Hi there, welcome to today's St Cross seminar. The title of my talk today is Waiver or Understanding.
Dilemma for Autonomist is about informed consent. The thesis for which I like to argue today is that we should reject the requirement
that understanding the standard disclosure is a necessary condition for valid,
informed consent. This is a conclusion that I've argued for before in previous work.
But today I want to argue for the same old conclusion, as it were, with a completely different argument.
So just to give you a little preview, there will be five sections in the talk.
I'm going to start with a very brief background on some elements of informed consent.
And then I want to try to outline the core dilemma that's going to structure my discussion.
And I'll begin by doing that in a kind of abstract way.
And then I want to sort of motivate or fill in the background to this dilemma a little bit by describing some
stylised cases to give the idea that the sort of presuppositions of the dilemma are plausible and on that basis,
that they want to argue to different kinds of thing.
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,
justification for informed consent, have to accept a version of my conclusion,
which is that they need a new argument for a main piece of their position.
And then finally, as a sort of secondary argument, I want to sort of pivot and address the same structure to everybody else,
the people who don't begin by believing that autonomy has this privileged position in the justification
of informed consent and to try to convince them or you that the same conclusion should be accepted,
that I tried to urge on the believers in autonomy.
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.
One is the clinical context and the other is context of doing research, particularly randomised clinical trials in principle.
My discussion is general and applies across both contexts,
but I'm going to develop it primarily in the context of research, in the context of clinical trials.
More specifically, as you'll see,
I'm going to understand the requirement of informed consent has really been kind of composed or broken down into two primary duties,
one related to disclosure and the other related to consent, I take it.
And that's pretty standard fare. More generally.
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,
which I won't review in great detail,
but I'm just taking it that the disclosure requirement and the understanding requirement are two of these sort of five standard features.
And in a way, my concern is about how we should understand the relation between them as part of the apparatus of informed consent.
So the detail that really kind of gives the special colour to this version of the argument in this
apparatus is the focus I'm going to provide on the idea that it's possible for either patients or subjects
to waive the duties that professionals have in relation to them to obtain their informed consent and
in particular to disclose various bits of information to them before seeking to obtain their consent.
There's a reasonably good discussion about this in a legal textbook by Jessica Baird and colleagues
that primarily focuses on the clinical context and on the kind of common law background.
But I think it's a sort of reasonably accepted general feature that in many
jurisdictions there is this right to weigh some or all parts of the required disclosure.
This is one context. There'll be a number of them in which, you know, I'd be actually quite interested.
To hear whether there are differences in this regard between the U.K. jurisdiction and what, you know,
one may regard as standard truths in an American context that actually don't travel as well as some people might think.
So in a way, that kind of main point about this availability of the right option to waive some part
of the disclosure is that a subject who waives all or part of the standard disclosure,
at least in the kind of common case where the subject doesn't already independently understand exactly what's being reviewed in that disclosure?
Exercising their waiver basically guarantees that they will fail to understand the relevant parts of the disclosure.
So it's not just that there's a right or an option available to way, but that the consequence,
the predictable consequence of exercising it is guaranteeing that the subject fails to understand the disclosure.
So on that basis, you can see that kind of basic parts of the dilemma that I want to work with.
My main kind of overarching background claim is that in this context,
it can't both be true that understanding the standard of disclosure is a necessary condition of valid consent
to join a randomised clinical trial and also that there is a right or if you want to say more specifically,
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.
But the basic point is that given what the consequence of exercising the waiver is,
it can't both be true that you're required to understand the disclosure, but you have a justified right to waive it.
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
only operate over part of the disclosure and also that the claim that understanding is necessary may only be strictly true.
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
right to waive can't operate with respect to the same part of the disclosure on pain of getting an inconsistency.
OK, this assumes in the background, which I am assuming, and which also sounds pretty reasonable to me,
that the existence and justification for a right to waive presupposes that exercising that right nevertheless leaves the subject
or the prospective participant with the option of continuing on to agree to participate in the randomised clinical trial.
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,
which includes exercising that right, but nevertheless hanging on to the option to participate in the clinical trial.
OK, if. Consenting to participate in a clinical trial is a necessary condition of
participating and having valid consent is a necessary condition of consenting.
And if understanding is a necessary condition about consent, you run into the basic problem of this.
OK, so that is the kind of abstract background of the argument, as you will,
before I proceed to the argument, I just want to sketch in some kind of stylised cases,
you might say, to give you the idea that it's actually reasonable, at least sometimes for some people in some context,
for someone to want to do both of the two things that the arms of the dilemma address,
namely to want both to be able to waive all or part of the disclosure,
but nevertheless also to want to agree or to have the option of agreeing to participate in the relevant trial.
In the abstract, you might think, well, who would want to put these two things together?
That's kind of crazy.
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.
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.
In his book, he's developing a critique of something that he calls mandatory autonomy.
There's a way in which both kind of in the abstract, but also in the use of these cases.
The critique or the argument that I want to develop is structurally similar to Snyders.
The difference being that he's focussing on the case of individuals who want
to get the information relevant to make a decision to be properly informed,
but then nevertheless to have the option of not making the decision themselves,
letting someone else, a family member or the doctor, make the decision for them.
Whereas I'm interested in the sort of reverse scenario, someone who's not interested in having some or all of the relevant information,
but nevertheless is interested in not only making the relevant decision, but making it affirmatively.
That's to say actually deciding that they want to participate in a trial in a different,
different course is that his discussion and cases are primarily drawn from the clinical arena where,
as I say, I'm orienting myself to the research case.
But that argument is actually pretty generic.
So the second and third cases I'm going to give you are variants of what Schneider calls his divided self hypothesis.
OK, here's a case, a you might say the basic sort of generic case of this kind,
it's a case of a person whose conception of what information is relevant or important to his or her decision
differs in one or more ways from the conception that's been standardised in the uniform disclosure.
Not only that, but the person is conscious, perhaps because she's aware of the quite strong data on the ways in which
information overload can lead to poor or bad or even self-defeating decisions,
aware of the dangers of information overload and having a different set of preferences
in terms of what's really important information relative to the standard conception,
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,
but runs the risk of landing her with information overload.
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.
So I apologise for that.
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,
in particular as part of an informed consent for bio repository study.
And they, amongst other things, found some striking differences in the preferences as between kind of experts and laypeople,
in particular differences in their preferences as between IRBM members,
research ethics board members, and the subjects concerning which parts of the standard disclosure were important or relevant to include.
So I'm just going to give you one example, and this is the bit I apologise.
You have trouble reading. I can tell you what it says.
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,
95 percent of them rated this as extremely important,
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.
So there's, you know, roughly 40 percent difference between laypeople and experts in the importance of this particular item.
OK, case B, again, these are modelled on Schlyter. Remember, as a person patient subject who has a terminal condition,
some particular randomised clinical trial offers them the last and only chance at an effective therapy.
This is information that's both true and believed by the subjects and subject trusts her doctor.
But subject nevertheless fears that learning the details of the risk benefit analysis
for this trial will scare her off her kind of already made decision to enrol.
So for her, waiving that part of the information in the disclosure is part of a Ulysse strategy,
in effect, to kind of bind her to the choice that she's already made.
That variant of this case has the same structure, only the difference is that now the person is not a terminal patient,
but an altruistic volunteer who just doesn't care about the details of a trial.
Their interest in participating has to do with their altruism, their desire to further science.
And, you know, the details of what exactly they're signing up for don't matter to that decision.
But they do fear that learning about them, in particular learning about the risk benefit details will scare them off the decision to enrol.
And so, again, waiving that information is a kind of U.S. strategy that they adopt.
OK. As a general thesis, you may say, you know,
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.
But here, I think we could add particular details both about the trial and the individual to make this a rational attitude.
So, of course, sometimes you might say in scary cases, for example, and in standard cases of individuals,
the attitude in question may be questionable, but in many other cases it may also be perfectly reasonable.
OK, as a general matter, the point is there may be a perfectly good reason for the patient subject to adopt the utilities strategy,
and that's what would give her a reason to combine the waiver strategy with nevertheless wanting to enrol.
OK, so that is the basic set up to the whole argument now I'm going to give you these two different arguments.
One pitched more specifically at people who believe in the importance of autonomy for justifying informed consent.
And then later, I'll come back to a sort of variant of the argument addressed to everybody else.
So, again, this is the second point at which actually I'd be interested to hear if my description
of a part of the target is one that fits better in the United States than it fits here.
Certainly, I think it's fair to say that in the United States,
the standard default justification offered for the requirements of informed consent is an appeal to autonomy.
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
the entire doctrine of informed consent in all its sort of multiform details.
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,
namely the claim that understanding, the required disclosure is a necessary condition of valid informed consent to participate in a trial.
And maybe that, to my mind, it's actually quite hard to find a well-developed, articulated example of such justifications,
as opposed just to the claim or the assertion that autonomy plays this role in that justification.
But for the purposes of a target for this argument, that doesn't matter to me.
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.
You OK? And the way I would do that is by beginning,
not from the question what's required or is it possible to justify the requirement of understanding as a necessary condition?
That left part of the dilemma.
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,
or more specifically, in a way, the justified option to waive the disclosure.
It's actually not important for my discussion whether we conceive of the option
to waive the disclosure of something that properly qualifies as a right.
And in particular, I want to say. The argument should begin by asking from the standpoint of autonomy,
how does a justification for having the option to waive the disclosure fair in general terms that I want to argue or suggest,
is that a justification for having the option to waive the disclosure is actually quite
easy or straightforward to justify in relation or by reference to the value of autonomy.
I want to give you two different examples of attempts to sketch in some such justification.
So the first attempt focuses on the fact that using or exercising the option to waive the
standard or part of the standard disclosure is a straightforward exercise of autonomy.
It's making a choice over the conditions of one's own life.
More specifically,
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,
in particular as an attempt to shape the conditions, to bring them better into line with one's own kind of values and preferences.
That description is using the waiver is an exercise of autonomy holds,
even if it turns out that a consequence of that decision is that some later choice one makes.
For example, the choice to enrol in the trial turns out to be less autonomous because, for example,
it turns out to be less informed and on the assumption that you think information or information is a condition of autonomy.
This all to the good just because it's perfectly coherent and possible to decide
autonomously to accept a limited loss of autonomy on some occasion in the future.
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.
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,
but in particular can't be justified by reference to the value of autonomy.
So one can accept that and even something weaker than that,
while still insisting that some choice to accept a limited loss of autonomy in the future is not only both possible,
but remains itself an exercise of autonomy.
Of course, one might insist in line with this position.
I take it the opponent will insist that as an autonomous choice,
the choice to waive the disclosure or some part of the disclosure itself has to be made under certain conditions,
and these conditions might well include understanding of relevant parts of information.
OK, so I'm happy to accept that that's consistent with the claim that it's both coherent and justified autonomously to decide
to accept a larger loss of autonomy in the future as long as the information that's required for the first choice.
The choice of the waiver to be autonomous is different from the information that's required for the later choice,
say the choice to enrol and the trial is required.
And on the face of it, I think that both looks correct and perfectly sensible.
So I go to an example in a minute. But more generally, the argument is.
If those two sets of required bits of information overlap,
then insisting that the choice to waive the disclosure can only be made autonomously if it's informed
in a way that actually will remove or obliterate the later choice is somewhat kind of incoherent.
But in any case, I think we can just by example and description, show that those two sets of information conditions are distinct.
So, for example, it may be that as part of deciding autonomously to waive the risk benefit information for a particular randomised controlled trial,
one is considering joining. One has to be told that the trial does have specific risk benefit ratio.
And if one waives that part of the disclosure, one will be ignorant of what that ratio is.
That's one kind of information. And you may need to receive that information in order autonomously to waive the disclosure.
Nevertheless, what's required, you know, in the standard view to autonomously enrol in the trial itself is a different piece of information,
namely the actual details of what the risk benefit ratio for that trial are.
OK? And so one can be given the information needed to make the waiver choice
autonomous without yet being given the information that one is trying to avoid.
And that's meant to be required for the enrolment. So these two pieces of the puzzle remain coherently fit together.
OK, that was one kind of way of trying to show how, from the standpoint of autonomy,
having the option to waive part of the disclosure is perfectly justifiable.
Here's the second kind of differently formed detent.
If you're presented with some individual who,
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,
if we deny this person, I guess that change the person's gender in the middle,
if we deny this person the option, that is tantamount to forcing her to receive the standard disclosure or at least forcing
her to receive it on pain of losing the option to enrol in the randomised clinical trial.
So a different way to put the second point attempt is to notice that denying people the option to waive the
disclosure in the case when they don't want to receive it is equivalent to forcing them to receive the disclosure.
So it's one question whether it's possible to justify forcing someone to receive the standard disclosure, as we'll see.
I'm happy to leave that question open. My point here,
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,
because this is equivalent to forcing her to decide under conditions that she rejects,
which is not a description that's consistent with the content of autonomy, let alone its value.
So here's where we go back to this phrase, mandatory autonomy.
And I kind of overlap to some extent in my argument with Schneider's critique.
So in this sense, part of the point is the idea of mandatory autonomy is a kind of contradiction in terms.
And unless we can reconcile or rescue that contradiction,
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,
as I say. It's a separate question whether there's a different argument that appeals to something other than autonomy,
a different value or different set of considerations,
that yields the conclusion that actually it's justified, all things considered, to compel unwilling subjects to receive kind of required disclosures.
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.
So let me go back to the dilemma in my title recall.
My suggestion is that the dilemma has the form of these two.
Horan's on the one hand, you can't have the idea.
You can't affirm that understanding is necessary as a condition about consent to join a randomised controlled trial,
while also affirming that there's a justified right or option to waive the disclosure.
Those two things are inconsistent, I claim, and so they can't both be justified.
What we've just seen the conclusion of this first line of argument is that there's a quite good,
perfectly compelling justification that begins in the value of autonomy and ends as a conclusion on the right portion of the dilemma,
namely the conclusion that there is a justified right to waive the disclosure.
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,
is that we cannot also appeal to autonomy to justify the conclusion that understanding is a necessary condition without consent.
So this kind of run of the main argument has a very simple form.
There are two propositions that are inconsistent. Autonomy yields a very good and straightforward justification for the second of these propositions.
Therefore, autonomy can't also be seen as the justification for the first of the propositions.
Can't also be seen as the justification for holding understanding to be a necessary condition of informed consent.
If therefore just spelling it out,
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.
My conclusion is you,
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.
Again, I'm happy to leave open on this plane an argument whether there's a different justification for this conclusion, I reject.
But my main point is the autonomy based justification can't be it.
Last little wrinkle on this kind of autonomist orientated part of the argument,
so I referred at the beginning to this textbook by Jessica Baird and colleagues,
this is going to be a perhaps funny use of the expression in fairness to but in fairness to them.
And it's kind of a striking feature of their discussion. I think they recognise all of the main elements of this argument,
namely that what I'm calling the right and left horns of my dilemma are two inconsistent
propositions that autonomy supports one of these two inconsistent propositions,
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.
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,
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.
OK, so we've come through four fifths of the structure and we've covered, as it were,
the main plank of the argument, which is meant to be addressed to believers in autonomy.
Nevertheless, I want also to kind of complete the tour, as it were, of the audience.
I want to address a similar argument to those of you who may not believe,
maybe never believed from the beginning that autonomy was the key to justifying elements of the informed consent.
Doctrine or a set of duties, so I'm going to skip over this like it's really just saying what I covered.
I want to shift now to talk about the people who think that the basis for the justification of informed consent lies elsewhere.
This second argument is going to be anchored in the same material in the sense that the thin end of the wedge
I want to drive is just the observation that the right and left horns of this dilemma are inconsistent,
or that these two propositions about informed consent are inconsistent and.
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.
It's just that I want that argument now to run forward on grounds that have nothing to do with autonomy.
That's the difference between the bit that's addressed to autonomous states and the bit that's addressed to other people.
So the two kind of alternate drivers that I want to put forward are quite different from each other.
How different this first one is from autonomy in effect,
I think depends on how precise or detail oriented you are in the formulation of what counts as autonomous.
So the first driver just appeals to what I would call the value of ordinary individual choice,
by which I mean nothing more kind of elaborate than the value of letting people decide certain questions
for themselves instead of making the outcome or decision be mandatory on the basis of some regulation.
And for my purposes, it doesn't really matter.
I think it's a host of, you know, general consideration that speak in favour of ordinary individual choice, starting with, you know,
what I'm calling and slide the old million saw,
which is just that people are the best judges of their own interests, or at least maybe slightly more considered.
By and large, for the most part, people are the best judges of their own interests.
So the value of ordinary individual choice also favours having the option to waive the disclosure of an informed consent here.
That's what I was alluding to at the beginning.
I'm presupposing that we should distinguish autonomy and ordinary choice in my terms on kind of offering you
a template for distinguish them just on the basis of kind of logical strength or theoretical sophistication.
So autonomy, I take it, is a more demanding, more theoretically elaborate notion.
Ordinary choice is really just a kind of plain notion.
It's got no sophistication in it whatsoever. It's kind of funny that in the literature,
people don't actually distinguish in the details between these two options much at all in the
sense that they often use the language of autonomy when they come to spell out what they mean.
Actually, what they're talking about is just ordinary choice in a way that's fine for me,
because my point here is just we don't need any fancy theoretical apparatus to see that there's a value
in ordinary choice in letting people choose what kind of information they receive or don't receive.
And that just is the value in letting them have the right or the option to waive.
OK, I'm skipping over that because I, on the one hand, take it to be a kind of commonsense notion.
But on the other hand, I think the second argument, which is kind of manifestly different, is also a quite compelling that.
I want to turn to that now. So this is an argument from what you might call institutional or regulatory design.
And the problem space in which it arises is a kind of familiar problem,
which centres exactly on the sort of calibration or formulation of the duty disclosure of the duty to disclose, rather,
which is the question of, as a policy matter, what information should be singled out as the information that physician
investigators are duty bound to provide as part of the informed consent process.
So in this debate, which may be familiar to you already,
the discussion typically precedes in relation to three possible standards by
which we decide what the information required to be disclosed is going to be,
one that's often called the professional practise standard.
Second, it's called individual preference standard, and the third that's referred to by means of escape, mythical figure of the reasonable person.
And again, in many American jurisdictions, anyway, as a matter of law, it's the reasonable person standard which is ultimately enforced.
It's a part of the debate.
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.
So for my argument,
the point to notice is that the reasonable person standard is in some sense a normalised version of the individual preference standard.
It's normalised kind of in two different ways, one calling a normalised by way of being standardised.
It's just sort of made to be kind of one rule, to fit all cases for the sake of simplicity.
And in fact, part of the main argument for the reasonable person standard is just it's kind of,
you know, administrative simplicity or non complexity in application.
In principle, you could also see a. Reasonable person standard as a normative televised version of an individual preference standard,
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,
as opposed to just taking the roped kind of real world facts on the ground about
what this person versus that person versus that person would prefer to know.
OK, in practise, I think the main kind of argument and ways of settling on which information is going
to be disclosed operate by just appeal to the standardised sense of normal lives.
So the starting point of this argument is just to notice that, in fact, typically, as a matter of policy,
the choice of standard to fix the content of the required disclosure is the reasonable person standard.
And it's done primarily by appeal to the considerations that favour standardising the procedure,
all the while acknowledging that in some kind of fairly clear sense, in principle, the individual personal preference standard would be better.
It's just that it's kind of unwieldy or impractical and so not worth kind of implementing at the level of general policy.
OK. What happens when you take the reasonable person standard in preference to the individual preference standard while considering the
individual preference standard in some sense to be better or ideally the correct standard is that you introduce two different kinds of error.
OK, in principle, on the one hand, you can have too much information in your standardised disclosure relative to a given individual's preference.
Or of course, you could also have too little information in your standardised disclosure relative to give an individual's preference.
And as anyone who has actually looked at some informed consent forms for research,
you will know immediately the overwhelming bias in the kind of application of
the reasonable person standard is to kind of lean towards the first error,
having too much information in the standardised disclosure.
Second argument for the availability of a waiver option is just an argument that says.
Adding the option to waive provides an obvious and simple corrective for the too much information error,
i.e. the one that is by far the preponderant error because it allows individuals
to bring the information that they actually get under the standard policy,
largely back to what the individual preference standard would actually say in the first place,
but does so without the practical defects of the individual preference standard, for example,
burdening physicians and assistants with the job of trying to find out in advance all of what exactly it is that this individual
and then the next time that individual would prefer to learn if you have a standardised kind of overgenerous disclosure up front.
But the option for individuals to peel it back in parts, in a sense, get the best of both worlds.
And that is itself a kind of administrative argument for the availability of the waiver option.
So like with the first plank of the argument for autonomist, of course,
all of these considerations only operate pro tanto and leaving it open by appeal to some other kinds of considerations.
You might have a countervailing case for the option to wait, but at least other things being equal.
Both of the arguments put forward that are distinguishable from the consideration of autonomy also support the option to wait.
So my conclusion is just both. If you're an autonomist and if you're not an autonomous,
there's a reason to affirm or believe in the justifiability of the option to waive parts of the disclosure.
Having that option is not consistent with insisting on the necessity of understanding the disclosure as a condition of valid,
informed consent, and therefore we should reject that proposition.
Thank you very much.