Monday 14 February 2022

The Ethics of ‘Opt-out, Presumed-Consent’ Organ Donation

By Keith Tidman

According to current data, in the United States alone, some 107,000 people are now awaiting a life-saving organ transplant. Many times that number are of course in similar dire need worldwide, a situation found exasperating by many physicians, organ-donation activists, and patients and their families.

The trouble is that there’s a yawning lag between the number of organs donated in the United States and the number needed. The result is that by some estimates 22 Americans die every day, totaling 8,000 a year, while they desperately wait for a transplant that isn’t available in time.


It’s both a national and global challenge to balance the parallel exigencies — medical, social, and ethical — of recycling cadaveric kidneys, lungs, livers, pancreas, hearts, and other tissues in order to extend the lives of those with poorly functioning organs of their own, and more calamitously with end-stage organ failure.


The situation is made worse by the following discrepancy: Whereas 95% of adult Americans say they support organ donation upon a donor’s brain death, only slightly more than half actually register. Deeds don’t match bold proclamations. The resulting bottom line is there were only 14,000 donors in 2021, well shy of need. Again, the same worldwide, but in many cases much worse and fraught.


Yet, at the same time, there’s the following encouraging ratio, which points to the benefits of deceased-donor programs and should spur action: The organs garnered from one donor can astoundingly save eight lives.


Might the remedy for the gaping lag between need and availability therefore be to switch the model of cadaveric organ donation: from the opt-in, or expressed-consent, program to an op-out, or presumed-consent, program? There are several ways that America, and other opt-in countries, would benefit from this shift in organ-donation models.


One is that among the many nations having experienced an opt-out program — from Spain, Belgium, Japan, and Croatia to Columbia, Norway, Chile, and Singapore, among many others — presumed-consent rates in some cases reach over 90%.


Here’s just one instance of such extraordinary success: Whereas Germany, with an opt-in system, hovers around a low 12% consent rate, its neighbour, Austria, with an opt-out system, boasts a 99% presumed-consent rate.


An alternative approach that, however, raises new ethical issues might be for more countries to incentivise their citizens to register as organ donors, and stay on national registers for a minimum number of years. The incentive would be to move them up the queue as organ recipients, should they need a transplant in the future. Registered donors might spike, while patients’ needs have a better hope of getting met.


Some ethical, medical, and legal circles acknowledge there’s conceivably a strong version and a weak version of presumed-consent (opt-out) organ recovery. The strong variant excludes the donor’s family from hampering the donation process. The weak variant of presumed consent, meanwhile, requires the go-ahead of the donor’s family, if the family can be found, before organs may be recovered. How well all that works in practice is unclear.


Meanwhile, whereas people might believe that donating cadaveric organs to ailing people is an ethically admissible act, indeed of great benefit to communities, they might well draw the ethical line at donation somehow being mandated by society.

Another issue raised by some bioethicists concerns whether the organs of a brain-dead person are kept artificially functional, this to maximize the odds of successful recovery and donation. Doing so affects both the expressed-consent and presumed-consent models of donation, sometimes requiring to keep organs animate.


An ethical benefit of the opt-out model is that it still honours the principles of agency and self-determination, as core values, while protecting the rights of objectors to donation. That is, if some people wish to decline donating their cadaveric organs — perhaps because of religion (albeit many religions approve organ donation), personal philosophy, notions of what makes a ‘whole person’ even in death, or simple qualms — those individuals can freely choose not to donate organs.


In line with these principles, it’s imperative that each person be allowed to retain autonomy over his or her organs and body, balancing perceived goals around saving lives and the actions required to reach those goals. Decision-making authority continues to rest primarily in the hands of the individual.


From a utilitarian standpoint, an opt-out organ-donation program entailing presumed consent provides society with the greatest good for the greatest number of people — the classic utilitarian formula. Yet, the formula needs to account for the expectation that some people, who never wished for their cadeveric organs to be donated, simply never got around to opting out — which may be the entry point for family intervention in the case of the weak version of presumed consent.


From a consequentialist standpoint, there are many patients, with lives hanging by a precariously thinning thread, whose wellbeing is greatly improved (life giving) by repurposing valuable, essential organs through cadaveric organ transplantation. This consequentialist calculation points to the care needed to reassure the community that every medical effort is of course still made to save prospective, dying donors.


From the standpoint of altruism, the calculus is generally the same whether a person, in an opt-in country, in fact does register to donate their organs; or whether a person, in an opt-out country, chooses to leave intact their status of presumed consent. In either scenario, informed permission — expressed or presumed — to recover organs is granted and many more lives saved.


For reasons such as those laid out here, in my assessment the balance of the life-saving medical, pragmatic (supply-side efficiency), and ethical imperatives means that countries like the United States ought to switch from the opt-in, expressed-consent standard of cadaveric organ donation to the opt-out, presumed-consent standard.



Thomas O. Scarborough said...

Thank you, Keith.

This is an answer more from feeling than from reason. Presumed consent seems too much of a chop shop to me, based on the assumption that life should be maximally long. Last month, I viewed a body, an African woman, which was treated with the greatest awe and respect. I couldn’t imagine the donation of the same body for redistribution, and that being consistent. Not only are donated bodies artificially kept functional, as you say. They are used for (for example) transplantation experiments, as now happens in the USA. There are other possibilities, quite logical, concerning which we shall spare the reader.

Related to the above, I worry that presumed consent crosses cultural taboos, an aspect which is only vaguely present in this post, if at all. And if consent ought to be by default, what does that say about one’s attitude towards culture—including first nations? Should cultural groups be faced with the issue at all? Is cultural imperialism implied?

I have some questions about definitions. In the case of ‘presumed consent’, what is presumed, and how is the presuming done? Also, the meaning of ‘can astoundingly save eight lives’. Bearing in mind that I live in a developing nation, in reality, in 2019, one life was saved for every 337 bodies donated.

Keith said...

As to this issue you raise, Thomas: ‘I worry that presumed consent crosses cultural taboos’. Each country — or in the United States, each state — would independently decide whether or not to implement a policy of ‘presumed consent’. That decision — yea or nay — would account for any number of factors based on each nation’s sovereignty and, to your point, culture: norms, mores, standards, creeds, history, politics, ethics, religion, and so forth. A country or state would honour, and be informed and guided by, societal ‘cultural taboos’ regarding organ donation, according to how they might bear on ultimate policymaking. Realistically, no one imagines organ-donation measures would, should, or could be global, in one-size-fits-all fashion.

docmartincohen said...

I tend to agree with Thomas. Let's say in a US state most people think organ donation is such a social good that it is passed - over the heads of say, native Americans or Catholics - or philosophers! This would be to me no way to decide the issue. Consent should be for each individual. And here I think the consent needs to be positive, not a 'default' arrangement. Where there is a positive desire by an individual to donate, that seems to meet the concerns raised by Thomas about dignity and culture. I would still worry that in some extreme cases people may receive less effort in keeping them alive than is optimal, with attention focussed instead on the medical value of their organs. Doctors have been a little too quick to accept organs from prisoners, or sold for money for us to be entirely confident that such decisions are always ethical.

Keith said...

This comment, Martin, strikes me as alarmist: ‘I would still worry that in some extreme cases people may receive less effort in keeping them alive than is optimal, with attention focused instead on the medical value of their organs’. I have greater faith, I suppose, in the integrity, honour, and empathy of doctors, who regard the Hippocratic oath as ethically sacred. I believe doctors are first and foremost dedicated to the medical welfare of their patients in their care, focused on fixing what ails. Frankly, I can’t imagine doctors in the United States (where I have firsthand experience), Europe, and many other communities lured by some irresistible urge to withhold best treatments simply to hasten the extraction of transplantable organs. That all sounds terribly cynical and macabre — and, candidly, not typical reality! I don’t see opt-out donation sinisterly altering any of that quality of medical care.

Keith said...

Your reference, Thomas, to ‘transplantation experiments’ points, too, to experimentation with advanced, interdisciplinary technologies for artificial organ design and manufacturing. The result is development of increasingly complex means to construct physiologically functional bioartificial organs that will improve the quality of health and extend the lifespan of humans through substitution of defective or failed organs. These techniques, despite how far they’ve reached, are still a distance from making biologic organ transplantation outmoded. But bioartificial organ manufacturing is likely the future.

Thomas O. Scarborough said...

People judged to be brain dead are kept alive indefinitely now, after, for example, animal hearts are implanted in them, so as to test aspects of their immune systems, immune suppressant medications, and so on. For this, their bodies need to be highly functional.

I am not convinced (perhaps I should be) that our isolation of the brain in the matter is satisfactory. May it not be the result of our scientific reductionism? For instance, a brain dead person may react violently to pain. But this is ‘misinterpreted as volitional’ (see the IBCC, as an example).

More philosophically, if it is to (quote) 'extend the lifespan', I do not see a clear way to distnguish between ethical and unethical practice. For example, animal cadavers are now used in certain impact tests. Why not humans? Ah, because there is something special about humans. Or is there? Some would think this discussion to be meaningless from the start.

There is, apart from the theory, the practice. I was present when a young man was declared brain dead. They didn’t have any equipment to decide whether he was, except a ventilator to switch off. Looking at statistics, (Hannah C. McLane, et al, 2015), all over the world, instruments such as EEG's are unavailable, to make a determination.

Keith said...

Partially to follow up on one of your points, Thomas, recently a person received a heart transplant from a pig that had been genetically modified through the use of CRISPR-Cas 9 in order to minimize (perhaps eliminate) the organ triggering rejection by the patient’s body. There were several unique circumstances in the patient’s case, posing both regulatory and ethical issues besides the science and medicine, which can be readily explored through online sources, like the magazines Nature and Science, as well as the New York Times. Apparently, the person is doing well, with strong odds of survival. At best, however, my ‘divining rod’ suggests that animal-to-human organ transplantation is only an intermediate measure — on a parallel track with the bioartificial organs I refer to above, but not in place of the development and manufacturing of artificial organs. It remains to be seen, I suppose, how events play out.

docmartincohen said...

There are all those decisions about people in comas too… most of the time people should be allowed to die but then along comes a case where someone "wakes up" long after they were supposed to be dead! I guess that's another post, though…

Faina said...

I think presumed consent is a great way to save more lives, although there is great ethical dilemma, giving ones organs to help those who are in need trumps that.

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