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Oral History of the

Belmont Report and the

National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research

Interview with

Patricia King, J.D.

Professor of Law

Georgetown University Law Center

Washington, D.C.

September 9, 2004

Belmont Oral History Project

The Tower Building • 1101 Wootton Parkway • Suite 200 • Rockville,
Maryland 20852 • (301) 496-7005

**[INTERVIEW]{.underline}**

*Interviewer: LeRoy B. Walters, Ph.D., Professor of Christian Ethics and
Professor of Philosophy, Kennedy Institute of Ethics, Georgetown
University.*

MS. KING: My name is Patricia King, and I\'m a professor of law at
Georgetown University Law Center, and I was one of the Commissioners for
the National Commission.

*INTERVIEWER: Where were you working at the time when you received the
invitation to join the Commission, Pat?*

MS. KING: At the time, I was the Deputy Director of the Office for Civil
Rights at HEW, and I had been the Acting Director of the Office of Civil
Rights at HEW. So I was at HEW when the Tuskegee syphilis study was
unveiled, and also when there was a panel set up to examine the study,
and I assume that I was appointed to the National Commission because I
had that civil rights background, although I had not worked on Tuskegee
itself. I don\'t know for sure, though.

*INTERVIEWER: So it remains a little mysterious how exactly you were
appointed to the Commission?*

MS. KING: I\'ve never had anybody confirm it for me, but I had a pretty
high position in the Department, so I had spent some time interacting
with both the Secretary and the Under Secretary, and I was planning to
leave HEW to start teaching, and all I remember is being called into
Secretary Weinberger\'s office to say goodbye. And at that point, he
asked me would I be interested in serving on this Commission, and I
said, absolutely. So I jumped at it. I didn\'t know much about it, but
I\'d heard\--there was a little bit in the newspapers about human
subjects protection. There had been a lot about the Tuskegee study, and
so I leaped at the chance.

*INTERVIEWER: Were you following the legislation as it made its way
through Congress about setting up a national commission?*

MS. KING: I\'m ashamed to say, no, because the civil rights issue of
that day happened to have been desegregating public schools, and the
initiation of affirmative action programs and higher education. Health
was way down on the civil rights agenda. In fact, probably just about
the same place today as it was then. So I hadn\'t been paying a lot of
attention in terms of my official capacity with anything to do with the
National Commission. I read the newspapers every day, and I found a few
things about fetal research, et cetera, that I found interesting in the
sense of having to think about tough, hard issues.

*INTERVIEWER: Had you done work in biomedical ethics before you joined
the Commission?*

MS. KING: No, I didn\'t even know the word \"biomedical ethics\" until I
read the Commission\'s title. I had no prior background. I had majored
in religion and philosophy in college, and of course I had a law degree,
but I have always assumed that there were political reasons for having a
minority and having someone who might have what others regard as a
relevant background, which was civil rights, because the Tuskegee study
did play a role in the establishment of the Commission, which I learned
after the fact. And so I would say that probably had something to do
with why I was appointed.

It\'s a long time ago, but it was unusual at that time to have either
minorities or women involved in National Commission of any sort. So the
National Commission was breaking new ground in many ways.

*INTERVIEWER: What were some of your first impressions at the early
National Commission meetings?*

MS. KING: Well, if you\'ll recall, the act required that the Commission
deal with fetal research right away, and they gave us a time limit. So
we really had to hit the ground running, and so there wasn\'t a lot of
time to understand the group dynamics in advance or understand a lot
about the issues. We sort of plunged right in. But in retrospect, that
was good. So my first impression is all about fetal research and an
unknown, a fact that we don\'t talk about a lot about at the National
Commission, is that it was the first national commission to operate
totally in public. And if I remember the most daunting thing, it was to
discuss issues like fetal research and abortion in public in the sense
that you had to deliberate in public. So no behind-closed-doors and
emerging with the consensus.

The consensus had to be hashed out in front of an audience, and that is
quite unnerving at the time. And so I remember those two
things\--controversial topic, probably one of our most controversial
topics of all, all in front of everybody else. It was quite astonishing,
but we reached consensus.

*INTERVIEWER: Were you pretty well satisfied with the first report on
fetal research as you look back or did you think it was too rushed, the
process?*

MS. KING: Well, in retrospect, I think having a deadline pushed us
towards reaching a consensus. In retrospect, I think that it is actually
amazing that we did given the fact that we had both pro-choice and
pro-life avowedly pro-choice and pro-life members of the National
Commission. Certainly, in the beginning, it seemed that we would never,
could never reach agreement about fetal research.

I, personally, thought we were fairly conservative in our agreement and
the consensus that we reached. On the other hand, the fact that we did
reach a consensus established I think an extraordinarily good precedent,
and it was important to reach consensus, and I think most national
bodies, bioethics bodies or otherwise since then, have learned the
importance of being able to do so, in terms of thinking about the clout
that your report might have. The 9/11 Commission, for example, comes to
mind.

*INTERVIEWER: You did have a consensus, but you did have some dissenting
opinions expressed at the end of that report?*

MS. KING: Well, tell you the truth, Leroy, who remembers the dissenting
opinions except those of us who struggled with the report. The message
that went out, and it was an important message was that a group of
diverse people with different value orientations had reached agreement
about something that could become a federal regulation that would govern
research, and I think that that was really important. It wasn\'t the
only report where we had dissents, but you\'re the first person to ask
about those dissents in a very long time.

*INTERVIEWER: I just remember that David Lewis would not have been
likely to accept the majority view, but he expressed his minority
viewpoint in such a respectful and articulate way that I think his
participation in that whole process was very important.*

MS. KING: It was very important because if you compare the National
Commission to some of the other policy bodies, bioethics policy bodies
that have dealt with fetuses and embryos, it has been much more
difficult. It has not always been\--people have not always been so
gracious to each other and so respectful in dissent as with the National
Commission.

And if I recall correctly, and I didn\'t look this up again, I\'m not
sure that the votes were cast, whether he dissented without actually
casting a formal no vote. Perhaps he did with respect to one
recommendation, but overall it was really very mild, and for the
National Commission, it was a good precedent. I\'m not sure it had
stayed that way with subsequent groups.

One of the things to think about with respect to the National Commission
is, although I didn\'t have a biomedical ethics background in any way, I
learned that people were very skeptical that establishing a National
Commission to think through issues of research on human subjects was a
valuable activity. I\'m told that at least in the medical community that
the medical community thought it was a really fairly foolish idea, and
so there was trouble establishing the Commission. But that was a
downside.

The upside was we were able to operate, even with very controversial
issues, and in public, without anybody thinking we had power, and that
is wonderful because you\'re allowed to deliberate and think through
issues without advocacy groups, lobbying efforts, political
machinations, in terms of who was appointed and who\'s not appointed,
and how you stack a group versus not stacking a group. And I attribute a
great deal of the success of the Commission to the fact that we operated
under the radar, at least the Washington \"inside beltway\" radar, and
that worked to our advantage.

*INTERVIEWER: How important do you think it was that the Secretary of
Health, Education and Welfare had to respond to your recommendations
within a certain period of time?*

MS. KING: Critical. I think those of us who care about how policy is
formulated know that that was a hidden power available to the
Commission. Whatever we did would generate a response, and I think the
fact that so many of our recommendations became regulations is due to
that. Now, not all our recommendations became regulations, but there
were reasons that were expressed, particularly with the mentally
impaired on why our recommendations were not being adopted. But the fact
that the\--just imagine what we could do today with making a Cabinet
official respond to something that you\'re doing, have to go on record
in terms of your work, it was a critical aspect of the legislation.

*INTERVIEWER: On the whole, which of the reports did you find the most
satisfying, intellectually or in terms of its impact?*

MS. KING: Well, I suppose, with all of its flaws, it was the report on
children. Even then it was clear that children were not little adults
and that we really needed to have information about children, and it was
one of those shifting periods where you reexamine your principles or
your values, and you try to give them a new interpretation or
understanding in light of changed circumstances.

Now, that\'s not something that lawyers have a problem with. I\'m not
sure that philosophers and others approach it the same way, but lawyers
have an experience of taking a Constitution and watching a document
grow, change, shift, emerge over time as circumstances require. I think
of the children\'s report as that sort of experience, where you were
taking a hard look at a hard issue and weighing and balancing the
implications, trying to find ways to ethically include children in
research not for their direct benefit, and to put in safeguards and
procedures that might protect them.

It really wasn\'t perfect, but it got us all started, and I think it was
a major breakthrough, and for parents, in particular, whose children
suffered from diseases or illnesses, I am sure that they were
particularly grateful. So I\'m proudest I think of the children\'s
report. It was the one that was the most contested, but I think overall
we did a pretty good job.

*INTERVIEWER: Do you mean it was contested within the Commission or
after it came out or both?*

MS. KING: Both, because, of course, it was a question of whether you
could consent to research that didn\'t directly benefit or was not
likely to directly benefit children. There still are questions about the
limits, if any, of parental consent to involvement of children in
research if it\'s not for their benefit, direct benefit. The whole
prospect of reviewing research for children and thinking about
additional safeguards, with new, when advocates might be required.

As a person who teaches family law, the Commission\'s work on ascent,
which was to give a position that allowed us to give children a role, if
they were mature enough, in determining whether they would participate
in research is a major breakthrough in allowing, particularly
adolescents to have any say in what happened to them.

So I think it was new ground, and that doesn\'t mean it was good for all
time, but I\'m proud of that report.

*INTERVIEWER: Do you think that the notion of a minor increment over
minimal risk is a useful concept. Were you happy with it at the time?*

MS. KING: I was happy with it at the time because I can\'t think of
anything better. I mean, it is slicing the apple very finely, but you
had to try to figure out a way to balance risk and potential benefits,
and it was a way of walking a very fine line down the middle. Remember,
this was all new. So you weren\'t going to just go wide open in one
direction or the other.

As I said, I\'m a lawyer. Lawyers work with standards that have to be
applied in specific circumstances. So while it can be tough sometimes,
it\'s not an insurmountable object. I don\'t quarrel what people who are
still trying to look for a better standard because I think having 20, 25
years experience with the standard should provide lessons that may help
you to articulate a better standard. So I\'m not suggesting that\--what
I\'m suggesting that I am quite comfortable with it as an initial step
in a direction that I thought it was important to go into.

*INTERVIEWER: Which of the reports did you find most frustrating or were
you least-well satisfied with at the end?*

MS. KING: The report on prisoners. And the reason I found it least
satisfactory is because it raised issues pretty clearly that we just
didn\'t know how to become, even begin to grapple with. The prisoner
report raised questions about both justice and autonomy. And as you
know, the Commission came down pretty heavily on the side of looking at
the autonomy questions\--the question of consent and coerced consent.
But the prisoner report raised questions of distributing burdens and
benefits of research that we talked a lot about. I remember being in a
lot of fierce arguments, but ultimately we didn\'t have a clue about how
to understand medicine in a broader social context because that\'s what
the prisoner report required that we do.

And I think we were, as Commissioners, unprepared for the fact that
prisoners who participated in research thought of us, to some extent, as
meddling liberals because, inside of a prison, what constituted a burden
and what constituted a benefit was not necessarily the same thing in the
outside world. That was a really difficult report, and nothing legally
ever really came of the prisoner report except to close down research in
prisons, and some would argue that was a very important and powerful
thing to do. But we just didn\'t\--we weren\'t able to work through some
of these justice issues, and that\'s actually my problem with a lot of
the work of the Commission, and that is that we were terrific at
understanding autonomy, informed consent, and pretty good at dealing
with questions of beneficence. We just didn\'t have too much of a clue
about what to do with this principle of justice, although it is to our
credit that we included it, so that there is still an opportunity to
have it evolve as a principle in bioethics issues, and it\'s beginning
to do that. It\'s beginning to happen, but that was my big
disappointment.

And we had a now-forgotten report on minority health care, which was our
effort to think about Tuskegee a little bit, but we, and I put myself in
this group of \"we\" pretty strongly, didn\'t know how to tackle that
either, so we turned it over to another group to have a conference. And
like all conferences, if you don\'t have papers, if you don\'t have
things prepared, then you have a conference, and you listen to the
people, you write up something, and it goes away, and that\'s what
happened to the minority\--you can\'t even find a copy of the minority
health report. You probably have it at the Kennedy Institute of Ethics
because you have everything.

*INTERVIEWER: We do. We have everything, yes.*

MS. KING: But it is\--people just didn\'t even keep it. I mean, it\'s,
you know, it\'s very hard to come by. And what I\'m really saying is we
just didn\'t follow through on the issues that the Tuskegee syphilis
study raised. Now, in retrospect, I think we probably didn\'t because we
had so much work to do, and the Tuskegee syphilis study had its own
group to examine it. There was a task force.

So, to go back and redo what had just been done the year before or two
years before, surely seemed like a bad allocation of resources. And I
also think that, in 1974, we were only 10 years post-civil rights
legislation, desegregating health facilities, period. And we were in
this\--a little bit euphoria about ending the Tuskegee-type problems in
health care. Those are plausible explanations I think for why we didn\'t
go beyond thinking about informed consent in Tuskegee without thinking
about what informed consent really means in a situation in which the men
in Tuskegee found themselves, but we didn\'t. And so all of the
Commission\'s report that might arguably\--reports\--that might arguably
have raised some of those justice issues, didn\'t, and that is my major
disappointment.

*INTERVIEWER: The Commission worked on a lot of reports on particular
topics, and then as it neared the end of its work, it tried to put
everything together. And out of that process came some ethical
principles. Do you think that was a good way to approach things\--to
work inductively?*

MS. KING: Well, it wasn\'t quite like that. We actually started trying
to do what became the Belmont Report about halfway through the
Commission\'s life\--four years. So, what was really important, I think,
was that we did it both ways. We worked on specific problems and then
had a Belmont meeting where we talked about principles\--

MS. KING: I\'ve got to get my days straight. Belmont is \'78?

*INTERVIEWER: Yeah.*

MS. KING: But the meeting at Belmont was\--Belmont is \'79. The meeting
at Belmont was much earlier.

*INTERVIEWER: Was it?*

MS. KING: Maybe two years earlier, yeah.

*INTERVIEWER: Maybe \'76, \'77. The Commission began by dealing with
very specific issues and then tried to move toward formulating some
general ethical principles. Do you think that was a good approach to
start with specifics and then move to general principles?*

MS. KING: I knew, particularly if you have some people in your group who
had no experience with the issues or topics under discussion, and that
was certainly true of me, and I believe it was true of people like
Dorothy Height, and David Loiselle, and Bob Turtle. In other words, we
were all immersed in our own professions and sort of hadn\'t thought
about this interdisciplinary area. And to have started trying to work on
a framework I think would have been not doable actually and a little
daunting.

But once we had started to talk about specific issues and the lines of
disagreement or the focus of disagreement had started to emerge, then we
were interested in trying to understand why we were having differences
or, in some cases, consensus, and we actually had the meeting at Belmont
long before, of course, the Belmont Report came out. And just having the
meeting made an enormous difference in the way we deliberated and talked
to each other.

My memory is very poor, but Al Johnson tells me or at least he put it in
his book that I reportedly said, when Belmont, the meeting itself was
over, that it had helped enormously in helping the media understand what
we\'d been doing because I didn\'t have that sort of framework.

So I think, in this kind of environment, interdisciplinary, people
coming from different places, different backgrounds, it helps to have
both facts and framework and have them interact with each other, attempt
to have a framework. And I thought it worked quite well, as a matter of
fact.

*INTERVIEWER: Were you pretty well satisfied with the three principles
that emerged? Do you think there should have been more or could one of
the three had been skipped?*

MS. KING: I really don\'t think any of the three could have been
skipped, actually. You know, there\'s a lot of controversy about the
Belmont report, but my view is you start somewhere. You know, sort of
think about the Founding Fathers who sat down and try to figure out what
they were going to put in their declaration or the Constitution. It\'s
not a perfect document. There are all these things that you can add
later, but you need to start with someplace, and you want to start with
a formulation that is broad enough to be able to evolve over time, and
lawyers would say even a framework that was susceptible to amendment or
additions.

Unlike the Constitution, we haven\'t done that with Belmont, and I\'m
not sure we ever could because we don\'t have a process for doing it. So
the fact that it is very broad and general I think is a good one, and it
certainly captures the prevailing norms, both in our political life, and
in our moral and philosophical life. So, in that sense, it was
satisfactory.

And of course it permits people now to debate so many things about
whether principles are the way to go or whether the formulation of each
principle was a good formulation, and it generated its own literature,
which I think is a good thing as a part of the debate.

We were only going to get a framework that the people who were members
of the Commission could generate. And when you take a look at us, I
think we did a pretty good job. We didn\'t have any idea that Belmont
would have the impact that it has. It\'s a convenient document, tight,
because it says everything and says nothing. But it helps people to
really think, to develop lines of argument or understanding, and it
provides a way for people across disciplines to be able to talk to each
other. I mean, you sort of get where you are in this wavelength, I
think, with the assistance of Belmont.

*INTERVIEWER: Is there one of the principles that you think is
especially important in the American context?*

MS. KING: Well, in the American context, the principle of autonomy is
the most, and the idea of individualism, of course, is the most
important principle.

And I think, given the time in which Belmont emerged, one would expect
that because, after all, we were in context too. We were a part of the
culture, at that particular time, with a great deal of emphasis on
individualism. But I think of Belmont as having three principles of
equal weight, equal importance, and specific situations might, and the
facts of specific situations, might cause one to be highlighted more
than others.

One of the, I think\--and I\'ve said this before\--unfortunate aspects
of thinking about that principles is that we\'ve spent subsequently so
much time talking about autonomy and informed consent without spending
what we probably need to do, a great deal of time, on both beneficence
and justice, in part, I think that if we had had economists on the
National Commission, we might have reached the utility questions
inherent in the beneficence principle much more readily, but we didn\'t,
and so we formulated them in terms of traditional medical ethics, in
terms of thinking about their doing no harm. And we talked about
burden\--not burdensome benefits. We talked about maleficence and
beneficences. They are now structured. But we couldn\'t do much more
with it because those kinds of assessments are not easily done outside
of the context of a specific problem.

*INTERVIEWER: We\'ve talked a little bit about respect for persons and
beneficence in the Belmont Report. What about justice?*

MS. KING: Well, it\'s my view that, though we stated a principle of
justice, that it\'s the forgotten principle. It was not a principle that
played a major role in the deliberations of the Commission, except in
the context of the prisoner report, where the issue, of course, did
arise.

And even though social justice questions were a major part of the times,
I mean, we had after all just finished the civil rights movement, and we
were just talking about equality, we\'d just come through Tuskegee, we
just did not pay a great deal of attention to it beyond recruiting
subjects to make sure that you didn\'t use vulnerable populations in
research which resulted, of course, in not using African Americans in
research.

But I think we are now in a period, almost a quarter of a century later,
where people go back to Belmont, and they think about the justice
questions raised, and they go beyond, actually, what we talked
about\--selection of subjects in Belmont\--and we hear a great deal more
discussion about distributive principles and what is fairness and
what\'s equality in health and in areas of medicine. So we\'re getting
there. So it\'s there, and that\'s the good part. The fact that we
didn\'t use it very much 25 years ago is the bad part, but I hope we are
correcting that. There are many people working on health care issues,
for example, that sort of go back to thinking about Belmont and other
philosophers as well and thinking about those issues.

*INTERVIEWER: For a while, it seems as if the concern was to protect
minorities and poor people against being exploited in research. And
maybe we overreacted and later on we needed to come back to the idea of
including minorities and poor people in research?*

MS. KING: Well, I think you\'re right, LeRoy, that we were\--that\'s
what Tuskegee did, and that\'s what all of the outrageous examples of
bad research, for instance, in children did for us, and we went very far
one direction, perhaps too far. But I also should say that it may be
that we just didn\'t understand how to include fairly either.

We all know that HHS has still not issued guidelines for conducting
research on vulnerable populations that don\'t fall into the category of
children or women or prisoners, vulnerable populations in terms of
educationally disadvantaged or economically disadvantaged. I don\'t
think that\'s for lack of thinking that it\'s an important thing to do.
I think that we just haven\'t been able to figure out yet how to include
people without putting them at more risk than we want to put them,
without creating greater risks than necessary.

And subsequent efforts to include minorities, and women, and children
have encountered that problem because we still think of all three
categories as being vulnerable, in some sense, although perhaps a
different sense from each other. And to strike a good balance between
inclusion and protection is just not so easy to attain.

We haven\'t debated this so much with respect to minorities, in part,
because we still have trouble recruiting minorities into research,
but\--

*INTERVIEWER: We were talking about the tension between inclusion and
protection.*

MS. KING: I think, frankly, to repeat myself, that it would have been
difficult\--it still is difficult\--for the Commission to strike a good
balance between inclusion and protection, and it was just easier to
protect.

And I think the subsequent years demonstrate all too well the
difficulty, particularly today with children, for example, as we are
convinced that we need to include them in research, and we struggle to
figure out ways to do that that are acceptable and don\'t put children
at too much risk.

We are still struggling with ways of including minorities in research
not so much in terms of the inclusion protection balance, in terms of
physical risk to minorities, although that exists, but how to include
minorities in research without fostering or promoting stigma or
biological understandings of race or conceptualizations of race.

So the harm is different. It\'s a quite significant harm, but it\'s a
social harm, in some cases, a psychological harm. But we still worry
that, since participation in research is a benefit to many, that
minorities, like other Americans, should have that opportunity, and we
also worry that perhaps there are differences between minorities and
nonminorities that are medically significant.

So we want to make sure we\'ve covered that base as well, but all the
while we really risk perpetuating risk, social risk, that we would like
to see go away, and of course all of the work with the genome project is
really bringing to the fore this hard question of inclusion and how to
include because we were worried about doing harm.

So, while I wish the Commission had made some initial efforts at
striking a balance between inclusion and protection, I recognize how
difficult it was then, and even now how difficult it is.

*INTERVIEWER: Some people have proposed that there should be a principle
of solidarity added to the Big Three that the National Commission
included in its report. What do you think about that?*

MS. KING: What do you mean, LeRoy, by principle of solidarity?

*INTERVIEWER: Somehow expressing the notion that we\'re in society
together. We ought to care for each other. We have some mutual
obligations to each other. What do you think about that?*

MS. KING: It\'s a notion that I\'m quite sympathetic to. And when I say
I\'m sympathetic to, I see it as somewhat of a counter to our very heavy
emphasis on individualism and essentially every tub on its own bottom in
the society as well as in biomedical research.

I think there is a role for groups or communities, as some people use
the term. It\'s not clear to me yet, however, just how we will go about
doing that. I\'m not so sure we need a principle of solidarity, as we
need the same kind of group that the National Commission represented, to
debate how you add that as an additional principle. It is particularly
important in international research, I think.

However, the issues for international research are also issues of
domestic research, and that is how to do benefit sharing, how to involve
communities in the consent process, what obligations are owed to groups,
as well as individuals, are all the kinds of questions I think that
deserve the same kind of attention that the first three principles
received, in part, because we may be in a period of correcting our
earlier emphasis or swinging back a little bit on that earlier emphasis
on what I call excessive individualism that also crept into biomedical
research.

*INTERVIEWER: Some people in bioethics have suggested that a fourth
principle should be added to the Big Three\--respect for persons,
beneficence and justice\--and that would be a principle of solidarity,
some notion that we\'re all connected to each other and that we ought to
help each other and support each other.*

MS. KING: Well, I don\'t know exactly how to describe it as a principle,
and I\'m not sure I would agree with all of the formulations that come
out, but I do think that it would be important to point to a\--or to
have a principle that would point us in the direction of the collective
that we are linked, that a good formulation is the Golden Rule
formulation\--\"Do unto others, as you would have others do unto
you\"\--somehow to show our connection to each other and that we are not
isolated individuals, a reaction, I think, to what I consider excessive
individualism.

But I think it\'s important not only to show that we live in families,
groups, communities, tribes, and what the relationships, those sorts of
relationships, the impact of those sorts of relationships. It may be
worth, I think it rather is, the\--composing a group to just deliberate
how you might think through some of those issues of the statue of the
original group.

I think it may be particularly important, in terms of genetic research.
I think it was particularly important in international research to start
thinking about some of those issues. But I\'m the first to say that the
issues of international research are also the issues that are here, in
terms of benefit sharing, for example, and we really don\'t have any
good way to get at some of those issues now, and I think they\'re very
important.

*INTERVIEWER[:]{.underline} Did your work with the Commission have a
major impact on your life between the \'70s and now?*

MS. KING: Well, it had an enormous impact because I started life as a
civil rights lawyer, and I became a bioethics\--I refuse to say
ethicist\--but I became a biomedical ethics expert I guess. All of my
writing, my teaching, is connected in some way or another with
bioethics. I\'m a co-author on the textbook on \"Law, Science and
Medicine,\" which is getting ready to go into its third edition. This
was the first legal textbook in the country that dealt with those issues
of the relationship between law, science and medicine.

I would not have done any of those things if I had not been a member of
the National Commission. And, lord knows, I have served on more public
policy bodies and committees, most of which have been absolutely
wonderful to do, and it just wouldn\'t have been possible if I hadn\'t
been this young, naive lawyer, asked to join this National Commission,
who ended up four years later convinced that this was the way to go. If
I hadn\'t been so old, I would have gone back to school and gotten
another degree in public health or in philosophy.

*INTERVIEWER: So it did open up an area of interest for your further
research and teaching that hadn\'t been there, although you had studied
the liberal arts, and you had majored in religious studies as an
undergraduate, so that part of your life was always there?*

MS. KING: Well, I reconnected with that part of my life, and I never
would have imagined that I would have done that. I just\--civil rights
law was where I thought that I was going to be. And it\'s very
interesting, the bioethics part is not perhaps as interesting or unusual
as ending up in family law because family law and tort law were the two
areas of the law that most closely connected with bioethics, those parts
that deal with death and dying or reproduction, et cetera. So it really
had an enormous impact. It just turned me all around.

*INTERVIEWER: What do you think were the major keys to the success of
the National Commission? Was it the staff? Was it the Commission
members? Was it action-enforcing power that you had or some combination
of all of those and other factors?*

MS. KING: Gee, that\'s really hard to answer because I can think of a
number of factors that, if they had not been present, I think that the
Commission would have totally gone awry. I\'ve mentioned some already
about the Secretary having to answer us, the fact that we got off on
such a good start with consensus, the fact that we were proceeding under
the radar.

But, you know, the Chairman of the Commission was an extraordinary man,
and he kept an often fractious and unwieldy group all marching in the
same direction. And you tend to forget those things over the years, but
during the four years that the Commission met, we always said to each
other\--and you know we met a lot, once a month every month for four
years, with very few exceptions, sometimes twice a month\--and we all
commented that it would not have been doable if Ken hadn\'t been there.

He didn\'t really crack a whip, but he was firm, and he kept us marching
forward, rather than allowing us to dissipate and scatter our energy.
And he set the tone. He was respectful. He lost his temper every now and
then, but not too often, but we were difficult sometimes. He was
respectful of our views. He listened to everybody\'s views. He kept his
own inclinations firmly in check as long as he was acting as Chair. And
I think that the product of the Commission\'s work is, as much as
anything else, attributable to his leadership. And I feel pretty
strongly about that.

And I\'d like to think that all of the other things in the ingredients
just helped him to do that job very well, but I think of him as being
indispensable.

*INTERVIEWER: So the Commission worked in the late \'70s, and it\'s now
early in the 21st century. I\'ll ask you a hard question, and that is,
on balance, do you think human subjects in research are better off today
than they were in, say, the late \'60s or early \'70s?*

MS. KING: Well, I don\'t know what measure to use to tell me whether we
are better off. I like to think that we are, although there are problems
now in our system that we just didn\'t anticipate or think very much
about 25 years ago.

What I think I would like to see is something that\'s already
beginning\--some careful assessment of how the system actually operates.
We do a fair amount with informed consent, for example, but I\'m not
sure that we have a sense of what studies are approved, and why, and how
harm is assessed, for example. I\'m not sure that we have an empirical
base for assessing how IRB\'s operate. We\'ve got a lot of ideas about
processes and procedures that might make functioning better, and I\'m
not suggesting such as accreditation, for example. I mean, there are
lots of ideas about what to do, including changing the regulations, but
I\'m struck by the fact that we may not know a great deal about actual
functioning. And before I thought we were in a better place, I\'d like
to know exactly how we were functioning.

We clearly spend more money. We clearly have pulled more kinds of
research, even with our remaining assumptions under a review process and
umbrella, but I think we don\'t have a good base on which to make the
kind of judgment that you\'re asking. In fact, I think it might be a
good question to debate whether, given the amount of resources going
into the system, whether all of the resources that are being used are
really important, in terms of keeping the lid on risks coming about or
whether we would be just about where we were before, in terms of harm to
people, if we had a less-elaborate structure. I don\'t know. I\'m sure
that quite a good deal of money is flowing into the system.

That said, there are of course big gaps that still remain, and I
appreciate that, but I don\'t know how I feel about that. What I think
we have done is increased the confidence of people that the system is
operating just about, not right, but is operating well, and that\'s
important so there\'s some trust in the system. But I don\'t know. I\'m
not sure I can make that evaluation. You always like to think your work
was for something good, and so I\'d like to think that we\'re better
off, but I\'m not sure.

*INTERVIEWER: One factor that the National Commission didn\'t have to
deal with in the same way as we do today, in research ethics, is the
huge amount of private money going to universities and to research
organizations. That\'s a qualitative change.*

MS. KING: It\'s a qualitative change, and it is a change that we have
been reluctant to take account of. For a long time, if you could impose
regulation on government-funded research, you could accomplish a great
deal, all sorts of government-funded research. and that, I would agree
with you, is no longer the issue. And the real question will be whether
we\'re willing to impose a system of protection on everybody because,
unlike government, private industry is very cost-conscious in terms of
the value to be obtained from imposing a stringent system of oversight
and monitoring.

So I don\'t know, but it certainly is the big issue, and I think that,
interestingly enough, one of the major side elements of the stem cell
research controversy, as well as our concern about reproductive
technologies and what happens to subjects in\--well, they\'re not called
subjects\--but what happens to people involved in reproductive
technology development may propel us in a direction of finally making
some\--Congress finally passing statutes that would apply more broadly.

They\'ve been surely reluctant to do it in the past because they don\'t
want to infringe basically on what they\'ve seen, a scientific endeavor,
which was good, but maybe we are at the point where we will have to
consider a broader focus than we were willing to do in the past.

*INTERVIEWER: So, if you were President, would you be urging the
Congress to enact a single high standard for all research regardless of
how it\'s funded?*

MS. KING: Well, I don\'t think they can enact a standard. What they
would enact would be a process, and the question would be whether the
process would have to apply to all. You might have some substantive
standards, don\'t mis\--we already have a little bit of that in embryo
research, and fetal tissue research, et cetera, but what you basically
want to have accomplished, I think, is to have some oversight mechanism
that would apply to private research, as well as publicly funded
research because that\'s actually what is the most valuable thing about
the publicly funded research, that there is monitoring, and oversight,
and an opportunity to impose substantive guidelines.

But if you take a look at the regulations carefully, many of them are
just guides, in which the review process occurs. But I wouldn\'t be
surprised, in the next 20 years, that we actually got a broader coverage
of research, particularly human subject research, because government is
playing a decreasing role.

*INTERVIEWER: Yes. So a single standard, regardless of whether it\'s FDA
regulated or federally funded or even privately funded\--*

MS. KING: I didn\'t say that.

*INTERVIEWER: \--and intrastate.*

MS. KING: I didn\'t say that.

*INTERVIEWER: Okay.*

MS. KING: What I said was that you might get review processes enacted. I
don\'t think it would necessarily be appropriate to have FDA regulation
look like NIH regulations. I don\'t know But to think about it as a
generic matter, should there be oversight of private research, as we
were contemplating with recombinant DNA research, for example, that
question is the question that I think we may start to deal with. Because
informal mechanisms are just not working for some areas of research, and
it\'s much more likely, I would think, that FDA is the inappropriate
place to lodge not in the new regulation because not all of it is going
to be safety regulation or safety regulation may not be extensive enough
to accomplish what you would like.

*INTERVIEWER: So maybe this brings you full circle in your career. You
started out being interested in civil rights, and maybe there\'s a civil
right or should be a civil right to be protected as a research subject
no matter in what context you participate?*

MS. KING: Well, I don\'t know if we will cal it a civil right. It is
likely to be called a human right because that\'s the new terminology,
but I think that it\'s an actually important topic that a woman who
participates in research, with respect to reproductive technology, is
treated and subject to protections that, as far as we know, are only in
terms of what the institute or the physician is willing to impose, while
a woman who is in a clinical research protocol at NIH or involved in
drug research understands and can appreciate that the research was
reviewed.

It\'s not so much the informed consent I worry about. It is the research
proposal and protocol itself and how to assess the risks and benefits
and the protocol. And the fact that the two are different makes no
sense. The safety issues in that case, for example, are the same.

*INTERVIEWER: So what was that last thought you were expressing about a
human right to be protected in research no matter what the funding
is\--*

MS. KING: Irrespective, right.

*INTERVIEWER: \--and so forth.*

MS. KING: The funding should, the funding\...the funding stream for
research should not be the determinative factor in terms of whether or
not potential subjects are adequately protected in the sense that their
research is adequately reviewed or monitored and that informed consent
is obtained in a proper manner.

*INTERVIEWER: And I think you\'re also concerned about the question of
risk\--in certain context as well as the consent issue.*

MS. KING: It seems to me that, in both the setting of experimentation,
and reproductive technology and fertility work, as well as when
participating in a drug study or participating in a clinical trial,
that, from the woman\'s perspective, the question is the same, and that
is has this research been adequately reviewed, do I understand the
risks, have all the risks been thought through in terms of the research?

And the answers to that question ought not depend on the particular, the
stream of funding for the research, and if we get a bad incident in
privately funded research, I am sure that this table will, this question
will be foremost. It is already emerging in areas like reproductive
technologies. Should we ever get stem-cell research and applications it
will be a question there too if there is not government funding.

Well, thank you, LeRoy. It is always a privilege to have a conversation
with you, especially about such serious matters.

Thank you.

--END OF INTERVIEW--