University Possibly Broke Federal and State Law Doing Research With Aborted Baby Parts

There is considerable and ongoing discussion whether the University of Pittsburgh (hereafter, Pitt) violated federal and state law when using NIH funds for research involving baby parts. For a succinct summary of the concerns, see this letter from members of Congress requesting that the Health and Human Services Office of the Inspector General investigate the issue. For a discussion of recent material obtained via FOIA, see here.

Aside from the question about failure to observe rules, these questions arise:

• Do inconsistencies or ambiguities in regulatory frameworks provide loopholes that institutions engaged in NIH funded research using baby body parts can exploit?
• Have lapses in enforcement by responsible entities created lax attitudes on the part of institutions, not just at Pitt?

Below is a non-exhaustive attempt to address related questions as they pertain to: University of Pittsburgh (hereafter, Pitt) and its Institutional Review Board (Pitt’s IRB); University of Pittsburgh Medical Center (UPMC); UPMC Magee-Womens Hospital (Magee); National Institutes of Health (NIH); and Pennsylvania Department of Health (PA DOH).

The following comments and questions are ones that naturally arise to a non-expert on the relevant regulations and laws. Correction of any mistakes of interpretation or any clarifications are of course welcome.

Magee, Pitt, & Pitt’s IRB

Pitt retained a law firm to deflect criticism. In December 2021, the firm issued its report, which relied on two strategies.

First, the report (p. 5) mentions that “we did not review the clinical decision-making or delivery of medical care, such as abortion, by individuals serving in their capacity as University of Pittsburgh Medical Center (UPMC) employees”.

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Second, the report claimed (p. 7) that once tissue is “de-identified”, i.e., removed of any identifying information that would enable tracing back the origin of the tissue, the tissue no longer falls under the scope of “human subject” research and therefore is not under the purview of Pitt IRBs scrutiny.

In October, Christopher Pushaw, Executive Director of the Pennsylvania Pro-life Federation, gave testimony to UPMC Magee-Womens Hospital (hereafter, Magee). (For full disclosure, I participated in its drafting.)

Magee is an especially relevant entity in the controversy. A Pitt website mentions that “the Pitt Biospecimen Core, which provides central support for Pitt research programs, receives all fetal tissues from UPMC Magee-Womens Hospital.”

Pushaw identified relevant sections of Pennsylvania’s Abortion Control Act. He also noted that

… [Pitt’s law firm report] suggests that … oversight would not extend to how Magee obtains its fetal tissue specimens….

Moreover, the report states that formal review by the University’s Institutional Review Board over the “method by which the researcher will obtain human fetal tissue” can qualify for an exemption” provided such tissue is “de-identified.”

He also mentioned:

If the [Pitt] IRB did not investigate how the fetal tissue was collected based on this exemption, it still begs the questions that would have been central to the investigation before it and the law firm– namely, what abortion procedures were used in the process of collecting these fetal specimens, whether some fetuses survived these abortions and whether continuing the procedure at that point induced fetal demise.

In sum, Pitt’s law firm report disclaims responsibility for Pitt’s IRB to investigate whether Magee’s tissue collection procedures, but did not address the point of controversy: what procedures did Magee use to extract the tissue, and do these procedures violate state law?

Another difficulty is this. Pitt’s IRB mentions its responsibility to “ensure that research activities are fully compliant with the federal regulations, …, as well as with state laws and university policies.”    Contra Pitt’s law firm report, then, Pitt’s IRB actually sees a responsibility to monitor whether Pitt’s source of tissue (Magee) observes state laws.

Yet another reason for concern about Pitt’s law firm report is the following statement at a Pitt website:

In general, The University of Pittsburgh IRB has jurisdiction over research projects that meet the following criteria . . . [one of which is:]

• Conducted in any UPMC owned, operated, or controlled domestic facility or program … and/or by any UPMC employee of any UPMC nonprofit corporations, program or facility.

This suggests that the distinction between Pitt and UPMC (including Magee) is not as marked as the report would have us believe.

While Pitt’s law firm report focuses on indemnifying Pitt from allegations about use of baby parts, it also has a section (p. 18-19) that addresses UPMC’s policies about abortion. Concerning Magee, on p. 18 the report identifies (fn. 35) Magee’s 2014 abortion policy. It would help if a copy of this policy would be made public and to hear details from Magee about how it monitors and verifies compliance with the law, including PA’s Abortion Control Act.

To my knowledge Pitt has not disputed its law firm report’s interpretation of Pitt’s regulatory responsibility, which appears inconsistent with its own stated policies, nor to my knowledge has Magee addressed the public controversy.

Turn now to NIH’s regulatory statements.

NIH

Pitt’s law firm report states that “since we understand that Pitt is not engaged in human fetal tissue transplantation research, we do not discuss those requirements in this report” (p. 6).

What does NIH say about non–transplantation research? On this webpage, the section about “Non-Transplantation Research on Human Fetal Tissue from Elective Abortions” says “NIH requires applicants to address HFT requirements by providing a justification of the use of HFT, details regarding procurement and costs, and information about how the applicant will use HFT.” What, in detail, is the NIH requirement for details about “procurement”? Does it include the actual procedures for collecting tissue?

Also, why does this section not include this statement that appears in the section of the webpage about transplantation uses of aborted tissue: “”In the case of tissue obtained pursuant to an induced abortion, the physician’s statement also must state that they … performed the abortion in accordance with applicable State and local laws.”

Is this discrepancy merely an oversight?

Another place to look for clarification about NIH policies is the new (but heavily redacted) FOIA documentation here, the topic of many recent articles. This is not the place for a detailed analysis, but some highlights are NIH’s Michael Lauer, M.D. questions (PDF page 7) for Rob A. Rutenbar, Ph.D., Senior Vice Chancellor for Research. The particular regulations that Lauer identifies are on PDF p. 55.

Rutenbar’s reply (on PDF pp. 108-109) appears consistent with the law firm report’s distancing from collection procedures at Magee. It does not address the questions addressed in this article and many other places.

The HHS OIG’s investigation, if it is still continuing, provides a public opportunity for HHS and NIH to commit to much more rigorous future scrutiny of tissue collection procedures to obviate the concerns expressed in the letter from members of Congress.

Pennsylvania’s Department of Health

Ideally, PA DOH would play an important role in monitoring whether federally funded medical research observes state laws. I do not recall, however, seeing any mention of the its involvement in addressing the controversy. Perhaps this lassitude is unsurprising, if we consider the serious lapses of this department in the Gosnell case.

Summary

If the interpretations offered above are correct, it is unclear what external entity rigorously regulates, and in an ongoing way, compliance with Pennsylvania’s Abortion Control Act and relevant federal regulations or laws at Magee. Is this in essence an honor system?

While it is important to evaluate whether Pitt or Magee violated Pennsylvania’s Abortion Control Act and federal law or regulations, it is also crucial to ask what entities are responsible for enforcing the law and how they frame their responsibilities.

More broadly, is Pitt’s NIH funded research involving baby parts merely one case study of regulatory problems replicated at other NIH-funded centers that use tissue from abortion?

Except through ongoing FOIA requests, thus far citizens seem to have no way of knowing how NIH funded institutions doing research with baby parts are using their tax dollars for illegal practices. There is a great deal of opacity in this research space.

Path Forward

What should pro-life advocates do, path forward?

In this post-Roe world, in which states can now determine the legal status of the pre-born baby, pro-lifers should advocate vigorous NIH monitoring of the procedures. They should also advocate that their state governments ensure observance of state law and make use of state right to know mechanisms to explore what actions their states takes to ensure compliance.

Given the example mentioned above of Pennsylvania government’s lack of oversight in the Gosnell case, NIH monitoring of compliance with state laws is valuable. This is because states that have some restrictions on abortion practices, but otherwise have permissible laws about abortion, may be relatively cavalier about monitoring whether medical researchers violate their laws when obtaining baby tissue.

Finally, pro-lifers should encourage the members of Congress who signed the 2022 letter to develop hearings about the issue of compliance with aborted tissue. This would enable cross-examination of legal scholars and government personnel.

LifeNews Note: Brian Simboli, Ph.D. is an independent researcher and writer. He volunteers with Pennsylvania Pro-Life Federation as a research associate.

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