Pandemic Ethics: Part 1

Today we start a three-part series on Ben Bramble’s just published open access book Pandemic Ethics. Part 1 (“Three Problems for Human Challenge Trials, and A Way Forward”) is below. Part 2 (“How Should Onlookers Live and Feel in the Pandemic?”) will get started here Wed. And Part 3 (“A Revolutionary Argument: How and Why to Change Things Post-Pandemic”) will get started here Fri.

Three Problems for Human Challenge Trials, and A Way Forward

Ben Bramble

Human challenge vaccine trials for COVID-19 would expose healthy volunteers to the virus in order to hasten the development of a safe and effective vaccine. Here, I want to raise a few new problems for such trials, and then suggest a way they could be made permissible.

  1. Analogies With Other Professions

Defenders of such trials often say that allowing people to volunteer for them is just like allowing essential workers to go to work during the pandemic, or people to become firefighters, police officers, etc.

But there is a big difference. These other people are, as their name suggests, essential. By contrast, if we do not allow people to volunteer for challenge trials, society will not collapse or grind to a halt. There is a viable alternative: run trials in the normal way.

  1. Full Information

Can trial subjects be sufficiently well informed of the risks of participation? This is unclear. The very thing that makes them eligible to be subjects (i.e., their being young and healthy, and so unlikely to become severely ill or die) means that they necessarily lack important, relevant knowledge.

As healthy subjects, they will not have been severely ill before. While such people might be able to theoretically grasp the risks of infection with COVID-19, they will not have a good grasp of ‘what it is like’ to suffer in these ways (i.e., the phenomenology of this). But this is surely crucial.

As young subjects, their experience of the world will be limited indeed. Will they understand how bad it would be for them to be unable to complete their studies, find a partner, travel the world, have children of their own, care for their parents in old age, etc.? Or how their parents, spouse, friends, or children would feel if they were to succumb to the virus? Many of these young people would not have adequately thought these things through, and might be unable to do so at their early stage in life.

This is not to say that young people should not be allowed to make any choices about their lives—but normally, they are not being asked to expose themselves to a potentially lethal virus.

  1. Society’s Fault

Defenders of such trials often say that we can make them permissible by choosing only subjects who have a high chance of exposure to the virus anyway (through their work or living arrangements).

But this seems wrong to me. Why are such people already so exposed to the virus? In large part, because of society’s failures. We have let these people down, by not adequately protecting them from the virus. Given this, it seems very unfair to call on these people now to subject themselves to an even greater risk. If anyone should volunteer, it is those whom society has not let down, even if they are otherwise unlikely to be infected.

Speaking of which, it is worth asking why so many people are volunteering to take part in such trials. I have no doubt they are, by and large, good and altruistic people. But how many of them are doing so (also) because they feel a dearth of meaning in their lives? Society does not make it easy for ordinary people to contribute to the good in the normal course of life. We are told by parents, teachers, and our culture more broadly, to focus more or less exclusively on ourselves: work hard at school, get a good job that pays well even if it contributes little of true value to society, all so we can raise a family of our own, and keep on making as much money as we can.

If there were more avenues for helping others in the normal course of life, it is unclear whether so many people would still be volunteering for these trials now.

It seems rotten to give people so few ways of helping others safely, and then to allow them to do so when it is potentially lethal.

  1. A Way Such Trials Could Be Made Permissible

Suppose that our lockdowns, testing, and contact-tracing have been so effective that there is no longer enough of the virus circulating for vaccine trials to be run in the normal way. Here, we might face a choice between staying in various forms of lockdown indefinitely, and doing these challenge trials. Here, it might be permissible to conduct these challenge trials, since the alternative to doing so would be a permanent and substantial diminishment of our societies. Trial volunteers would then be truly analogous to our essential workers, needed to prevent a kind of societal collapse.

Suppose this is right. It seems to follow that right now, even though there is still a lot of the virus still circulating, we could count on doing permissible challenge trials in a couple of months from now if we committed to locking down properly, and engaging in proper testing and contact-tracing.

Yet another thing seems to follow. Suppose (as might actually be the case) that some of the vaccines are ready to be tested now, but that there is still enough of the virus circulating to do the trials in the normal way (but that this would take many months indeed). It would still be true that if we did properly lockdown, test, and contact-trace, then we could count on doing permissible challenge trials in a couple of months from now. In this case, though, we might as well do them immediately, on the proviso that we really do carry out the lockdown, testing, and contact-tracing. Why wait?! (If we went ahead with the challenge trials, but then failed to make good on our commitment to properly lock down, test, and contact-trace, then it would turn out that our having conducted them was morally wrong.)

The upshot? We can make challenge trials permissible, not only in several months from now, but immediately, by committing to properly locking down, testing, and contact-tracing, and then actually carrying out these things.

15 Replies to “Pandemic Ethics: Part 1

  1. Thanks to Ben for writing such an accessible (in both senses) book!

    My biggest concern with the substance of the argument is the presumption that we can so easily justify what we might call anti-beneficent paternalism: disallowing people from doing wonderfully beneficial things, on the paternalistic grounds that their altruistic act comes at some (lesser) risk to themselves. Reasonable people can dispute the conditions under which individuals might be forced to sacrifice their own interests to better promote the general good. But this alternative view, that individuals might be forced not to promote the general good, strikes me as entirely unreasonable. What is the basis for this coercion? Not autonomy; not beneficence. What competing value can simultaneously outweigh autonomy and beneficence?

    A couple of more minor objections:

    (1) Many so-called “essential” workers are not literally essential for the continuation of society. Even medical professionals are not truly “essential” in Ben’s sense: society would not grind to a halt if hospitals closed down; we’d just have more deaths. (Going longer without a vaccine, by contrast, involves both more deaths *and* more of society “grinding to a halt” via lockdowns and such.)

    The deeper point, which Ben doesn’t engage with at all here, is that we manage risk all the time. Participating in a covid challenge trial may well be less risky than being a skydiving instructor, lumberjack, or coal miner in normal times (while likely being vastly more beneficial for society). Critics of challenge trials don’t seem to have a consistent attitude towards risk, that could be systematically applied across society without absurd results.

    (2) Raising generic concerns about the capacity of young adults to give informed consent seems troublingly infantilizing, and again has obvious broader implications, e.g. for the permissibility of military service, driving a car, or (again) doing much of anything in life. It also seems misguided to give this one (I think relatively minor) moral risk lexical priority over the (obviously far greater) harms of continued pandemic.

    (Some of these points are developed in my paper with Peter Singer on ‘Pandemic Ethics’, which broadly defends challenge trials and other forms of “risky research” to address the pandemic.)

  2. Hi Richard, and thanks for these wonderfully thoughtful comments. You raise some deep questions, and I’ve many things to say in response. I’ll make only a brief start here.

    You make it sound like I am against giving, which I certainly am not. But I do think there are certain kinds of giving that can cause problems.

    Part of the problem with challenge trials is that this is not a spontaneous gesture from people. Rather, it is *in response to governments asking for help*. And given that these same governments are asking only because they have been so neglectful themselves (and moreover, in some cases, unwilling to endanger themselves or their primary support base—wealthy people safe at home), this creates a moral problem here. It lets governments (and their wealthy support bases) off the hook. And it sets a dangerous precedent. These are not isolated acts, you’ve got to look at them in the context of a system, a system that is failing. When systems fail, things are worse for everyone. (What are the effects of allowing people to be altruistic in this way? Are there any bad effects on systems? I think there are. I’d be interested to hear whether you think there are.)

    Also, to emphasise: there is a viable alternative to people endangering themselves in this way in this particular case. Namely, all of us shouldering a bit more economic burden (a couple more months in a much more relaxed lockdown).

    On one of your other points, I think there are real moral problems with allowing people to be coalminers and soldiers. Soldiering is fine if we (or some other country) is facing an existential threat. But much armed conflict is wrong, and it is deeply wrong to allow people to sign up for combat when their alternative options are so lousy (again, because we as a society have failed to give them decent ones).

  3. > “Part of the problem with challenge trials is that this is not a spontaneous gesture from people. Rather, it is *in response to governments asking for help*.”

    What makes you think that? 1daysooner is not a governmental organization. All the advocacy I’m aware of is from academics and other concerned citizens, asking the government to let them help in this way, not the other way around. I honestly do not know what would count as “spontaneous” to your mind, if this does not.

    The US government’s response to the pandemic has of course been atrocious. But maintaining harmful regulations (and medical ethics practices) that prevent people from improving matters compounds its errors, it does not mitigate them. And I see zero reason to think that preventing non-governmental actors from helping would somehow make Trump (or anyone else) more competent.

    Your “viable alternative” is much more harmful, including more unchosen harms (both medical and economic) on people who did not choose them. What reason is there to prefer that over smaller risks of harm that are freely chosen?

    I really want to emphasize the point about justifying net-harmful coercion here. It’s one thing to say that there are “problems” with letting people freely help others. One can, of course, raise “problems” with just about any imaginable action (indeed, this seems pretty close to the limiting case!). The question is how you justify coercively interfering with them. The standard justification for coercion is to prevent greater harms to others. But that’s clearly not available in your case. So how do you justify it?

  4. Richard, of course you’re right that the idea was not kicked off by lawmakers. But nevertheless, if it happens, it would still be lawmakers ultimately who are calling for the assistance of these volunteers.

    If you’re just looking at the costs/harms to volunteers of involvement vs. the medical and economic costs to the rest of us of a couple of more months without a vaccine, then I agree with you that the latter costs are probably greater in sum. But as I’ve argued, *the costs to volunteers here are not the only costs* (of conducting these trials). If, when governments fail us, we allow ourselves to fall back on the sacrifices of super altruistic individuals, this decreases pressure on governments to be responsible in the future, and on the rest of us to restructure society so that ordinary people have more opportunities in the normal course of things to live lives that are good for them and socially useful (because if they had such opportunities, it is unlikely that so many would be volunteering to help out with things as risky as challenge trials).

    My answer, then, to your question of how I justify restraining people here is: by appeal to the systemic or institutional costs of allowing them to go ahead.

    To emphasise: if we were talking here about really averting a catastrophe, I’d be in favour of the challenge trials (hence why I think they could be justified if there were no other way of running the trials). In such a case, I might even be okay with conscripting people to be involved in them (just as conscription of soldiers can be justified in wartime when we’re facing an existential threat). But the cost here is not war: it is a couple of months less of a greatly eased lockdown.

    Out of interest: if some super altruistic people wanted to somehow risk their lives so that everyone could get free gym membership (which would, given the large numbers of beneficiaries, maximise the good), would you let them do that?

  5. Hi Ben and all,

    First of all, like Richard I’d like to thank you for writing this and making it completely open access, Ben. I’ve also been made to think harder about some of these issues having read the book, so I’m grateful to you for that. (Perhaps more of my comments to come later in the week on other parts of the book.)

    One small, general point about how the debate between Ben and Richard has gone. Although there are some differences, it reminds me of a familiar line of criticism re. charity-giving. There are plenty of reasons to give to charity and to give to particular charities, but doing so is sometimes criticized because it lets governments and other appropriate bodies ‘off the hook’. They should be sorting out the problems and misfortunes that arise, so the critics say, and the activity to do so should be funded properly through an appropriate system of taxation. (Etc.) Of course, some people think this criticism is too extreme. We can think there should be appropriate systems of taxation and we can also think that governments should intervene, and perhaps do so more than they do. But, goes the line, it is compatible with thinking those things that we should allow people/citizens the freedom to contribute more as individuals to some charitable cause if they wish to through donations of time and/or money. The counter comes back: the more we allow people to contribute, the more it continues to let governments ‘off the hook’ and cements injustice. (Etc.) There are differences between this example and the Covid trials example. (Ben stresses how serious the repercussions could be if one volunteers, for example.) However, I hope the similarity is striking: to what extent should we curtail such volunteering? How much does such volunteering let governments ‘off the hook’ in sorting out proper public health policies such that trials are, in fact, needed less? The charity debate can be framed as one of short-term versus long-term actions and effects. There are always cases, it seems, where one could and should intervene to help a charitable cause. But frequent interventions of aid will never allow for the re-setting in society that is required according to critics of charitable giving.

    Hope it helps to read how this debate struck me.
    See you later in the week, all being well

  6. Hi Ben, just to clarify, is it your view that allowing challenge trials would so diminish governmental capacity going forward that expected utility is actually maximized by disallowing them and enduring months more of the pandemic?

    That seems empirically dubious to me, but I guess I’m more concerned about the underlying philosophical principles. So if you’re happy to grant that challenge trials would be justified if you’re wrong about that empirical conjecture — that we should allow them if that really would better promote the good — then our philosophical disagreements are perhaps not as great as I thought upon first reading your piece (and other parts of your comments).

    P.S. I’m not sure that free gym memberships would have any value at all for most people (how many ppl actually use their gym memberships?). But if we accept your stipulation that it would do more good than harm, then YES, of course I would allow that. I’m a liberal consequentialist. I like allowing people to do things (even life-risking things like driving cars), and I like promoting the good even more. This is a no-brainer, by my lights.

  7. Hi Ben and all,

    Enjoying thinking about this–thanks to Ben, and to the rest of you.

    I find Richard’s responses compelling, and sufficient on Ben’s weaker worries #1, 2. Let me add a few smaller points, primarily on Ben’s more distinctive worry #3, about society’s fault.

    (a) One may conduct challenge trials without the characteristic that gave rise to Ben’s worry #3. The worry is based on the recommendation to focus challenge volunteer recruitment on people at high risk of getting infected even without trial participation—I believe my coauthors’ and my own recommendation (see “Human challenge studies to accelerate coronavirus vaccine licensure,” Journal of Infectious Diseases 221; and “Why Challenge Trials of SARS-CoV-2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events,” Ethics & Human Research). I had imagined e.g. dentists at high risk of future exposure, or inhabitants of large cosmopolitan hubs with multiple expected future local Coronavirus “waves”. If Ben thinks that that would necessarily be unfair toward people we had failed (which I would deny), he should have recommended instead conducting challenge trials without that recruitment strategy. He could have supported e.g. challenge trials that exclude people at high risk of getting infected outside the trials.

    (b) Part of conventional vaccine testing, including the Coronavirus vaccines currently in development, is phase I trials on healthy volunteers, to rule out vaccine toxicity. The volunteers are placed at risk, for no foreseeable health gain (for safety reasons, the dosage is too low to be protective). Does Ben oppose conducting phase I trials as well, e.g. in societies that are failing to fight the pandemic sufficiently? For example, does he think that truly informed consent to phase I trial participation is impossible, making these trials impermissible, because (most of) the vaccines being tested are “first-in-human” and there is simply no way for candidate volunteers to imagine their potential injurious effects (much more than it is impossible to imagine the injurious effects of Coronavirus infection, whose survivors tell their stories in the media, and could repeat them during the informed consent process)? Does he think that it is “rotten” that societies saddle those seeking meaning in their lives to pick risky phase I volunteer opportunities? But without phase I, it is hard to see how vaccines could be developed at all.

    (c) If one’s argument generates the conclusion that during later stages of WW2 it would have been morally wrong for the allies to bomb concentration camps, presumably the argument is invalid. But elements of Ben’s argument would seem to generate precisely that absurd conclusion. After all,

    i. If the camps remained operative, the war would not be lost, so “society [would] not collapse or grind to a halt.” Their continuous existence would claim “only” the lives of thousands of people a day—as does the current pandemic.

    ii. The young pilots, even when volunteers not conscripts, allegedly couldn’t give truly informed consent to participation in the dangerous mission, given their tender age and typical inexperience crashing planes and serving in prisoner of war camps.

    iii. The fact that the concentration camps were there and that dangerous missions were necessary was, at that late point, partly the allies’ fault. If only they had previously “gone hard, gone early” on antisemitism, on Hitler, and on these camps in construction, the problem might not be there.

    Thanks again Ben for thought-provoking ideas,

    Nir

  8. Thanks, Nir, for your kind words and super interesting comments.

    Re: (a), you ask why, given my worry #3, I do not simply support challenge trials that exclude people who are at high risk of getting infected outside the trials. It is because of worry #2. It is also partly because of something I mentioned in outlining #3—namely, that many people volunteering are doing so only as a result of feeling a tremendous lack of meaning in their lives as a result of society’s failures. Once we exclude volunteers whom we’ve collectively let down by exposing them to the virus, we will be left largely with volunteers whom we’ve collectively let down by failing to give them opportunities to contribute to the good in safer ways in normal times. (Why is this morally problematic? Again, it is because of the larger societal effects of allowing people in these positions to volunteer. It lets us off the hook for our failures, and reduces our motivations to improve things in the future.)

    Re: (b), I have no problem with allowing people to volunteer for phase I trials, since, as you say, there is no alternative. These volunteers are relevantly like soldiers needed to defend our civilisations against existential threats.

    Re: (c), I of course agree with you that the allies should have destroyed these camps (and could permissibly have allowed young pilots, whether volunteers or conscripts, to face lethal threats in doing so). Part of the difference with challenge trials here is that allowing these camps to stay open would be much, *much* worse (both in terms of lives lost and also the future effects on society of its being discovered that we did not destroy them) than (in the current pandemic) our having to endure a couple of extra months of a greatly eased lockdown. While the pandemic is killing several thousand people a day now, it is hard to believe that it still will be in, say, a year from now, or even six months from now (which is the relevant time period to consider). Moreover, there are, as I’ve argued, bad effects on social structures of allowing challenge trials, whereas I doubt that there would be similar bad effects on society of allowing the camps to be destroyed.

  9. Thanks, Simon! Yes, I definitely think there are some parallels between this debate and debate over the institutional critique of effective altruism, in part for the reasons you suggest. It would be interesting to chat more about this. I look forward to your contributions later in the week, all being well.

  10. Thanks again, Richard, for these challenging remarks.

    If A wants to help B, and the benefit to B is greater than the harm to A, and there are no other harms or benefits to consider, then of course we should let A help. But sometimes letting somebody help somebody else has other sorts of effects, including harmful ones. Suppose A wants to help B, and the benefit to B is greater than the harm to A, but there is another consequence: C, D, and E die. Clearly, we shouldn’t allow A to help B (assuming there are no other relevant consequences to consider). So, it is not always right to allow some people to help others at a risk to themselves. My claim is that challenge trials have an additional bad effect like this one, by affecting systems/institutions (and also, incidentally, the character of citizens). (So, my primary concern here is not actually–or at least, not fundamentally–one for the welfare of the volunteers (or at least, not their immediate health risks from involvement in the trial) (though that is certainly part of my concern). It is a concern for those and others like them who have few opportunities to contribute to the good in normal life, and for those who suffer in normal life as a result of governments and the wealthy classes failing to discharge their duties.) Note also my other point about the benefits of challenge trials being much smaller than is commonly claimed—not millions or even thousands of lives saved, but probably just a couple more months of a greatly eased lockdown (since that’s where most or all countries will be in a year from now). This point seems to have been overlooked in this discussion so far.

    To answer your question, yes, I’m happy to grant that challenge trials would be justified if I’m wrong about these empirical conjectures (I thought I was pretty clear on this in section 4 of my Pea Soup post…which was, after all, a defense of the permissibility of such trials if certain empirical facts obtain!).

    Ben

  11. Hi Ben,

    While so far you haven’t done so explicitly, perhaps it’s fair to summarize your response to my point (a) above as coming around to conceding that your argument that society is at fault by having failed to stop COVID fails against challenge trials in general—it works only against a particular way to conduct challenge trials (if it does). You then seem to put all/most of your eggs against challenge trials in the basket of the alleged societal fault of failing to give young people more benign avenues to find meaning in their lives, and in its alleged unfairness toward them. But that basket cannot hold the weight of those eggs.

    1. The case that your argument must be able to establish is for knowingly wasting an opportunity to save thousands of human lives every day, over a few months. Not sure wherefore your continuous dismissive tenor about anything other than actions “needed to defend our civilisations against existential threats.” After all, you appropriately accept the importance of bombing camps in WW2; but that would have prevented “only” thousands of deaths a day (Google up the numbers of deaths per camp per year). You do write, “While the pandemic is killing several thousand people a day now, it is hard to believe that it still will be in, say, a year from now, or even six months from now (which is the relevant time period to consider)”. I don’t think this optimistic speculation is widely shared. And besides, the option of using challenge trials to accelerate the process is arising now – Oxford University’s Jenner Institute is hoping to complete challenge trials before the end of 2020. Note also that COVID’s major harms to people include not only (1) direct COVID deaths, but also: (2) direct COVID morbidity, (3) economic impoverishment, especially in the developing world, (4) indirect mortality and morbidity from disrupted healthcare services and from adverse side effects of necessary response measures, (5) and indirect mortality and morbidity from impoverishment (e.g. from famines). Not all of those have parallels in the WW2 analogy. In short, it seems inconsistent for you to—appropriately—take very seriously the harmful continued existence of camps in WW2 while remaining blasé about harmfully dragging COVID for a few months longer.

    2. By contrast with this momentous humanitarian cost of deferring the arrival of a proven vaccine, your main remaining line is speculative, dubious, and, even if it works, comparably insignificant. What now mainly worries you is that “many people volunteering are doing so only as a result of feeling a tremendous lack of meaning in their lives as a result of society’s failures.” But you fail to provide supportive evidence. You did not interview the volunteers, and there is no major empirical evidence of the utter barriers to finding meaning that would be necessary in order to establish your case. On the face of it, there do seem to be socially-created opportunities out there for finding meaning in one’s life. Everyone can nowadays Google up “volunteer opportunities” or, better still, “effective altruistic volunteer opportunities”. Even if your point stands in some countries, surely different countries vary in that respect (the volunteers hail from 157 countries: https://1daysooner.org/). And even if you are right, and societies worldwide are failing to make opportunities to gain meaning salient enough to young people, is lacking that societal channel to meaning a personal harm of the scale that would leave people no acceptable choice but to take on serious risks to life and limb? I really doubt that. Finally, if you think we should in all fairness exclude volunteers who join because they perceive their lives as otherwise meaningless, why not just do that, and let others among the nearly 35,000 global volunteers (https://1daysooner.org/) participate in a challenge trial, which requires several dozen participants?

    All in all, you seem to have tweaked with the accents of your case against relying on the fastest design for getting to a proven vaccine. But the revised version founders as well. The case for averting tremendous human death, injury, impoverishment, and misery through a fast design and earlier proof of a novel Coronavirus vaccine remains much stronger than the case you bring against it.

    Best

    Nir

  12. Hi again, Nir,

    First, let me say that I am certainly not “blasé about harmfully dragging COVID for a few months longer”. Sorry if I gave that impression. Even if I’m right that in 6-12 months from now, the daily cost of COVID-19 will be significantly smaller than it is today, it will still be a big cost.

    Now, why can’t we permissibly run such trials if we exclude volunteers who are otherwise likely to catch the virus? My concern is not *only* about the perpetuation of a society that offers few opportunities for normal people to live lives that contribute to the greater good. Crucially, it is this as well:

    *If we just got our acts together, then we could suppress this virus in a couple of months, and then largely relax lockdowns.* We could do so while assisting those in lockdown, and providing significant aid to people in poorer countries. We have the smarts and resources to do these things. Why aren’t we doing them? *It is because of epic moral failures of ordinary people (who aren’t listening to experts who prescribe these things, or who are too concerned about the consequences of lockdowns for their own investments or stock portfolios, or who are too loyal to the President to oppose him–and so are not pressuring governments and citizens to take such actions).* I am deeply concerned about the effects of allowing people (even effective altruists who might not otherwise be in the firing line of the virus) to volunteer for these trials *upon these millions of Americans (and Brits) who are morally failing here, and on their moral character going forward.*

    If the harms to others were great enough—if, in 6-12 months from now, it was still thousands of people dying each day from COVID-19—then I might be willing to accept that we should conduct challenge trials now despite the bad effects of doing so on social structures and on the character of those who are morally failing. But I really do question that things will still be this bad in 6-12 months from now, even with Trump at the helm. Faced with more death and disruption in coming months, even the most ardent Trump supporters are going to come around to accepting hard lockdowns, masks, and other measures to suppress the virus.

    Best,
    Ben

  13. Thank you for writing this book, Ben! I wish it was around when I co-taught what I believe was the first English-language graduate course dedicated solely to COVID-19 Bioethics this past summer. Thanks also to Richard, Simon & Nir in the comments here for a rich discussion.

    While I agree that informed consent is ethically important in clinical contexts (and many other contexts besides!), I object to the phenomenological requirement you endorse above (and in the book), when you write: “As healthy subjects, they will not have been severely ill before. While such people might be able to theoretically grasp the risks of infection with COVID-19, they will not have a good grasp of ‘what it is like’ to suffer in these ways (i.e., the phenomenology of this). But this is surely crucial.” You seem to imply that having a good grasp of ‘what it is like’ is a necessary condition for sufficiently well informed consent. But this would prevent obtaining such consent from many patients offered medical interventions for the first time because they lack such a grasp: chemotherapy treatments for cancer, removal of wisdom teeth, C-section during birth, late second-trimester abortions (done for the benefit of the future neonate and family) and many, many, many other examples. However not only do we think that such informed consent can be obtained without such a grasp, we also justifiably believe that (barring other countervailing reasons), those procedures are ethically permissible.

    You may object that I have used non-research clinical contexts. However note that for many of the aforementioned type of medical interventions, they were experimental in the past (furthermore, many such interventions are still the subject of clinical research) and so researchers were required to obtain sufficiently well informed consent in research contexts from research participants who also don’t have such a grasp of how it feels. I selected non-research clinical contexts to show the extremely widespread nature of counter examples to your phenomenological requirement of sufficiently well informed consent.

  14. Hi Gerard! Thanks for the kind words. I hope you are going well.

    You raise an interesting counterexample. I agree (of course) that we can permissibly allow people to have their wisdom teeth removed, etc., even when they have not had the relevant experience before. I agree even that we can permissibly allow patients to volunteer for experimental treatments that might involve experiences they could not possibly have anticipated. But these seem very different contexts to the one under consideration in challenge trials. In these other cases, we are allowing people to do things *that are good for them*, and good for them *not only because society has failed them*. This is why we can permissibly allow it even though they might not have a very good grasp of what it would be like to suffer the relevant consequences. The context matters. But there is an additional point: patients who want to volunteer to trial experimental drugs are already (generally speaking) suffering badly. So, they have a firsthand appreciation of bad suffering. Young health volunteers for challenge trials do not.

    PS. Please send me the syllabus that you used. I’d love to see it!

  15. Thanks for your reply, Ben! I agree that the contexts in the set of counterexamples I raised are different in a number of respects to human COVID-19 challenge trials. My response to your reply is two-fold.

    Firstly, note that my objection was not to the conclusion of your argument against human COVID-19 challenge trials, but instead about your phenomenological informed consent requirement. I can’t see why the following – “we are allowing people to do things *that are good for them*, and good for them *not only because society has failed them*” – makes a difference to our ethical standards of informed consent. Indeed not only am I unsure of how or why that empirical difference grounds a difference in the ethical standards of informed consent, there are good reasons to doubt the dialectic relevance of that empirical difference. Informed consent is ethically important independent of any impact on well-being. There are ethical reasons to obtain such consent in clinical contexts even if what clinicians seek is unambiguously and certainly good for the patient or research participant. The important differences between promoting well-being and respecting autonomy are well established and widely respected in both healthcare ethics (e.g. beneficence, non-maleficence and autonomy are distinguished well in Beauchamp & Childress’ four principles) and research ethics (e.g IRB policies) – the two sub-disciplines that cover most biomedical clinical cases.

    Secondly, there are some counterexamples of the kind I raised that do not have the main difference you point out. In many clinical research trials (for the kinds of interventions I raised), the research participant is not benefiting from the trial (e.g. because they are assigned to a placebo control arm of the study, or because the intervention is inefficacious). Furthermore, in some other cases research participation may be good for the research participant but only because society has failed them. For example, consider trials involving people experiencing preventable homelessness or diabetes caused by living in a ‘food desert’ etc. In such trials, informed consent is still ethically important yet does not require a good grasp of ‘what it is like’ to participate in such trials. Finally, very many clinical trials are done on young, healthy, volunteer participants – indeed for many trials, this is a necessary condition for participation in the clinical trial. That empirical difference is also not dialectically helpful to your case here.

    As for the COVID-19 Bioethics syllabus, because we were building the course concurrently with the evolving pandemic (e.g. adding discussions on US protests during the pandemic in the middle of the course), we don’t have and didn’t use a traditional syllabus. We primarily built out teaching materials (e.g. video guides to set readings) on our Canvas LMS pages, so its more difficult to share than just attaching a syllabus to an email. I should also note that this class wasn’t for graduate philosophy students but instead we had Bioethics MA students, public health PhD students, biomedical researchers and a range of healthcare professionals (from chaplaincy, medicine and nursing). Let me reach out to my co-teachers to see if they’re happy to share and then see how we can share such materials.

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