On Ignoring Consent Rules on Fetal Tissue Donations

As Congress began hearings last week to examine the federal laws guiding the procurement and sale of fetal tissue for medical research, the focus has remained on the role Planned Parenthood plays in harvesting this tissue.  We argue that Congressional leaders need to begin paying attention to the end-stage users in the value chain surrounding fetal body parts—the federally funded university-based researchers, who may be out of compliance with federal laws governing maternal consent and coercion.

The National Institutes of Health (NIH) provides strict guidelines for all research involving human subjects. Most notably, the NIH clearly states that it is not ethical behavior to use individuals solely as a means to an end. During the informed consent process, the principle of respect for persons is applied by requiring all subjects in a research project to provide voluntary informed consent to participate.  Federal law mandates this informed consent from mothers offering to donate fetal tissue following abortion, and prohibits abortion providers from profiting by the sale of fetal tissue. However, undercover videos produced by the pro-life group called the Center for Medical Progress indicate that Planned Parenthood personnel may be violating both these and additional federal laws, and altering abortion procedures to ensure that fetuses or body parts are extracted intact to increase their value to researchers. This has serious implications for university-based researchers who are required to comply with federal guidelines on research with human subjects.

Defending their practices, Planned Parenthood claims that they always get consent for tissue donation from mothers choosing abortion. The Center for Medical Progress has provided a copy of the form Planned Parenthood uses.  Unfortunately, the consent form does not explain exactly what is going to occur for the mother and her unborn child. The phrase “fetal tissue and blood” is a mere euphemism for the products of conception, and does not describe the kinds of organs and body parts the way Planned Parenthood abortion doctors do in undercover video; they use words like “heart,” “liver,” “calvarium” and “lower extremities.” The consent form also fails to indicate that the Planned Parenthood physician will use an ultrasound in order to guide the harvest process and ensure intact organs and body parts.

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For example, in one undercover video, a Planned Parenthood doctor discussed using a “less crunchy” technique to increase the chance of recovering intact organs; and a second Planned Parenthood doctor described “crushing” above or below the desired organ of the unborn child during abortion in order to maximize its harvested value.  These revised abortion procedures are intended to deliver the best possible supply outcome to its end-stage customers—the university- and hospital-based medical researchers demanding the best possible fetal tissue specimens.  To be sure, it is in the supply chain management that we discover the real scandal surrounding fetal tissue research—both at the procurement level and at the federally funded medical research level.

Without end-stage buyers—many of them funded by taxpayers—there would likely be no fetal tissue selling scandal.  And, although the practices of infant organ and body part harvesting at Planned Parenthood are indeed horrific, the role of federally funded medical researchers at the country’s most prestigious universities and hospitals must also be investigated by Congress.  Last year, U.S. taxpayers provided $76 million for fetal tissue research—adding to the more than $400 million since 2011.  The NIH lists grants in 2014 to hospital- and university-based fetal tissue research projects at institutions including Yale, Harvard, Stanford, UNC-Chapel Hill, UCLA, U Colorado-Denver, NYU, UC Irvine, UC Berkeley, UC San Francisco, UC Davis, UC San Diego, UC Los Angeles Johns Hopkins, Temple, USC, Penn, West Virginia University, University of Nebraska, University of Texas, University of Miami, University of Rochester, Temple, Tufts, MIT, Washington State University, Cornell, George Washington University, University of Nebraska, Colorado State University, Drexel, Oregon, UMass, Columbia, and others.

While university-based researchers purchase fetal tissue from tissue procurement companies like StemExpress—the brokers in the value chain involving the sale of fetal body parts—all academic research is still governed by university-based Institutional Research Boards, which are guided by federal laws designed to protect human subjects.  Although university-based researchers may try to claim that, since their research specimens are not obtained from living individuals, they are not bound by federal guidelines regarding human-subject research, federal guidelines still mandate that all research involving human persons must “treat persons in an ethical manner, not only by respecting their decisions and protecting them from harm.” While the fetus, of course, cannot give consent, the mother has every right to understand the risk she faces as abortion providers tailor their procedures to maximize profit.

Holly O’Donnell, former StemExpress employee-whistleblower, has disclosed on video that in many cases, mothers did not even give consent for the harvesting of their unborn child’s organs or body parts. She stated: “If there was a higher gestation, and the technicians needed it, there were times they would just take what they wanted, and these mothers don’t know and there’s no way they would know.”

In addition to O’Donnell’s disclosures, abortion provider Dr. Nucatola admitted in one unedited video that Planned Parenthood has no real “procurement guidelines” protecting consent because according to Nucatola, the work at Planned Parenthood does not fit into a research study or fall under the guidance of an Institutional Review Board. The purpose of university-based Institutional Review Boards is to ensure compliance with federal guidelines on the conduct of research. But Planned Parenthood does not participate in Review Boards. For Dr. Nucatola, the IRBs require “too much work…. Too complicated…. It was a nightmare.”

NIH guidelines mandate that researchers minimize risk—including psychological risk, like anxiety, sadness, regret and emotional distress—to their subjects. Women whose fetal tissue was removed and used for research without their informed consent have indeed been harmed.  The NIH directives governing research involving human subjects emerged in an attempt to establish the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of medical research following the Nuremberg Trial in 1947.  The Nuremberg Code is the model for Institutional Research Boards throughout the country, and has served as the first international standard for the conduct of research. It is time for university-based fetal tissue researchers to begin asking the hard questions about the origins of the sanitized specimens they receive from their tissue procurement brokers.  Allowing fetal tissue research to continue without extending the Congressional investigation on issues of maternal consent, coercion, and risk to include university-based research  would be a serious violation of this Code.


  • Anne Hendershott

    Anne Hendershott is Professor of Sociology and Director of the Veritas Center for Ethics in Public Life at Franciscan University of Steubenville, OH. She is the author of The Politics of Envy (Crisis Publications, 2020).

  • Stephen Sammut, PhD

    Stephen Sammut, BPharm, PhD, is a Professor of Psychology at Franciscan University of Steubenville. Dr. Sammut received a BPharm from Monash University in Victoria, Australia and a PhD in Neuroscience from the University of Malta. For more than 20 years Dr. Sammut has conducted varied research in animal models to investigate questions related to psychopathology, including depression, schizophrenia, Parkinson’s disease, and drug abuse.

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