that a doctor and abortion patient might discuss the scientific benefit that fetal tissues provide. Physicians do not change the method of termination based on a patient’s decision to give their fetal tissue to medical science.
(Surgical abortions are performed with vacuum suction that removes the fetus. If the procedure is done during the second trimester the cervix is dilated and likely requires higher levels of negative pressure.)
The report notes that providers have discrete roles during this process so as to guard against the possibility that a patient might be coerced into choosing abortion for the purpose of creating research materials. Therefore, the provider who receives written consent for the abortion is separate from the person who approaches the patient to obtain written consent for the tissue donation. Neither of these individuals will be the doctor who performs the abortion.
No contact between researchers and tissue donors
After the fetal tissue is collected, it is sent to the Pitt Biospecimen Core, which maintains a variety of human tissues obtained from UPMC patients.
In addition to preserving these materials for research, the Biospecimen Core “de-identifies” the specimen, meaning a patient’s personal details such as birthdate, name, and medical information are removed. This prevents scientists from learning donors’ identities. Likewise, donors can’t designate a specific researcher to receive their tissue.
This system means there is no direct contact between UPMC and Pitt scientists.
In some cases, the report says non-UPMC providers might donate fetal tissue to Pitt. And a handful of Pitt studies use materials obtained from research institutions or consortiums other than the Biospecimen Core, such as the University of Washington.
In these instances, investigators found that state and federal regulations were followed – including the prohibition against paying patients or providers for a donation. Both federal and state law allow for reasonable payments in regard to the retrieval, storage, and transportation of human fetal tissues.
Recommendations
Though investigators found that Pitt responsibly handles fetal tissue, they advised that the university issue more detailed instructions on its consent forms – such as clarification of legal terminology.
Also, they recommended that Pitt periodically conduct audits “to verify that the University continues to meet legal requirements for fetal tissue research.”
As the investigators acknowledge, the use of fetal tissue for medical research is not universally accepted. But the report finds that Pitt’s practices break no state or federal laws, and that the university’s approval process for studies that use these specimens present no inherent conflict of interest.
“The process for obtaining informed consent from donors of human fetal tissue is proper,” investigators wrote.
