Flawed Assumptions: Ethical Problems With Proposed Presumed Consent Legislation

To the Editor: At present, there is a House bill in the Texas Legislature that would shift Texas from an opt-in organ donation model—a model requiring explicit consent for organ donation from the donor or donor’s family—to an opt-out, or presumed consent, model. Under this new bill, the state would assume that a person agreed to organ donation unless the donor registered an objection. If passed, this law would be the first of its kind in the United States, and it represents the direct inverse of the nation’s current opt-in model as outlined by the Uniform Anatomical Gift Act (although the bill does not violate federal law) (1REVISED UNIFORM ANATOMICAL GIFT ACT (2006). 2009. [cited 2017 Mar 8]. Available from: http://www.uniformlaws.org/shared/docs/anatomical_gift/uaga_final_aug09.pdf.Google Scholar). Recently, lawmakers in other states such as Delaware and New York have proposed similar bills. Proponents’ intentions are clear: to increase the number of available organs. They argue that data from other countries suggest that a shift from opt-in to opt-out could increase organ procurement (2Bill would require Texans to opt out of organ donation - Houston Chronicle. [cited 2017 Mar 8]. Available from: http://www.chron.com/local/texas-politics/texas-legislature/article/Bill-would-require-Texans-to-opt-out-of-organ-10963486.php.Google Scholar). We contend that proponents’ arguments rely on several ethical assumptions, which are briefly described here and elaborated upon elsewhere (as provided in our references). These ethical assumptions should be empirically tested before proposing wide-reaching legislation. First, proponents presuppose that donation rates would increase through presumed consent, because other countries’ donation rates increased. Some evidence suggests otherwise, however, and in some nations—France and Brazil, for example—their respective variations of presumed consent models has corresponded to a decrease in organ donation (3Rieu R The potential impact of an opt-out system for organ donation in the UK.J Med Ethics. 2010; 36: 534-538Crossref PubMed Scopus (19) Google Scholar). Further, while studies in the United States are few, the available data suggest that the donation rate would not increase. Specifically, in 1940s and 1950s, at least 10 states adopted weaker versions of presumed consent, where families could object at the time of donation. Those laws failed in increasing donation rates because the laws were too loose or too restrictive. Laws were criticized as too permissive because officials and coroners could, in some limited cases, make procurement decisions, which could potentially create public distrust by exacerbating fears of “organ poaching” from unwilling donors (4Orentlicher D Presumed consent to organ donation: its rise and fall in the United States.Rutgers Law Rev. 2008; 61: 295-332Google Scholar). The current House Bill does not provide an opportunity for families to object at the time of procurement. If history indicates future behavior, a presumed consent law without a “family dissent” provision will create public dissention. Since there was a 9.2% increase in the number of deceased donors from 2015 to 2016, topping off 5 years of consecutive increases, it would be a loss to the United States pool of potential organ donations if public trust were compromised (5US organ transplants and deceased donors set new records in 2016 - OPTN. [cited 2017 Mar 8]. Available from: https://optn.transplant.hrsa.gov/news/us-organ-transplants-and-deceased-donors-set-new-records-in-2016/.Google Scholar). Second, in order for the law to be autonomy-enhancing, proponents have to assume that most people would have consented to donate their organs if asked, and that these people were not able to document their preferences to donate while they were alive. Specifically, proponents argue that requiring explicit consent (as is required through opting-in) results in the failure to procure organs from those individuals who may have wished to donate their organs but merely failed to make this wish explicit. Thus, presuming consent (or foregoing consent altogether) will increase the number of available organs, which promotes an important social good. Opponents argue that, under presumed consent, organs might be procured from people who did not want their organs procured but who also did not register an objection, which violates autonomy (4Orentlicher D Presumed consent to organ donation: its rise and fall in the United States.Rutgers Law Rev. 2008; 61: 295-332Google Scholar,6Jacob M-A Another look at the presumed-versus-informed consent dichotomy in postmortem organ procurement.Bioethics. 2006; 6: 293-300Crossref Scopus (23) Google Scholar). Thus, proponents and opponents base their arguments on ethical considerations, drawing upon autonomy and social good, but the merits of each view can be assessed through balancing harms. In order for one to prevail, the model with the least amount of harms and greatest amount of benefits would arguably be ethically preferable. Intuitively, it would seem that the harm from an erroneous donation under presumed consent may be of greater consequence than an erroneous decision to NOT donate under an actual consent or opt-in model, particularly when we consider that many minorities (and other vulnerable populations) already exhibit distrust in the United States health care system and do not want to donate (7National survey of organ donation attitudes and behaviors–Division of Transplantation, Health Care Systems Bureau, HRSA, DHHS. [cited 2017 Jun 6]. Available from: https://www.organdonor.gov/dtcp/nationalsurveyorgandonation.pdf.Google Scholar). Third, proponents of the bill have included a clause claiming that the lack of a potential donor’s objection to join the organ donor registry is equivalent to “providing consent.” A lack of objection, however, does not justify presuming consent, in the same way that “not saying no” does not equate to saying “yes.” In order to justify presumed consent, we must have strong empirical evidence that individuals would consent to donation if asked (8Veatch RM Ross L Transplantation ethics.2nd ed. Georgetown University Press, Washington, DC2015Google Scholar). Data suggests, if anything, the opposite. One representative Gallup survey indicated that one-third of people would “definitely or probably” refuse donation. Thus, for a substantive minority of the population, the presumption of consent would be based upon a mistaken inference (7National survey of organ donation attitudes and behaviors–Division of Transplantation, Health Care Systems Bureau, HRSA, DHHS. [cited 2017 Jun 6]. Available from: https://www.organdonor.gov/dtcp/nationalsurveyorgandonation.pdf.Google Scholar). In summation, proponents’ assumptions may be flawed. The Texas law could amount to ill-informed legislation which, if passed, could create negative perceptions with little benefit in the form of increased donations. However, it is impossible to tell whether our predications are correct, just as it is impossible for legislators to make assumptions about donor behavior or perceptions. An ethical assessment of a presumed consent donation model in the United States requires further empirical research and a particularized harms assessment and evaluation of autonomy-based considerations, including donor behavior. Pilot studies are not without risk and should include protocols to safeguard against potentially long-term adverse effects, including having ethical oversight while conducting studies. Only through cautious empirical investigation can we fully evaluate the ethical and clinical feasibility of a presumed consent model or any initiative to increase organ donation that would alter the status quo. The authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation. Professor Bruce is a member of the ethics committee for the United Network of Organ Sharing (UNOS). Her comments are her own and not necessarily representative of the organization’s views. The other author has no conflicts of interest to disclose.