Presumed Consent and Default Effects in Organ Donation

Lives Saved?

The policy changes examined here include countries switching from opt-in systems to presumed consent and proposals considered by some U.S. states. The changes are usually justified on the grounds that the presumed consent policy saves lives. The issue is not simple, but we do not think the evidence for that conclusion is compelling. Much of the confusion concerns the difference between recorded preferences and the process that leads to an actual donation.

To begin with, we think that people have drawn the wrong conclusion from that famous Johnson-Goldstein graph. The demonstrably correct conclusion to draw is that defaults have a huge impact on the elicitation of preferences. We have seen evidence to support that conclusion throughout the book, and this example remains one of the best empirical tests of that finding. But it is wrong to conclude that adopting a presumed consent policy and obtaining a low opt-out rate will necessarily save lives.

That would be a reasonable conclusion if countries were implementing a hard presumed consent rule, meaning that Families would not need to be consulted. Donor consent would literally be presumed. Such a policy would completely eliminate the time and effort needed to get the permission of Families in a process that is highly time sensitive, as well as remove the risk that Families will block the donation. However, we have found that few if any countries actually implement that policy. To give just one example, in Italy, which is nominally a presumed consent country, the official website says this about the role of Families (our translation): “In the case in which the deceased person did not leave a statement regarding organ donation, the donation of an organ is allowed only if the relatives (in order: spouse, partner, adult children, and parents) are not opposed to the donation. For minors, it is always the parents who decide; if even one of the two is against, the donation will not take place.” 23

Even in countries that have legally adopted hard presumed consent, such as Austria and Singapore, in practice doctors consult with Families before organs are removed. In Sweden, another supposedly hard presumed consent country, Families can overrule unless the donor has actively opted in during his lifetime. These policies are understandable. In a highly emotional situation, with uncertainty about the wishes of the deceased, doctors are reluctant to press grieving family members about organ donation, even if they are legally within their rights to coordinate the donation. Doing so might also run the risk of creating blowback against organ donation in general.

For England and Wales, as well as many other countries, the arrangements described in this account stipulated soft presumed consent. Families or close friends are always consulted before organs are used, and if no one can be reached, no surgery is performed. Given these rules and customs, it is less than obvious how a presumed consent policy actually saves lives.

To clarify the policy as we see it, let’s classify people according to the system present in their country (opt-in or opt-out) and their preferences as indicated by either their action (an expressed preference) or their inaction (no expressed preference). There are four possibilities shown in Table 13.1.

Table 13.1. Implied preferences from action and inaction in organ donation schemes *

	NO EXPRESSED PREFERENCE	EXPRESSED PREFERENCE
Country Is Opt-Out (Presumed Consent)	A Ambiguous. Ask my family.	B No, do not donate my organs.
Country Is Opt-In (Explicit Consent)	C Ambiguous. Ask my family.	D Yes, donate my organs

The default system would matter a lot if the A and D groups (which are either implicitly or explicitly agreeing to be organ donors) were treated the same way, or even similarly, but they are in fact handled very differently. Those in Group D (registered donors) in the United States, with its first-person consent laws, are treated in the most organ-donation-friendly manner: the law backs the donor’s active wishes. But those in Group A, who have merely failed to opt out, are treated similarly to those in Group C, those who have not registered. There is some logic to this: treat those who have not actively indicated a preference the same way, regardless of the system. And we know from that famous graph that this applies to most people!

In contrast, the wishes of Groups B and D are generally accepted since they made active choices. A benefit of the opt-in architecture is an additional opportunity for a yes—if an individual doesn’t register, the family will be asked for permission. Alexandra Glazier, an organ donation expert, refers to this as “two bites of the apple.” 24 By contrast, under presumed consent, especially in the absence of a registered donors list, there is only one chance to say yes, and it comes from Families.

All of this means that in practice, the phrase “presumed consent” is misleading. No one’s consent is ever presumed. We think part of the allure of presumed consent laws rests on confusion about the implications of changing the default. Hard presumed consent would remove the need to obtain family permission for a donor who had not opted out. Whether that change would save lives would still depend on the rest of the donation process. But as we have stressed, we have not found any country that does this in practice, even if, as in Austria and Singapore, the law technically requires it.

Still, it is an empirical question. Does switching to presumed consent save lives? Many studies have tried to answer this question by comparing actual organs transplanted across countries, but the conclusions vary. One reason for the lack of clarity is that the number of countries studied is less than fifty, which is a pretty small sample, and the countries studied differ in important ways that can affect organ donations. To cite just one example, Catholics tend to be favorably disposed toward organ donation, and predominantly Catholic countries are more likely to adopt presumed consent. So, if presumed consent countries have higher rates of organ donation, is that because of religion or public policy? Yes, multivariate analyses can try to untangle this mess, but this is why the small sample problem looms large.*

An even more basic problem for empirical analyses is deciding which countries should be categorized as using presumed consent. Consider the case of Spain, which has long led the world in organ donations. Spain is usually included in the presumed consent category, in part because it was one of the first countries to enact a presumed consent law, back in 1979. But that law was clarified just one year later to make clear that Families should always be consulted. Consent by the donor is never presumed, and there is not even a registry of those who wish to opt out. Thus, de facto, Spain is an opt-in (by Families) country. There is certainly no sense in which that old law has any bearing on its outstanding organ transplant record.

Rafael Matesanz, the creator of Spain’s National Transplant Organization, and Beatriz Domínguez-Gil, the organization’s director general at the time of this account, clearly state that their success cannot be attributed to that law: “To the contrary, infrastructure, organization around the process of deceased donation, and continuous innovation are deemed the keys for success.” 25 A core aspect of the “Spanish model” is the country’s three-layered transplant coordinator network. At the local level, each procurement hospital appoints a dedicated transplant coordinator, a physician who is responsible for ensuring the early detection and referral of organ donor candidates at her hospital. Medical staff involved in organ transplants are also specifically trained in the entire donation process, and deaths in critical care units are routinely audited by external and internal experts to determine whether potential donors have been missed—and how to further improve the system. There has also been an emphasis on ensuring that hospitals are adequately reimbursed for organ donation costs so that there is no financial incentive to decrease donations.26

Certainly, miscategorizing Spain as an opt-out country can skew empirical tests because it has the highest number of deceased donors per capita in the world. But more basically, because few, if any, countries actually practice hard presumed consent, we are not even sure what it means for any country to be included in this category. We believe the fact that a country enacted a law a long time ago that is not currently being implemented as written (because of regulations or customs) is more accurately viewed as a signal that the country has (or had) a favorable attitude toward organ donation, rather than as a legal framework that overcomes the problem of obtaining permission from the family members of brain-dead patients.

There are also studies that conduct a before-and-after analysis when a country changes the policy, but they are not definitive either. When Brazil introduced presumed consent in 1997, the government failed to invest in the other aspects of the infrastructure and then reversed course a year later. Following Wales’s change of policy, there was an increase in organ donations from deceased donors, but there are many confounding factors. When Wales introduced the opt-out system, accompanying the change were lots of other activities, including a £2 million media campaign, increased staff training, and ongoing efforts to encourage people to actively join the register of willing donors.* From 2016 to 2020, more than 150,000 people actively registered as organ donors in Wales, compared with fewer than 17,000 opt-out registrations.27 These other factors make it difficult to attribute the increase in organs donated to any specific cause. In fact, it is possible that if Wales had devoted all its efforts to these other activities, rather than focusing on a nominal policy change, it would have achieved as much or even greater success.

One simple way to evaluate the organ donation process in a state or country is to use the number of organs donated per ten thousand deaths. This controls for the fact that some jurisdictions have higher death rates than others. Using this measure, the United States, with its prompted choice opt-in system, has one of the highest donation rates in the world, with some individual states outperforming Spain.28 In fact, treating U.S. states as countries, Alexandra Glazier and Tom Mone estimate that donations are 27 percent higher in opt-in jurisdictions than in those using opt out. In looking at the potential benefits of switching to a different system, it is important to evaluate the possible risks. Countries that have seen some apparent benefit to switching to presumed consent started with donation rates far below where the United States is currently performing. Also, a Gallup poll from 2019 found that as many as 37 percent of those surveyed in the United States say they would opt out if the United States moved to a presumed consent system—a number that might include cases of reactance, meaning that some people can react badly if their preferences are presumed about anything.29 If this figure proved to be accurate, the United States could actually experience significant decreases from its current rate by changing to presumed consent.