Report on fetal tissue research process finds Pitt in compliance

In September 2021, Pitt hired an outside law firm to do an independent review of its fetal tissue research processes and practices, after the University came under fire from conservative circles.

The Washington, D.C., law firm Hyman, Phelps & McNamara issued its report on Dec. 31. In the report’s conclusion, it said: “Although the use of human fetal tissue in research may not be universally accepted, federal and state laws, as well as NIH (National Institutes of Health) grants policy, permit these activities as long as certain requirements are met. We have completed our assessment of Pitt’s activities involving research using human fetal tissue and conclude that the University is fully compliant with federal and state regulatory requirements.”

The firm reached this conclusion after thorough review of established procedures and the 31 relevant studies conducted to date.

The University has repeatedly denied any wrongdoing in its research practices and said fetal tissue research is “subject to robust internal controls and highly regulated at the state and federal level.” 

In response to the report, a Pitt spokesman said: “As we have stated in the past: Fetal tissue research plays a critical role in advancing life-saving discoveries. We remain committed to maintaining robust internal controls and to extending our record of compliance at the state and federal levels, and we take these responsibilities seriously.”

Scientists have used fetal cell lines to develop and test several vaccines, including those for COVID-19, polio, chickenpox, shingles, measles, rubella and rabies. Anti-abortion advocates oppose fetal tissue research because the tissue primarily comes from abortions. Scientists say that for certain types of experiments, there is no substitute for human fetal tissue cells. In 2020, the top 10 NIH-funded institutions — which includes Pitt — received NIH grants for projects that utilize fetal tissue research.

By law, all fetal tissue donations are voluntary and informed consent is required for fetal tissue to be collected for and provided to researchers, who are not involved in collecting the tissue. The NIH and Pennsylvania law expressly forbid entities from profiting off the collection, cataloging, storage and transfer of fetal tissue donations.

Specifically, the report concluded:

  • Because the University researchers are blinded to a patient’s abortion decision and the procedure itself, there is no pathway for the researcher to influence a woman to terminate her pregnancy or to donate fetal tissue for research.

  • There is no inherent conflict of interest in the Pitt Institutional Review Board (IRB) process for reviewing study protocols involving human fetal tissue.

  • The assessment did not find any illegal arrangement or quid pro quo between Pitt and Planned Parenthood of Western Pennsylvania. Pitt has no contractual arrangement with Planned Parenthood of Western Pennsylvania. … We also confirmed that Planned Parenthood of Western Pennsylvania does not even collect human fetal tissue for research purposes, which undermines any allegation that Pitt engages in a relationship with Planned Parenthood to obtain fetal tissue.

  • Pitt does not use its access to fetal tissue from abortions conducted at UPMC as a mechanism to obtain NIH grant money. NIH grant money is not tied to the source of human fetal tissue.

  • The process for obtaining informed consent from donors of human fetal tissue is proper and is intentionally silent as to the ultimate research use for the donation.

The review did identify four administrative recommendations — which have no bearing on compliance — that the Pitt spokesman said the University is working now to implement. These include:

  • Providing more detailed instructions for how to complete the consent forms that are used as part of the Tissue Collection Protocol.

  • Using Pitt’s audit authority through the Education and Compliance Committee, or other designee, to conduct periodic audits of the Tissue Collection Protocol, including the fetal tissue consent form, and of its implementation in individual fetal tissue studies conducted at Pitt.

  • Introducing a formal procedure that comprehensively documents this process (i.e., from submission of an application to the IRB through disbursement of tissue by the PBC). This documentation can be used for training purposes and could also provide good evidence of Pitt’s compliance with federal and state laws. 

  • More closely reviewing the consent forms that contain gaps and following up, if needed.

— Susan Jones


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