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Hi there, welcome to today's St Cross seminar. The title of my talk today is Waiver or Understanding.

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Dilemma for Autonomist is about informed consent. The thesis for which I like to argue today is that we should reject the requirement

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that understanding the standard disclosure is a necessary condition for valid,

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informed consent. This is a conclusion that I've argued for before in previous work.

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But today I want to argue for the same old conclusion, as it were, with a completely different argument.

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So just to give you a little preview, there will be five sections in the talk.

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I'm going to start with a very brief background on some elements of informed consent.

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And then I want to try to outline the core dilemma that's going to structure my discussion.

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And I'll begin by doing that in a kind of abstract way.

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And then I want to sort of motivate or fill in the background to this dilemma a little bit by describing some

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stylised cases to give the idea that the sort of presuppositions of the dilemma are plausible and on that basis,

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that they want to argue to different kinds of thing.

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On the one hand, which is my kind of primary argument, I want to argue that people who, as it were, believe in an autonomy,

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justification for informed consent, have to accept a version of my conclusion,

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which is that they need a new argument for a main piece of their position.

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And then finally, as a sort of secondary argument, I want to sort of pivot and address the same structure to everybody else,

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the people who don't begin by believing that autonomy has this privileged position in the justification

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of informed consent and to try to convince them or you that the same conclusion should be accepted,

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that I tried to urge on the believers in autonomy.

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OK, so in very general terms, there are two different contexts, medical context, in which it's common to talk about requirements of informed consent.

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One is the clinical context and the other is context of doing research, particularly randomised clinical trials in principle.

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My discussion is general and applies across both contexts,

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but I'm going to develop it primarily in the context of research, in the context of clinical trials.

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More specifically, as you'll see,

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I'm going to understand the requirement of informed consent has really been kind of composed or broken down into two primary duties,

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one related to disclosure and the other related to consent, I take it.

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And that's pretty standard fare. More generally.

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You can see it's a common feature of analysis of informed consent in sort of medical research contexts to single out five elements or components,

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which I won't review in great detail,

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but I'm just taking it that the disclosure requirement and the understanding requirement are two of these sort of five standard features.

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And in a way, my concern is about how we should understand the relation between them as part of the apparatus of informed consent.

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So the detail that really kind of gives the special colour to this version of the argument in this

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apparatus is the focus I'm going to provide on the idea that it's possible for either patients or subjects

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to waive the duties that professionals have in relation to them to obtain their informed consent and

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in particular to disclose various bits of information to them before seeking to obtain their consent.

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There's a reasonably good discussion about this in a legal textbook by Jessica Baird and colleagues

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that primarily focuses on the clinical context and on the kind of common law background.

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But I think it's a sort of reasonably accepted general feature that in many

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jurisdictions there is this right to weigh some or all parts of the required disclosure.

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This is one context. There'll be a number of them in which, you know, I'd be actually quite interested.

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To hear whether there are differences in this regard between the U.K. jurisdiction and what, you know,

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one may regard as standard truths in an American context that actually don't travel as well as some people might think.

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So in a way, that kind of main point about this availability of the right option to waive some part

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of the disclosure is that a subject who waives all or part of the standard disclosure,

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at least in the kind of common case where the subject doesn't already independently understand exactly what's being reviewed in that disclosure?

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Exercising their waiver basically guarantees that they will fail to understand the relevant parts of the disclosure.

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So it's not just that there's a right or an option available to way, but that the consequence,

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the predictable consequence of exercising it is guaranteeing that the subject fails to understand the disclosure.

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So on that basis, you can see that kind of basic parts of the dilemma that I want to work with.

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My main kind of overarching background claim is that in this context,

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it can't both be true that understanding the standard of disclosure is a necessary condition of valid consent

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to join a randomised clinical trial and also that there is a right or if you want to say more specifically,

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a justified right to waive the disclosure. So I'm going to refer to these as we go along as the kind of left heart and the right heart of the dilemma.

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But the basic point is that given what the consequence of exercising the waiver is,

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it can't both be true that you're required to understand the disclosure, but you have a justified right to waive it.

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If you like. You can kind of fine tune this a little bit by kind of taking advantage of the fact that the right to waive the disclosure may

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only operate over part of the disclosure and also that the claim that understanding is necessary may only be strictly true.

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For part of the disclosure, the fine tuned version of the dilemma is just the scope of the understanding requirement and the scope of the

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right to waive can't operate with respect to the same part of the disclosure on pain of getting an inconsistency.

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OK, this assumes in the background, which I am assuming, and which also sounds pretty reasonable to me,

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that the existence and justification for a right to waive presupposes that exercising that right nevertheless leaves the subject

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or the prospective participant with the option of continuing on to agree to participate in the randomised clinical trial.

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So by saying there's a right to waive the disclosure, what I have in mind is there's a right to waive the disclosure,

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which includes exercising that right, but nevertheless hanging on to the option to participate in the clinical trial.

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OK, if. Consenting to participate in a clinical trial is a necessary condition of

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participating and having valid consent is a necessary condition of consenting.

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And if understanding is a necessary condition about consent, you run into the basic problem of this.

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OK, so that is the kind of abstract background of the argument, as you will,

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before I proceed to the argument, I just want to sketch in some kind of stylised cases,

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you might say, to give you the idea that it's actually reasonable, at least sometimes for some people in some context,

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for someone to want to do both of the two things that the arms of the dilemma address,

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namely to want both to be able to waive all or part of the disclosure,

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but nevertheless also to want to agree or to have the option of agreeing to participate in the relevant trial.

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In the abstract, you might think, well, who would want to put these two things together?

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That's kind of crazy.

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I want to try to suggest that actually, at least in some context, that's a pretty reasonable pair of things to want to have the option to do together.

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And here I might say that the second two of my stylised examples kind of draw on Karl Schneider's work in his old book, The Practise of Autonomy.

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In his book, he's developing a critique of something that he calls mandatory autonomy.

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There's a way in which both kind of in the abstract, but also in the use of these cases.

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The critique or the argument that I want to develop is structurally similar to Snyders.

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The difference being that he's focussing on the case of individuals who want

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to get the information relevant to make a decision to be properly informed,

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but then nevertheless to have the option of not making the decision themselves,

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letting someone else, a family member or the doctor, make the decision for them.

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Whereas I'm interested in the sort of reverse scenario, someone who's not interested in having some or all of the relevant information,

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but nevertheless is interested in not only making the relevant decision, but making it affirmatively.

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That's to say actually deciding that they want to participate in a trial in a different,

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different course is that his discussion and cases are primarily drawn from the clinical arena where,

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as I say, I'm orienting myself to the research case.

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But that argument is actually pretty generic.

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So the second and third cases I'm going to give you are variants of what Schneider calls his divided self hypothesis.

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OK, here's a case, a you might say the basic sort of generic case of this kind,

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it's a case of a person whose conception of what information is relevant or important to his or her decision

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differs in one or more ways from the conception that's been standardised in the uniform disclosure.

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Not only that, but the person is conscious, perhaps because she's aware of the quite strong data on the ways in which

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information overload can lead to poor or bad or even self-defeating decisions,

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aware of the dangers of information overload and having a different set of preferences

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in terms of what's really important information relative to the standard conception,

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this person wants to kind of fine tune or tailor which information she receives and just not receive information that isn't relevant to her,

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but runs the risk of landing her with information overload.

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So here's an example. It turns out I can tell you already that the main part of my slide is not that easy to see.

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So I apologise for that.

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So Laura Mesko and Kevin Wynford, colleagues of mine at Duke, did a bunch of survey work kind of investigating people's preferences for information,

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in particular as part of an informed consent for bio repository study.

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And they, amongst other things, found some striking differences in the preferences as between kind of experts and laypeople,

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in particular differences in their preferences as between IRBM members,

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research ethics board members, and the subjects concerning which parts of the standard disclosure were important or relevant to include.

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So I'm just going to give you one example, and this is the bit I apologise.

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You have trouble reading. I can tell you what it says.

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So the right to withdraw as a standard part of what's disclosed as part of an informed consent process when something that IRBM members,

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95 percent of them rated this as extremely important,

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whereas only 58 percent of the subjects reported this as an item that they thought was very important to know or to be told as part of the disclosure.

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So there's, you know, roughly 40 percent difference between laypeople and experts in the importance of this particular item.

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OK, case B, again, these are modelled on Schlyter. Remember, as a person patient subject who has a terminal condition,

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some particular randomised clinical trial offers them the last and only chance at an effective therapy.

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This is information that's both true and believed by the subjects and subject trusts her doctor.

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But subject nevertheless fears that learning the details of the risk benefit analysis

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for this trial will scare her off her kind of already made decision to enrol.

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So for her, waiving that part of the information in the disclosure is part of a Ulysse strategy,

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in effect, to kind of bind her to the choice that she's already made.

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That variant of this case has the same structure, only the difference is that now the person is not a terminal patient,

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but an altruistic volunteer who just doesn't care about the details of a trial.

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Their interest in participating has to do with their altruism, their desire to further science.

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And, you know, the details of what exactly they're signing up for don't matter to that decision.

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But they do fear that learning about them, in particular learning about the risk benefit details will scare them off the decision to enrol.

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And so, again, waiving that information is a kind of U.S. strategy that they adopt.

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OK. As a general thesis, you may say, you know,

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alarm bells go off when you are told that a particular altruistic volunteer doesn't care about the details of the trial, that enrolment for.

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But here, I think we could add particular details both about the trial and the individual to make this a rational attitude.

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So, of course, sometimes you might say in scary cases, for example, and in standard cases of individuals,

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the attitude in question may be questionable, but in many other cases it may also be perfectly reasonable.

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OK, as a general matter, the point is there may be a perfectly good reason for the patient subject to adopt the utilities strategy,

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and that's what would give her a reason to combine the waiver strategy with nevertheless wanting to enrol.

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OK, so that is the basic set up to the whole argument now I'm going to give you these two different arguments.

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One pitched more specifically at people who believe in the importance of autonomy for justifying informed consent.

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And then later, I'll come back to a sort of variant of the argument addressed to everybody else.

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So, again, this is the second point at which actually I'd be interested to hear if my description

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of a part of the target is one that fits better in the United States than it fits here.

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Certainly, I think it's fair to say that in the United States,

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the standard default justification offered for the requirements of informed consent is an appeal to autonomy.

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Both, I would say, at the general level. That's to say that this is meant to be the crucial part of the justification for

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the entire doctrine of informed consent in all its sort of multiform details.

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But also more specifically, it's meant to be a crucial part of the justification for the very requirement that I'm targeting in the discussion,

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namely the claim that understanding, the required disclosure is a necessary condition of valid informed consent to participate in a trial.

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And maybe that, to my mind, it's actually quite hard to find a well-developed, articulated example of such justifications,

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as opposed just to the claim or the assertion that autonomy plays this role in that justification.

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But for the purposes of a target for this argument, that doesn't matter to me.

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What I'm going to try to show is that in a certain way, the conclusion can't be right, no matter how you fill in the background.

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You OK? And the way I would do that is by beginning,

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not from the question what's required or is it possible to justify the requirement of understanding as a necessary condition?

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That left part of the dilemma.

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But rather, I want to focus on the right horn of the dilemma, the question of the right to waive a part of the disclosure,

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or more specifically, in a way, the justified option to waive the disclosure.

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It's actually not important for my discussion whether we conceive of the option

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to waive the disclosure of something that properly qualifies as a right.

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And in particular, I want to say. The argument should begin by asking from the standpoint of autonomy,

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how does a justification for having the option to waive the disclosure fair in general terms that I want to argue or suggest,

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is that a justification for having the option to waive the disclosure is actually quite

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easy or straightforward to justify in relation or by reference to the value of autonomy.

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I want to give you two different examples of attempts to sketch in some such justification.

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So the first attempt focuses on the fact that using or exercising the option to waive the

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standard or part of the standard disclosure is a straightforward exercise of autonomy.

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It's making a choice over the conditions of one's own life.

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More specifically,

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it's making a choice over the conditions of some particular decision that one has to make and making that choice over the conditions of that decision,

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in particular as an attempt to shape the conditions, to bring them better into line with one's own kind of values and preferences.

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That description is using the waiver is an exercise of autonomy holds,

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even if it turns out that a consequence of that decision is that some later choice one makes.

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For example, the choice to enrol in the trial turns out to be less autonomous because, for example,

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it turns out to be less informed and on the assumption that you think information or information is a condition of autonomy.

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This all to the good just because it's perfectly coherent and possible to decide

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autonomously to accept a limited loss of autonomy on some occasion in the future.

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And that's both true and coherent, even if one holds that there are limits to the extent to which one can autonomously decide to forego autonomy.

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So at the extreme, it's a well known position, for example, that contracts to sell or bind oneself into slavery not only are void,

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but in particular can't be justified by reference to the value of autonomy.

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So one can accept that and even something weaker than that,

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while still insisting that some choice to accept a limited loss of autonomy in the future is not only both possible,

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but remains itself an exercise of autonomy.

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Of course, one might insist in line with this position.

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I take it the opponent will insist that as an autonomous choice,

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the choice to waive the disclosure or some part of the disclosure itself has to be made under certain conditions,

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and these conditions might well include understanding of relevant parts of information.

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OK, so I'm happy to accept that that's consistent with the claim that it's both coherent and justified autonomously to decide

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to accept a larger loss of autonomy in the future as long as the information that's required for the first choice.

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The choice of the waiver to be autonomous is different from the information that's required for the later choice,

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say the choice to enrol and the trial is required.

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And on the face of it, I think that both looks correct and perfectly sensible.

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So I go to an example in a minute. But more generally, the argument is.

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If those two sets of required bits of information overlap,

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then insisting that the choice to waive the disclosure can only be made autonomously if it's informed

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in a way that actually will remove or obliterate the later choice is somewhat kind of incoherent.

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But in any case, I think we can just by example and description, show that those two sets of information conditions are distinct.

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So, for example, it may be that as part of deciding autonomously to waive the risk benefit information for a particular randomised controlled trial,

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one is considering joining. One has to be told that the trial does have specific risk benefit ratio.

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And if one waives that part of the disclosure, one will be ignorant of what that ratio is.

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That's one kind of information. And you may need to receive that information in order autonomously to waive the disclosure.

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Nevertheless, what's required, you know, in the standard view to autonomously enrol in the trial itself is a different piece of information,

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namely the actual details of what the risk benefit ratio for that trial are.

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OK? And so one can be given the information needed to make the waiver choice

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autonomous without yet being given the information that one is trying to avoid.

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And that's meant to be required for the enrolment. So these two pieces of the puzzle remain coherently fit together.

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OK, that was one kind of way of trying to show how, from the standpoint of autonomy,

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having the option to waive part of the disclosure is perfectly justifiable.

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Here's the second kind of differently formed detent.

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If you're presented with some individual who,

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as it happens once and reports that he would like to waive the disclosure and nevertheless hang on to the option to enrol in trial,

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if we deny this person, I guess that change the person's gender in the middle,

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if we deny this person the option, that is tantamount to forcing her to receive the standard disclosure or at least forcing

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her to receive it on pain of losing the option to enrol in the randomised clinical trial.

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So a different way to put the second point attempt is to notice that denying people the option to waive the

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disclosure in the case when they don't want to receive it is equivalent to forcing them to receive the disclosure.

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So it's one question whether it's possible to justify forcing someone to receive the standard disclosure, as we'll see.

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I'm happy to leave that question open. My point here,

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this is the nub of the second attempt is that forcing someone to receive the standard disclosure can't be justified in the name of autonomy,

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because this is equivalent to forcing her to decide under conditions that she rejects,

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which is not a description that's consistent with the content of autonomy, let alone its value.

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So here's where we go back to this phrase, mandatory autonomy.

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And I kind of overlap to some extent in my argument with Schneider's critique.

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So in this sense, part of the point is the idea of mandatory autonomy is a kind of contradiction in terms.

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And unless we can reconcile or rescue that contradiction,

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that's an argument for saying that autonomy itself justifies not forcing people who want to wait the disclosure to have the option of waiving it,

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as I say. It's a separate question whether there's a different argument that appeals to something other than autonomy,

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a different value or different set of considerations,

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that yields the conclusion that actually it's justified, all things considered, to compel unwilling subjects to receive kind of required disclosures.

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And I'm happy to leave that open. The main point is that case, whatever it is, would have to be based on something distinct from autonomy.

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So let me go back to the dilemma in my title recall.

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My suggestion is that the dilemma has the form of these two.

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Horan's on the one hand, you can't have the idea.

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You can't affirm that understanding is necessary as a condition about consent to join a randomised controlled trial,

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while also affirming that there's a justified right or option to waive the disclosure.

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Those two things are inconsistent, I claim, and so they can't both be justified.

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What we've just seen the conclusion of this first line of argument is that there's a quite good,

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perfectly compelling justification that begins in the value of autonomy and ends as a conclusion on the right portion of the dilemma,

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namely the conclusion that there is a justified right to waive the disclosure.

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So if that's right and the two things are inconsistent, the conclusion that follows and this is the main conclusion that I would like to urge today,

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is that we cannot also appeal to autonomy to justify the conclusion that understanding is a necessary condition without consent.

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So this kind of run of the main argument has a very simple form.

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There are two propositions that are inconsistent. Autonomy yields a very good and straightforward justification for the second of these propositions.

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Therefore, autonomy can't also be seen as the justification for the first of the propositions.

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Can't also be seen as the justification for holding understanding to be a necessary condition of informed consent.

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If therefore just spelling it out,

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you are a believer in the value of autonomy and in particular in its relevance for justifying some elements of the doctrine of informed consent.

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My conclusion is you,

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those people in those camps need to give up on the idea that autonomy is the way to justify the understanding requirement as a necessary condition.

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Again, I'm happy to leave open on this plane an argument whether there's a different justification for this conclusion, I reject.

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But my main point is the autonomy based justification can't be it.

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Last little wrinkle on this kind of autonomist orientated part of the argument,

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so I referred at the beginning to this textbook by Jessica Baird and colleagues,

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this is going to be a perhaps funny use of the expression in fairness to but in fairness to them.

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And it's kind of a striking feature of their discussion. I think they recognise all of the main elements of this argument,

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namely that what I'm calling the right and left horns of my dilemma are two inconsistent

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propositions that autonomy supports one of these two inconsistent propositions,

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and also that it's possible for the decision to waive to be a perfectly well informed decision and therefore qualify for the description autonomous.

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The only thing they don't do is draw the conclusion that I am here urging us to draw, which is therefore autonomy doesn't offer,

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in fact can't offer a justification for the remaining proposition, which is the main proposition that they affirm and affirm on the basis of autonomy.

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OK, so we've come through four fifths of the structure and we've covered, as it were,

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the main plank of the argument, which is meant to be addressed to believers in autonomy.

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Nevertheless, I want also to kind of complete the tour, as it were, of the audience.

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I want to address a similar argument to those of you who may not believe,

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maybe never believed from the beginning that autonomy was the key to justifying elements of the informed consent.

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Doctrine or a set of duties, so I'm going to skip over this like it's really just saying what I covered.

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I want to shift now to talk about the people who think that the basis for the justification of informed consent lies elsewhere.

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This second argument is going to be anchored in the same material in the sense that the thin end of the wedge

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I want to drive is just the observation that the right and left horns of this dilemma are inconsistent,

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or that these two propositions about informed consent are inconsistent and.

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I want to make the driver of the wedge again be an argument that having the option to waive parts of the disclosure is a perfectly justified option.

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It's just that I want that argument now to run forward on grounds that have nothing to do with autonomy.

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That's the difference between the bit that's addressed to autonomous states and the bit that's addressed to other people.

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So the two kind of alternate drivers that I want to put forward are quite different from each other.

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How different this first one is from autonomy in effect,

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I think depends on how precise or detail oriented you are in the formulation of what counts as autonomous.

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So the first driver just appeals to what I would call the value of ordinary individual choice,

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by which I mean nothing more kind of elaborate than the value of letting people decide certain questions

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for themselves instead of making the outcome or decision be mandatory on the basis of some regulation.

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And for my purposes, it doesn't really matter.

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I think it's a host of, you know, general consideration that speak in favour of ordinary individual choice, starting with, you know,

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what I'm calling and slide the old million saw,

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which is just that people are the best judges of their own interests, or at least maybe slightly more considered.

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By and large, for the most part, people are the best judges of their own interests.

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So the value of ordinary individual choice also favours having the option to waive the disclosure of an informed consent here.

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That's what I was alluding to at the beginning.

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I'm presupposing that we should distinguish autonomy and ordinary choice in my terms on kind of offering you

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a template for distinguish them just on the basis of kind of logical strength or theoretical sophistication.

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So autonomy, I take it, is a more demanding, more theoretically elaborate notion.

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Ordinary choice is really just a kind of plain notion.

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It's got no sophistication in it whatsoever. It's kind of funny that in the literature,

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people don't actually distinguish in the details between these two options much at all in the

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sense that they often use the language of autonomy when they come to spell out what they mean.

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Actually, what they're talking about is just ordinary choice in a way that's fine for me,

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because my point here is just we don't need any fancy theoretical apparatus to see that there's a value

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in ordinary choice in letting people choose what kind of information they receive or don't receive.

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And that just is the value in letting them have the right or the option to waive.

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OK, I'm skipping over that because I, on the one hand, take it to be a kind of commonsense notion.

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But on the other hand, I think the second argument, which is kind of manifestly different, is also a quite compelling that.

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I want to turn to that now. So this is an argument from what you might call institutional or regulatory design.

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And the problem space in which it arises is a kind of familiar problem,

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which centres exactly on the sort of calibration or formulation of the duty disclosure of the duty to disclose, rather,

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which is the question of, as a policy matter, what information should be singled out as the information that physician

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investigators are duty bound to provide as part of the informed consent process.

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So in this debate, which may be familiar to you already,

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the discussion typically precedes in relation to three possible standards by

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which we decide what the information required to be disclosed is going to be,

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one that's often called the professional practise standard.

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Second, it's called individual preference standard, and the third that's referred to by means of escape, mythical figure of the reasonable person.

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And again, in many American jurisdictions, anyway, as a matter of law, it's the reasonable person standard which is ultimately enforced.

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It's a part of the debate.

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It's just a question about what are the grounds for preferring the reasonable person standard to these other two standards as a matter of policy.

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So for my argument,

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the point to notice is that the reasonable person standard is in some sense a normalised version of the individual preference standard.

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It's normalised kind of in two different ways, one calling a normalised by way of being standardised.

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It's just sort of made to be kind of one rule, to fit all cases for the sake of simplicity.

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And in fact, part of the main argument for the reasonable person standard is just it's kind of,

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you know, administrative simplicity or non complexity in application.

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In principle, you could also see a. Reasonable person standard as a normative televised version of an individual preference standard,

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by which I mean that involves a certain amount of idealisation on the individuals in front of you with respect to what their preferences are,

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as opposed to just taking the roped kind of real world facts on the ground about

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what this person versus that person versus that person would prefer to know.

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OK, in practise, I think the main kind of argument and ways of settling on which information is going

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to be disclosed operate by just appeal to the standardised sense of normal lives.

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So the starting point of this argument is just to notice that, in fact, typically, as a matter of policy,

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the choice of standard to fix the content of the required disclosure is the reasonable person standard.

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And it's done primarily by appeal to the considerations that favour standardising the procedure,

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all the while acknowledging that in some kind of fairly clear sense, in principle, the individual personal preference standard would be better.

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It's just that it's kind of unwieldy or impractical and so not worth kind of implementing at the level of general policy.

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OK. What happens when you take the reasonable person standard in preference to the individual preference standard while considering the

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individual preference standard in some sense to be better or ideally the correct standard is that you introduce two different kinds of error.

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OK, in principle, on the one hand, you can have too much information in your standardised disclosure relative to a given individual's preference.

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Or of course, you could also have too little information in your standardised disclosure relative to give an individual's preference.

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And as anyone who has actually looked at some informed consent forms for research,

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you will know immediately the overwhelming bias in the kind of application of

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the reasonable person standard is to kind of lean towards the first error,

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having too much information in the standardised disclosure.

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Second argument for the availability of a waiver option is just an argument that says.

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Adding the option to waive provides an obvious and simple corrective for the too much information error,

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i.e. the one that is by far the preponderant error because it allows individuals

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to bring the information that they actually get under the standard policy,

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largely back to what the individual preference standard would actually say in the first place,

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but does so without the practical defects of the individual preference standard, for example,

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burdening physicians and assistants with the job of trying to find out in advance all of what exactly it is that this individual

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and then the next time that individual would prefer to learn if you have a standardised kind of overgenerous disclosure up front.

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But the option for individuals to peel it back in parts, in a sense, get the best of both worlds.

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And that is itself a kind of administrative argument for the availability of the waiver option.

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So like with the first plank of the argument for autonomist, of course,

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all of these considerations only operate pro tanto and leaving it open by appeal to some other kinds of considerations.

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You might have a countervailing case for the option to wait, but at least other things being equal.

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Both of the arguments put forward that are distinguishable from the consideration of autonomy also support the option to wait.

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So my conclusion is just both. If you're an autonomist and if you're not an autonomous,

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there's a reason to affirm or believe in the justifiability of the option to waive parts of the disclosure.

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Having that option is not consistent with insisting on the necessity of understanding the disclosure as a condition of valid,

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informed consent, and therefore we should reject that proposition.

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Thank you very much.