Thursday, September 12, 2002
Session 1: Toward a "Richer Bioethics" 4: Science and
Discussion of Hans Jonas' essay; "Philosophical
Reflections on Experimenting with Human Subjects."
CHAIRMAN KASS: At this
meeting we continue our discussion of two topics that have
been afloat for several months, topics under the general rubric
of regulation, topics under the general rubric of enhancement.
Neither of those titles are strictly accurate, but you all
know what I'm referring to.
As an introduction in a way to the further consideration
of both of these topics, I have asked Council members to read
for opening discussion Hans Jonas' classic paper on "Philosophical
Reflections on Experimenting with Human Subjects."
There are a number of reasons why we thought that this is
a good idea. First of all, the ethics of experimentation with
human subjects is a critical moral point in which science
and ethics intersect and in which one has a look at the relation
between the scientific enterprise and the social values.
The goals of medical progress run up against our concern
for the inviolability of the human person, and this is a place
where society, usually with more-than-willing collaboration
of scientists and physicians, erect restrictions, mostly procedural,
on what scientists and physicians may freely do to human beings.
Second, those institutional arrangements and procedures for
protecting human subjects are also instances of the attempt
to put principles into practice. The Institutional Review
Boards, which will be the subject of our discussion in the
second session, are the places where we try to give effect
to the moral concerns that society has, concerns that express
themselves in procedures for recruiting subjects, for securing
consent, and for monitoring results.
It is well to keep in mind, as we think about current efforts
to reform the Institutional Review Boards, what the moral
principles and what the human goods are that we are eager
to protect and promote. So that the first session today will
be largely philosophical; the second one will be largely institutional.
It is important, I think, as we think about each, to keep
the other in mind.
Third, it does seem to me that both with respect to the ethics
of experimentation, but also with respect to all of the things
that are of interest to this body, it is important that we
try to become self-conscious about what exactly it is that
we are trying to protect in these discussions. Of course,
we are trying to protect human health and safety. We are trying
to promote medical progress. We are interested, of course,
in not violating people's freedom, as expressed in our concern
for their consent.
But the question is, is that the whole story? Are there other
things having to do with human dignity that are of importance
here? And that consideration is relevant to the ethical aspects
of all of our work, including, for example, things that might
concern us in the area of using mood-altering or personality-altering
drugs, the topic of our discussions this afternoon.
So it seems to me, for all of those reasons, a look at the
kinds of issues raised by Hans Jonas in this essay seems an
appropriate way to begin this meeting.
Let me introduce the discussion of the paper with at least
one person's formulation of what I think he's about in this
paper. It's a dense paper, and it's not the easiest thing
to read and follow.
But let me at least state what I take to be the question
at issue and something of the way in which Jonas tries to
work his way to an answer to this question, and then throw
it open for comment and discussion and see where we go.
I think the point of departure is on page 107 in the paper,
where Jonas points out that human experimentation, for whatever
purpose, is always also a responsible, non-experimental, definitive
dealing with the human subject himself, and not even the noblest
purpose of such experimentation would abrogate the obligations
that this involves.
So he wants to put the conflict in these terms: On principle,
it is felt human beings ought not to be dealt with as mere
subjects. On the other hand, these dealings are increasingly
urged upon us by considerations also appealing to principles
that claim to override the objections of treating human beings
in this way.
And he goes on to state what is for him the most serious
difficulty, down toward the bottom of the page. "What is wrong
with making a person an experimental subject is not so much
that we make him thereby a means, which happens in social
contexts of all kinds, as that we make him a thing, a passive
thing merely to be acted on and passive not even for real
action, but for token action whose token object he is. His
being is reduced to that of a mere token or sample."
And he goes on to distinguish being conscripted as a subject
for experiment and being conscripted as a soldier for war,
while though you're still subject to someone else's orders
and are still a means, nevertheless, are still acting in the
way in which you understand yourself to be acting and as an
Now the question of the paper is: What in the world could
be of sufficient weight to justify treating human beings in
this way? And I won't rehearse much of the analysis except
to say that he doesn't find the answer sufficient in the notion
of a social contract or even in the notion of health as a
public good, because averting a disaster is different from
promoting a good, and that medical research, though it falls
in between, seems to be closer to the second than the first.
That, to be sure, society has adopted medical progress as
its cause, but that the goals, however important they are
for the professionals and urgent for the patients, nevertheless,
medical progress is societally gratuitous, however noble,
and in an interesting move, suggests that even when one goes
out to appeal for consent and solicit volunteers for research,
one is engaged in something that he calls semi-conscription
— semi-conscription — in which in fact, and he doesn't elaborate
on this, but the moral authority of the physicians, the moral
authority of the people in the white coats, and the desire
to please those upon whom one is dependent for help makes
this not absolutely a free and innocent request, however well-meaning.
And the solution is somewhere to be found in his remarkable
discussion where he says, the ideal would be the self-recruitment
of scientists and where there would be the maximum motivation,
the fullest understanding, the freest and most spontaneous
decision, integration of this choice into one's overall life
project, and, most important, the identification
of the research subject with the purpose of the experimentation.
It's that last idea which seems to have gotten lost, speaking
now editorially, from the concern purely with consent, which
is the granting of permission.
There are things that follow for research, the descending
order of who's available and the like; no research on diseases
not relevant to the patient. But it points to a kind of ethics
of research that goes beyond just calculating benefits and
harms, and even beyond merely giving permission and consenting,
to something that seeks to do justice to the human person
whom one is, nevertheless, inviting into this project as perhaps
a co-partner in experimentation.
I wonder, I mean I don't think that's an unfair summary.
There's lots of richnesses that have been left out, but I
think I take it that's the shape of the discussion. I wonder
to what extent we find this paper, written now almost 35 years
ago — it was written in 1968, published in 1969 — whether
this strikes us as sound and whether it offers an adequate
ethical foundation for thinking about this subject.
PROF. MEILAENDER: Let
me just pick up really with what you noted in the paper. I
mean, this paper, it is one of those rare papers that at least
I think is sort of so profound that one would be glad to die
having written it, kind of.
But I want to think about the problem that you highlighted
there. I mean, the way he puts it, the difficulty with recruiting
research subjects is that it, as it were, "thingafies" the
person, which is a little like the concept of alienated labor
actually, I think, in the sense that the person is used for
an alien cause, not fully one's own, in which he or she is
not fully invested, something like that.
Then the question is, how can you make that a human endeavor
that fully dignifies the person? And the interesting thing
to me, you mentioned it, is that the Holy Grail of consent
doesn't seem to be a sufficient answer, as far as Jonas is
concerned. Not that it's unimportant, of course. I mean, he
doesn't want to suggest that we should ignore it, but it is
interesting to ask why it is insufficient.
I think it is, as it were, too negative. It only protects
the person against abuse, and that alone doesn't overcome
the problem of alienation, the problem of not being fully
invested in the undertaking. That is where you get the principle
of identification that you pointed to.
If you say, "Why is that so important?", it is because this
descending order that he sorts out is a way of trying to see
to it that we at least first attempt to recruit those most
fully able to identify with the project, which is probably
almost the reverse of the way we actually go about doing it
most of the time these days.
I think he even says it at one point: that, I mean, really
it comes up in the discussion of why you wouldn't use patients
as research subjects on something wholly unrelated to their
disease. It is because you would be tempted to use them because
they're handy in a way. What you are trying to avoid is simply
using someone because he's handy, because then that person
is in a certain sense alienated from it. Only that principle,
which somehow goes beyond just the sort of negative understanding
of consent as protection, can deal with the "thingafying"
I think that's, even apart from the context of research,
an interesting notion to puzzle over and contemplate a bit.
It may relate to a whole variety of other issues, some of
which we'll take up, because in a certain sense we might describe
Jonas as asking the question: How do we think about the presence
of the person in what we do in or to the body, or in what
we take into the body?
Overcoming the "thingness" is a way of asking about what
it means to be personally present and invested, not alienated
from, the action that we undertake. I mean, I don't know how
to make all the connections with other questions, and maybe
they can't be made necessarily in advance entirely, but that's
an issue that has kind of a larger resonance than just questions
about experimentation, and in that sense it seems to me we
can think about what Jonas says with respect to experimentation,
but he's also driving toward something that cuts deeper and
will involve or will be involved in lots of other questions.
CHAIRMAN KASS: Paul?
DR. MCHUGH: I can't add
a lot to what you've said already, but I want to just give
a couple of examples of how at all of our hospitals there
are monuments to people who were scientists and who did contribute
themselves to this work.
At Hopkins there's a large plaque to Jesse Lazear, who was
one of Walter Reed's group in the yellow fever expeditions
and died as an experimental subject. He was a young physician
But perhaps the one that's not known and yet is perhaps the
most distinguished human subject at Hopkins was William Halstead,
the first surgeon, who in his early career, interested as
he was in peripheral anesthesia, did experiments on himself
and on others of his colleagues with cocaine as a peripheral
anesthetic, ultimately opening up the whole sphere of peripheral
anesthesia and dental anesthesia for our benefit, but in the
process developing tremendous addiction of himself and on
some of his young friends, several of whom died. Halstead
was fundamentally carried as an addicted victim throughout
the rest of his career by people like William Welch and William
So the one great advantage of the lineage that Jonas lays
out here is that it's been done, and in the process of being
done, does show us what can happen to an experimental subject
in the most dramatic ways.
We honor them and the plaques for Lazear and our knowledge
about William Halstead, of course, encourage us when we're
asking other people and ourselves to contribute to similar
CHAIRMAN KASS: Janet?
DR. ROWLEY: I'd like to take a somewhat
different approach to this, and I'm sure it is because, though
I do not myself treat patients, my colleagues do, and the
patients they treat are those with cancer and leukemia. Very
often, these patients have tried all of the standard treatments
for their disease, which seems to continue sort of relentlessly
progressing. They are often the main protagonists for what
is new: What can you give me that might even give me some
remote chance of cure?
So the patient as sort of a partial victim, as is portrayed,
I think may be true for some studies, is certainly true for
some studies, but I think that it totally loses sight of those
cases in which patients are desperate for any straw of hope,
and they are more than anxious to participate in experiments
that might give them some benefit, but also benefit patients
in the future who have the same disease.
Certainly, for the treatment of childhood leukemia and a
number of other cancers, the remarkable treatment successes
we have now are built on those patients. I think that's totally
lacking in this analysis.
CHAIRMAN KASS: Just to this point, Alfonso,
DR. GÓMEZ-LOBO: It is my understanding
that Hans Jonas does take that into account. For instance,
on page 127 he says, "Introduction of an untried therapy into
the treatment where the tried ones have failed" — where the
tried ones have failed — "is not experimentation on the patient."
In other words, he excludes that as an instance of experimentation,
it seems to me.
CHAIRMAN KASS: Gil, to this?
PROF. MEILAENDER: Yes, right to this. I
think we would want to ask a question, Janet, in the kind
of circumstances you describe, whether the person is, to use
the language I used before, fully invested in this undertaking
as a research subject or as a desperate person hoping for
If the researcher is involved in what he or she thinks is
research, and the person is invested in it not simply as a
research subject but as a desperate person grasping at a last
straw, the researcher's purposes may be somewhat alien from
those of the subject. I mean, so we still have to think about
that concern that Jonas has.
DR. ROWLEY: But is that really — I mean,
I guess you are in territory where I'm on very weak grounds
in terms of trying to think of the concepts, the nuances,
and the dividing line between these. I'm not even sure that,
for at least some of my colleagues in their work with untried,
experimental therapies, but which have some rational basis
— I mean, these aren't just picked off of somebody's shelf;
they've all gone through both a fair number of trials in other
animals, in animals before you approach patients — how to
separate out the scientists' desire to learn and to see if
this is going to be beneficial for the patient and his desire
as a physician to do the best for that patient, that's a nuance
I think I can't deal with.
PROF. MEILAENDER: Just really quickly, I
mean I agree it is very difficult and probably can't be separated
out and sorted out sometimes. All I wanted to point out was
that nobody is handier than the desperate man.
Insofar as that's Jonas' concern, one would have to continue
to worry about the intersection of those two sorts of roles,
DR. ROWLEY: Yes, but at the same time, if
you're not desperate, you're not going to be willing to be
a part of something that is experimental and untried, and
things come with terrible toxicities, as we all know from
any friend who has had cancer and been treated. So I don't
know; it's a very gray area, I think.
CHAIRMAN KASS: Rebecca?
PROF. DRESSER: I was just going to comment
that there's been some interesting research done actually
by the University of Chicago physician researchers on Phase
I oncology trials. I think the contemporary concept that people
try to use in a formal way to go beyond just permission to
be a study subject, it's informed and voluntary consent. I
think in the abstract it sounds nice, but there are a lot
of studies showing that many subjects don't have the kind
of understanding that I certainly would like them to have.
In these Phase I trials, somebody looked at a number of trials
and said they have about a 4 to 6 percent chance of directly
benefiting the subject, and in terms of direct benefit, that
doesn't necessarily mean extended life or even palliation.
It's just tumor shrinkage. When they asked people who participate
in these studies about possible benefit, many of them cling
to that belief, that there's something in there that's going
to help them as individuals.
Zeke Emanuel has written on this. So maybe he can comment.
But this thing called the therapeutic misconception, where
people who are in studies confuse what's going on to advance
knowledge with their personal treatment, is a serious problem
I think in Phase I trials, at least in actuality.
DR. ROWLEY: I think Chris Daugherty and
others have certainly looked at this. See, I think, again,
you have to put it in the context in which these studies are
done. You're a physician; you treat patients, a very large
proportion of whom are going to die. You are trying desperately
to advance things. So it's true, you have a personal, psychological,
vested interest in trying to come up with something miraculously
which will change the situation, so you just don't go in and
see one dying patient after another, which when my colleagues
come off of the service, they're devastated emotionally for
the trauma that they have experienced during the month that
they've been on this intensive service.
So these are human activities carried out in very real, desperate
circumstances. I think to dissociate the reality from, or
to dissociate our dissection from the actual reality, makes
this a somewhat unreal exercise.
CHAIRMAN KASS: Let me comment just briefly
on that. I would underscore Alfonso's pointing to that place
in the text where one acknowledges that desperate people in
desperate situations, eager for cure, treated by people profoundly
eager and willing to help them, can participate in things
that are very risky with very uncertain promise of gain.
But even so, I guess the question is, in what way does one
approach these people and what is it that one is — what of
their humanity, in addition to their pain and suffering, is
one also trying to respond to? I think that's partly the concern.
If one simply says, "These are the only subjects that are
possibly available to advance our knowledge," however true
and necessary that is as a condition for using them, the question
is whether it's sufficient and whether one doesn't want to
try in some kind of honest way to elicit their identification
with the enterprise and not simply exploit their desperation.
It's not an objection to proceeding with that research, but
the question is: How should they be regarded? How should they
be treated? How should they be spoken to?
I think Jonas is suggesting that merely getting the consent
form filled out as a permission to subject one's self to the
risk is a formal procedure that might point to something else,
but by itself isn't sufficient.
DR. ROWLEY: Let me just respond to that
because this is a situation where I believe some of his perspectives,
at least in some circumstances or some hospitals and teaching
centers, has changed. It is certainly true over the last decades
that our own informed consent sheet that a patient signs has
gone from a simple, one-page form to about a five-page form
that you would need a college education to understand. You
are dealing with many patients who do not have that level
We have specially-trained nurses who talk with patients,
try to explain all of this, but it is not simple. I'm not
saying that medicine and physicians and individuals conducting
this kind of research should not be even more attentive to
patients, but I have to say, as an observer of what goes on
in hematology/oncology at the University of Chicago, that
I think that the physicians and the nurses bend over backwards
to try to make sure that the patient understands the risks.
Of course, many patients decide they don't want to do that,
and there is no pressure on those patients to participate
if they say, "I've been through two years of treatment and
here I am, and I accept my fate and will deal with it."
But I am also certain that there are many places where this
has not been emphasized as much as it is in some of the teaching
hospitals where these concerns are probably much more applicable.
CHAIRMAN KASS: Thank you. Alfonso and then
DR. GÓMEZ-LOBO: I'm going to step
back a little bit in the discussion and try to go back to
the basic philosophical framework.
Needless to say, I was delighted when I saw that Leon had
included the article by Jonas. I had the good fortune of hearing
Professor Jonas deliver a lecture at the University of Turin
many years ago, and I was very, very impressed.
Now this is a wonderful paper because here we have someone
whose main concerns were really abstract, philosophical thinking,
and he's invited to think about the problem of experimenting
on human subjects. It's admirable how he carefully sorts out
all of the different issues, different possibilities, and
at the same time I think is very careful to preserve the genuine
interests of promotion of medical knowledge.
Now reading this article in the present times, it seems to
me that there are two very important differences in the setting
for the paper and the setting in which we find ourselves.
Let me just go into two of them: difference in the facts and
difference in the ethical approach.
With regard to the facts, of course, we have gone already
through the Tuskegee scandal, et cetera, and we all know that
there are these very serious efforts to overcome questions
of consent, informed consent, that the people know exactly
what they are going to be subjected to.
Now this assumes that we are talking about adults as the
objects of research in the paper. However, as we know from
our previous discussion of cloning, the big problem today
is having human subjects, say, at the embryonic stage, who
of course would be experimented upon without there being any
chance of consent or something of that sort. So that creates
a totally new situation, it seems to me.
Now the second difference I think is this: Again, I point
back to our previous discussions. All of these trials that
Jonas has in mind are, of course, therapeutic, and he insists
that there be therapy in the benefit of the sick person herself,
and that's what prompts this extension of saying, well, in
certain cases, when some therapeutic means have failed, of
course, one goes further for some kind of experimental treatment.
From a moral point of view, it seems to me that's perfectly
reasonable and permissible.
But from the stem cell research issues that we dealt with,
there we are in a different situation. The human embryos are
being destroyed, which of course is very different from what
Jonas had in mind. In other words, there's intentional action
there of a sort that he never even imagined, it seems to me,
at least from this paper.
Now the second area where I think it is remarkable and what
a different situation we find ourselves is, as I said, on
the philosophical framework. It seems to me that Jonas takes
clearly a Kantian approach. He has the philosopher Kant in
the back of his mind, because he assumes that the first principle
is that one should not reduce a human being to a thing or
mere means, not just means but mere means, and he says, well,
in order to violate this, we need very, very, very strong
reasons and unusual circumstances, and he adds lots of qualifications.
That's why he mentions war and mentions such other things.
Now if we think about our predicament today, it seems that
the reverse holds: that what is socially accepted is the goal
of promoting health and well-being, and it is the other principle
that then needs justification. In other words, how can you
justify not using, say, certain human organisms, if or since
they are going to lead to all of these benefits? So it seems
to me that that is extremely important in order to understand
the direction of the moral debate that this article generates.
CHAIRMAN KASS: Gil, to this or what? Well,
if this is a direct response to Alfonso, yes; otherwise, there
was a queue. Okay, Mary Ann, I'll just put you in.
PROF. GLENDON: Okay, this
is a somewhat different subject, but this article was written
in 1969. So much has happened, not only in terms of scientific
and technical advances, but also changes in the culture, that
I would be curious to know — and I think the other non-scientists
would be curious to know — about whether there have been
significant shifts in scientific opinion on some of the problem
points that Jonas raises.
I mean, to be quite concrete, when you get to be a certain
age and you go to a physician, and all of a sudden your physician,
she looks like she's 14 years old, but she's probably 30,
but, nevertheless, you can't help but wondering, what kind
of culture has she picked up in medical school and what does
she think about these issues that Jonas discussed in a certain
way in 1969?
So I have three points that I would be curious to know whether
anyone can enlighten us on, whether there have been significant
shifts in scientific opinion. The first is where he mentions,
as a somewhat peculiar point of view expressed at a conference,
someone said, "Society cannot afford to discard the tissues
of the hopelessly unconscious patient." And he raises the
question, well, wait a minute, what does that say about who
owns these tissues, if you talk in terms of discarding and
That put me in mind of the discussion that goes on in my
state, Massachusetts, which I realize is somewhat exceptional.
We have organ donor cards that we may sign when we get our
driver's licenses where we can give consent to have our organs
taken, but there's some discussion about whether it wouldn't
be better to just have a presumption that people's organs
are available unless they sign a card that says they don't
want their organs taken. It really reverses this presumption
that Jonas is talking about in the area of experimentation.
So that's one point about which I'm curious, whether there's
some widely-shared view about whose decision this ought to
be and what the presumptions ought to be.
Then, secondly, Jonas proposes very strongly that, not only
as we have been saying there's an ideal subject for human
experimentation, but that there is a category of subjects
that are the least morally-justifiably subjects and those
are the people who are least informed and least free. I wonder
there whether we are seeing an increasing sense that actually
that last category is the one that's most available because,
well, as Gil said, because they are available.
Then, finally, the definition of death and the warning that
he issues that there will be enormous pressure to alter the
definition of death, so as to make more subjects available.
CHAIRMAN KASS: Does someone want to join
directly these questions? Interestingly, Mary Ann, those are
all things that would fit with Alfonso's comment earlier,
where Alfonso suggested that his view of the cultural shift
is that what is taken as the given is in a way the imperative
or the necessity of medical progress or the saving of lives,
and that the burden now falls on those who would object in
the name of, say, the dignity of the person, something of
that sort. I think it would take all three of your examples
and make those specific instances of where his claim could
Does someone want to join, respond to Mary Ann? Paul?
DR. MCHUGH: Yes, I would like to respond
to both Alfonso and Mary Ann, but perhaps to begin, to say
that I think that there has been an important and, to some
extent, a very useful cultural change that has occurred over
the last 50 years and that relates a bit to what Jonas is
saying but carries it another step.
You see, I agree with you that there's a Kantian thing here,
but Jonas is calling for virtues, and virtues, Aristotle said,
are tied to practices. The practices have been enhanced. What
Dr. Rowley was saying is that we have seen wonderful things
happen for our patients and for our world and for ourselves,
and in that process a lot of us, patients, citizens, as well
as physicians, have said, "We want to join these practices
because they do call for virtues." Yes, virtues of the doctor/patient
relationship, but also virtues of the subject, and that we
want to be part of that.
We want to have this grace or virtue that we'll take part
in this great advance that has occurred for our patients,
our cancer patients, our endocrine patients, our heart patients,
our hypertension patients. I mean these are wonderful things
that have come forward, and lots of us have begun to think
about how we could be part of that virtuous practice.
In that way, to some extent, we can go too far. I agree with
you, we can go so far as to sweep by the people who don't
understand what we're doing.
Now in my case in particular, after all, I am often talking
about asking patients who are mentally disturbed to help take
part, and that's a big problem that Jonas doesn't take into
account here. He never mentions it and the like.
I also agree that there is besmirching of this virtue when
grants, indirect costs, paying of subjects, and things of
that sort come into play as well.
But at an important level, the culture has changed, and changed
to advantages, because of the things that we have worked on.
We should be talking about the virtues that are implied in
the practice of this kind of research and avoiding the pitfalls
that are here.
CHAIRMAN KASS: Is it your suggestion, Paul,
that for the most part subjects that are recruited or volunteer
for research are really entering in the spirit of identification?
When you say that they want to join in this virtuous activity,
that it's not just they give permission to run certain risks,
but that they become, to use Paul Ramsey's phrase, co-partners
in the experimentation?
DR. MCHUGH: I think that's far more true
now than it was 50 years ago, as people have heard about the
things which are potentials and which are happening. I must
say they can be greatly taken advantage of. They can be abused.
They can be given consent forms that, as Janet said, require
a college education.
By the way, I think all IRBs now know that fact and submit
the consent forms to these computer techniques that tell you
what grade level you have to have to understand it, and show
you that, you know, that you can have really impressive ideas
that are at the third or fourth grade level. I mean, the Psalms
are a good example of just how wonderful they can be, but
that's a sideline.
But I do think that the issue of virtue and the acceptance
that we have been not only great beneficiaries, but in a sense
a common legion to attack the problems of illness in our society,
in our world, is a broad theme in the citizenry, and that
many patients come forward with that sense of being part of
the process with the doctors.
For all the things that Jonas warns us about, I do think
that Janet is onto something when she says, gee, you know,
talk about this context, and this context is very broad on
DR. ROWLEY: Can I intrude and just ask,
Dan, you're probably, along with Paul, a physician who is
involved in teaching medical students. If you think of how
some of these issues were discussed when you first started
as a faculty person and as they're discussed now, I would
be very interested in briefly your comments or perspective
on this issue. It's not fair for me to put you on the spot,
but I think, of all the people besides Paul —
DR. FOSTER: You're always putting me on
DR. ROWLEY: — you really have practical
experience and can comment.
DR. FOSTER: Well, the culture clearly has
changed. When I started in academic medicine, you were either
a basic laboratory investigator or you didn't work in a medical
school, for example. I mean, there were very few clinical
trials with humans which were going on. There were the heroic
efforts in yellow fever, and so forth, where many physicians
put themselves at risk.
You know, there were things that were going on, but clinical
investigation is now a huge operation, both in the private
sector for people who develop instruments and drugs, and so
forth, but also in the context of teaching in the medical
schools. So you find in all medical centers you have to have
courses these days in understanding statistics, the consent,
and all of those things.
Now do I think that the average — that that intrudes very
much in the four years that they are medical students? I don't
think so. I mean, I think that it's those sorts of issues
about partnership and consent have been cast more in terms
of individual patient care than they have in terms of the
larger issue of how one gets consent, and so forth. So the
culture has changed.
I think I want to say that the sort of conversation we're
having today does not intrude on the real world. I mean, one
of the dangers is, I mean these sort of sophistications that
we're talking about here are not real-world problems.
I once heard somebody in a counseling session say, if you're
worried about what people are thinking about you, don't worry,
they ain't thinking about you. That's sort of the situation
The issue of literacy has to do with just reading of prescriptions,
and so forth. I mean, you really do have to cast these things
in terms of just consents that are understandable. Many times
the corporations, if you're doing a trial, the lawyers put
in these things that nobody can understand. Most of the time
— we just had a grand rounds on this — you have to communicate
the level of the fifth or sixth grade for most things, just
the instructions on it. So this kind of conversation doesn't
So I don't think that — I mean, I think it's important to
do because there have been terrible abuses of humans, and
I think we need to focus on that. But I think that the effort
— I mean, I thought this was a very scholarly paper, sort
of ethereal in some sense for most average people. They wouldn't
really understand it.
But there seems to be, and I certainly don't want to say
— this is a warning — I don't want to go back to the discussions
that we had about embryos, and so forth. I mean, we've already
been through that in great detail. I think we ought to talk
about the real practical problems that we have here.
There seems to be built in a view that I kind of hear that
anything that you want to do in terms with humans, regardless
of the virtue, is either dangerous or shouldn't be done. I
mean, it's very carefully said here, well, okay, if it's a
desperate situation, a patient is dying from cancer, you're
worthy of trying to do something.
But to find out about a drug that just shrinks a tumor, in
the first place, everybody I've taken care of in an experimental
drug, if they have a tumor, that gives them at least a month
or two of joy. I mean it does, and that's part of the foundation
to build up — you know, it took 15 or 18 years to get Gleevec,
or something like that. You know, you've got to get these
So I'm sort of rambling to say that I don't think that this
enters into medical education in detail about consent until
you get into start doing clinical trials.
As long as I'm here, I might make one other point. We began
with talking about Kant and this issue of "thingifying" humans.
That seems to be, for all the ethicists, sort of a holy grail
about what we should do. But there is an element where in
just clinical care the physician is more, or the scientist
is more, than just an equal partner.
I want to illustrate that by a real-world case and then I'm
through. I think that most people are happy to have somebody
that they think they can trust to be working on things for
their disease individually or for the long run.
The long-term editor of The New England Journal of Medicine,
Franz Ingelfinger, as many of you know, was probably the most
influential person during his lifetime about things. When
he was a scientist, he had worked on esophageal cancer, and
he got esophageal cancer.
He wrote an article in The New England Journal called, "Arrogance."
That is the arrogance of the view that a physician should
be not co-equal in terms of the care of the patient. Because
he knew everybody in the world, he was besieged by: Should
he have radiation first? Should he have surgery first? Not
only that, he had kids who were physicians, and everybody
— he said he was just torn to pieces.
Finally, somebody said to him, "Franz, what you need is a
doctor." And he said, "I followed that advice and turned to
my internist and was at ease that he would take care of me,
and then I got back to my usual activities of editing this
Journal and giving talks," and so forth and so on.
In other words, his learning, his plea was not for — I mean,
he wouldn't consider himself a thing, but he certainly considered
himself to be cared for by somebody that he trusted, and so
So the bottom-line answer: The culture has changed, but it
has changed mostly not in the undergraduate work in the medical
school, but subsequently I think that there are very marked
abuses that we have to limit. In the practical world, I think
that consent is not simply a negative thing. I think it is
a very important thing.
I am very worried continually about a subtle sense that medicine
and medical science, which I consider to be a high and noble
virtue, becomes cast in terms that it is automatically in
some sense negative for those who are participating in it
or those who do it. I would say that's not real world in this
country. I think people who are sick want to do it.
If I had been prepared to say something, I would have said
it a little better, but, anyway, I'm trying to answer your
DR. KRAUTHAMMER: Could I make a point on
that, a response to that?
CHAIRMAN KASS: Charles.
DR. KRAUTHAMMER: Dan, I don't think that
the issue is that we're casting advances or the noble or wonderful
things that medicine has done as negative. I think what we're
trying to do is to point out certain inherent difficulties
That is that when you do medical experimentation on humans,
you necessarily introduce "thingness." That, in and of itself,
is inevitable, and that, in and of itself, is a problem. It
does not mean that you don't carry on that research, but it
means that you have to be very careful and think about it.
We know what extremes of "thingness" can do. We saw it at
Auschwitz. We saw it at Tuskegee. Those are the seminal examples
which warn us that, however noble and beneficial medicine
is and can be, the very nature of experimentation, which is
to treat a person as a thing because we are studying it as
a thing, is inherently dangerous. All that we're saying is,
let's examine the dangers and ask what kinds of protections
one has to introduce.
I was struck, incidentally, by the "thingness" of it. It
always strikes me in blind experiments. We all read a few
weeks ago about this new discovery that a certain kind of
surgery for arthritic knees is useless, and it was discovered
by having two sets of subjects, one-half of whom received
sham knee surgery. It was shown that there was no difference
in outcome between those who had the real and those who had
I always ask myself, how would you feel if you were the one
who had that sham surgery? I mean, it's rather remarkable.
There's a more famous case, I think about 30 years ago, where
that was done with heart disease. Also made a wonderful discovery
of the uselessness of a certain kind of invasive surgery,
right, with the mammary artery transplants which were useless.
But it was discovered by doing sham surgeries on half of the
patients, actually opening their chest, sewing it up, and
So we have here an inherent problem. That was a great discovery,
that the mammary artery surgery was useless. On the other
hand, we had real people who were wheeled in, anaesthetized,
chest opened and closed, and nothing happened to them.
If I could make just one other point in response to what
Paul had said about participation, being part of a great enterprise,
I agree entirely that is the ideal. I think it's exemplified
most dramatically when the physician himself engages and becomes
But consent is a separate issue, and it introduces itself
here. There are three categories of patients in whom you can
never really get true consent. That's children, the mentally
disabled, and prisoners. Those are the classic cases.
Even if you exclude those cases, you have patients, adults,
who are sentient and who are not in prison; you always have
the questions of desperation and naivete. Those always contaminate,
and I would contend that it is almost impossible to get a
Again, this doesn't mean that you don't engage in the therapy,
in the experimentation, but it has to be a real caution.
DR. FOSTER: Let me just respond to that.
I would be absolutely first in line to preclude the sort of
issues that give interesting data but are totally unacceptable.
I could probably spend a lot of time today, which I'm not
going to do, giving you examples of things that have been
done that I think are absolutely wrong. So count me as first
in line for that.
I think that if we can bring some insight into that, but
I just don't want to go over so far — I mean apart from the
dialogue, which I think, as I say, is ethereal for the average
person. I mean the illiteracy in this country may be as much
as 23 percent. I mean in the West you can't talk like this.
I think everybody understands about protecting subjects and
getting them to do that, but I don't think that most people
are going to be involved in the Kantian thing. I would rather
us concentrate on how we improve the process.
CHAIRMAN KASS: Bill May?
DR. MAY: On this question of recruitment
and depths of identification, I suppose the most obvious analogy
is recruiting for armed services. There used to be the practice,
as we say, of shanghaiing people for service in the Navy,
and so forth. Informed consent or signing on was a protection
against dragooning people into military service.
But there's the next category of, if one especially went
after those folks who would be highly motivated, let's say
immigrants or convicts maybe destined for execution, those
folks that you would hope could recoup significance for a
life in danger of losing or rapidly losing the capacity to
recoup or signify, and, look, you can't become a citizen of
this country, but join the armed services and you'll find
your way into citizenship, and so forth. So you're offering
not the inevitability of it, but the possibility of it. Then
the question is, what degree of possibility?
The final level that Hans Jonas is talking about, and that
Gil highlighted for us, is a kind of patriotic investment.
I mean people who join the Army and the Navy for reasons of
patriotism. But what lies behind that, it's a conception of
the country. I mean, if they are disposed to sacrifice, it's
not simply because just out of nothing they're disposed to
sacrifice, but they belong to something; they're participating
in something that in a sense they're joining a history of
This was talked about in terms of some idealistic physicians
who felt themselves belonging to a tradition of sacrifice
that precedes them. That tradition may not be very alive amongst
The problem is, the larger problem is, we live in a setting
of a society where we do not think of the society itself as
founded in sacrifice. Its origin was a deal where you surrender
something and you get something, and then the terms of that
deal is, what allows the State to do things? It is the fact
that it gives you something. In order to be able to give you
something, it, of course, has to stay alive. So a fundamental
warrant granted to the State is its capacity to conscript
if its survival is at issue, and that's where Hans Jonas takes
But there are, of course, other old traditions of the origin
of the State where the State was founded not on a deal, 17th
and 18th century, but is founded on sacrifice, the sacrifice
of the gods or magnitude of investments on the part of individuals,
and so forth.
There's an echo of that, I guess, in immigrant folks who
weren't dragooned to come to this country, but whose parents
made great sacrifices to bring them here. In a sense one belongs
to a tradition of sacrifice, so that what you do is simply
your mode of participating in it.
It seems to me that is what is largely lacking in the particulars
of professions or the kind of warrants that we can present
to people. So we have to suppress that speech. Hans Jonas
gives us an illustration of that speech, almost mockingly,
because you know it will chill people. They will not act,
because the ordinary terms of relating through such an undertaking,
such an enterprise, is signing on. Then the question is, what
will I get out of it? That's understandable.
CHAIRMAN KASS: I have Rebecca and then Bill
PROF. DRESSER: One interesting thing about
that sham surgery study was that, as part of it, they made
people write down, "I understand that I am going to go through
surgery and they might not do anything to me." They lost a
lot of people after they said, "Yes, I want to do this," but
then they had to write this in their own words, and people
said, a certain percentage said, "No thanks."
I think this paper is brilliant and timely, and it really
forces us to step back from something that we accept so much
as a society today, this idea that progress is not optional,
but it's nearly mandatory and this kind of sense that we are
in a war against disease and we must go forward with research.
So progress is almost mandatory, and progress of a certain
sort, progress in the form of advancing knowledge to produce
miracles or unknown effective treatments, as opposed to progress
in providing measures that we have available today to more
people, such as established health care and even more basic
things, like decent housing and education, and so forth. So
it's we must make progress and we must make progress in a
certain way and not another way.
Then it becomes interesting, why do we see it this way? Why
is our culture at that point? You know, I don't know; I think
we've gotten more that way than we were when Jonas wrote partly
because of the patient advocacy movement, which started with
HIV/AIDS activists where they started presenting research
not as something to be afraid of, but something that we will
demand. "You must do research on our disease." Then women
and other groups got involved in saying you must study women
because we want to know whether to take an aspirin, and all
this sort of health advice that's being given to men.
So research is seen as a benefit, and that view is really,
I think, promoted through patient advocacy groups and also
through journalism. I really think the way that research is
reported on reinforces that image.
But I'm not sure if those are cause or effect. So I would
be interested in hearing if anyone else has thoughts on that.
CHAIRMAN KASS: Bill and then Gil.
DR. HURLBUT: What interests me about this
essay most strikingly is the way Jonas puts the ethical, foundational,
central significance and progress as contingent upon the preservation
of the ethical.
Central to the essay is a dignified and exalted view of human
beings and a recognition that the ongoing existence of society
and the progress of science depend on this view of humanity
as the source of something that can't be legislated or enforced.
The progress — it seems to me in his essay he says it plainly
— progress is not the highest concern, that progress flows
forth out of a society where you preserve humanity's central
core of individual dignity and its commitment to personal
devotion, what he calls authenticity and spontaneity.
In an interesting way, this places the essay as a hinge-point
between our previous six months and where we're heading next,
because our disagreements and discussions at least hinge to
a large extent in the first half of the year on the question
of how to preserve this humanity that we're trying to promote,
nourish, and heal.
The thing that strikes me about this essay so strongly is
how Jonas acknowledges the central concern for all of the
other benefits of society of the preservation of the crucial
qualities at the core of humanity. In that sense, as we go
forward now, we talk about enhancements. The issue is, how
do we preserve this crucial, ethical quality within human
beings, this central core on which all things depend, both
meaningful individual existence and social cohesion?
He speaks of a sphere outside the sphere of social contract,
of public rights and duties, of a trans-social upwelling of
personal idealism, the noble of grace, not decree, and intangibles
even of a religious order, and what Bill was saying of self-sacrifice.
It strikes me as an interesting place to start our discussions
of where we are heading with our progress, that we need to
preserve these qualities as central. Just to give a couple
of his own words, he says, "The ethical dimension far exceeds
that of the moral law and reaches into the sublime solitude
of dedication and ultimate commitment, away from all reckoning
and rule, and shored into the sphere of the holy."
And he says, "A society cannot prosper without this. It must
draw on them, but not command them."
And then he goes on to say how this source is powerful and
wells up from natural humanity. All we have to do is be sure
not to preclude or quench it. He says, "We have laid down
what must seem a forbidding rule to the number-hungry research
industry" — in his essay, that is — "having faith in the
transcendent potential of man. I do not fear that the source
will ever fail a society that does not destroy it, and only
such a one is worthy of the blessings of progress."
I found this a very striking essay for that because it called
me back to that commitment to the central significance of
the ethical in not just the individual, but the whole outplay
of social process; that we need to be concerned not just with
what we preempt, but what we promote as well and what we preserve,
perhaps more centrally.
CHAIRMAN KASS: Thank you. Gil.
PROF. MEILAENDER: I want to go back to Mary
Ann's comment quite a while ago and make my way from that
to Dan's, in order to try to persuade Dan that this really
is the real world here.
At least as long as some of your fellow human beings seated
around here obstinately intend to talk about it, Dan, it's
going to have a certain kind of reality. We're just going
to keep beating you over the head with it.
DR. FOSTER: I wouldn't have been in this
discussion if it was not for Janet. Okay?
PROF. MEILAENDER: It's her fault, that's
The interesting thing, in terms of the three kinds of issues
that Mary Ann raised and just inquired sort of how things
had or had not shifted in the roughly 30-year period, say,
since Jonas wrote, is that in fact I think I'm right to say
that a lot of people worried about those questions, and that
the increasing attention to consent, you know, free and informed
consent, the increasing kind of codification and requirement
of consent was precisely designed in many cases to deal with
some of those issues that you raise, and does deal with it
in many ways. I mean this was Paul's sense that something
good has happened.
The peculiar thing is, though, that I think if you took those
three, you would see that they all remain quite contested
areas actually. Indeed, for a while we thought consent solved
the problem, and I think you would say that many aren't so
sure that consent has solved the problem, partly for reasons
Rebecca referred to in her comments.
See, that brings me back to the, to me, interesting thing
about the Jonas article, is that you somehow have to dig a
little deeper than just consent. Just a notion of consent
won't turn out to satisfy us in terms of the sorts of issues,
and the enormous amount of attention that's been paid to it
in the past 30 years and real concern about those issues and
progress in certain ways still doesn't turn out to solve it
That brings me to Dan's comment. I think part of what Jonas
is getting at, and part of the reason for that, is this is
not just a concern about researchers out there, Dan. We love
them all, though they are, of course, subject to all the vices
and temptations that the rest of humanity is.
The concern is not just that they might misuse their research
subjects or their patients or those desperate people, or whatever.
The concern is that we might being using the researchers as
I mean, we do all, to some degree, live off of each other,
of course. But we don't just want to live off other people.
Insofar as we all benefit from what medical research does,
we do need to think about whether what that really means is
that some of us benefit by living what others have largely
What Jonas forces us to ask is, to what degree those people
off whom we are living really thought of themselves as sharing
with us in some kind of undertaking or to what degree we're
simply living off them with nothing more? So it's really not
just a question about what researchers are doing, though if
their consciences bother them, you know, that's good and they
should worry about it, but he is really getting at kind of
what all of us do in benefiting from research.
I will say, I mean, if you go to a teaching hospital and
you look around at the people who are there, it ought to lead
you sometimes to worry about whether you are living off some
other people who are very unlikely to have some sense of sharing
in a joint venture.
So that's where I think Jonas ought to point us. If that's
not a real-world problem, then I wouldn't know what an important
real-world problem would be.
CHAIRMAN KASS: Dan?
DR. FOSTER: Just one quick comment: I mean,
I think your concern about living off others is not limited
to biomedical research. I would wonder about the stock market
and everything else. I mean it seems to be sort of a systematic
desire for a few to live off others.
I mean, I think that one cannot eliminate the human need
or evil, or whatever you want to say, to live off others in
that sense. I accept your comments, and I love bioethicists,
too, even though they are often ethereal, as I say.
CHAIRMAN KASS: Alfonso?
DR. GÓMEZ-LOBO: Just a little clarification
for Paul, if I may, on the question of virtues. But let me
start from what Charles said because Charles — it happens
to me very often — expresses with great clarity what I would
have liked to express, but never managed to do.
What we are talking about here is a question of caution,
of being very careful with what we're doing when there's research
with human subjects. Now that can be expressed either in terms
of respect for the dignity of persons, but it can also be
expressed in terms of virtues.
One of the key and fundamental areas to deal in virtues is,
of course, the virtue of justice. One could say the endeavor
here is this: that in the overwhelming majority of cases there
are no violations of justice, I presume, but we should be
very careful in these very special cases that justice is being
done. So I don't see it as mutually-exclusive. By the way,
Kant does have a very strong theory of virtues as well.
A further remark is this: We hear in the paper and in Bill
May's remark the constant parallel with conscription. I find
it a little bit unsatisfactory myself because I'm not sure
that all instances of conscription are morally justifiable.
I think that a case can be made that in certain instances
it's morally wrong to conscript young people.
Now the extreme case would be, of course, the conscription
of young Austrians to fight for Hitler in World War II. Some
young Austrians drew that conclusion, and they were duly shot,
CHAIRMAN KASS: Paul, and then I'll have
a comment, and we'll break.
DR. MCHUGH: I'm always in your debt, Alfonso,
to explain to me these differences amongst the philosophers.
But I think we're all at least talking in similar ways about
what we want to do as practitioners. I want to get away from
this idea that it is ethereal, Dan — I have to speak as the
psychiatrist here — that it's ethereal to work in a full
and expanding consciousness. That's really what I want to
do as a doctor, and I think that's what you want to do.
All of the activities that I do every day I want to have
in full consciousness and appreciating my place in this community,
because it's the community issue that I believe the virtues
ultimately emerge in, in the practitioners who are fully conscious
of what they're doing all the time and who are listening to
people like Jonas and others about how they should think.
But I still want to come back to the idea that the full consciousness
of a community does come in advance and does advance along
with things which a community accomplishes. The tremendous
accomplishments of things in medical science, along with,
as Gil said, refinement of our research procedures, has been
a tremendous uplift to what we can accomplish as members of
a community, whether we are subjects or whether we are investigators.
I also agree that we haven't ever completely answered all
of the issues that Mary Ann raised, because these are always
vexed questions, and there's, to some extent, an asymptotic
approach to the justices in them in which we can't be completely
satisfied that we have an absolute forum.
Now Charles wonderfully explained that there are three groups
of people in whom research is — well, he said it shouldn't
be done: children, the mentally disturbed, and prisoners.
I want to salute that. I want to get up and say, "Right, I'm
all for that."
But then, gosh, wait a minute, I want at some time to be
able to talk about why I might want to persuade people who
have mental disturbances to work with me and to be pa
rt of this virtuous community, to take on the virtue of being
an independent signer-on, as Jonas says, a commitment to this.
I'm also losing it a bit, but it was this idea that this
is too ethereal. It is not ethereal, I think, to anyone who
believes that he should, or she should, be acting in his practice
in full and advancing consciousness of what is happening and
finding the words that deal with the feelings that he has,
or she has, when he asks patients and subjects to commit to
being in part a "thing" in this work.
DR. KRAUTHAMMER: Leon, I must make a clarification
here. I didn't say that you should never experiment on them.
I simply said that you could inherently never have informed
DR. MCHUGH: Right.
DR. KRAUTHAMMER: — which is why you have
a difficult problem of delegated or implied consent or proxy
consent, and there are all kinds of regulations which, in
fact, in a previous life, a quarter of a century ago, as a
psychiatrist working in the Carter Administration, I worked
on those regulations.
But these are three categories of people which make the problem
of informed consent very, very clear, since it is impossible
to get that kind of consent out of them. So you have to devise
a mechanism to get around it. It is not as if you can never
have experimentation. I would never argue that you can't have
experimentation on children.
DR. MCHUGH: Yes, fine, thanks. Thanks, Charles.
I think my point continues just in the same way, that that
kind of discussion, that kind of interaction, that kind of
explanation of and misunderstanding makes my life and my practice
more enriched. That is the whole reason why I want to do it.
CHAIRMAN KASS: Okay, we're coming up on
break. Let me make a couple of comments. A lot of people stirred
me up, but I will just be very, very brief.
It does seem to me that, however abstract the text is and
however philosophical, and, therefore, seemingly remote from
everyday practice the article is, and certainly can be a big
jump from this to talk about the regulations and the IRBs,
it does behoove us, I think, to think very hard about what
it is we are trying to protect and preserve in all of these
arrangements with our patients, not just as experimental subjects,
mind you, but in all the human encounters.
If it turns out that the attempt to protect these things
produces documents of five pages long, which one needs not
just a college education, but a legal education, to understand,
and it is in fact the lawyers who have seen to it that it
looks like that because they're interested primarily in protecting
the institution, and not necessarily protecting the things
that we are interested in, then it seems to me one might have
gone off the road.
It ought to be possible to explain to someone with a fifth
grade education but with a human heart what it is that one
is trying to do here in the same way as one could explain
to them what one is trying to do in all other kinds of human
Jonas is, I think, trying to get at something which lies
beneath and ought to inform the procedures and the human interactions,
and I think not just in the experimentation, in the area of
human experimentation, using human subjects for research.
It seems to me both Gil and Bill Hurlbut in their own way
called attention to the fact that the principles that are
operative here will be relevant for the discussions that we
are going to have this afternoon, and they ought to at least
be in our mind — I'm not sure we've clarified them yet —
but ought to be in our mind when one thinks about trying to
adjust the procedures that are, in fact, meant not just to
encourage the research to go forward, which we all want, but
in fact to protect, whether it's human dignity or human virtue
or the sense of community or the notion of paying one's price
for the benefits of having a community and the sacrificial
norm that Bill spoke about.
Those abstract things are, nevertheless, tacitly present,
and we probably, at least the presupposition of this conversation
is that we would be better off making them not just tacitly
present, but, as Paul says, matters of consciousness, when
we try to fiddle with various things.
We have gone over a few minutes, not too bad. Why don't we
reconvene at 10 minutes before the hour, and Dr. Emanuel will
(Whereupon, the foregoing matter went off the record at 10:33
a.m. and went back on the record at 10:52 a.m.)