The recent revelations about Planned Parenthood’s fetal tissue and organ donor program raise a number of medical ethics questions.
By way of background, for several years in the late 1980s and through the ‘90s I focused on medical ethics, including sitting in on or helping establish some hospital ethics committees and a 10-year stint as an unpaid ethicist for a medical school’s institutional review board (IRB) for human experimentation. That’s the committee that reviews and approves all human experimentation occurring at a medical school.
Planned Parenthood posted this statement after the release of the first video [full transcript here] in which Dr. Deborah Nucatola, the organization’s senior director of medical services, discusses selling aborted fetal tissue and organs. Planned Parenthood asserts:
Our medical practices and guidelines in this area [fetal tissue donation] are clear, and we do this important work just like other high-quality health care providers—with full, appropriate consent from patients, under the highest ethical and legal standards, and with no financial benefit for the patient or Planned Parenthood.
Really? Then maybe the organization would be willing to answer a few detailed questions.
Can Planned Parenthood explain its informed consent process and produce the consent forms?
The taking of human tissue for donation requires the donor—or a parent or guardian if the donor is a minor—to consent to the donation, usually by signing an informed consent document. The U.S. Food and Drug Administration sets out its guidelines for informed consent in medical research:
Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
In the interview Dr. Nucatola discusses Planned Parenthood’s informed consent process several times, including the fact that a patient may decline to participate to the Planned Parenthood staff, only to agree to it after meeting with the research company’s staff.
That change raises the question of whether there undue pressure being imposed on patients? Does Planned Parenthood keep all of the consent forms? Can it reveal how many people have signed informed consent documents to donate fetal tissue? And can the public see them (with the names obscured), or at least see what the consent form looks like?
Has an independent medical ethics committee reviewed the informed consent documents and approved them?
When proposing human research protocols, an independent IRB has to review the informed consent document to ensure it is understandable, accurately describes the procedures, makes clear the risks and benefits, and explains that the patient has the right to refuse to participate without any repercussions—just as the FDA statement above requires.
Dr. Nucatola implies [p. 56] that an IRB has been involved—apparently a commercial IRB—but also tells the tissue buyers (actors), “Yes, one thing I can promise you, it won’t have to go through the rigorous role of a research project, because there is precedent for this now, and affiliates know how to deal with it. Like I said before, it was a nightmare, it had to go through an IRB, not just your IRB, it had to be an IRB for the affiliate.”
Is Planned Parenthood using an independent IRB that is willing to raise objections? Is the organization skirting the oversight process in order to minimize the raising of legitimate ethical concerns?
Planned Parenthood claims it did not “sell” the organs or benefit financially from the procedures. Can it verify that claim or are we just supposed to trust them?
It is legal in the U.S. for medical facilities to be reimbursed for their reasonable costs for harvesting human tissue and organs, but it is illegal to sell them for profit. That distinction can be a very fine line, as a former Planned Parenthood staffer has explained to the Washington Times. Can Planned Parenthood produce documents that prove it only received reasonable reimbursement costs?
Planned Parenthood may have good answers to these and similar questions; if so it should provide them.
There is a huge black market for human tissue and organs that evades the laws and ignores the rules, where the standards are low and the money is high.
Many pro-life people say the video proves Planned Parenthood employees have a low regard and callousness for human life. The organization needs to demonstrate that its practices are part of the legal, ethical world of medical research and not the dark underside.