Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

Consent forms given to potential subjects in research protocols typically contain a sentence like this: “You have a right to withdraw from this study at any time without penalty.” If you have ever served on an institutional review board or a research ethics committee, you have no doubt read such a sentence often. Moreover, codes of ethics governing medical research endorse such a right. For example, paragraph 24 of the Declaration of Helsinki says, “The subject should be informed of the (...) right… to withdraw consent to participate at any time without reprisal.” Similarly, section C of the Belmont Report says that subjects must be informed that they have the right “to withdraw at any time from the research.” And in section 46.116 of the Common Rule, it says that one of the elements of informed consent must include a statement that “the subject may discontinue participation at any time without penalty or loss of benefit to which the subject is otherwise entitled.”. (shrink)

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

Most codes of research ethics and the practice of Institutional Review Boards (IRBs) allow human subjects to withdraw from research at any time. Consent forms invariably make a statement to this effect. So understood, a subject's right to withdraw from research is inalienable; she cannot, through her consent, surrender this right. Recently critics have argued that in selected circumstances the right to withdraw from research is alienable; subjects have the moral authority, through their consent, to obligate themselves not to withdraw. (...) Two kinds of cases have been cited to support this. In one case, there will be great benefits lost if subjects are permitted to withdraw before the completion of the protocol. In the other case, there will be harm to third parties if subjects withdraw from the experiment. In this paper, I defend the inalienability of the right to withdraw from research. I argue, first, that securing the desired benefits and avoiding the feared harms can be achieved without allowing waiver. Second, I show that permitting waiver in these cases does not guarantee that the ends sought will be achieved. And third, I articulate positive reasons for conceiving subjects' right to withdraw from research as inalienable. (shrink)