April 21, 2006
COUNCIL MEMBERS PRESENT
Edmund Pellegrino, M.D., Chairman
Floyd E. Bloom, M.D.
Scripps Research Institute
Nicholas Eberstadt, Ph.D.
American Enterprise Insitute
Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School
Michael S. Gazzaniga, Ph.D.
University of California, Santa Barbara
P. George, D.Phil., J.D.
William B. Hurlbut, M.D.
Leon. R. Kass, M.D.
American Enterprise Institute
Peter A. Lawler, Ph.D.
Gilbert C. Meilaender, Ph.D.
Janet D. Rowley, M.D., D.Sc.
University of Chicago
Diana J. Schaub, Ph.D.
SESSION 5: CHILDREN AND CLINICAL RESEARCH
DR. PELLEGRINO: Good morning. We've
got some members missing but we'll just move ahead. When they hear
our dulcet voices, they no doubt will come in, as long as we keep it
dulcet. This morning our first speaker is Tom Beauchamp. Tom is a
member of the Kennedy Institute of Ethics but more famously the
co-author of the most popular book in biomedical ethics in the world, I
guess, and of course, beyond that a Yung Scholar as well. But I'm
not going to go into all his credentials. As you know, that's
available and we'd like to keep our introductions short and I know
Tom appreciates that as well.
We've asked Tom, who was a member of
the Belmont Report Committee, played a prominent role as you all know,
to give us the present status of the Belmont Report, what's
happened since then, with particular emphasis on children, our concern
this morning. Tom, can you take it from there?
DR. BEAUCHAMP: Is that all right? Can you
hear in the back, Marti? Good, okay. Many of you know that I have
had a long association with Ed and Alfonso, a member of my department
for how many years, Alfonso?
DR.GÓMEZ-LOBO: Thirty or so.
DR. BEAUCHAMP: Thirty, right, and also with
Rebecca Dresser, my dear friend and co-author and I believe Rebecca
will not be here today, as I understand it and I'm very sorry
about that. I'd like to tell you that when Ed called me I was
really very worried about what time he was going to call this meeting,
because Ed just decided we'd find out when we were free during
the day and Ed would say, "Well, I'm here at 5:00 o'clock,
how would that be?" I was afraid he was going to ask me to
be here at 5:00 o'clock this morning. So this is a very decent
hour to get started.
I should also say in the spirit of
disclosures of the sort we're supposed to make these days, that I
have a long, long, long history with Bob Levine and that history is, in
some respects so close that we might even sound like we're speaking
from one voice. So it's not as though you get very different
characters when you have us around at the same time.
All right, so let's get down to business. I'll stay fairly
close to my text. I like to do that because otherwise I depart
and stray and digress and I don't want to do that. This morning
you've given me a time limit and I'll try to stay within
it. I trust you being very good about time, you'll nudge me
if I'm going on too long. Okay. Ed and Dan have asked me to
discuss my quote "Views on the Belmont Report as the ethical
basis for the regulatory framework governing clinical research in
this country" and then to generalize beyond that circumstance
to the quote "regulatory framework governing clinical research
ethics" and then to include my own view of quote "the
current state of the ethics of research with human subjects",
and I understand that that means in terms of the historical continuity
with what happened back in the 1970s. So I will try to stick reasonably
closely to this assignment.
I will state what I believe really
happened when the Belmont Report came into existence, how it captured
some reasonably deep and significant themes in research ethics and how
some of this might still be of help today. I will then, at the end, as
I understand my assignment, offer you some recommendations based on
what I have said. Recommendations are, of course, just that.
They're recommendations. So let me talk first about the National
As is reasonably well-known, the National Commission was established
in 1974 by the U.S. Congress with the charge to identify the ethical
principles, that was in the charge, that should govern the conduct
of research involving human subjects and to develop guidelines for
the conduct of research. It was hoped that the guidelines would
insure that the basic ethical principles would become embedded in
the research oversight system of the United States. Its more than
100 recommendations, the Commission's recommendations for reform,
went directly to the desk of the Secretary of the Department of
then Health, Education and Welfare and many were codified in federal
regulations. You know them all well, there's US 45 CFR 46.
The Belmont Report is not itself written in the style of federal
regulations or anything even approximating it and was never so codified.
The Belmont Report is a tiny philosophical document for the most
part. Carol Levine offers the following sobering but I believe
accurate statement of the historical context in which the National
Commission deliberated. I quote her, "The Belmont Report reflected
the history of the 30 years immediately preceding it. This emphasis
is understandable given the signal event and the modern history
of clinical research ethics, that is to say Nazi experimentation.
American public opinion was shaped by the revelations of unethical
experiments such as the Willowbrook Hepatitis B Studies, the Jewish
Chronic Disease Hospital Studies and especially the Tuskegee Syphilis
Study. Our basic approach to the ethical conduct of research and
approval of investigational drugs was born in scandal and reared
in protectionism. Perceived as vulnerable, either because of their
membership in groups lacking social power or because of personal
characteristics suggesting a lack of autonomy, individuals of that
sort were the primary focus of the Commission's concern,"
I want to go now — I want to go in a
moment directly to the Belmont Report but I know that you are now
thinking about children and I want to start with the Commission's
Children's Report, still a document, I believe, well worth your
reading, and a problem in that report that kept coming back over and
over again during the National Commission's deliberations. This
problem was never resolved adequately or fully or whatever the term
should be, nor is it likely that you will resolve it here during your
deliberations. It is a deep problem that will always be around.
But it captures, I think, one of the great
questions of research ethics and one with which you must grapple
because it's unavoidable. I will not summarize or interpret any
document. I want to go to the moral heart of what I understand the
debate to have been about and in this way to offer you an understanding
of what the Belmont Report is about. I think this problem could easily
become the center of debate for you as well. But historical
understanding is important in its own right, a view that I have always
shared with both Alfonso and Ed. Alfonso, as you may know, is a
historian of philosophy and so am I, in our own way. I take historical
analysis of that sort with very great seriousness and I think it's
important to look at the history of bioethics in much the same way.
So I take fidelity that history is my
first obligation in what I'm about to say. In 1975/'76, the
National Commission deliberated on the topic of research involving
children and eventually produced a volume on the subject, one written
and published well before, before, the Belmont Report. It is easily
the most important of the Commission's 17 volumes for an
understanding of why Belmont takes the shape that it does. Belmont was
forged in the context of discussing research involving children. I
know that because I wrote it. I know exactly how the context was
forged. Without this background, I think you lose something.
By the way, I wrote almost all the Belmont Paper. Bob Levine
wrote the section on boundaries in that paper so that you know how
the authorship — because it was revised many, many times by
the Commission. You know the process well. For about a year, no
exaggeration here, the Commission found its deliberations grinding
to a halt over a significant moral problem; how much danger or risk
could justifiably be presented to children in so-called at that
time non-therapeutic or non-beneficial research? On one side of
the debate were the apparent defenders of research. They argued
that severely restricting the involvement of children would bring
pediatric research to a standstill, with, of course, grave consequences
for children who would be sick in the future.
On the other side of the debate were the
apparent defenders of research — I'm sorry, children. They argued
that openly using children with exposure to significant risk when the
intervention was not therapeutic or of direct therapeutic intent, was
to use persons without their consent to the ends of science. Children
would be, in short, exploited without any benefit flowing to them for
their sacrifice. During this debate, most Commissioners found
themselves somewhere in the middle of the two sides and reluctant to
choose sides. So how to bring a very long body of deliberations to a
Ultimately the defenders of research would
be, so to speak, victorious although I'll be careful about that
word in this debate, but with two dissenting votes among the 11
Commissioners and two dissents filed. The most difficult ethical
issues for the Commission arose with respect to research presenting
more than minimal risk, where there is no immediate prospect of direct
benefit to the individual children involved. Some members of the
Commission urged that the limit for such research remain at the level
of minimal risk. Others pointed out that such a limit would almost
certainly eliminate much research that has genuine scientific
significance as well as the promise of substantial long-term benefit to
children in general.
Ultimately the Commission decided with two
members dissenting, that if three conditions are satisfied, research in
this most difficult class of cases could be justified. First, the risk
must be only a minor increment beyond minimal. Second, the procedures
to be used must be reasonably similar to those with which prospective
subjects have already had some experience. Third, the research must be
likely to yield generalizable knowledge important for the understanding
or amelioration of the specific disorder or condition.
Thus, foreseeable benefit in the future to an identifiable class,
class, that was the key notion that was landed on, of children was
held to justify a minor increment of risk to research subjects.
Dr. Robert Cook then Chancellor of the Medical System in the State
of Wisconsin, objected vigorously to these conclusions and, as I
understood him, he objected to the moral premises underlying them
as well. He wrote as follows in his formal dissent. Quote, "In
the ethical justification of its recommendation, the Commission
can invoke only the principal utility. This, in itself, does not
constitute any breach of ethics but it does indicate the perilous
nature of the recommendation and the ethical uncertainty of the
Commission." Lawyer, Robert Turtle, was even tougher on his
fellow Commissioners. He says in his dissent, that the Commission
notes that it was, and I quote, "Impressed by reported examples
of diagnostic therapeutic and preventive measures but," Turtle
says, quote, "that rationale provides no basis at all for segregating
children in to separate classes. The rationale is strictly utilitarian.
I do not believe a strictly utilitarian rationale can provide adequate
justification for a policy creating a doubly disadvantaged class
of children, doubly disadvantaged because they're already sick
and you — they're sick and then you add an additional risk
on top of their sickness."
I agree with the minorities'
interpretation, the Commission had reasoned heavily by appeal to
considerations of public utility, but this was certainly not the only
evaluative commitment of the Commission and it would misunderstand the
deliberations and its moral commitments to cast its conclusions in this
narrow way. The historical record and transcript clearing indicates
that the National Commission, was very concerned throughout its work
that it had become too easy in the biomedical world to use utilitarian
justifications of research. The Nazi experiments, Tuskegee and Jewish
Chronic Disease Hospital case, all the cases that were very much on the
horizon and being examined at the time, had left a legacy of being
driven by a very utilitarian view of social beneficence, the justified
using human subjects on grounds of benefit to the broader public.
That is, a major purpose of the report, of
the Commission's Report, was to properly balance the rights and
interests of subjects with those of science and society.
Considerations of autonomy, justice and risk control were set out to
limit utilitarian balancing, explicitly so, that's why these
considerations are there, not to promote utilitarian balancing.
However, it is doubtful that the question of how best to control
utilitarian balancing was ever resolved with the Commission and, in
truth, I do not believe that it has ever been resolved by anyone in
bioethics. That is the theme, so to speak, of my talk today to the
extent that it has a theme that cuts across all of its sections.
Now, to the Belmont Report. When I wrote
most of the Belmont Report for the National Commission, what I have
just explained to you was the framework of deep issues that was always
before me. These concerns had already been laid out by the history of
the Commission's deliberations, most clearly, I believe in the
children's report. So it was easy for me to grasp the nature and
importance of these questions, in other words, people have already done
the work for me. I never forgot this context for even a single
sentence when I was writing that report.
But before I explain this background
further, I should state what the Belmont Report is known for and how to
interpret its framework of basic principles. These principles are
still today referred to in many contexts as the Belmont Principles and
rightly so in my view. The Commission identified three general
principles as underlying the conduct of research; respect for
person's beneficence and justice. These principles, though often
quoted in bioethics have often not been well understood because the
historical context has been dropped in the invocation of the
principles. I will cite a simple example which will be readily
understandable to you and it will also, perhaps, motivate you to find
the historical context I'm now drawing out a little
On page 19, Roman 19 of your Volume "Being Human," there
is a brief discussion of these principles. And I think you wrote
that, Leon, am I right or did you all write it together? I'm
not quite sure how that worked.
DR. KASS: The report?
DR. BEAUCHAMP: Yeah, the introduction to the
report. It doesn't matter. That was my understanding but it
doesn't matter. The principles that are there said to be; and
I quote, "The major principles of professionalized bioethics."
The principles are then explained. They are explicated wholly in
terms of the patient, for example, as discussed here, patient autonomy,
and also in terms of distributive justice in the health care system
as well as in terms of public health. There is no mention of research,
not even a hint of it. The oddity of this to me is that these principles
were born and bred in a research context. That is where they came
The concerns were not about patients, per
se, but about subjects. The concerns about distributive justice were
entirely about the fairness of the selection of human subjects, not
about distributive justice in the healthcare system. In other words,
the embeddedness of these principles in the history of research in the
1970s is easy to lose and it has for the most part simply dropped away
in the contemporary understanding of what these principles are. And
yet, if you're going to understand that Belmont Report, that is the
only way, I believe, that it can be understood.
And so if we're to understand the
National Commission and what it brought to be codified in federal
regulations, as well as the connection of this history to the
development of research ethics over the course of the last 30 years, it
is truly important to understand not only the principles but what gave
birth to them and the original context of their birth. This is what
I'm trying to accomplish now. There's a key organizing
conception underlying the Commission's presentation of their
principles and use. The simple conception is the principle of respect
for persons, commands in the research context, obtaining informed
consent, be it first party or be it third party. The principle
beneficence commands that a risk/benefit assessment be done and that it
not be a narrow one but a broad one.
Justice demands that you pay — the
principle of justice demands that you pay very careful attention to the
way in which subjects were selected so that that selection process be
fair. That's in outline, the essence of what the National
Commission was about in constructing these principles as the framework
of what it had morally done. In this way each principle makes moral
demands in a specific domain of responsibility for research. Here is
what is noteworthy. Beneficence in the world of biomedical research is
very different than beneficence in the context of patient care where it
is confined almost exclusively to the medical welfare of the patient.
In the research context, beneficence has to be understood and should be
understood in terms of benefit to the public and the social imperative,
so to speak, of biomedical research. Quite explicitly the principles
of respect for persons and justice in the Belmont Report are not in any
respect whatsoever to be allowed to be brought under the context of or
to be subordinated to public beneficence. That was the architectonic
of the document.
Those two principles, axioms and the
framework, so to speak, are erected intentionally at the heart of the
National Commission's moral framework to serve as moral constraints
on beneficence, to be just as important as social beneficence, what
some philosophers like to call the ontological constraints. The whole
point of this framework is that neither of these principles is to be
compromised or lost under public beneficence, medical research,
ambitions and the like. The Commission spent a huge amount of time on
the place and purpose of informed consent.
In historical context, there wasn't
much informed consent at the time or much of an understanding for the
notion, for that matter. The Commission insisted that the purpose of
consent provisions is not protection from risk. Indeed, that
risk/benefit and their balance is wholly the wrong way to understand
the place of informed consent.
I've heard it often said in both the
United States and Europe that there has been an over-emphasis on
autonomy in the frameworks spawned by the National Commission,
sometimes expressed in Europe as an American obsession. I think this
is false to the historical facts and I think it shows no insight into
the history of bioethics. The National Commission was as concerned
with personal dignity as it was with autonomy and this is one reason
why its first principle is the principle of respect for persons.
However, I don't want to carry on about this subject as at this
point, it would take us too far astray. Back to the main theme.
We have seen repeatedly throughout the history of research involving
human subjects that we cannot avoid coming to some form of delicate
balancing of the human values that we attempt to collect and then
distill in the form of principles expressed in the biomedical —
in the Belmont Report. We then must contextualize balance and specify
their significance when we confront particular issues such as those
that confront us with children. The Belmont Report was written
in significant part to try to insure that we appropriately balance
appeals to social utility in the justification of research together
with respect for persons and considerations of fairness.
If you lose that perspective, in my view, you lose almost everything
of real and enduring importance about the history of the National
Commission and much of the history of recent research ethics. The
whole of the work of the National Commission, all 17 volumes, came
to one fulcrum; how to balance and specify the moral considerations
that it called, following the mandate of the U.S. Congress, principles,
as those principles could be brought to bear in problems arising
from research involving vulnerable groups, that is after all what
we were up to: embryos, prisoners, the institutionalized, mentally
infirm, children and so on.
I want to say just one more thing about the Commission's framework,
by the way, how am I doing on time, before ending this first part
of my assignment? The principle of justice in Belmont requires
fairness in the distribution of both the burdens and the benefits
of research. The Commission insisted that this principle requires
special levels of protection for vulnerable and disadvantaged parties
but that attention to questions of distributive justice should always
remain at the forefront of research ethics.
This principle demands that researchers
first seek out and select persons best prepared to bear the burdens of
research, for example, healthy adults, and that they not offer research
only to groups who have been repeatedly targeted, for example, mentally
retarded children. The Commission notes and laments that historically
the burdens of research have been primarily placed and indeed heavily
so on the economically disadvantaged, the very sick and the vulnerable,
owing to their ready vulnerability and availability. Yet, the
advantages of research are calculated to benefit all of us in society.
The over-utilization of readily available, often compromised segments
of the US population was a matter of the deepest moral concern to the
Commission throughout its deliberations. The theme of justice and the
proper selection of subjects was Belmont's way of saying that since
medical research is a social enterprise for the public good, it must be
accomplished in an inclusive and participatory way.
If participation in research is unwelcome and falls on a narrow
spectrum of citizens because of their ready availability, then it
is surely a questionable enterprise. Sadly, the Commission never
got much beyond these themes of justice but what the Commission
did is still a good start and I will return in a moment to these
questions of justice and explain this a little further. I conclude
this little historical discussion as follows. The Belmont Principles
are in some respect present in every document the National Commission
published. These came to be the backbone of federal law in the
area. From this perspective, as Christine Grady has observed in
her recent book and I quote her, "Probably the single most
influential body in the United States involved with the protection
of human research was the National Commission." I believe
that she is right. Biased as my judgment may be, I think Christine
is right about this. But whatever the influence and enduring legacy
of Belmont and the Commission's other reports, it is not clear
that scientists who today are involved in research with human subjects
are really familiar with the Belmont principles or understand them
or for that matter actually use them.
When the National Commission deliberated
it seemed to many at the time that the general system in the United
States of protecting human subjects was in need of serious repair, that
research investigators were not educated about research ethics and that
subjects were not adequately protected. To some observers, the system
still seems today caught in a notably similar state of disrepair, I
mean right now. I am not here today to make any judgments about this
claim as I'm really unqualified to do so. It takes a different
kind of knowledge. I say only this; it would be a shame if you, a
great national deliberative body, could not find the time to figure out
where we are today and to do as much as possible to remedy defects in
With this general perspective now out in
the open and before us, I will turn to my recommendations to you based
on what little I do know of the system today, what might be important
to you and the history that I have just sketched. So at the risk of
reducing myself to a kibitzer that you, perhaps, think I am anyway, I
have several things to recommend and in four areas.
First, the research oversight system; some
in bioethics have argued that problems with research ethics are largely
a matter of getting just right how to adjust the present oversight
system for clinical research in the United States, which supposedly
protects subjects against excessive risk and exploitation while
demanding scientific rigor and promise. If the system fails, this view
goes, then to avoid moral problems, we need to patch up or reform the
system. This view puts tremendous weight on the oversight system that
we have and it is this that I suggest you be cautious about. There is
no evidence that research oversight systems have a particularly good
grasp on various moral problems of research ethics. And in any event,
I don't think the oversight system is the only way to process or to
present these problems.
Moreover, in a globalized world, one needs
to think globally irrespective of a particular country's system of
oversight. There are many oversight systems. I do not, myself, assume
anything about the adequacy of oversight systems in thinking about
research ethics and I recommend that you not make any such assumptions
either. Frankly, many people now believe that the system of protection
we've erected in the United States stinks and is in need of deep
reform. I take no position on that issue before you today. If you
wish to get into this, I would applaud the effort. At the same time, I
do not think that moral problems should be confined to this arena.
Performing the IRB system and the like could wholly consume your time
for months and months. Try to think far beyond this to the underlying
moral views and how to present them clearly.
Second area, problems of justice which I
said earlier I would return to. The National Commission came into
existence in the aftermath of public outrage and congressional
uncertainty over the Tuskegee Syphilis experiments, the Willowbrook
experiments and other apparently questionable uses of human subjects.
The socio-economic deprivation of the subjects who had been enrolled
in the Tuskegee experiments and involved at Willowbrook made them
vulnerable to overt and unjustifiable forms of manipulation at the
hands of health professionals.
What we know today about the recruitment and usage of human subjects
is less than I would like us to know, at least I believe it to be.
What do we know about that system, including how children are used
in it? This is an empirical question that I hope you spend the
time to investigate. I am not an empirical scientist but I suspect
from a survey of the literature that less is known than people often
believe. Since I am no expert, I say only this; consider what we
know about economically disadvantaged persons in the United States
today. Several issues are apparent. Are those persons, when used
as subjects, vulnerable to morally objectionable forms of involvement
in research? What kinds? Where, where does this occur? If so,
what is it that renders them vulnerable? Is it morally permissible
to trade off some level of risk and research for some benefit such
as money or health care?
Answers to these questions are not readily available and they are difficult.
It is also not clear which populations, if any, if any, should be
classified as vulnerable. Discussion of issues about the vulnerability
of research subjects, so-called vulnerable groups, have historically
focused on embryos, fetuses, prisoners, children, psychiatric patients,
the developmentally disabled, those with dementia and the like.
Until recently, relatively little attention had been paid to populations
of persons who possess a capacity to consent but whose consent to
participation in research might, nonetheless, be compromised, invalid
or unjust. Prisoners have been the most frequently mentioned class
of such persons but there could be many other such populations,
especially among the economically disadvantaged. It is known that
persons of this description are involved in some research in North
America though the extent of their use, I believe is not well understood.
It is also known that persons of this description are used in other
parts of the world, sometimes in so-called developing countries.
The scope of their use there is even less
well-understood and reported and I believe that to be the case with
children as well. I recommend that you look into such questions with
some care but these are not the only issues of justice that you may
wish to consider. One of the major problems of research is the
potential injustice that occurs when a benefit is generated for the
well-off through a contribution to research made largely by
disadvantaged members of society including potentially many children.
Research, as currently conducted, places a
minority of persons at risk in order that all, sometimes only the
well-off, might benefit, but how the burdens of research involvement,
if they are burdens, if they are burdens, a much under-discussed
problem, are to — how those burdens are to be distributed across
society has never been established in any authoritative code, document,
policy or moral theory known to me.
Nothing in federal policy, to my
knowledge, speaks to it. The notion of equity, commonly invoked in
these discussions, is poorly analyzed and even more poorly
implemented. As a result, it remains unclear and controversial when a
practice becomes a morally objectionable marginal form of coopting the
economically disadvantaged for the benefit of the privileged. I
strongly recommend then, that you do your very best to understand this
situation and provide remedies as it is possible for you to do so.
Considerations of justice suggest that society should take a far
greater interest in these individuals than it often does, not because
they have become or might become research subjects but because of their
status as economically disadvantaged and exploitable members of society
at many levels. There are here many unresolved questions. For
example, there are questions about the disproportionate use of the
economically disadvantaged, emphasize disproportionate there.
It may be appropriate to have selection
criteria so that the research enterprise does not so frequently use the
economically disadvantaged or any vulnerable population for recruitment
of subjects and that it set, as a goal, that the percentages of the
economically disadvantaged subjects in research be restricted while
insuring that research subjects are drawn from suitable diverse
populations. This was a great concern to the National Commission but
frankly, we never adequately resolved that problem or, in my view,
addressed it. I'll say something more about that in a minute.
This does not imply that it is always unfair to recruit even heavily
from an economically disadvantaged population. I suggest only that
certain patterns of recruitment and enrollment introduce problems
of distributive justice. Diversity in a subject pool might protect
against several conditions that might otherwise too easily be tolerated
in the research process; for example, that studies would be conducted
in dreary, inhospitable and even inhumane environments. That the
same subjects would be repeatedly used in such studies and that
a dependency on money would set in so that subjects would become
dependent on studies for their livelihood. A related problem is
whether it is problematic for individuals to be repeatedly involved
in multiple studies, a problem that presumably would be exacerbated
as financial inducements are increased to be involved in those studies.
Let me conclude about this part about
justice with this confession to you and that's what it is. I find
it somewhat painful to admit but it needs to be said. The idea of
justice in the Belmont Report and throughout the National
Commission's work is deeply under-analyzed. The problems are not
well-developed and the answers are thin. This is my own personal
failure as well as the failing of the Commission and I take full
responsibility for it.
What I am recommending to you is that you
take care not to find yourself in the situation I now find myself
before you today some years down the road. These are powerfully
important issues and they are difficult ones.
The third area I want to say something about, informed consent;
among the great worries about research at the very heart of what
the National Commission did or worries about inadequate or compromised
consent, the typical concerns center on whether the consent is adequately
informed of whether subjects have the ability to give an informed
consent. I'm not concerned now with the ability to consent.
That won't be where my comments go but rather with the process
used in the research context to obtain consent and the ways in which
consent can be compromised.
The most frequently mentioned problems of
consent in research are concealed data and inadequate discussion with
trial participants about risks and inconveniences, a common complaint.
Some practices of obtaining consent are clearly shams, where consent is
invalid even if a written consent document exists. However, there are
many more subtle and difficult problems of informed consent, including
ways in which information is presented initially and then throughout a
clinical trial. Without appropriate monitoring of consent, even an
initially informed and legally valid consent, can become uninformed and
invalid at least morally. I don't want to get here into the
business of constructing an appropriate framework for obtaining and
gaining consent in research but I do want to appeal to you to keep
practices of informed consent at the center of your investigations of
research ethics. The research enterprise and many of its parts still
must learn that informed consent, properly so-called is very often not
a single event of oral or written consent, but a supervised
multi-staged arrangement of disclosure dialogue and permission giving
that takes place far beyond the point of adequate oversight of a
I am not convinced that this model is
deeply embedded in the research system in the United States still today
or elsewhere and I recommend that you look carefully at the problem,
including issues of consent or perhaps assent as we used to say in the
National Commission, by children themselves. Research that proceeds
without a voluntary and informed consent is simply an inexcusable
disregard of the right of subjects.
A final comment, I want to say something
about the political context of contemporary bioethics since you have to
operate in them, in some context of bioethics. I have a longstanding
disagreement with some of even my best friends in bioethics regarding
whether or not National Commissions, Advisory Committees, Presidential
Councils and the like have been and/or must be political bodies.
Crudely stated, the argument to this goes roughly as follows.
The political views of Commissions reflect
their political appointment sources which always have some political
edge to them, whether it be the President or Congress or whatever.
Whenever an issue turns in a political direction, it is reasonably
predictable what the outcome will be. There might be something to this
view, especially if it can be made subtle so that it is not cast too
broadly. Discussion of it needs to be placed in historical context and
made specific to particular issues, but this can be done by an
historically sensitive scholar. However, I do not, myself, believe
that this position is historically accurate or that things need to be
in this way as some people have told me they are.
I believe deeply that such a
characterization of the appointments to and the deliberations of the
National Commission is false to the historical facts. I believe it is
historical imagination getting in the way of real historical
understanding. But now, pertinent to your context here, it is surely
good advice that you protect yourself against the possibility of such
an interpretation of your work, most especially in the context in which
your charge is the protection of the interests of children and research
subjects in the United States.
Few things could be more distasteful even
disgraceful than a political arena for such discussions. I do not
believe that Ed Pellegrino would tolerate it for a minute. Indeed, I
do not believe that he would tolerate it in any arena. The problem
here, of course, is that there is, I quite agree, a sort of political
dimension to the work that you do. You can see that clearly emerging
right now, for example, in discussions of the TGM-1412 case of the six
London Hospital patients so tragically effected by an experiment gone
wrong. This is real human tragedy and what happened in London spanning
across four countries has to be sorted through very carefully.
We do not yet know, I believe, what
happened here. It is too early for judgment. But listen now to the
cacophonous voices reaching for judgment and speaking to the press with
their opinions. Look carefully at what has been said by so-called
bioethicists and others about this case. Watch the political jockeying
that is every day in the newspaper. It will pay you dividends to watch
this and not to make similar mistakes.
What I am recommending to you is that you
take every precaution not to find yourself in a comparable
circumstance. I think that is not as easy as it sounds, although
I'm personally pretty confident here about Ed Pellegrino's
leadership skills. So what I've been trying to tell you is how it
was at the National Commission and that's the way I deeply believe
that it was. This was not a political body ever. It was an anguishing
grinding struggle over the importance of scientific research and the
imperative to protect people from undue risk, but the National
Commission left many stones unturned.
There is a great deal for you to look
into and much hangs on it. Do it well, indeed, do it excellently.
I'm sorry, I couldn't avoid that last line, given so many
Aristotle scholars around the table. Thank you, Ed.
DR. PELLEGRINO: Thank you very much,
Tom. Dr. Beauchamp's talk is up to discussion and I have Dr.
DR.GÓMEZ-LOBO: Thank you very much,
Tom. That was a very clear and affirmative exposition. Let me start
with an information question. And it has to do with the following; I
was wondering if we're so far away now from Tuskegee and
Willowbrook, et cetera, that some of the historical assumptions may
have changed. What I have in mind is this; yesterday, we heard
basically from Dr. John Lantos the following and I'm sorry I
didn't have a chance to have him give us a broader view of this,
but his claim was nowadays that the participation in a research project
may not only not be as risky as it was but even beneficial and his
claim was that in pediatric research subjects, that seems to be the
proper word, would fair better or did, in fact — do, in fact, fair
better than people who might have qualified for the research and
didn't. So there is this presumption that because of the care,
because of the concentration of efforts, probably as a result of
Belmont Principles, the scene may have changed and I would like to hear
more about that as a point of information about what's going on in
DR. BEAUCHAMP: I'm sure things are
better and I would like to think they're better because of
documents like the Belmont Report. I would enter a discussion of this
with some skepticism about the point of view being quite as sanguine as
you just laid it out as being John's view.
I think actually we know very little about
this. How much does anyone know about what actually goes on out
there? We tend to pay attention to things like hospitals, academic
research context, clinics and universities. One of the things that
drops out of sight, would be very easy to drop out of sight with you,
for example, is corporate America. Stunningly little discussion of
what goes on in corporate America, but there may be — and even in the
case of a single CRO, there may be at any one time, as many as 100,000
subjects arranged for by the — at least these are the figures that
have been given to me.
There's a huge number of human
subjects involved in the research enterprise in this country. How much
do you actually know about that and I think the answer is relatively
little. I surely hope that things have been made much better in the
last 30 years but this is an empirical question. I can't really
answer it, because, I mean, I'm not an empirical scientist. I
haven't empirically studied this and that's the kind of
question that I see it. I think, though, when you see a case like the
TGM-1412 study that I just mentioned, you see what can erupt at any
time in the research context. Things can go very badly wrong. And you
may even not be sure why they went so wrong in that context. So though
I'm sure there are many, many studies where people are benefitted
by being in the studies and, of course, you can certainly imagine to be
not only in the case of the United States but in many other countries
as well, I'm sure there are such circumstances. I would ask — I
mean, I would be very reluctant to frame it in that way.
I would ask, yeah, but what about the
DR. PELLEGRINO: Peter, Dr. Lawler.
DR. LAWLER: So I was — to follow up on
what Alfonzo said, I was thinking about the happy conclusion that Dr.
Lantos gave us yesterday that if you're in a heavily regulated
environment you're safer. So I will be safer later on this
afternoon when I'm flying back to Atlanta than I am sitting here
right now because then I will be in a more heavily regulated
environment. I mean, there's some truth to this. The studies do
show, so to speak, the safest place you can be in the world is on a
plane flying, okay. But this seemed — I agree, your skepticism
concerning this finally, that this doesn't simply resolve the
situation so we can now put burden in quotes, "the burden" of
being a research subject because it's not really a burden because
we should all want to be research subjects. It couldn't be this
So if I understood the beginning of your presentation correctly, there
is an irreducible conflict between what's best for the individual,
what's best for the person, and what's best for scientific
research. There is no way of coherently resolving this on the level
of ethics so all you can do is balance it in such a way as to minimize
DR. BEAUCHAMP: Be constantly on guard for
it, yes, that's right.
DR. LAWLER: Right, so in other words,
there's no coherent ethical resolution to this problem given that
both of these interests in isolation are valid, the interests of the
individual person and the interest of science to progress which
everyone benefits from.
DR. BEAUCHAMP: Yeah, if I can comment on
that critically, I'm often astonished at the literature of
bioethics and the attempt to what we sometimes call hierarchically
structured principles or something else. I'm just astonished at
the idea that — this is not a knock at you — beneficence should be
above everything else or that justice should be above everything else
or autonomy above everything else. It's not the world and never
will be. I'm sorry.
DR. LAWLER: Right, so that seems very
reasonable. So your concern about justice confuses me a little because
DR. BEAUCHAMP: Confuses you?
DR. LAWLER: Confuses me. I think lurking
in your presentation is this premise, that citizens have a duty to
advance scientific research. That premise must be there because you
were against giving incentives to people to participate in scientific
research because that then would have too high a proportion of the
DR. BEAUCHAMP: I'm sorry, I
didn't say either of those things actually, but go ahead.
DR. LAWLER: No, no, the — well, I think
you did implicitly because diversity is a goal in terms of subjects.
How exactly would you achieve this given that if you offer incentives,
those who are disadvantaged would be more likely to accept the
DR. BEAUCHAMP: Well, I have a 30-page
unpublished paper on the subject that I will send to you if you would
like to see it. I think it is an extremely difficult problem. It is
way more — there's vast literature on undue inducements and undue
influence and that kind of stuff in bioethics, most of which I find so
confusing or incomplete that I really don't know quite what to do
with it. And I don't think it's something that we can really
I'd be happy to e-mail with you and,
you know, talk about it at some length. It really is a subtle and
difficult problem, more — way more nuance, I think than most people
have appreciated but no, I don't hold either of the views that
you're attributing to me, that you thought you saw in my talk,
DR. LAWLER: Well, then I'm relieved,
PROF. GEORGE: Dr. Beauchamp, I want to
take you to those comments that you made at the end on the — well,
really I think you're warning against the vulgar politicization of
advisory councils and ethics councils and so forth and I thought your
sound and subtle distinction between that and the sense of working in a
political environment that was inevitable and not of itself something
that needed to be rejected in any way.
A council like ours or any of these
councils, our predecessors, other councils does work in a larger
environment where there are particular elements of the society who are
paying particular attention. I think in the case of a council like
this and our predecessors one is particularly aware of the academic
world and particularly the bioethics academics who are interested in
the work of the Council, commenting on the work of the Council and so
forth and also the media. I mean, we'll open the newspaper on a
given day after a meeting of the Council and you know, there might be a
report, something in the Washington Post perhaps, something in
the New York Times and so forth.
Now, plainly you're right, I don't
think anybody would disagree that a council like ours really needs to
be careful to avoid politicizing itself or being politicized in that
vulgar and bad sense. My question is not about that. It's about
the steps that I think you were implicitly urging us to take to avoid
not only that vulgar politicization, but the appearance of vulgar
politicization. Now that, too, sounds right to me, since the effective
work of the Council depends to some extent not only on doing our job
well, but being perceived by opinion shaping elements of the society as
doing the job well.
But I would just ask for your reaction to
the following thought; it's not as if there are neutral observers
standing apart from a political environment and free of political
convictions and concerns of their own who are then assessing the
question whether the Council is politicized in the vulgar sense or is
doing its job well or is doing its job less well than it should because
of vulgar politicization. Rather there are political realities that
are describable about the people who are paying attention and writing
and seeking to shape opinion.
And my own experience with this Council is that in the end there's
very little that you can do that will enable you to avoid an allegation
of vulgar politicization where at least as in this case, you're
talking about a council whose members are appointed by a President
who holds very publicly and defends certain views which are just
out of step with major constituencies who are paying attention to
the Council and commenting on it in the public media, whether people
who are themselves professional pundits and commentators or people
who are in the academic world and particularly with the world of
Now, I guess I would not suggest that that
doesn't mean that the effort should be — that doesn't mean
that the effort should not be made, and by the effort I don't mean
simply the effort to avoid vulgar politicization, I think there's
no doubt that I mean, just as a matter of morality and virtue, that
should be avoided. I'm also saying, I guess, I don't think it
means that the effort to avoid the appearance of vulgar politicization
shouldn't be made, but I simply have my doubts about how much can
be done to avoid that.
Now, I could go through and cite examples
and give you chapter and verse and so forth, but I think you know what
I'm talking about and I'm wondering if you just have any
reaction to that thought and any concrete advice about whether there
are — whether I'm wrong and perhaps there are some steps maybe
things that we haven't thought about that could be taken on the
appearance question. Have I made myself clear?
DR. BEAUCHAMP: Yeah, I guess I'd like
a more richly drawn description of — it's almost as if you're
saying at one point in your comments you think it's difficult to
transcend the political context and I'm wondering, I guess, what
the underlying interpretation is there and what you think about that?
Do you think that the context is so political and you have to have
arrangements with such and such, the media, with let's say the
White House or whatever, such that you're unable to transcend that
political — to use the language of neutral observers was it, to become
a kind of neutral observer of your own situation and/or the political
context? Am I following you right? Is your view that strong?
PROF. GEORGE: I don't — perhaps I
haven't made myself clear. Whatever we do is going to be observed
and commented on by people who are interested in it.
DR. BEAUCHAMP: That's a given.
PROF. GEORGE: Okay, that's going to
be a given. That is, itself, part of a larger political world, the
elements of that commenting society.
DR. BEAUCHAMP: That's a given, too,
but not a world that you have to, so to speak, conform to. You have to
conform to its expectations and —
PROF. GEORGE: It's certainly true and
we haven't. I think it's fair to say we haven't conformed
to anybody's expectations. The Council has been, you know, quite
publicly very divided on many, many issues. We have managed to achieve
sufficient consensus to get out some reports that are valuable but in
very many cases, what the reports are doing is not defending a single
view, but putting forward the best arguments that we think are
available for competing points of view and the reason we're doing
that is that those points of view are represented on the Council.
But even those efforts seem not to be able
to persuade significant commentators on the work of the Council that
the Council is avoiding the kind of vulgar politicization that
you're, you know, rightly warning any council against. And I think
that's because people have political views and people have
political agendas beyond the — beyond the Council and there's
really very little we can do about that.
DR. BEAUCHAMP: There's nothing you
can do about that. You're stuck with that problem. I mean, you
just have to remain true to what you know are the right values, the
right kind of information that you should assemble, be sure you have
proper discourse and something that I personally think is very
important is not to be in any way intimidated by or unduly influenced
by any kind of political constituency and after that, what more could
anybody really expect of you?
If people then draw the conclusions that
they wish to draw because they have an agenda of some sort or an
ideology or whatever, there's nothing you can do about it.
They're free to say whatever they want to say.
PROF. GEORGE: Yeah, I think that's a
good answer and I think it's in a way a very important answer as
well, because it strikes me that there is a danger, your last comment
really highlights it, that a concern to avoid the appearance of
politicization in a certain sort of environment, might very well lead
you to take steps that are out of line with your substantive mission to
give the best possible advice on bioethical questions that we're
facing. And so, while the concern for the appearance of doing a good
job is important, you can't let that deflect you from actually
doing a good job.
DR. BEAUCHAMP: That's right.
DR. PELLEGRINO: Dr. Eberstadt and then
DR. EBERSTADT: Professor Beauchamp, I
realize that statistics and quantification may not be your metier but
DR. BEAUCHAMP: That's for sure.
DR. EBERSTADT: — but it's kind of my
thing so let me torture you just a little bit or avoid torture as the
case may be. When we talk about minor increments beyond minimal in
terms of acceptable risks for subjects, patients, is there, in practice
any sort of literature that would indicate what is taken as acceptable
and what is taken as not acceptable risks in practice? A subsidiary
question there. I thought we had a very illuminating and valuable
discussion yesterday about the differences between harms and wrongs.
I can see how harm is amenable to
quantification. I'm not sure that wrong is amenable to
quantification in the same sort of way. Any thoughts about that? And
finally, just as a general observation, the mortality levels for
children in most developed societies are vastly lower than mortality
levels for adults. Does that suggest to people who are looking at the
question of minimal acceptable risk for children the standard for
children in absolute terms should be a much higher threshold than for
DR. BEAUCHAMP: A three-part question, I
guess. On minor increase beyond minimal, I would be embarrassed to try
to make an answer to your question when one of the world's leading
authorities is sitting in the front row back there. He knows more
about this than anybody that I know. But I will tell you this; it was
the view of the National Commission that it was not our job to try to
fill in exactly with great precision what that means. That was the job
of the IRB. That was the whole point of coming up with the conception
in the first place, which is to say, if you want to put it, you know,
rather negatively, nobody really knows what that means. It has to be
decided at the IRB level in the research context.
On harms and wrongs, it's always been
a very important distinction to me. It's a subtle distinction. I
think it's beautifully analyzed in the work of Joel Feinberg, if
you want to know sort of where I am on that issue and I guess I would
agree with what you said about that.
And the other was about threshold of —
DR. EBERSTADT: Minor increment beyond minimal,
acceptable, minor increment beyond — should there be a stricter
standard for children?
DR. BEAUCHAMP: The way the National
Commission went at that was to say we ought to use healthy adult
populations first. Now, is that the right view? I don't know. I
don't know that that is always the right view. So to harden that
principle may be the wrong way to go. Still, you've got to see
children in most contexts as more vulnerable than a healthy adult
capable of consent, knowledgeable about the situation, and so I
don't really know what much more to say about it than that.
DR. PELLEGRINO: Gil is next.
DR. LAWLER: Although his question was literally
because children are objectively less vulnerable the standard should
be higher. They're more likely to die just hanging around —
DR. BEAUCHAMP: That doesn't mean
they're less vulnerable, yeah.
DR. PELLEGRINO: Gil, Dr. Meilaender.
PROF. MEILAENDER: I won't ask
anything statistical, so —
DR. BEAUCHAMP: I wouldn't expect that
PROF. MEILAENDER: — so we're okay on
DR. BEAUCHAMP: Maybe something Lutheran?
PROF. MEILAENDER: Not for today, I think.
We'll see what your answer is, you know, and where it takes us.
Two questions. The first is just a kind of — it may just be
a personal curiosity for me but when you were talking about the
importance of seeing the Belmont Report embedded historically in
a context where the issue was research and so forth, I mean, I don't
dispute that but I just have the feeling that there was a sub-text
that I was missing in a way. I mean, after all, there is that well-known
book "Principles of Biomedical Ethics" that has some kind
of historical relation to the Belmont Report, which —
DR. BEAUCHAMP: But nothing what people
PROF. MEILAENDER: Well, but which
isn't confined to research ethics, right, and a somewhat similar
structure morphs out in a way to deal more broadly. So I mean, if I
was missing something, if there was something really important about
locating the Belmont Report in that historical context, I'd just
appreciate it if you could say a bit more about why you emphasized that
so much. That's the first thing.
The other sort of less just kind of personal inability to get
something, the notion of this sort of unresolvable and irreducible
tension between respect for the individual and concern for the well-being
of society, and the just sort of inability to get over that, there
would be sort of two things I'd say about that. One, you —
when you were talking about it in your talk, you used at one point,
I wrote it down, in terms of these several different principles
and some constraining others, you used the phrase "balance
and specify the moral considerations." I would have thought
that balancing and specifying are not the same thing in the way
one goes about dealing with sorting out conflicting principles.
I never — I never know what balancing means actually. I have some
sort of idea what, you know, Henry Richardson means by specification
and so forth.
So if you could illuminate the balance
metaphor a little bit, I'd like that. And the other thing is, I
don't know why we should necessarily think this tension is
irreducible and unresolvable. It depends a little bit on what you
think a person is and what you think a society is and what the relation
between the two might be. And on some views of the relation between
the person and society, there wouldn't be — the tension
needn't be left to stand. Certain views might clearly, you know,
give primacy to the claims of the individual and the well-being of the
society would just have to suffer a bit.
Other views would think of the person as
more a part of a whole, who's good had to be taken up in that. So
the tension is only unresolvable, I think, if one's just kind of
willing not to push farther on some what I admit are sort of
quasi-metaphysical kinds of questions, but if we push on those
questions, we might well get some kind of answer to it or so it seems
And I just wonder if you think I'm
mistaken about that or if I'm right but you'd just prefer not
to push on those questions or sort of how you come at that.
DR. BEAUCHAMP: Well, that's a heck of a set of
questions. It would take a lifetime to get to all of those adequately
but let me say something about it. The main point that I wish to
make about the three principles is that in order to understand those
principles and what is the meaning of those principles, it has to
be understood in the historical context. It cannot be understood
in any other way, I believe, and understand that because it's
been presented as a framework of principles. Understand that framework
of principles requires a historical understanding. Of course, you
could take respect for persons, do what a lot of people do, which
is to give it say a Kantian spin or a Kantian interpretation. This
is most certainly what the National Commission did not do. In fact,
I tried that with the National Commission. I tried to explicate
Kant and build it into the document. They said, "We don't
want that. We want plain talk so that the entire American public
understands it." So that really the larger point that I was
making is that that framework is a historical framework.
If you don't understand it in its origins, you just abstract
it out and you say, "Well, here's what respect for persons
means," and then you go and you read Ed Pellegrino and you
say, "Well, this is what beneficence means," and then
you go and read Jack Rawls or something like that about "This
is what justice means." You just won't get it. Right,
you don't understand what's going on. Moreover, there's
been a tremendous amount of confusion of the very sort that you
elude to, which is between the principles of biomedical ethics and
the principles that are present in the Belmont Report. People are
so confused then that what they've done is to interlock the
frameworks. Of course, they don't interlock, they're incoherent
actually. So those are the kind of concerns that were in the back
of my mind. I've taken a long time to sort of unravel that.
On balancing and specifying, it's a
hard question. I've struggled with this. I've argued with
Henry Richardson about it. I have argued with David DeGrazia about
it. I have argued with Jim Childers about it. It is a difficult
problem. I agree with you. I can tell you Jim Childers agrees
strongly with what you were saying but it's not easy to get out and
the reason it's not easy to get out is because you get more and
more into the theory of what happens with specification and it looks
more and more like you're balancing. That's the logic of the
In simple terms, I think of it in this
way; it think balancing occurs in judgments that are made in specific
context and it is something that we have to do and we don't have
time to specify, we don't have time to think about the consequences
and the implications of the kind of thing that goes on in
specification. We have to make judgments and we do the best that we
can to balance the different considerations that are present in that
Specifying, I think of largely in a policy
context. We are able to sit back and think and figure out well, what
if this and what if that and what if the other thing and try to
articulate what the policy would be under those different
contingencies. But it's — I think it's a deep problem and I
most certainly don't think that I've resolved all the
Now, metaphysical questions; gee, I'm
really reluctant to say anything with Alfonso in the same room with
me. It might come as a surprise to you to know that most of my own
teaching career has dealt with metaphysical questions. These among
them, but many other metaphysical questions as well of the sort that
say Alfonso and I would deeply share. So I have the deepest kind of
respect for pushing in the direction of metaphysical questions. At the
same time, the most influential philosopher on me, and I don't know
on Alfonso, but the most influential philosopher on me is David Hume.
And Hume asks you to approach metaphysical questions with a certain —
a certain carefully edged skepticism and I do. I am very skeptical to
go directly to the concept that you mentioned which is a concept of
person. I'm very skeptical that that concept can be explicated,
theorized about, and presented in a way that resolve, I think, exactly
the kind of questions that you're talking about.
Now, there may be other ways to go at
those questions but I am very skeptical that metaphysics persons will
do it. That's another long paper as to, you know, what the
skepticism is and how it would be manifest, but it's the long and
the short, I think, of the answer. I don't discourage anybody ever
from engaging in metaphysical thought. Just understand that it may
have limits. It may have deep and sharp limits and not be able to get
you, especially in the area of ethics, to the conclusions that you want
Is that okay, Alfonso, or am I making a
fool of myself?
DR.GÓMEZ-LOBO: I think the key
metaphysical issue is the issue of community rather a common good
rather than persons in Gil's question, if I understood it
PROF. MEILAENDER: I would have said the
relation between the human being and the community. I mean, on a type
of person of language here, actually I should prefer human being
language, but one might find arguments suggesting — actually, we could
find some in Luther by the way, but I won't trot them out right
now, suggesting that there's a sense in which the human being
transcends the community and cannot be understood to the whole extent
of his or her being to be a part of that community. That kind of
approach might begin to suggest a certain way to resolve the tension
and not leave it unresolvable, for instance. I
mean, it's just an example, so I would have said that what I had in
mind was, yes, it is community but it is the relation between the human
being and the community and how to understand that but it does seem to
me that different ways of understanding that might lead to different
resolutions of this tension rather than just leaving it to stand
alone. That doesn't mean it will persuade everyone but I never
worried about that.
DR. PELLEGRINO: Dr. Hurlbut and then Dr.
DR. HURLBUT: Why don't you go first?
DR. KASS: Just a couple of comments and
then a question, just sort of try again on something that was in
Gil's — part of Gil's question. I appreciate the historical
context of Belmont Principles. That's a very valuable addition to
our consideration. I also share — sympathize with your frustration
about how a careful piece of work has been misunderstood, confused by
others and abused. It's an occupational hazard.
DR. BEAUCHAMP: We all have our
DR. KASS: And you can fill in the blanks
as to why I and members of this Council might have some sympathy for
that concern. We are in part responsible for the way in which we are
misunderstood and in the field of bioethics generally the Belmont
Principles, not by us primarily but by many people, have been taken,
expanded and used beyond the research context and there are also people
who try to push almost all kinds of ethical questions into the research
analogy. So — but I think — I mean, on balance, I think this is a
very valuable revisiting and clarification of what those principles are
Second, I appreciate that the principles are intended not as a
licensing of a simple utilitarian approach to research with human
subjects but in fact, to introduce non-utilitarian considerations.
I appreciate that but I think part of the reason why the charge
that this is somehow in the service of utilitarian, of a utilitarian
consideration in the end, comes through the balancing — through
the metaphor of the balance. The metaphor of the balance presupposes
commensurables, presupposes some kind of measure, presupposes an
adjudication amongst competing goods, but the — you don't balance
the right against the good on the same scale if there really is
such a thing as the right.
And there are people who think that there
are certain kinds of inviolable — that there are certain kinds of
conduct that simply should not be done and cannot be balanced, this
would be an argument, cannot be balanced by certain considerations of
social good or what have you. So I guess I wonder — I wonder really
about the sort of underpinning of this notion of the need to balance
and whether that doesn't finally contribute to a view which will
eventually lean harder and harder against those kinds of restraints in
the name of the good and in which you don't sort of say no matter
how much good comes from this, this is — you're somehow traducing
something deeply important about human beings.
I didn't put that very well, Tom, but
I think you get the gist of what I'm talking about.
DR. BEAUCHAMP: Leon, you always put
things well. I think that the essence of that last part which might be
the most important part is about what I've referenced in the
language of the paper as deontological constraints.
DR. HURLBUT: Right.
DR. BEAUCHAMP: This is maybe, maybe the most important
discussion and philosophy of the 20th and 21st
Century as ethical theory unfolded. And I would be very, very reluctant
to try to say anything about how you resolve it. I do not think
it is a simple question and no one has ever convinced me that there
are clear deontological constraints that one must follow wherever
they take you irrespective of the consequences and that's where
the balancing will come back in. As the consequences are upped
and frankly, as what might be at stake under the rubric of these
deontological constraints are reduced, there may come a point where
you say, "Well, even though ordinarily it would be very wrong
to do this, in this case I think it is the right thing to do."
Now, I know these are very abstract
notions and philosophers divide heavily over this. I do think the
notion of a deontological constraint is a terribly important one and
you could probably tell that that's the way I'm representing
how I understood the National Commission as putting forward views about
justice and respect for persons as precisely as deontological
constraints. I don't know how to push harder on that without
getting deeply into Thomas Nagle's theory of this and that sort of
thing, which I don't think would be the right way for us to go.
DR. KASS: Could I just a small thought?
Let's assume that there are constraints which are not always but
for the most part, and that you might imagine yourself saying that, you
know, the rule against adultery is more or less absolute but if
it's necessary to provide an heir to Queen Elizabeth I to avoid
civil war, we make an exception, et cetera.
But would you then be thinking of what
you're doing under the metaphor of balancing? I mean, are you sort
of creating a — or is the very notion of balance a kind of
homogenization of the various considerations such that you can get them
DR. BEAUCHAMP: Yes, I would think what
you're doing is balancing. The problem there is you have to
articulate some kind of an account of what it is to balance and what it
is that are the balancing considerations in these cases. Yes, I think
that's in part what you're talking about exceptive case kind of
circumstances or counter-examples or something like that and playing
that game, which I personally think is a very important game or
strategy or whatever in moral theory, I believe it inherently involves
you in balancing considerations all along the way. You can't
ultimately escape them.
PROF. GEORGE: Could I follow up very
briefly on this, just to get clear on the distinction between
specification and balancing? I can understand, we could argue it every
step of the way but I can make sense of the idea that it's
specification at work when we move, for example, from the principle of
respect for persons to the norm against direct killing of the
innocent. It also strikes me as pretty clear that what we're doing
is specifying when we move from the norm against direct killing of the
innocent to the principle of noncombatant immunity even in justified
Then if we get into a debate about exceptions to the principle
of noncombatant immunity, I can understand how that would be a debate
between people who say, "Well, you can't balance a principle
like noncombatant immunity off against other considerations,"
you know, even prevailing against a wicked enemy and so forth and
so on, and how other people would argue, no, no, there you do have
to balance. I mean, noncombatant immunity is for the most part
and usually but there comes a point at which.
But I thought that at one point you were saying that the idea of specification
itself becomes problematic, so that in moving from say — now these
are my examples, not yours obviously, from respect of persons to
no direct killing of the innocent or from no direct killing of the
innocent to noncombatant immunity, what looks like specification
does, itself, even there involve balancing.
DR. BEAUCHAMP: That's right. It may
be very hard for you to articulate — I mean, specification is
progressive specification in the way in which I believe you are
suggesting. So as you progressively specify, render the principle or
the norm more and more specific, it may be impossible to do that
without bringing balancing considerations into the focus of what
you're doing, at the very base of what you're doing.
That's what I was suggesting.
PROF. GEORGE: Okay, I mean, I understand
the position. I would want to argue against it. It would be an
interesting argument there.
DR. BEAUCHAMP: Yeah, these are hardly
DR. PELLEGRINO: Dr. Hurlbut?
DR. HURLBUT: Several times you mentioned
the questions and problems associated with international considerations
and I just wanted to generalize this discussion a little bit to a few
practical and theoretical problems just to get your insight from your
experience, a reflection on these kinds of problems. The Belmont
Report is, by its own admission, your writings, provides general
guiding ideals and sort of a general analytic framework for reflection
and it seems to me that at the best, that will work well within a
context where there's a certain cultural center of gravity to draw
your thinking down to consensus.
But now we're facing the strange
problem of what you might call the outsourcing of ethics, a troubling
dilemma of not just US scientists being lured overseas to do work that
is proscribed in the United States, but also the hints of corporate
commercial interest by outsourcing clinical trials and so forth. And I
think there's a really big problem brewing here and the problem is
exacerbated by our own inability to find tangible kind of structure or
skeleton to our own ethical thinking.
I know it's a vague question but
I'd just like your reflections on this. It seems to me the three
major zones where we are going to have to face up to some difficult
dilemmas and the first one is the one that's the least troubling
and the most troubling to me, it's the question of when you have a
possibility of doing a clinical study in a population that is so
wracked by disease and so under-served that you may be bringing the
only medical care they have to the community, the only supervision.
You know what I'm talking about.
DR. BEAUCHAMP: Yes.
DR. HURLBUT: So that's one thing. And especially
with regard to children, you can imagine that you could do both
a lot of good and a lot of harm in that context but then there are
the practical problems associated with competitive commercial advantages,
but overarching all of this is the more metaphysical concern with
the question of pluralism and I just would like your — I know that's
another very big set of questions but can you give us some reflections
on those concerns?
DR. BEAUCHAMP: Tell me what worries you
the most about them. Is it competitive commercial concerns or what
DR. HURLBUT: Well, I'm not accusing
anybody of anything in saying this —
DR. BEAUCHAMP: No, I understand that.
DR. HURLBUT: — but I'm worried that
if one country has different standards for what's acceptable
practice and research ethics that they can test drugs more quickly and
more efficiently on poor human subjects, unhappy situations. There are
rumors of such things and I'm not saying they're true, but if
it's true that drugs are being tested on prisoners of in orphanages
for example, that would provide a very troubling foundation. It would
be a very efficient foundation for later testing in above board
transparent ways and it might increase the efficiency of your success
in filtering drugs, but it wouldn't be good for human dignity and
it wouldn't be good for individuals who are subjected to it.
And likewise, I can imagine situations
where scientists go places where they're allowed to do things and I
mean, we're now arguing in this country over the stem cell issue
and the 14-day limit on the use of embryos but there might very well,
I'm not saying any of our scientists want to do this, I'm not
making any accusations, but there might very well be some people
somewhere who want to use embryos later than 14 days if it could be
done and it probably can be done technically some time. So, I mean,
from a purely scientific standpoint, we would both want to know the
science of embryo genesis after 14 days, plus it might turn out to be
an efficient way to get cells, more advanced cells, tissues and organs
for therapeutic use.
So I just — I know this is a very vague
question, but it worries me a great deal that we're now becoming a
global civilization. We're gravitating toward a globally standard
material culture, but we don't seem to be able to find a moral
culture of similar — of a similar uniformity.
DR. BEAUCHAMP: I guess I think what you
are doing is rightly placing on your own shoulders a certain
responsibility for creating such a moral environment because major
public policy groups or bodies such as your own really do have that
responsibility. I think it's built into the fabric of what you
do. You started, I think, with the international domain. Let me first
say that Bob Levine is one of the most distinguished figures in the
world in international research ethics and again, I'm sort of
reluctant to move into territory where he knows so much more than I do
and he's sitting in the front row here.
But I've watched some of these things
and been to some of these places and I've come increasingly to the
view that there are a lot of American biases that — American biases,
that's not — some are American biases and some are biases that
come from institutions and so on that we should be careful about.
For example, a lot of people seem to
reflect in conversations I've had with them, the view that well, of
course the United States, we're very careful about human subjects
and we have such a great health care system that will back up anything
that goes wrong, and so on and so on. And in these other countries,
well, of course, they don't — I'm not so convinced about that,
that that's just even factually the case, that the healthcare
systems in many, many, many countries in which the research is done
quite as bad, and in fact, might be even better in some cases than the
opportunities that we can provide them in this country.
So when you go to disadvantaged
populations, there are disadvantaged populations in virtually almost
every country of the world, I wouldn't leave the United States
out. I wouldn't be so worried about say a population in China or
India or something like that thinking that somehow inherently
they're more disadvantaged than populations here. I worry about
them in all of these places and what happens.
Another bias that has disturbed me over
the years and might deserve a little bit of reflection on your part
does come through your language of competitive commercial, I believe
was the wording that you used. My own view, for what it's worth, I
just give it to you for what it's worth, is that people who come
from universities have a deep bias in thinking that, of course, their
work is completely free of bias and so on when they do research and so
on. And then there are these commercial interests where things get out
of hand. Is this sort of, should I say hubris, Leon, would that be the
right word to use in this context? It's certainly a kind of
presumption here that I've personally not found to be borne out.
I should have to tell you, I was not
raised in an academic home or environment. I was the son of a CEO of a
healthcare corporation, a non-profit one, but that was the way in which
I was raised and I came to deeply respect that culture. Now, things do
get out of control, but they also, I think, also in our academic work
and the research that we do, things can spiral out of control and we
can misuse populations and so on. So I would be careful in
understanding the context, careful in what your expectations are for
certain groups and the like, but I don't have any cosmic solutions
to these problems. They are not atypical, just a lot more complicated,
I think, than people usually think they are.
I certainly do think that your
reservations are well-taken. I guess I would just try to broaden them,
contexturalize them a little bit.
DR. HURLBUT: I certainly think that the
issue of commercial competition has its parallel at the level of
individual ambition for which academics as well as other human beings
DR. BEAUCHAMP: Exactly.
DR. HURLBUT: But still, and I wasn't
even accusing commercial interests from our country to export their
problems or outsource their ethics, I was just saying that regardless
of who the originating source is for the decisions to do research of a
certain type on — say on children, you can see how unless you — when
you dispense with ethical concerns, you can do — you probably could do
science and biomedical science particularly more quickly and
efficiently but that's — the whole point of ethics is to put into
the equation the more fundamental concern that to my mind has primacy
actually, the protection of —
DR. BEAUCHAMP: I couldn't agree with
you more. Sometimes that gets a little out of control. We think
ethics always has primacy over everything else. I'm not so
convinced that's true, but, yes, there is kind of a basic primacy
DR. HURLBUT: Well, if you see ethics in a
broader context rather than just the frosting on the cake, but the very
substance of the cake itself, the thing that knits the pieces together,
the coherence of life, then it's — then it does trump everything
else because without it, you have nothing.
DR. PELLEGRINO: Dr. Foster?
DR. FOSTER: I'll be very brief, I
know we're at break time. I'm concerned about two things, Tom,
about the practical things that you've talked about. It's
certainly is clear. I've read the Belmont Report and all of those
things and I get different insights from what you've said and the
problems, you've hinted that there's sort of a loss of
understanding about many of these problems of human research.
And I should say, I've never done
human research. I mean, the most sophisticated animal I ever worked
with was you know, a mouse or a rat, you know, or something, so I
don't do this kind of research. But there is a huge increase in —
with the NIH emphasis on translational research. You're going to
see more and more human research coming along which means more and more
problems we have to say. And we don't — in the first place about
the risk; in 2004 there were 550,000 papers published in the 4,000
journals at the National Library of Medicine archives. Okay,
that's one paper a minute, okay, just to keep up with risk.
I saw something this week that in all my
life I have never seen and there are three cases in the literature of
something that's such a common disease that every physician knows
about it and it comes up, I mean, you can't predict always what
risks are going to happen even with the Internet. So people who work
on these things have a huge burden to try to comprehend — let's
say only one out of 1,000 of those papers are important, that's
still 500 major papers you have to learn about and so forth.
So there's not much time to spend on
learning more about deep ethics and so forth. I mean, I don't
understand a lot of the dialogue that goes between — you know, about
specification and all these things, you know, and I don't think
the thousands of people who are actually doing the research and the
IRBs on which they serve have the slightest inclination to study in
deep detail the sort of things that would be very important to you and
to other ethicists as a discipline which should be but in terms of just
running a clinical trial, I mean, it's not possible to do the sort
of informed consent that you have described that's ongoing,
reaching in great detail. Many times people can't understand the
If you've ever tried to talk to a very sophisticated professor
of medicine and get them to take a drug that they need desperately,
like a statin or something like that, and they've read the PDR
and they've read every possible negative thing that can happen
and you can't get them to, you know, give consent to do that.
How am I going to do that to somebody who's got a grade school
education? You know, I mean, so there's the problem in — there's
a problem in carrying out this research is that there's not
an inclination or the time for either all the knowledge — I mean,
you have to try to do it. I mean, one of the things I know a lot
about is diabetes.
I can't keep up with just the papers
on diabetes mellitus, you know, that go on. So the question I want to
ask to you, isn't it sort of unreasonable to say, as we've
heard in some of these things, that we need to deepen, broaden the time
and intellectual expenses in trying to do things more perfectly and
more in accord with what the wonderful report Belmont meant? I mean,
is that really possible? I can tell you very frankly as a chairman of
medicine who deals with people who do all these things all the time, I
think that's absolutely impossible and unrealistic and one of the
thrusts we heard yesterday, we need to try to diminish the safeguards
that are coming up with the IRBs in order to get a better assessment of
what the true problems are. That's — and I don't want you to
answer much about that except — because the time is up, but that's
what really worries me. It's in seeing people who are actually
doing all these things and on occasion you get heinous mistakes and
some of them are deliberate, you know, that people have done wrong
things but I don't know how — I don't think we're going to
have a discussion in IRBs like we've had here this morning. I just
don't think there's a chance in the world that that will
DR. BEAUCHAMP: Dan, I don't have much
to say about that. I agree with you wholly and completely. You are a
— you're still a Donald Seldon Professor of Medicine; is that
DR. FOSTER: Sixteen years and I've
passed that on.
DR. BEAUCHAMP: You've passed that on,
okay. Well, let me say there are only a few Donald Seldons. Donald
Seldon, for those of you who don't know him, is one of the great
Professors of Medicine of our time, Dan's predecessor and he has
the capacity to consume all of this literature and process it, but he
is just about the only person I have ever known in my life who can do
so. I agree with you wholly and completely, and therefore, the system
has to find some accommodations and it has to be streamlined in certain
One of the things that we looked at when I
was on the Institute of Medicine Committee looking at responsible
research, was how do you take what is clearly a broken backed system,
the IRB system, and try to reduce the workload to straighten it out so
it can do its work properly. That in itself is just a huge, huge chore
and so what you've got here is you very nicely lay out the tip of
an iceberg that we have to deal with.
DR. PELLEGRINO: Dr. George.
DR.GÓMEZ-LOBO: Can I make a — sorry,
thank you. Just a quick remark, but isn't that precisely the
reason to have something like distribution of labor?
DR. BEAUCHAMP: Absolutely, absolutely.
DR.GÓMEZ-LOBO: Because of course, the
clinical physician, of course, can't do all of this but there has
to be someone thinking through these problems it seems to me.
DR. BEAUCHAMP: No, no, let me give you an
example. One of the things that we talk about a lot at the Institute
of Medicine was the problem of conflict of interest by contrast to the
work of IRBs. Quite a few institutions throw several kinds of conflict
of interest onto the IRB. The IRB should not deal with conflict of
interest. That should all be handled, done and over with before they
even begin to process things. In other words, you should have a
separate conflict of interest committee.
Now, I personally think that conflict of
interest is a deeply under-analyzed notion not well attended to
particularly non-potential conflicts of interest. That, then becomes
itself — can become itself a major preoccupation. Most certainly IRBs
in my view should be shielded from it. So yeah, of course, I'm
going to agree with you.
DR. PELLEGRINO: Dr. George?
PROF. GEORGE: Yes, I've been —
DR. PELLEGRINO: Last comment.
PROF. GEORGE: Yeah, and thank you for the
third opportunity. Sorry to take us beyond the limit but just I'll
try to do this quickly because Dr. Beauchamp's comments as I've
been reflecting on them brought a question to my mind about how we
think about the common good and how we think about what you've been
referring to as deontological constraints.
In professional bioethics, I think a lot
of people conceive of the common good or social benefit in utilitarian
terms. So they think that there's a common good and they've
got a conception of the common good and that conception is a
utilitarian conception. Now, for bioethicists for whom that is just
part of a larger or more comprehensive utilitarian approach to ethics
and to life, that's the end of the story. But there are other
people in professional bioethics who aren't satisfied with the
utilitarian story as a comprehensive approach to ethics and, therefore,
they see a need for constraints on thinking of things in utilitarian
terms and ordinarily those constraints are matters of protecting
individuals who could be sacrificed in a way that would be unethical
for the sake of the common good where the common good is conceived in
utilitarian terms and where they're prepared to conceive the common
good in utilitarian terms.
And then you have a debate between
utilitarians and non-utilitarians. But of course, there are
alternatives to thinking of the common good in utilitarian terms. I
mean, there could be, for example, a purely deontological theory. I
think it would be problematic. There's no doubt about that, it
would be problematic but there could be such a way to try to solve the
problem that you've identified as the problem that nobody has
solved and probably nobody will solve, thinking about individual
interests and the common good.
But in addition to that option, there is
the kind of conception of the common good, I would say a
non-utilitarian conception of the common good, that's part of a
longer tradition, you know, going well back before the great founders
of utilitarianism, and which still has very articulate exponents today,
I mean, some in this room like Gil and Leon and Alfonso. I mean, the
way their thinking and I, myself, try to think about the common good is
to begin with a non-utilitarian conception of it and on such a
conception, rightly or wrongly, there may be all sorts of problems with
this, but on that sort of conception, what you are talking about and
what a lot of professional bioethicists talk about in terms of
deontological constraints on the pursuit of the common good, are really
conceived as aspects of the common good. So there's not a
contrasting of individual interests or rights with the common good, so
we would never think with Ronald Dworkin in terms of rights being
trumps on the pursuit of the common good conceived in utilitarian
But rather we would see those individual interests, there's...
one might even say individual rights, as aspects of the common good
itself. So that there's an attempt, at least at seeing individual
interests and the social good in more of a harmony and when we would
restrain ourselves from certain courses of action that might otherwise
be regarded as ways of advancing the common good, we wouldn't
be, even on our own understanding, sacrificing the common good for
the sake of deontological constraints or the individual or individual
rights. We would be pursuing the common good, because the common
good itself included a concern for the dignity and worth and rights
and welfare of the individual.
DR. BEAUCHAMP: I think I agree with you
completely. Let me only add that sometimes you find your situation is
one of strange bedfellows. And it should come as no surprise here, I
believe, that that's so. My own greatest teacher in philosophy,
including in matters of this sort was David Hume and Hume's
fundamental commitment was to the common good. But the moral theory
doesn't really turn on the common good. The moral theory unlike
what many people have said about him turns actually on the theory of
the virtues. And so what's buttressing and supporting the
over-arching view of what is in the common good is that ethics
originates only in the bosom of a conception of common good as fostered
in a society is the importance of virtue.
Now, the funny thing there is so many people have interpreted
Hume as a utilitarian. I personally think that's a difficult
interpretation to get out of him, but what you're saying could
easily be explicated along the lines of Hume's view. What you're
saying could easily also be explicated along the lines of John Stuart
Mill's view in many ways. One possible way to understand Mill
is his doing exactly what you just laid out. Now what a lot of
people want to say, "Oh, yes, but he contradicts himself along
the way. He screws up."
Well, maybe he did. Maybe he did, but I
think he has in his philosophy in mind exactly the objectives that you
have in mind and by the way, sometimes when I hear Edmund talk about
beneficence and the common good, it sounds an awful lot like Mill to
me, talk about strange bedfellows. But that's at any rate — I
mean, we need to frame these things in terms of what people really held
and what these frameworks are in a broad way committed to.
PROF. GEORGE: Yeah, I take your point actually
about Mill. I remember reading years ago when I was doing my own
doctoral work, a very interesting book by John Gray, one of John
Gray's early works trying to harmonize the Mill of "On
Liberty" with the Mill of "Utilitarianism."
DR. BEAUCHAMP: Yeah, that's exactly
what you have to do, yes.
PROF. GEORGE: Yeah, and I thought it was
actually a persuasive case.
DR. PELLEGRINO: Thank you very much, Tom,
and the commentators. We're a little bit overtime so that
we'll have our break and return at 10:30.
(A brief recess was taken at 10:12 a.m.)
(On the record at 10:35 a.m.)
SESSION 6: CHILDREN AND CLINICAL RESEARCH
DR. PELLEGRINO: This session, this last
session of the morning, will be a little bit different. This is the
first time we're trying something of this order and we'll
invite your participation. I'm speaking to the members of the
Council. In fact, the emphasis will be on your continued
participation. I'm very pleased with the way the Council has taken
part in every discussion and we fill every moment of time with their
discussion, which I think is crucial and important and relevant.
But we've asked Dr. Bob Levine to
present a case, maybe our clinical colors are beginning to show but I
think you may find this a very interesting way to look at some of the
problems we've been cogitating over the last several days in a
particular circumstance. And while bioethical issues must rise above
individual's general perceptions and concepts, nonetheless, they
come back to individuals and this is the final point. It's really
the moment of truth to see how a principle or a rule or a policy
effects the person who is ill or the person who is a subject, how it
effects individual human beings.
Forgive me for that interest as a
clinician. I hope you'll find that it is not irrelevant to the
larger issues we've been discussing.
So Bob is going to present a case and then he's going to involve
the Council members and then make some comments and if I can restrain
myself, I will not make too many, but I probably will make a footnote
here and there. I've been practicing restraint in the interests
of maintaining a little bit of neutrality. Bob.
DR. LEVINE: Thank you very much, Ed. Here I
am again. I thought the first half of this morning was a very interesting
and important discussion and when Tom Beauchamp said that he and
I speak as if with one voice, I thought, "Don't I wish?"
The case that you have in front of you, Ed has asked me to just
go through it, not read the whole case to you but go through it
to pick up on some of the important points and then to turn this
over to you for discussion.
This is a case that was published in the IRB Journal about 15
or so years ago. In the publication, which is footnoted at the
end of the second page, in case you want to read the full case,
there's a careful analysis of the ethical issues. When I recommended
this case to Dan Davis, he decided to use it and I want to congratulate
Dan and Ginger Gruters for a very skillful job of restoring this
case to its original position, that is in the form that it was presented
to the IRB rather than after the IRB did its work and wrote its
interesting ethical analysis. So I congratulate and thank them.
I think one of the interesting things
about presenting a case is that some of you are clinical scientists who
probably have complained about all of the things the IRB has asked you
to be responsive to. It's my experience, though, that when we all
get together and review a case as if we were an IRB, you will find
emerging from your respected colleagues some of the things you've
been complaining about that the IRB was doing.
Without further ado, I will get into this. The study is a proposal
to investigation mechanisms of diabetic instability in children.
The study uses techniques that are very well-tested and have been
used extensively and safely, but in adults. The study requires
— well, first, it's necessary to look at young people. Yes,
DR.GÓMEZ-LOBO: Could you define diabetic
instability for the lay person?
DR. LEVINE: I don't dare with you
sitting next to Dr. Foster.
DR. FOSTER: It's difficulty in
controlling the blood sugar.
DR. LEVINE: Thank you. They want to look
at very young subjects. They want to see if there are any changes that
are related to the changes at puberty. So it's important for them
to look at children from the age of about eight until about the age of
18. This is quite a span. The studies will involve diabetic children,
children with unstable diabetes, insulin dependent diabetes and it will
also involve their siblings. Siblings are designed to give them normal
They justify involving the siblings
because according to the regulations, if you want to do studies of this
sort, you must be developing information that's responsive to the
condition or disorder that the child subjects have. And they define
the condition or disorder as being situated genetically as having about
a 25 percent risk of developing diabetes themselves. This
distinguishes them from the mainstream of normal children.
They recognize that this is a compromise,
that siblings who are somehow genetically pre-disposed to develop
diabetes might have some abnormalities of glucose metabolism but they
felt this was the best they could do. The studies involve a 48-hour
admission to the hospital for each child. The first day they will have
a 24-hour profile of blood hormone levels and this requires the
insertion of an intravenous cannula, a small plastic tube put in their
vein and then they can periodically attach a syringe to that tube and
pull back a little bit of blood.
On the second day, they plan a four-hour
hormone sensitivity test. For the clinicians here, the test is called
a glucose clamp or a hyperglycemic clamp procedure. The procedure will
require that the child be immobilized in bed for four hours with his or
her arm on a board, taped to a board to keep the elbow from flexing.
In this way they can continuously monitor blood levels of sugar and
There was concern, not so much, for the risk of physical injury. The
probability of a physical injury in this procedure is vanishingly
small. What they are concerned more about is the possible emotional
effects on the child, what is the meaning of a child, of taking
him or her into the hospital for an overnight stay? What is the
meaning for a child to be confined to bed with the arm extended
and an intravenous cannula in place with infusion of — actually,
during the hyperglycemic clamp procedure, two intravenous cannulas;
one to put things in and one to take things out?
I think what I've done — oh,
according to the investigator's initial assessment, the diabetic
children were accustomed to being in hospitals. For some it was an
unpleasant experience and for some it was a pleasant experience, but
they certainly would understand that invitation to spend time in a
hospital and have the arm extended and so on. They would be very well
situated to give a knowledgeable consent or assent or refusal. The
siblings, generally, had never been in a hospital before. And so they
might not be able to really appreciate what was in store when they were
asked for their assent. The parents were going to be encouraged to
attend any and all parts of the child's admission in the studies.
They were going to make determined
attempts to keep the patients entertained during the infusion study,
providing them with books and even having somebody turn the pages for
the child or DVDs or movies or whatever, video tapes. So that's
the case. I would like to now turn it over to you to see what you
think might be the major issues in deciding whether or not you will
approve or disapprove this research activity.
DR. EBERSTADT: Could I ask two questions
for clarification? Are the children to be immobilized just for — the
arms immobilized just for the four-hour second intervention or is this
48-hours of immobilization?
DR. LEVINE: No, no, no, four hours of
DR. EBERSTADT: And the second question of
clarification; are the parents — the parents are invited to be —
participate in all this. Does that mean the parents could stay
overnight, for example?
DR. LEVINE: Yes.
DR. EBERSTADT: I see, thank you.
DR. LEVINE: And they can — the parents
would also be put on notice that in case they think the child is
experiencing anxiety or discomfort that they have the authority to put
a stop to the study of their child. Yes, sir.
PROF. MEILAENDER: Also, just a question
of clarification. It says right at the start and you mentioned it that
the techniques that they're studying are well-tested and have been
used extensively in adults. How were they developed for use in adults?
DR. LEVINE: May I once again defer to Dr.
DR. FOSTER: I haven't read the whole thing
but — you'd think after four and a half years I'd learn
to turn on the light, but I've always been a little slow, so
— the glucose clamps, I am a little puzzled as to why they wanted
to do this particular — the hyperglycemic clamp, if that's
what Bob said they're doing is you raise the blood sugar to
a given level, and they're infusing insulin and the sugar to
keep it at a fixed level and probably looking at hormonal responses
during this period. So it's just like having an IV in the hospital.
I mean, there's no risk at all.
I mean, you know, you may get a bruise if
you — you know, from putting the needle in but there's really not
anything there at all. This is usually — the hyperglycemic and
insulin infusion clamps are usually used to assess insulin resistance.
In other words, if you infuse insulin and you have to infuse more
glucose in one patient to keep the blood sugar that the fixed level
than you do with another, it means that the one that you had to use
more insulin for was resistant to the action of the insulin.
So usually, this is a measure of how well
insulin is working in the intact human. So that's — and then I
don't know what else they were going to measure in the test, what
other hormones and so forth. So does that answer your question?
PROF. MEILAENDER: Well, what I really
want to know was when these techniques that they're now going to be
testing on children were developed to use in adults, were they
developed through the use of controlled trials analogous to this one or
were they developed more retrospectively through, you know, treating
diabetic patients and learning how to do it and so forth?
DR. LEVINE: No, this is not a matter of
treatment. This is a matter of studying basic physiology. When they
do it on normal or, I don't know if we can really define what
normal is, when they do it on people who have no known disease,
they're studying basic physiology of carbohydrate metabolism. When
they do it on people who are diabetics, they're still looking at
basic physiology. In most studies of physiology, you would want to
have a simultaneous control population. With adults it's easy.
They tack up a sign on the campus bulletin board and see who walks in,
often a lot of students.
DR. FOSTER: I've been gone for so long,
I don't even remember when the first studies were done, but
I'm sure that they did exactly that when they started off.
I mean, it's such — in the language we've used before,
it's a minor increase risk of doing nothing, you know, I mean
DR. PELLEGRINO: Dr. George?
PROF. GEORGE: Do I interpret this
correctly under subjects and controls as saying that the subjects in
the experiments will all be either diabetic children or their siblings
or any relatives? So there will be no going beyond that pool of
DR. LEVINE: I also learn slow. We are
not going beyond — actually, the way it ultimately turned out, they
narrowed it even further to use only siblings.
PROF. GEORGE: Only siblings, okay. And
no one is being compensated for their participation in this in any way.
DR. LEVINE: No one is getting paid. The
parents might be given a bit of money to cover their taxi fare or
babysitter fees or something of that sort.
PROF. GEORGE: Yeah.
DR. PELLEGRINO: Peter, Dr. Lawler.
DR. LAWLER: So the premise of this is
these relatives would have a higher, much higher than normal chance of
getting diabetes themselves, so they would stand a chance of
benefitting from the results of this study.
DR. LEVINE: That's the premise.
DR. LAWLER: But —
MALE PARTICIPANT: Is it stated?
DR. LEVINE: It's here, yes.
DR. LAWLER: But it seems to me there are
many problems with that, including this. Presumably, the purpose of
the study would be to figure out better how to treat diabetes around
DR. LEVINE: Let me clarify that. They're not
trying to figure out how to treat anything. They're trying to
get — contribute to the basic fund of information of how do diabetic
children metabolize carbohydrates? What is their hormonal response
to maintaining a constant high blood sugar level and do any of these
things change during and after puberty. Now, based on this information
— I mean, we did studies. I used to do studies. We do studies
all the time that are attempting to get basic information with no
particular vision of how that information might be used in the future
to better treat or diagnose diabetic children, but very often it
does lay the ground for some new understanding and it very often
— it may contribute to an improved diagnostic ability or therapeutic
DR. LAWLER: So it's unlikely these
particular children who are participating in this study would actually
benefit from it.
DR. LEVINE: It's — let me put it
this way; it's unlikely that these particular children are going to
benefit or derive any benefit from the results of this study.
DR. PELLEGRINO: At the moment. They
might in the future.
DR. LEVINE: It's not impossible, but if they're
going to benefit, we can't specify how. The apparently normal
siblings would have an even lower probability of getting any benefit
because only one out of four of them, more or less, will ever develop
PROF. GEORGE: But there's an explicit —
there's a sentence under subjects and controls in the first
paragraph that says, "Moreover, since the risk of developing
diabetes is greater than that of the general population, these children,"
I gather the siblings, "have a correspondingly greater chance
of benefit from the results of the investigation."
DR. LEVINE: Yes, it is greater.
DR. LAWLER: Is that consistent with what
you just said or am I missing something?
DR. LEVINE: Yes, it is much greater but
it's still very small.
DR. LAWLER: I think it's highly
unlikely that they'll benefit from this study, right, the control
PROF. GEORGE: This is where — now to move from questions
and clarifications at least to start, in my own case thinking about
how I would evaluate this from an ethical point of view, it does
seem to me relevant that they could benefit and if, in fact, that
opportunity or chance or likelihood of benefitting is very, very, very
small to the point of being negligible, then that would erase that
DR. LEVINE: Not negligible.
PROF. GEORGE: Not negligible, okay.
DR. LEVINE: It's small.
PROF. GEORGE: Small, but not negligible.
DR. LEVINE: Yeah, and let me say that in
the normal population if you did these studies —
DR. HURLBUT: Well, it specifically
implies, though, that they could benefit because it says the
opportunity for further diabetes education will be used and we're
not talking only about medical benefits here. Understanding their
sibling and having the general knowledge of what a hospital is like, I
mean, it does seem to me there are arguable benefits here.
PROF. GEORGE: I would add another point
on top of the benefits just to get my own cards on the table here. It
seems to me because of the natural relationship of siblings and
familial obligations and so forth that it counts very much on the
positive side of the agenda, at least as far as I'm concerned, that
we're using siblings here and not just children off the street.
DR. LEVINE: Let me add that the
statements you are reading are statements that were made by the
investigators who were proposing this study to the IRB. There is
invariably a tendency on the part of investigators to over-estimate the
benefits of their work and you know, they need this to get out of bed
in the morning. They've got to believe they're going to do
something important. But the IRB is experienced at ratcheting these
PROF. GEORGE: So it's like letters of
recommendation for undergraduates applying to law schools. The
professors know they have to exaggerate and the admissions committees
know they have to take into account the exaggeration.
DR. LEVINE: I think you've got a nice
DR. FOSTER: Let me just help a little bit in this.
You can — no matter all the studies that you do in animals, they're
different in humans. So you always ultimately have to do physiology
in humans, and you can never understand a disease or normality until
you understand normal physiology. Most people think about Type
1 diabetes which is what they have here, the autoimmune form, think
of it about being a deficiency of insulin and then we give insulin
and then sometimes the blood sugar gets too low and then it goes
too high and so forth.
It was — I don't know how long ago
this was, but we now clearly know that there are six hormones involved
in the control of the blood sugar day to day. I mean, insulin is on
the one side. It lowers the blood sugar, makes fat and all that sort
of stuff. And then there are five hormones on the other that protect
you against hypoglycemia. That's what keeps us alive every night.
Yeah, it is.
It keeps us alive every night because our brain has to have either oxygen
or glucose and it doesn't. So what happens is, every night
when we're not eating, insulin drops and these so-called counter
regulatory hormones come up and make the liver make glucose to protect
our brain. In the diabetic state there is always a relative or
absolute deficiency of insulin and a relative or absolute increase
of the major counter-regulatory hormone which is glucagon. The
others are secondary things. And so it's well-known that in
both types of diabetes that you — if you just have a deficiency
of insulin and glucagon, if you just take out the pancreas, you
don't have much in the way of diabetes, because you've got
to have that glucagon elevated.
Well, this is potentially — people have
been working for a long time on trying to get a blockade of glucagon
which is high in all forms of diabetes. You've got to understand
this. It may be that they — that some of these children may be
unstable because their glucagon is not as high. So when you give them
insulin, they get low blood sugar.
So this is studying physiology that will be applicable and has
to be done in humans to ever look at therapy and but it's not
— I agree that the chance for the siblings — and I think most
people would say that in Type 1 diabetes, there's maybe a 15
percent chance, 10 or 15, not 25 percent chance. In Type 2 diabetes
the genetics is overwhelming, it's almost 100 percent. So these
are things that are relatively safe, but I don't think in this
particular case — the children themselves, you might get an immediate
benefit if you saw how they handled, you know, insulin infusion,
and that they were too sensitive to it or they were less sensitive
to it, you might alter your therapy in that diseased child, but
not likely in the sibling.
Now, maybe you'd learn something if we
get a glucagon antagonist later on that would help, but I hope that
clarifies a little bit as to what they — you know, as to what's
going on here.
PROF. GEORGE: But Dan, you interrupted
yourself in mid-sentence just on the point I think that's
relevant. You were about to say what the percentage chance was, I
think, for the siblings.
DR. FOSTER: I thought I said — no, I
can't say — I don't have an idea. I think the —
PROF. GEORGE: A ball park figure?
DR. FOSTER: Less than one percent.
PROF. GEORGE: Oh, less than one percent,
DR. FOSTER: That's what I said, the
16 percent or 10 to 16 percent is the inheritance, and it's also —
there's implanting of genes and so you're more likely to get
Type 1 diabetes if you get the genes, the HOA genes and so forth from
the father as opposed to the mother and so forth. But, no, I think
it's very — probably considerably less than one percent that the
siblings would get any immediate or short-term.
PROF. GEORGE: That sounds to me
DR. LEVINE: Let me say that when I
recommended this case, I did not know Dr. Foster was a member of your
group and I'm so grateful that you are.
DR. FOSTER: Thank you.
DR. PELLEGRINO: Dr. Bloom.
DR. BLOOM: Bob, maybe, Dan has purposely
simplified the protocol description but it would help me elevate the
benefit to risk ratio if I knew what they were going to do with the
blood samples and how many of the hormones that were just eluded to are
going to be measured and in terms of the puberty question, whether
they're also going to measure gonadal hormones and where would the
sibling be relative to the proband (phonetic) in terms of advancing
into or coming out of puberty.
DR. LEVINE: These are all very good questions.
Let me tell you that this case was published in 1985, so the work
was probably done in `83 and at that time there was certainly not
an awareness of six counterveiling hormones in this. As far as
the details of what they were going to measure, I don't remember.
I think, though, what I would like to do is all of these questions
about details are very important and the real IRB experience, we
would probably write a letter to the investigator saying, "Exactly
what are you measuring here, are there any gonadal hormones, et
And at the end of this exercise, I'm
going to ask you to come up with a decision on how you would like to —
whether you want to vote this up or down, but part of the — one of the
contingencies might be we'll vote to do this if, and only if,
they're going to measure gonadal hormones. That's one of your
options. I think Leon won by one millisecond.
DR. KASS: Yeah, this is more — I'm
holding back because I'm hoping that after all of these
throat-clearing questions of clarification, somebody is going to take a
seat at the IRB and offer an analysis of this and I'm hoping that,
in fact, some of the clinicians might give us the benefit of their
thoughts on this, but would it be welcome, Bob, or to the group, if we
sort of tried to bracket some of these details which might sooner or
later make a difference, and stipulate for the sake of the discussion
of this case that we're not counting any benefit, any likely
benefit to the siblings? We'll just simply dismiss that as a way
of making it either more complicated or easier and also stipulate that
this is terribly important work for understanding if not immediately,
fairly soon, understanding how one can help these unstable juvenile
diabetics regulate their insulin, so that the importance of the work is
not in contention. The necessity of the control group for
understanding this work is not in contention and that we don't
somehow try to lard up — to weigh up lots of potential benefits for
the siblings and then simply ask the question, is this a reasonable use
of those siblings for this study. Doesn't it come down to that or
am I being —
DR. LEVINE: I would be very happy if the
group agreed to stipulate one, that there's no likely benefit or no
likelihood that these particular siblings will derive any direct
benefit, health-related benefit from participation and two, that —
stipulate that it is important to have this information in order to
better understand unstable diabetes around pre, during and post-puberty
but I would ask for a third stipulation, that you have a good account
of the physiology of unstable diabetes unless you have some control
group to compare it with.
So basically you are saying if we want to
really deliver the fullest benefit to the unstable diabetes group,
we've got to have controls.
PROF. GEORGE: That's fine, Dr.
Levine. On the point about the benefitting though, for the diabetic
children themselves, we're also stipulating that there is a
substantial likelihood that them or some of them will benefit, 25
percent or whatever it is. Is that right?
DR. LEVINE: I need a philosopher to help me
PROF. GEORGE: Well, not negligible. I
mean, that there's a good chance that some of these kids themselves
— they're not going to go through this just in the hope of
benefitting future diabetic children.
DR. PELLEGRINO: There's a reasonable
possibility. Would you agree?
DR. EBERSTADT: One last question of clarification,
at least as far as I'm concerned; the consent process, is it
the parents who provide the consent for children ages eight through
18? Do the 18-year-olds provide their own consent? Do the eight-year-olds
provide their own consent? What's the process there?
DR. LEVINE: The process is necessarily this;
and what I'm about to tell you is required by regulation. Every
child who comes into the study will be called upon for assent.
The eight-year-olds will be able to give you a much less sophisticated
assent than the 11-year-olds. And between 11 and 14 you've
moving into a range where they can manipulate extractions that approaches
the ability of an adult.
By the time you're — you generally recognize the authority
of adolescents to override their parent's approval even when
what you want to do is evaluate something that's good for them.
So certainly, they will have complete authority to veto this and
in fact, even the eight-year-old will have the authority to veto.
Now, in addition to the assent, which
looks for all the world like consent except it's not legally
effective, the parents must give their permission and their permission
is obtained through a process that is exactly like consent, informed
consent. It's just that the Commission said it's not consent
unless you're talking about yourself. We will call this instead
DR. EBERSTADT: And the children will not
go into the — it's a double or nothing situation. You want to
have a controlled child without diabetes in addition to a child that is
DR. LEVINE: No, no, it's not a paired control.
So we might have a half a dozen diabetic children whose siblings
don't go out — or don't want to do this. They would prefer
in the case of the siblings, to always have a diabetic sibling being
studied at the same time. And the reason for this is to give the
child a sense of familiarity. You know, this child might say to
his or her diabetic sibling, "What is the meaning of this tube
in my vein?"
DR. PELLEGRINO: Gil?
PROF. MEILAENDER: I know we keep asking
these questions, sorry, but is it possible to give me an idea of what
we're going to say to the children in the control group when we
seek to get their assent to their parents? In particular, I mean, what
are we going to — are we going to tell them that — are we going to
say that we need some basic physiological knowledge and this will help
us get it? Are we going to tell them that it may — that we're not
only going to learn that but we're learning something that may be
of help to other children who are diabetic or even more specifically
that it may be of help to, you know, their sibling, who's a
diabetic or their child and so forth? Can you give me an idea of what
we're going to say to them?
DR. LEVINE: Let me say, this case coming from
20 years ago, I don't remember exactly, but in general, what
they would be inclined to say is, "We want to do some research
and it's to get information about people who are like your sibling
and we hope that some time in the future this information will help
us diagnose or treat people like your sibling." One thing
we rule out, it's a no-no, you can't say, "If you get
in this, you're going to do some good for your brother or sister."
I mean, that would be — the common sense around IRB people is that
that would be considered an undue influence, and I agree with it.
PROF. GEORGE: But having said that, obviously,
this is beyond your control, it would seem to me to be not unreasonable
for the parents in explaining to the siblings why they would like
the siblings to participate and would approve to say, "Your
brother or your sister is afflicted with this terrible disease.
We're hoping that the work that is being done by these investigators
will benefit possibly him — that child himself or herself and also
other children now and in the future who may be afflicted by this
You couldn't stop that if you wanted
to stop that, but my sense is you probably wouldn't — I
wouldn't want to stop that. That seems to me a reasonable
statement for parents to make and a reasonable consideration for the
parents to have in their own minds.
DR. LEVINE: I think it's reasonable. However,
other pediatricians here, the way kids are brought into the metabolic
unit in a university hospital, before they're brought in, before
there's any discussion of assent or permission or anything,
there's a conference which includes the parent or both parents
and the child. It also includes the investigator, usually a research
nurse and invariably a social worker. And the purpose of this is
to give a full account of what to expect, what are we doing here,
why do we want to do it? And in case the parent comes on strong
saying, "Look, kid, you know, you've got to do this for
Johnny," the social worker and the investigator will generally
say, "Whoa, wait a minute, let's put a little brakes on
PROF. GEORGE: And that strikes me as
exactly right. That strikes me as something they should be doing and I
think that's consistent with you know, the parents reasonably
saying what I said a moment ago, it would be reasonable to say.
DR. LEVINE: Yes, but then after this,
they go home and we can't go home with them.
PROF. GEORGE: Absolutely.
PROF. MEILAENDER: There are people who
think that Robby and I think alike on a lot of things and I want to
dispel that notion.
PROF. GEORGE: We are siblings after all.
PROF. MEILAENDER: Right. I think this
question is more complicated than you seem to hear, Robby. I mean, on
the one hand, particularly with the children on the younger end of this
spectrum, I mean, I can conceive of thinking of encouraging their
participation on the grounds that it might at some point help their
brother or sister. I can conceive of encouraging them to do that,
precisely as part of my carrying out my responsibility for their moral
education and to try to foster in them certain kinds of attitudes and
But I can also conceive of it as placing a certain kind of pressure
on the child that wouldn't — you know, if this were — I mean,
that's why I wasn't sure what I thought about recruiting
siblings here as opposed to just a random group of people, because
if it's just a random stranger, we'll get a clearer sense
of whether "I'm just prepared to do this or I feel a certain
kind of pressure."
So, I mean, on the one hand, it may conduce to a certain kind
of moral training and rearing that the parent is interested in.
On the other hand, I'm not sure it's fair to the child.
It makes it much harder to say, "No, this isn't really
something that I want to do."
PROF. GEORGE: I agree that that's an
important worry. I don't think that this is an easy case and I
think that it's something that does need to be taken into account.
You're right to take it into account in evaluating it. On the
other hand, I guess I'm enough of a familialist and
anti-individualist, perhaps, to think that when diabetes strikes the
child, because of the relationship of the child to the family, the
diabetes strikes the family and that, too, has got to be factored into
the equation here.
I'm not saying that it's
definitive, that it resolves every —
PROF. MEILAENDER: You push that too hard
and the research begins to look like it's a direct benefit not just
to the child who has diabetes but to the one who doesn't and you
surely don't want to say that.
PROF. GEORGE: Well, what do you mean? A
benefit to the child who has diabetes is not a benefit to the family of
the child who has diabetes?
PROF. MEILAENDER: Well, we have to talk
about how broadly or narrowly we wish to construe the language of
benefit here. You're right about that, but at least — it's a
very different sort of benefit from the kind of benefit to the child
who has — possible benefit to the child who has diabetes.
PROF. GEORGE: Well, I think this raises a
really important issue that people who share as much as you and I share
by way of background ethical conviction really need to talk about. I
mean, what does it — how — what does it mean to have the special
connections that people have by virtue of being members of the same
We know, for example, that parents have
certain obligations to their children, unchosen obligations to their
children just by virtue of being the parents of those children. You
have taught us better than anyone that children have certain
obligations to their parents, despite the fact that they did not ask to
be born by virtue of being the children of those parents. I think
it's fair to say that siblings have certain obligations to each
other. Now, I'm not trying to force this case into a
case of sibling obligation, so I'm making the points that I'm
making in terms of obligation not because I think that this is a
question of sibling obligation but because I want to highlight the
implications, that the implications can be very strong of natural
DR. PELLEGRINO: Dr. Gomez-Lobo?
DR.GÓMEZ-LOBO: On this same topic, of
course, the flip side of recruiting a sibling of the child with
diabetes is that as the presentation of the case indicates, you can
provide a much better atmosphere for the child and if really the
physical harms are negligible, as I understand it, and the real worry
is the fact that there can be emotional effects, the fact that, you
know, the child comes in with the whole family, it to me makes a lot of
I think it's a form of respecting the
child and inviting the child to a form of solidarity, I would say.
DR. LEVINE: I'm going to ask that we
— the point you're pursuing here I think is fascinating and what
was left out of yesterday's discussion in the McCormick-Ramsey
debate is that McCormick said part of the parent's responsibility
is to try to bring the child up to be the right sort of person. And he
interpreted this as having a general obligation to contribute to the
well-being of the community when you could do this with little or no
The standard he specified was no
discernible risk. Ramsey almost bought it but he said he would insist
on it being discernibly no risk, right? No discernible risk means
there's unknowns out there. Ramsey wanted to say not fair,
you've got to know what you're doing. And then all of their
followers, Friedman, Ackerman, all that wrote about research involving
children afterward, focused on bringing the child up to be the right
sort of person.
DR. PELLEGRINO: Peter Lawler?
DR. LAWLER: Well, I think that's right,
exactly. So in order to justify this, the benefit to the kid with
diabetes in the family is questionable. The benefit to the kid
in the family without diabetes is not there or negligible minus.
So how would I justify this if I had a kid in my family that had
diabetes and another kid of the appropriate age? It would be something
like this; there are a lot of diseases in the world and as charitable
as people are, we can't take an interest in them all. If someone
in my family has this terrible disease, I'll take a special
interest in this one. So I would give money to this one. I would
participate in walks and such for this one, but would I go the extra
mile and participate in research in this way in this one? And the
answer is, well, I would, but I would as an adult. I would consent
to as an adult. As an adult I would do this, sure.
But the pressure put on the kid here to look at it in this kind
of way becomes a question, especially to an eight-year-old kid.
This disease is now our family project. We're all making sacrifices
for it. And this — we are very interested in this disease because
your brother has it and so we want to get this disease cured or
done away with because of the terrible things it does but don't
be deceived that this experiment will likely benefit your brother
at all or very little but we, as a family, have taken an interest
in this and as part of our interest in this, we want to participate
in experiments such as this. Will you consent or would you agree
with this? This is a real burden to place — I think with a 17-year-old
there's no problem here. With a eight-yea-old, this is quite
a question, quite an abstract issue.
DR. PELLEGRINO: Dr. Bloom?
DR. BLOOM: Well, when I said before it
would increase my benefits to risk ratio if we knew what the hormonal
profile that it was going to be measured with, I was talking about
benefits to the future management of pre-pubertal Type 1 diabetics. So
if we take ourselves back to 1984, the two axis that would most concern
me are not the other gluco-regulatory hormones, but the stress access
and the gonadal access. And unless we knew where they were in their
progress towards puberty, we wouldn't be able to ask the main
question that they're asking. Unless we knew what their reaction
was to the hospital environment, we wouldn't be able to assess the
orthogonal influence of the stress access on glucose metabolism.
So my suggestion to these PI's would
be to use same gender siblings who are already post-pubertal as the
control for the diabetic. And that, to me, would increase the
generalizable knowledge to be derived from the study to the point where
the relatively modest risk becomes much more reduced in a relative
DR. LEVINE: Let me say that — let's stipulate
one more thing. In case this group decides to approve the protocol,
let's say it would be contingent upon developing a satisfactory
response to Floyd's proposals — to Floyd's questions, but
now let me move you towards some things we must address in order
to decide whether we want to approve this. The first question is,
can we call this "minimal risk," recalling that minimal
risk is risk that one expects to encounter in a regular medical
examination and it's supposed to be somehow related to the risks
of everyday life. Would you call this minimal risk?
DR. EBERSTADT: I would say this is
minimal risk. It's a lost weekend. It's an inconvenience.
It's a pain in the neck, perhaps. It is possibly an emotional
stress for the child but that emotional stress, it seems to me, by this
design, may be dramatically if not entirely mitigated by involvement of
DR. HURLBUT: This idea of encountering
risk in daily life is an interesting one because you're talking
about all people and the risk that everybody takes or the — I mean,
you look at adolescents, they actually subject themselves to risk and
they flirt with risk, they experiment with risk.
DR. LEVINE: The risk can be very different in
different areas of the country and of the world, but what I think
most of the people who have addressed this issue say, "We ought
to be thinking about what is the risk that's out there in the
routine experience of people in comfortable situations, not the
risk of living" — I was going to refer to some borough of
New York but — well, I gave a lecture on research involving children
in German South Africa and the day before the lecture, I was on
a free range, which means that in the next block a leopard had come
and eaten one of their neighbor's dogs, and it struck me that
saying to the children, "Go out and play" —
DR. PELLEGRINO: Leon and then Gil.
DR. HURLBUT: Can I add just a little comment
to that? I don't know quite how to put this into the equation
but it does strike me that our civilization has sanitized quite
a few of what you might call basic human realities. Among them,
for example, is the fact that we have no — very little consciousness
where our meat comes from. We don't that — we don't relate
very quickly to the fact that animals die for us to eat their meat.
That takes us out of the realm of what you might call the order
of sacrificial existence and takes us out of the realm of the sense
that there's a hierarchy of beings subservient one another's
needs by some people's analysis.
And it strikes me that medical realities
are one of the primary areas we've distanced people from
fundamental knowledge of reality and even though my father was a
physician and even though I saw his medical books all over our house,
including some very graphic things, when I got to medical school, I had
to go through the same experience that I think several of us have of
encountering medical realities and having to realign my overall life
philosophy in relationship to those realities.
I think when you start to add that into
the equation of consideration here, even though we've been talking
about direct benefits to the individual, there is something to be said
here about the value of knowing how serious the issues we're
dealing with are generalizing them, I like to get my undergraduates to
go over and see medical realities at Stanford Medical Center when I can
because I think it informs their ethical reflections and their personal
increase in overall understanding of life.
Now, that's not to shift the equation of consideration here
entirely to philosophical goods or whatever you want to call that,
but it does strike me that there's something pretty important
going on here, not just for the development of the individual, but
for the reality of what Leon eluded to earlier if the real question
is, "What are our obligations to others where we have no direct
benefits?"Then we should at least know the context of the realities
we're evaluating that situation against.
DR. LEVINE: Again, I think that's a
very important set of concerns you've presented us with but I would
like to ask you to decide whether you think within the confines of the
admittedly fuzzy definition presented to us by the regulations, would
you be willing to call this minimal risk? Would anyone not be willing
to call it minimal risk? Gil?
PROF. MEILAENDER: We're a recalcitrant bunch, hard
to channel, and I just wanted to say, you introduced this question.
I do not want to derail — I'll say this and I'll shut up
because I don't want to derail the direction that you want to
get us to go. But when you introduced the question about getting
us to think about minimal risk by saying, this is the first question
that has to be asked. See, I do not think it is the first question.
I think the first question, at least for
the younger children in this spectrum is whether anyone ought to be
able to consent to their use as research subjects, the children in the
control group at least. So I would just put that on the record and
that will make a difference in — I mean, to the degree that I give a
no answer to that question, I don't actually have to answer the
question about minimal risk.
DR. KASS: Yeah, I'll also — I'll answer
because it seems to me when asked a question, one should not hide,
but I wonder — well, let me ask you a question. If this really
were the IRB sitting, would this be — would we be obliged by law
or is it in your view the way to proceed that we somehow go through
these checklists and answer the question minimal risk? Or would
one say, "Dr. Foster, Dr. Bloom, Dr. McHugh, Dr. Kass, other
people, yes or no, and then why do you say yes or no?"
I mean, I'm going to wonder at the end
having sort of answered this checklist of questions, what a conclusion
necessarily falls out of that or whether we're still left with some
kind intuitive judgment for which we then have to give an explanation.
DR. LEVINE: No matter what your answer,
you're also going to be — it will be necessary for you to respond
to your intuitive judgment.
DR. KASS: Okay, well —
DR. LEVINE: But let me say this: that if you
were really an IRB and part of the purpose of this exercise is to
give you an experience of the IRB interpreting current policy, you
would be required not only to say minimal risk, yes or no, but you
would be required to document that the IRB raised that question
and answered it. Then if you say no, then there's a whole series
of additional questions.
DR. KASS: Okay, well, I'm a law
abiding fellow. I think this is minimal risk.
DR. LEVINE: I hear no dissent from this
being minimal risk. Well, that settles that. I don't have to ask
you all those other questions.
PROF. GEORGE: On minimal risk, is it fair
to say that when one judges that it's a minimal risk, one is
judging the entirety of the circumstances in which the child would be
brought into the scheme and supervised and so forth. So I want to hold
out the possibility that there may be a child for whom this would not
be a minimal risk but that there are protections that have been put in
place, and you've described them to us, for that child even late in
the day if it becomes apparent that this child has high anxiety, as
you've described the procedures, there is a very, very strong
likelihood that that child is going to be removed from the — removed
from the system.
And bearing all that in mind, I would
agree with Leon, this is minimal risk.
DR. PELLEGRINO: Dr. Gómez-Lobo?
DR.GÓMEZ-LOBO: I think I'm going
to take a seat on the IRB finally. I'm — what I'm trying
to think about is what are the relevant moral norms that should
be taken into consideration in this case and in my mind, I've
discarded a couple of them. Clearly, there's no intention to
produce harm. There's no intent on evil, to put it in general
terms. There is a pursuit of the good, it seems to me, the better
knowledge of physiology. Whether it is conducive to therapies,
short-term or not, it still seems to me of value.
The chief concern is the one that Gil mentioned is whether a child
is being manipulated, used, used simply as a means. My inclination,
I don't use the word "intuition" actually, goes something
like this: From my familiarity with children at the age of eight,
nine, 10, I think that many of them are able to give assent. I
mean, if you explain to them what's going to go on along the
lines Peter suggested, of course I would not force a child, but
I think a child could be easily persuaded.
And the fact that there are all of these
safe-guards in the sense of the protected environment, the presence of
the family, the fact that the child can be withdrawn at any point
inclines me to say this is a morally permissible form of research.
That would be my first reaction unless I hear very strong arguments
DR. LAWLER: Let me just agree on both those
points. It is no more minimal risk for the reason Bill described.
It's less than minimal risk because many of these teenagers,
again, in this heavily regulated environment, this is going to be
the least risky weekend they have all year, probably. But I think
that question is not so important. I agree with Gil on the question
of the appropriateness of thinking eight- and nine-year-olds could
consent to this or even realize what's at stake and what's
not at stake.
What's not at stake is the health of your sibling. What's
at stake is carrying this horrible disease. That's a pretty
abstract thought. I'm not an expert in child psychology, but
I wonder. You might be right, Gil might be right, but that's
the tough question.
DR. PELLEGRINO: Paul?
DR. McHUGH: Well, I also have been on IRBs
and so I know how it will come out on this, but there were a couple
of things that have not perhaps been sufficiently emphasized in
relationship to the context in which we're asking these kids
to do it. We are working with diabetically unstable children and
if they live in a family, they have seen the effects of diabetic
instability in their siblings. They have seen the distress that's
come over them and even at the age of eight, I know a lot about
kids age eight because I've got several grandchildren that are
flourishing around there. They appreciate the suffering of each
other and so I think that they would, given that they're being
told that they're going to be guinea pigs in this way, that
they would begin by wanting in some way, I think most of them.
The problems for me with this case and
this experiment are several though. The first one is that the
importance of this subject is clear but we're talking about
unstable hormones and we're taking new — taking kids and putting
them into a very distressing environment, kids, by the way that we have
not evaluated psychologically in any way. We have a research social
worker there, but, you know, kids are not like collie dogs. They
aren't all the same. And some of them would be much more
vulnerable and a reasonable assessment of them for their psychological
vulnerability should be there.
The second thing is, why does this have to be done in a hospital?
Now, maybe in 1985 and in metabolic units that's the best and
easiest way, but fundamentally we're just talking about an indwelling
catheter for which these kids can run around and sleep in their
own beds and do things like that. And I would ask on the IRB, "Why
aren't you doing this at home and then four hours in the ambulatory
outpatient clinic? What better (information) are you going to get
and how much more do you worsen the problem of studying the hormones?"
I've done 24-hour hormone things under distressing circumstances.
How do you complicate the issue of studying instability when you're
putting kids into unstable situations?
So my response would be to say this is minimal risk, but whether the
research is really done in a proper way and whether the subjects
have been properly selected before they suffer the distress, I don't
know. But I wouldn't — I would appreciate that the kids cared
about their siblings and they had seen them suffering and we could
explain to them even at the age of eight, that this is due to the
instability that comes from their hormone imbalance.
DR. FOSTER: Let me just make one — I
don't think you can do glucose clamps at home because you'd
have to have the pumps, and in addition to that, you're constantly
measuring every minute or so the blood glucose and the hormone. So
it's not possible to do that — so they always have to be done —
yeah, and they have to be done in a general clinical research unit to
do that, just because it's not like just drawing blood out. You
could do — the 24-hour that you're talking about you could do at
home but this is —
DR. McHUGH: Okay, that is an important
PROF. MEILAENDER: A couple of things; I mean,
I do think that I'd probably call it minimal risk if I'm
going to come around to answer the question you actually asked,
but I have — I mean, I have a clearer idea about what I really
thought about that. If we complicated the research protocol in
such a way that that parents didn't just accompany the children
but that the parents wore an IV — had an IV line for the 48 hours
and had their arm tied down to a board for periods of time and had
some hormone sensitivity test done, you know, it may just be a weekend
and a pain in the neck but I'd bet most of us wouldn't do
it under many circumstances. So I just have a clearer idea of what
minimal risk for someone who is really in a position to say, "No,
I don't want to do this," meant if we included that. That's
the one comment.
The other is that I mean, I think that —
I mean, I am worried about the younger children, at least, in this.
And I think that if I were to — because I think one could wrong them
by simply using them this way. I think if I were going to justify is,
as I might try to, it would be precisely on the grounds of trying to
initiate one's child into a moral understanding of helping others
and so forth.
I just think we shouldn't over-estimate our ability to do
that and if I may, just a brief story. I don't think I told
this one here before. I forget where I told it, but when I moved
to the University of Virginia to teach, our oldest son — he wasn't
quite eight yet, he was, I think he was six, but we moved there
in the middle of the summer and we were very — it was very sad.
You know how you are with your children. The little groups of boys
in the neighborhood were already set and everything and our poor
kid was out there kind of looking at them and nobody was playing
with him and so forth. And you just feel sad for your child but
you know there's nothing you can do. Time will solve it and
by the end of the summer he had a group of about three other little
boys that he played with and so forth.
And at that point, another family moved in, a new faculty family
moved in next door to us with two little boys and I watched my son
and his three friends, you know, studiously ignore these and exclude
these little boys and so forth. And so the ethicist swung into
action and I took him aside and I said, "Peter, remember when
we moved here a while back and nobody played with you, how you were
kind of sad." And he said, "Yes." And I said, "And
now you have some friends to play with you and that's good."
Yes," you know, and so forth. "Well, how do you think
Johnny and Tommy here feel when you guys don't play with them?"
— simplest form of Golden Rule reasoning.
And he said, "But we don't want to play with them."
And I always think of that when I think
about this notion, you know, which I'm willing to buy in this
case. I mean, I'm willing to buy the argument that, in fact, I
ought to try to initiate my child into a world of moral concern, but we
should be a little careful about our confidence in our ability to do
that, that's all.
DR. LEVINE: Do you know what I would like to
do, I would like to pause at this point and let you know what the
IRB decided, what the outcome was and then have you continue your
very interesting discussion. The IRB decided that it was more than
minimal risk. It said, putting children in the hospital overnight,
they considered that in and of itself as more than minimal risk,
but also lashing the arm down to a board for four hours, they thought
would be traumatizing. So they called it more than minimal risk.
They then had to reach a determination as to whether or not it
would fall under the rubric of a minor increment above minimal risk
and they agreed that it did. They then said, "We are concerned
that not all children from eight to 18 can be treated similarly,"
so they insisted that the first cohort be limited to 14 to 18 and
the next cohort could be, I think it was 10 to 13. And then the
youngest children came last.
Then if they detected any problem in the
older children, they would call it off and not go any further. Since
it was a minor increase over minimal risk, they had to reach a
determination in the language of the regulations that the information
being pursued was of vital importance to understanding the child's
condition. This was easy for the diabetic group. And this is what
lies behind the agreement to use siblings of diabetics rather than
normal children at large.
They were able to persuade themselves that siblings had a condition
that needed understanding, too. So they reached that. The next
hurdle was the regulations say that the procedures that present
more than minimal risk must be commensurate with what these children
would experience in their actual or anticipated medical circumstances.
This is not by way of saying, look the kids already had one spinal
tap, what's another one. This is by way of getting a more knowledgeable
assent. They know what they're doing. They've seen it.
And some of your discussion of witnessing what their siblings went
through during their periods of diabetic instability figured into
this but also this is why they wanted the sibling in the hospital
at the same time as the diabetic, so they could see what was being
done, and so they can say, "I'm looking at that and I don't
Let me give you the outcome. We interviewed Dr. Emil at the end
of the whole thing even after the — we interviewed her several
times along the way. But she said that the chief problem she encountered
with the children was that they were bored. They said, "I
am bored," not "This hurts," or, "I'm frightened."
"I'm bored." So she decided she was going to show
them all a video tape and she showed them two movies, one of which
was "Raiders of the Lost Ark." The kids were delighted
The only complaint she got was from one mother who said, "You
know, I really wish you'd have shown them a Disney movie,"
she thought "Raiders of the Lost Ark" was a bit advanced
for an eight-year-old.
PROF. GEORGE: I mean, if they weren't
traumatized by the snake pit scene in Raiders, these kids are tough
kids and we don't have to worry about them.
DR. LEVINE: Snakes, what about the
spiders? So there you are. This is what happened. I want to give an
epilogue, too. About ten years later the Office of Protection — we
were so proud of this study, that's why we invited publication.
About 10 years later, the Office for Protection from Research Risks
closed down the research operation at the National Institute of Child
Health and Development because they were doing a protocol that is
almost precisely the same thing except that instead of diabetes it was
I mean, we were so proud of our thing, but
OPRR, when they noticed it going on in Bethesda, closed it down. So
there can be very differing judgments about all of this. And
that's all I wanted to say. I would love to hear the rest of your
DR. PELLEGRINO: Any further conversation?
PROF. GEORGE: I want to say that I do share Gil's
worries. I think they're legitimate, especially the worry about
possible undue family pressures on a small child and for understandable
reasons, where you have a family that has suffered this terrible
affliction of a child in the family and who might themselves be
tempted to exaggerate the potential benefit for their own children
of the research.
Gil made one point that I think is — might shift me across the
line to really thinking this shouldn't be approved, if I thought
Gil was right about it, and this was the question, I think it's
the right question: Would the parents themselves be willing, if
it would have been useful in the research, to subject themselves
to having the arm lashed for several hours to the board and so forth?
And I think Gil was suggesting that probably a substantial percentage
That's not my sense. Now this is not
a normative judgment. This is our impression of what people are like
or what parents are like. I think most parents, if they thought that
it would possibly benefit the children and certainly benefit lots of
children who are afflicted with what their child has been afflicted
with, probably would agree to do that, and I'm wondering, Gil, why
you're skeptical. It might be this Lutheran side of things with
the original sin very strongly —
PROF. MEILAENDER: Well, you have
actually, perhaps, hit upon part of it. No, I think it's
two-fold. One is you're obviously just a better person than I and
that's part of it, but I don't actually presume a whole lot of
altruism even in well-formed adults. I just don't anticipate a lot
of it necessarily. And so I think a certain skepticism is in order.
PROF. GEORGE: Let me try to ameliorate
some of the skepticism in you. I notice that in my own experience,
people who have afflictions in the family will put themselves out —
often put themselves out in ways that require physical exertion and
doing boring things, like stuffing envelopes and things like that, and
really giving their time to fund-raising, for example, for research on
breast cancer or another affliction that might happen to be in the
family, which leads me to think that, gosh, if those people are willing
to exert themselves and inconvenience themselves in those ways, even
for fund-raising, they probably would be willing to subject themselves
to this level of inconvenience where they're actually involved in
the research, they're not just raising money for somebody else to
do the research and, you know, pedaling 20 miles on a bicycle or
running 10 miles to do it.
They're actually involved in the
research. Don't you think so?
DR. LEVINE: Let me offer something here. As
the Chair of an IRB, I reviewed no fewer than 50 protocols which
involved doing hyperglycemic or insulin clamps on adults. We had
as one of our faculty in those days a man named Ralph DeFronzo,
who did these clamp studies in almost every possible condition.
So I, myself, have — you're from Stanford. I don't know
if you knew Gene Robbin, but when he was — when I was an intern
at Brigham or what used to be called "the Brigham," and
he was on the faculty there, he did sleep studies on all of my intern
cohort. I mean, we spent eight — oh, you too. Then you know, he
not only had our arms on a board but he passive tilted us and gave
us radioactive iodine and —
DR. PELLEGRINO: Final comment, Paul.
DR. McHUGH: Yeah, I just think that it
was splendid, Dr. Levine, that you showed us the second step, namely,
the things that happen in real IRBs, namely the interactions between
the IRB and the investigator, where the investigator shows a
responsiveness to the IRB's concerns and comes up with solutions
and suggestions that will permit the process to go forward and yet has,
as well, trip lines along the way.
I think that was a demonstration of why
when the — back in 1985, IRBs were interesting programs to be on in a
way that they aren't in 2005. Let me tell you, this is the kind of
interactions with investigators that made the — that brought great
pleasure to lots of us who were on IRBs at that time and maybe we can
get back to that.
DR. PELLEGRINO: Bill.
DR. HURLBUT: Maybe this is already obvious from
what's been said, but it does seem to me worth pointing out
for our broader reflections both on human dignity and the use of
children in — as human subjects, the significant factor of actual
life context in which the individual subject is having their life
experience, reflecting on this specific case, I think if I imagine
putting it in the context of my own family, I think I would favor
my children being involved in such a study, not just feel neutral
about it. And for the very reason that I know personally the value
of siblings understanding the afflictions of their unfortunate brothers
or sisters, but I don't think I would say to my children, "Hey,
there are people out there that have these problems. I'm taking
you down to the medical center to participate in a study."
And the reason is because I think that we
should acknowledge that this somewhat mysterious and wonderful quality
of altruism or in its extreme form, actual sacrifice of self in some
way that depletes something or gives up something — I noticed in —
let me finish that sentence. That it does have a very personal context
and we should, in our methodical thinking acknowledge that.
I very, very much liked Leon's essay
on the organ donation, but I did come to one point where I wished
instead of — I can't remember what the word was that was used but
it had to do with — it was a word that had to do with giving and I
wish that the word giving up had been part of the sentence because I
think — I'm sorry, I can't just generate this but it just
strikes me that one of the things we have not put into the equation of
our ethical thinking adequately in our civilization is the very
personal context in which the best things of human beings are brought
I often reflect on the fact that there's an AIDS epidemic
going on in KwaZulu-Natal and there are circumstances where relatively
small amounts of money could help people extraordinarily, and yet
we feel perfectly justified using that same amount of money going
out for a fancy meal or something like that and I think we need
to come into better balance on that.
But I also think there is a kind of concentric circle of giving
in life that we need to acknowledge, that when you're closer
and there's a more personal context to things, that changes
the equation a little bit and we should wrap that into some of our
DR. PELLEGRINO: Thank you.
DR. LEVINE: One more thing I neglected to say
from our exit interview with Dr. Emil, she reported to us that the
siblings were thrilled to have this opportunity. The way they described
it to her was that their brother or sister had access to this mysterious
place where they did things and the kids felt left out and many
of them said, "Look, I'd like to be in there, too. I want
to be kind of an insider," which I found astonishing, but —
DR. PELLEGRINO: Thank you very much.
Thank you very much, Bob, for providing the case and discussion and
thank all of you participating.
SESSION 7: PUBLIC COMMENT
I just didn't press hard enough.
Wendy Wright, is she here?
MS. WRIGHT: Yes.
DR. PELLEGRINO: Of Concerned Women of
MS. WRIGHT: Thank you for this
opportunity (inaudible) but I am speaking to you today on organ
procurement as a donor. Four years ago I donated a kidney to a young
man from Ethiopia. I knew him from — I knew his sister actually,
didn't actually know him. Yesterday in listening to the
discussions I felt like there were two groups of people that were being
overlooked and these two groups are represented by myself and by Sora.
Sora comes from a low income family. If payments were allowed
for organ procurement, he would not be able to afford — he'd
always be at the bottom of the list because he would never be able
to afford paying for an organ. And so there was much discussion
yesterday about how payments would affect the poor, but that attention
was all on potential donors, not on recipients.
The second group of people are those like
myself, who donate altruistically and one comment that was made
yesterday is that there is no moral impact of allowing payments on
those that are of a middle or higher income. I very much disagree.
One week before my surgery, there was an editorial in the Wall
Street Journal that advocated allowing payment for organ
harvesting. Well, I, one week away from doing this, was incredibly
offended, incredibly insulted, it actually caused me to think twice
about what I was doing. That if payment was allowed for this gift that
my gift would be tainted and I'd be ashamed to tell people in the
future that I had done this because it would appear as if I did it in
order to get paid.
So, yes, there is a moral impact and
unintended consequence on the group of people that everyone wants to
have more of, those are the altruistic donors. Yesterday, Professor
Epstein, who, by the way, I think he authored that article in the
Wall Street Journal that so offended me, he stated that
transplantation is the only place that is regulated where compensation
is treated as coercion.
That's not true. Adoption, adoption is an area that is regulated
that we certainly don't want to allow any perception of buying
of babies. So I have two recommendations for the Council. One
is, find out about altruistic people. Learn about us, what motivates
us, where are we. There was a study that was done, written into
a book called "The Altruistic Personality." It's
a study of people who had rescued Jews in Nazi occupied areas.
And they found that there are three types of people. Fifty-two
percent, the largest group, were those people who belonged to a
group in which this is what you did. This was the right thing
The second group, 37 percent were those
who had empathy for the victim and the smallest group, 11 percent, were
those who were principled, they had very strong core beliefs that this
was the right thing to do.
So I believe that the first priority that
ought to be when you're looking at organ procurement, is to grow
the pool of altruistic givers and in order to do that, first find out
about them. And also find out how to make the opportunities available,
more known. I've been willing to donate for years. I've been
on bone marrow registry for over 15 years but had never gotten a call.
It wasn't until there was someone I knew of that needed a kidney
that gave me then an opportunity to come forward and to do this.
My second recommendation is "do no harm." Please do
not recommend anything that will have the unintended consequence
of reducing the pool of altruistic givers or that would create more
harm to the most poor patients who would not be able to afford to
pay for organs. Thank you.
DR. PELLEGRINO: Thank you very much.
PROF. GEORGE: Dr. Pellegrino, could I
invite Wendy back to the microphone just to ask a question?
DR. PELLEGRINO: Yes, surely.
PROF. GEORGE: Wendy, if there were to be
permitted a regulated market in organs, would something about that have
precluded your making an altruistic private donation of the kidney to
Sora or could there have been a market in which those transactions, if
I can use that inappropriate word in these context, would be
permissible anyway? I mean, why would it preclude — why would a
market preclude your doing for Sora the generous thing you did?
MS. WRIGHT: That's a good question.
All I can really go back to is that one week time, when — the one week
before the surgery when I read about this and to me it would have been
a huge hurdle. It would have been — I would have felt like this
decision was now tainted. It would not be perceived as altruistic. And
that's even if you have these — they say two areas. You could
have one which people could go into this arena and be paid or you could
choose this other route of altruistic. The average person out there
wouldn't be able to make the distinction and that was something
that concerned me.
Now, I still would have gone through with
it but I enjoy telling people what I've done because I want to
encourage them to do the same thing. And one friend of mine is willing
now to donate a kidney if the opportunity arises. I would not feel as
willing to tell people if there was this concept of doing it for
PROF. GEORGE: Not to press you too hard
or to subject you, Wendy, to a cross examination, but if you have a
physician who is willing to, because he's already made quite a lot
of money and he's got enough to retire on and take care of his
family responsibilities and so forth, and is now going to dedicate
himself to providing free medical services to the poor, can do that
without his generosity being tainted by virtue of the fact that most
other doctors are providing their services to people for money and he,
himself, did that.
Why couldn't it be the same with organ
donors? We would still praise the altruistic people who did it without
financial incentives and people would know that some people do that and
that's terrific and it wouldn't detract from our sense of their
virtue that other people are — I'm not doing this —
MS. WRIGHT: No, no.
PROF. GEORGE: — to promote the idea of a
market, but it seems to me these are obvious possible lines of
objection to the point you're making.
MS. WRIGHT: Right, I think it's the
same kind of difference we have between those that are paid for their
labor and prostitution. Giving up an organ, it's a part of
yourself that I believe we don't really have the right to sell.
And so I think there is a distinction, a distinction between labor and
selling of human beings and their parts.
PROF. GEORGE: But that makes me thing
that it's not really so much a perception that other people
won't understand the virtue of what you've done, rather that
the foundation of it is this view that —
MS. WRIGHT: Yes.
PROF. GEORGE: — which Dr. Kass articulated so well,
that there's something about the organ and its relationship
to the person that makes it, perhaps, just inappropriate to be in
MS. WRIGHT: I completely agree with that.
PROF. GEORGE: Okay.
DR. PELLEGRINO: Thank you very much.
Meeting adjourned, thank you.
(Whereupon, at 12:01 p.m. the
above-entitled matter concluded.)