Nearly every state in the U.S. maintains a registry of people willing to become deceased organ donors. The intent of an individual to be a donor is stored as a Boolean value (meaning only yes or no responses are allowed) within the driver’s license database. Nearly all states use what is called an opt-in registration process. That is, the states start with the assumption that drivers do not want to participate in the registry (default=no) and require them to declare their desire (called explicit consent) to be a member of the registry either in-person, via a website, or in writing.

One of the frequent proposals to increase the number of deceased organ donors is to switch the registration of donors from an opt-in system to an opt-out system. In an opt-out system, all drivers are presumed to want to participate (default=yes) and people who do not wish to participate must state their desire not to be listed.

Let’s look at the logical and ethical issues this change would present.

Not just a framing problem

Several well-known behavioral economists have stated that switching from opt-in to opt-out is simply a framing problem. For instance, see chapter 11 of Richard Thaler and Cass Sunstein’s book Nudge and a TED 2008 talk by Dan Ariely using data from papers by his colleagues Eric Johnson et al., in Transpl. Dec 2004 and Science Nov 2003 (subscription required).

The basic argument is that deciding whether to donate organs upon death is cognitively complex and emotionally difficult. When asked to choose between difficult options, most people will just take the default option. In the case of an opt-in donor registration, this means they will not be on the organ donor registry. By switching to an opt-out process, the default becomes being a donor. Thus, any person who refuses to make an active decision will automatically become a registered organ donor (this is called presumed consent). This will increase the number of people in the donor registry without causing undue hardship since drivers can easily state a preference when obtaining a driver’s license.

However, these authors overlook two important practical factors. First, switching from opt-in to opt-out doesn’t just reframe the decision the driver must make between two options. It will actually recategorize some drivers.

Second, it changes the certainty of the decision of those included in the organ registry, which affects the interaction between the organ recovery coordinators at the organ procurement organization (OPO) and the family member of a deceased patient.

There are more than two states for drivers regarding their decision to donate

Note that the status of a driver’s intent to be an organ donor is not just a simple two-state Boolean value (yes, no). There are actually at least three separate states related to the intension to be an organ donor. First, upon the driver’s death, if no other family members would be affected, would she like to be an organ donor (yes, no, undecided). Second, has she expressed her decision to the DMV and have it recorded (yes, no). Finally, would she like her family to be able to override her decision (yes, no, undecided). The table below shows the various combinations of these variables.

Category

Driver would like to be organ donor
Driver tells DMV of decision
Driver would permit family to override decision

Comment

1a Yes Yes No Strong desire
1b Yes Yes Yes or Undecided Weak desire
2a No Yes Yes or Undecided Weak reject
2b No Yes No Strong reject
3a Yes No Yes, No, or Undecided Unrecorded desire
3b No No Yes, No, or Undecided Unrecorded reject
4 Undecided Yes or No Yes* Undecided

*No or Undecided options make no sense in this context

Opt-in incorrectly excludes some drivers from the donor registry

Now let’s sort these people into two groups, one that we will call the organ donor registry and the other not on the registry.

Under the opt-in process, only drivers in categories 1a and 1b are listed on the organ registry. These drivers have given explicit consent to being on the registry. Drivers in categories 2a, 2b, 3a, 3b, and 4 are excluded from the registry. Thus, we can be quite certain that everyone on the registry wants to be a donor. (There is always a small possibility that the driver accidentally selected the wrong box, changed their mind between the time they obtained their driver’s license and the time of death, or a computer error occurred.)

In most states the drivers not on the organ registry are treated as if they have not decided (i.e., as if they were in the fourth category). When drivers not on the registry die under conditions where the organs can be recovered, the families are asked to decide on behalf of the deceased.

Under an opt-in process, drivers in category 2a are miscategorized. They don’t want to be donors and didn’t want their family to override that decision, but the family is still allowed to decide. The drivers in categories 3a and 3b are miscategorized as well. The ones who don’t want to be donors (3b) are also forced to allow their families to decide. The ones who want to be donors (3a) are now left to let their families decide.

Opt-out incorrectly includes some drivers in the donor registry

Under an opt-out process, drivers in categories 1a, 1b, 3a, 3b, and 4 are grouped together and placed on the organ registry. If the donor registry is binding and the family is not allowed to stop the donation, then the process is called presumed consent. (Note that many authors use opt-out and presumed consent interchangeably. However, they are distinct ideas. Opt-in is a mechanical process of deciding which driver names are added to the registry. Presumed consent is a legal condition that avoids the need to ask the family for permission to recover the organs.)

Drivers in category 3a who wanted to be registered are now correctly placed on the registry. But any drivers in category 3b who don’t want to be on the registry are now assumed to want to be donors, a completely incorrect categorization. Similarly, all drivers in the fourth category who were undecided are now members of the definite donor group and the family no longer has a say.

Only drivers in category 2a and 2b are excluded from the registry. We can be quite certain these people do not want to be donors. But some (category 2a) were willing to let the family decide. Now they are combined with the group of drivers who explicitly do not want to donate.

The distribution of categories into the registry under the opt-in and opt-out process and how they are treated are shown in the table below.


Categories added to donor registry
Categories not added to donor registry

Implications

Opt-in process 1a, 1b both treated as if in category 1a (explicit consent) 2a, 2b, 3a, 3b, 4 all treated as if in category 4 (family choice) Drivers in registry are nearly certain to want to be donors. Actual desire of drivers not on registry is ambiguous
Opt-out process 1a, 1b, 3a, 3b,4 all treated as if in category 1a (presumed consent) or 1b (family choice) 2a, 2b both treated as if in category 2b (explicit reject) Drivers not in registry are nearly certain to not want to be donors. Actual desire of drivers on registry is ambiguous

 

Ethical implications of misclassification

If there are no drivers in categories 3a, 3b, and 4, then switching from opt-in to opt-out will have no impact on the size of the donor registry. However, if there are any drivers in these categories, then some will be incorrectly categorized regardless of whether opt-in or opt-out is used. This miscategorization will lead to some ethical problems.

Under opt-in, there may exist cases where the drivers has made a decision to donate (category 3a) or not (categories 2a or 3b) but family members overrules it. These errors are hard to avoid because they are caused by the lack of agreement between the drivers and other family members.

However, under opt-out combined with presumed consent, there may exist cases where neither the driver (category 3b) nor the family want to donate, but cannot stop it. Similarly, the driver may want to let the family choose whether to donate (category 4) and the family does not want to donate but cannot stop it.

It appears that from an ethical perspective, opt-in is less likely to create a situation where the respect for individual’s right to make decisions about how the body should be treated is denied. For further discussion of the ethical issues see  J. Med. Ethics Jun 2011, and J. Med. Ethics Oct 2011 (subscription required).

Next we will look at the impact switching from opt-in to opt-out will have on the interaction between the organ recovery coordinator and the family. See Part 2 here.

[Update: This blog post was significantly modified to clarify the “decision framing” issue.]

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