Karen G. Gervais

Fetal Tissue Research and the Misread Compromise

The bill to restore federal funding for human fetal tissue research has been passed by the House and awaits Senate approval. But it requires women who are willing to donate fetal tissue to certify that they did not have an abortion with the intent to donate. It further requires researchers to keep the certifications on file and available for government audit. Both requirements spell trouble.

Health care workers' willingness to work in a pandemic

Malm and colleagues (2008) provide a valuable and compelling analysis of the effectiveness and feasibility of different strategies for establishing a duty to work during a severe pandemic. To encou...

Wanted: More Assistance in Benefits Design

The Oversight Body of the Ethical Force Program (EFP) has provided initial, important steps toward an ethical process for health care benefits design decision making (Wynia et al. 2004). However, as Steinberg (2004) notes and the EFP authors themselves acknowledge (Wynia et al. 2004), a process alone is insufficient to ensure that decisions will be ethically informed, let alone defensible. In this commentary, we focus only on the EFP’s proposal regarding health benefits design, not its proposal for administering covered benefits. In the spirit not of criticism, but of enlarging the conversation, we would like to comment on two efforts to provide more substantive guidance to the decision-making process.

Ethical and policy issues in human fetal tissue transplants

A review of human fetal tissue policies over the past 40 years reveals an increasing awareness that the use of this tissue raises unique ethical and policy issues. Initially it was believed that the use of fetal tissue was no different from using any other abandoned surgical waste specimen. Then state laws were passed requiring fetal tissue to be treated with the same respect and protection as tissue obtained from cadaver donors generally. Most recently, a few state and federal policies suggest that the use of fetal tissue requires a unique set of provisions, that it is unlike either the use of tissue from a routine cadaver donor or the use of tissue from abandoned waste specimens. In this paper we identify four central features of fetal tissue donation that make it a unique type of tissue donation requiring its own framework of respect and protection for the parties involved. We then critically review the most important current state and federal fetal tissue policies, including the NIH Revitalization Act of 1993.

Risks of Fetal Tissue Donation to Women

Treating the aborted fetus as a human cadaver is believed to be justified because it is respectful and protective of the fetus. In the United States, most states permit the donation and procurement of human fetal tissue for educational, research, or therapeutic purposes in accord with the Uniform Anatomical Gift Act (UAGA). These state laws specify the protections necessary for the fetal cadaver and the circumstances under which the next-of-kin may donate its remains. However, treating the woman who agrees to donate fetal tissue merely as one of the next-of-kin who may consent to donate the tissue of her deceased relative is disrespectful and leaves her vulnerable to harm. It overlooks both the risks that donating fetal tissue pose to her as well as the unique relationship that exists between a woman and a fetus. The cadaver donor framework, for example, does not require the woman’s consent before fetal tissue may be used; the consent of the father is considered sufficient. And, in any case, only minimal information is required to be disclosed to those deciding whether to donate the tissue of a deceased relative. The following are possible risks to a woman’s privacy and well-being associated with donating tissue for transplantation after elective abortion: Her blood may be tested for infectious agents such as HIV. The tissue may be labeled with an identifier that makes it possible to trace the woman who had the abortion and donated the tissue. Persons uninvolved in the woman’s care may have access to her clinic records to obtain information about her medical history. The abortion procedure may be modified in ways that prolong or intensify discomfort, or that increase the risks of physical harm to the woman. The living organ donor framework is more respectful and protective of the woman who is asked to donate fetal tissue than the cadaver donor framework. It acknowledges that the woman has a unique and privileged relationship with the fetus and that donation poses a variety of significant risks to the woman. Her respect and protection should be secured in the following ways: Her consent should be necessary; the father’s consent should never be sufficient. She should be informed of the proposed use of the tissue. She should be informed of the risks that donation poses to her privacy. She should be informed of the risks associated with testing her blood or urine to establish the quality of the tissue, labeling the fetal tissue with an identifier traceable to her, and tissue procurers or others not directly involved in her care gaining access to private information in her clinic record. She should be informed of any modifications of the abortion procedure and the associated risks to her well-being. She should be informed of the risks of prolonged or intensified discomfort as well as the risks of incomplete abortion or trauma to the cervix associated with any modifications, e.g., slowing the abortion procedure, decreasing the pressure of the suction, or increasing the dilatation of the cervix and the cannula. Neither the cadaver donor framework, nor the living organ donor framework, by itself captures the full range of obligations to both the fetus and the woman involved in fetal tissue transplantation. Combining these frameworks, however, so that they complement and constrain, rather than conflict with one another, will ensure that both the woman and the fetus are protected and respected.

Adequately Respecting and Protecting Fetal Tissue Donors and Their Next-of-Kin

Is it ethical to use the tissues of electively aborted fetuses for transplantation purposes, and if so, under what conditions? The answer depends on the respect and protection owed those involved in the donation of fetal tissue, and whether it is possible to implement policies to assure such respect and protection.

The Social Construction of Death, Biological Plausibility, and the Brain Death Criterion

judgment and decision making. Instead, one person’s facts have become another’s propaganda. We need only recall the infamous Republican Congressman and Nixon loyalist Earle Landgrebe, who in an exasperated fit of candor during the Watergate proceedings declared: “Don’t confuse me with the facts. I’ve got a closed mind” (Benko 2012). Even for those inclined to view medical data as fact, recently reported instances in which awareness has been detected through functional magnetic resonance imaging (fMRI) in patients diagnosed as vegetative suggest that mistakes can be made. While false positive determinations of brain death may be mercifully rare, reports that individuals who meet brain death criteria can nevertheless have their “vital signs” and physiologic systems artificially maintained for months thereafter lend credence to those who seek to persuade the general public that brain-dead patients are merely profoundly disabled but not beyond hope for some measure of recovery (Shewmon 1998). From this perspective, public policy grounded on a legal or moral fiction of “as good as dead” will likely be deemed not simply unwise but unconscionable, regardless of how many authoritative figures in the health professions and bioethics sign on to it. As to these and other contentious issues, the goal of a deliberative democracy in the midst of a secular-pluralist peaceable society eludes us still. &

Fetal Tissue Guidelines Depart from the Cadaver Donor Framework

259 It is widely held that human fetal tissue used in transplantation should be treated as any other human cadaver tissue. Treating the dead fetus as a cadaver is more respectful than treating it as a tissue specimen. However, despite the prevalence of references to the cadaver donor framework in several national fetal tissue guidelines, provisions that depart from this framework are frequently included. These departures provide both the fetus and the woman with respect and protection beyond that offered by the cadaver donor framework. The cadaver donor framework consists of the following: * Next-of-kin must give explicit written consent to the use of the tissue in education, research, or therapy * Consent disclosure may be minimal * Next-of-kin may base consent on their own interests, preferences, and values * Next-of-kin may designate recipients or specific use * One next-of-kin may veto anothers decision * Users must be involved in neither the care of the deceased nor in the determination of death * Tissue may not be bought or sold. Additional provisions for the fetus are of two types. The first stems from the belief that electively aborted fetuses deserve a respect unnecessary for other cadavers. For example: * Tissue may be used only for biomedical pur-poses/2/ * Information must be unobtainable by other means/1,2, * An institutional ethics committee must oversee the research/1-4/. The second type stems from the belief that the living fetus deserves special protection. The use of fetal tissue must be prevented from encouraging abortion for donation in ways considered unnecessary to prevent cadaver donation from encouraging suicide or murder. For example: * The woman must consent to abortion before discussing donation/2,4,5/ * The woman may not abort for purposes of donating tissue/1,2/ * The woman may not specify how tissue is to be used/2,5/ * The woman may not designate recipient /2,4,5/ * An intermediary should be used to transfer tissue and information between abortion provider and tissue user/2/ * Abortion providers and women should receive no inducements/2,4/. Additional provisions for women asked to donate tissue are of two types. The first stems from the belief that such women deserve respect that is unnecessary for next-of-kin in cadaver donation generally. For example: * The womans consent is necessary/1-5/ * The father cannot veto the womans decision /2,5/ * The woman must be given all information requested/1,4/. The second type stems from the belief that women …