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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

Charles R. McCarthy, Ph.D.

NIH Liaison to the Commisison

National Institutes of Health

Bethesda, MD

July 22, 2004

Belmont Oral History Project

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

**[INTERVIEW]{.underline}**

*Interviewer: Patricia C. El-Hinnawy, Office for Human Research
Protections staff*

*INTERVIEWER: Charley, thank you so much for letting us come. Just for
convenience, instead of saying The National Commission for the
Protection of Human Subjects as biomedically indicated on research, we
will refer to it*

*as The Commission, if that\'s okay.*

DR. McCARTHY: That\'s fine.

*INTERVIEWER: Could you tell us a little bit about the circumstances
when the Commission was formed.*

DR. McCARTHY: I\'m Charley McCarthy. I studied mathematics out in St.
Paul, then I studied law. Then I came to Washington, D.C. and studied
theology, philosophy and theology for about seven years and finally went
to the University of Toronto where I got a double doctorate in politics
and philosophy, and came back to Washington - then thinking I would
spend my life as a teacher of political science, political theory and
philosophy. And I did that for close to 12 years between the years of
1960 and \'72. And then I\--but, increasingly, I was getting interested
in active politics. I was ordained a priest in 1956, and in 1971 I left
the active priesthood, I married my wife Estelle, I moved to the
National Institutes of Health into their Legislative Development Office,
and as it turned out, 1971 was, and 1972, were big years for the
formation or for the events that led to the formation of The National
Commission.

So I happened to be in the Legislative Development Office at the time
that all those events fell into place, and they played out for four
years. My initial job was just to cover all the health legislation
introduced into each Congress. And as you may know about, in the typical
Congress, about 115 to 120 health fields are introduced; in a typical
Congress about five bills are actually enacted dealing with health
matters. So we tracked all those bills not knowing in the beginning
which ones might have a future and which ones would be abandoned. And,
in fact, the ones that do survive usually incorporate features from the
ones that don\'t.

So we have to track them all and try to figure out the impact on the
health system of the United States and particularly the research end of
the health system at NIH. So that was the job I took on, and that meant
that I spent about half my time on the Hill going to hearings. I got to
know a lot of congressional staff. I got to know a number of congressmen
and senators, and began to figure or, or to learn very slowly, how the
system actually worked as against the theoretical background that I had
already learned how it was supposed to work.

In those years\--that was the first years that Senator Kennedy was
elected to the Senate, so Kennedy was quickly named the Chair of the
Senate Health Subcommittee.

And so I attended many, maybe all, of the hearings that he held through
those years. The Kennedy family\--a little background on them\--have had
at least one retarded child, and they created what came to be known as
The Kennedy Foundation for Handicapped Children, and it included both
cognitively-impaired children and children with physical disabilities.

And sometimes many of the children in the Kennedy Foundation had both
kinds of difficulties. So the Kennedy family was very interested in
finding ways to do research in this particular vulnerable population.
And Senator Kennedy began to hold hearings, which he called \"ethics
hearings.\" Sometimes they were just about the health care delivery
system and how it affected handicapped people; sometimes it wandered far
afield and dealt with such matters as giving testing contraceptives in
women who did not speak English and were told that they were taking a
contraceptive, but half of them were taking a placebo. And so in a
number of those studies a number of women, thinking that they were
protected by contraceptives, all got pregnant.

And Kennedy held hearings exposing some of those injustices. He also
held hearings on sterilization of handicapped persons, even though the
federal government was not directly involved in any of that. That was
left to the state governments.

And I now live in Virginia where, finally in this last state
legislature, the state has apologized to women who were handicapped and
who were sterilized. But there was a long tradition of sterilizing
cognitively-impaired women in this state that\'s only recently been
overcome.

So I attended all those hearings. Many of them had some bearing on NIH;
many of them had little bearing, but the Kennedy family was interested
in figuring out what kind of research is ethical and what sorts of
research is not. So they also put some money into the Kennedy Institute
at Georgetown University, and Andre Helligers (ph) was the first
director, and his first hire was a very close friend of mine, recently
at that time graduated from Yale University, Leroy Walters. And Leroy
and I attended lots of those hearings together. We prepared lots of
testimony for the government witnesses and worked together along with
other staff members at NIH to present the government position on the
bills that were introduced and the abuses that were uncovered by the
Kennedy hearings. He held about four sets of hearings. Each one lasted
about a week and about four a year.

And so it quickly came to my responsibility to write the government
testimony for all of those hearings. And we supported some of the
suggestions and opposed some of them. And it was largely seen in terms
of how they would affect the party in power.

And, of course, in those days the Congress was predominantly democratic,
very different from today\'s climate, and the administration was,
alternately, democratic or republican.

In 1972, [The New York Times]{.underline}\--I don\'t think it was the
first to break the story, but it featured the story on the
Tuskegee\--so-called Tuskegee Syphilis Study. And that was front-page
news for a very long time. I think it was a newspaper in the West that
first broke the story, so a couple of days before [The
Times]{.underline} got the story my boss came in, dropped about 20
pounds of paper on my desk and said, \"Write the government defense for
this research.\" I had never heard of the research at that time, but it
was the so-called Tuskegee Study that is the syphilis study that
involved some 400 black syphilitic males from Nathan County, Alabama,
all of whom were systematically denied treatment for their syphilis.
There were about 200 controls also involved in that study who were
black, illiterate and did not have syphilis, but they were used as a
control to compare the development of the disease of those who did have
syphilis with those who did not. The government promised them health
care and delivered health care except for treatment of syphilis for
close to 40 years, and they followed those men. They intended to follow
them all till they died.

But the story broke, and, of course, these men had never been told what
the diagnosis was, their syphilis was untreated, and in the beginning
that may not have been such a bad thing because the standard treatment
at that time for syphilis was compounds of arsenic and mercury, and the
idea was to poison the disease and poison the person with the disease in
hopes that the disease would die before the person did. So it was a very
horrendous kind of treatment, and they were spared that.

But in 1943, of course, penicillin was discovered, and by 1944 it was
plentiful. And from \'44 until \'72 these men were deprived of any
treatment for syphilis which would be the drug of choice for the
disease.

Anyway, I read through the whole study. It took me a couple of days
because the study was, at that time, some 30 years old, and all of the
data and all of that had been collected. And then I wrote a very short
memo saying, in effect, there can be no government defense for this
study. No consent was obtained in the beginning from any of the
participants; their rights were systemically denied or overcome and, as
a consequence, the only stand the government can take is to say: We will
take steps to make sure that this never happens again.

Now, this study did not come out, as it now sometimes appears in our
history books, in isolation from a lot of other lesser abuses that had
also been conducted, and I mentioned some of those: whole body radiation
was another one of the hearings that Kennedy held where the government
radiated the entire body of persons with cancer in hopes of replacing
their bone marrow and saving them. But the rescue technique never worked
so that all of those subjects died. And it may, although it was much
less publicized, may have been as serious a violation of rights as the
Tuskegee study itself.

But in any case, I wrote a memo that was about a half-page long and said
the government cannot defend itself other than to say it will take steps
to see this does not happen again. For reasons that I\'ve never
understood, that memo went right through the system up to the Secretary.
Now, if you understand what it\'s like to be a Grade 12 federal employee
and write a memorandum, you know that before it ever gets to somebody
who\'s high enough to do anything about it, it\'s ordinarily revised
six, seven, eight, ten, twelve times. So that it was the one and only
time in my life that I ever wrote a memorandum that went unchanged from
my desk to the Secretary of HEW, the predecessor to HHS, and that person
was Elliot Richardson, who was and is much better known for his later
activity in standing up to Richard Nixon and refusing to fire the
special prosecutor associated with the Watergate scandal.

But at that time Richardson was the Secretary, HEW, and I was called to
his office. He asked me a few questions, was satisfied that the Tuskegee
study could not be defended, asked us to write the testimony, and he
presented it before a hearing in the Kennedy subcommittee. Most of those
hearings were not well attended, but, of course, it was standing room
only that day, and even lined up way up and down the corridor because by
that time the press had picked up the story, and it was front page news
for two or three months at least.

After the hearing\--and it was kind of interesting\--Richardson read
that testimony the night before he made a couple of minor editorial
changes, and he took his hearing book with all kinds of background
information to the witness stand or desk in the hearing room and never
opened it. And he gave that testimony word-for-word as it was written.
And he must have had a photographic memory because as far as I know he
read it through only once and was able to repeat it about nine or ten
pages of testimony without so much as hesitation.

He also did another thing that was interesting. The administration was
just being killed by the press, and so not only was Senator Kennedy
there but congressmen and senators from both parties were prepared to
pepper him with questions. And the idea was since it was a democratic
congress was, at least in part, to embarrass the republican
administration. Richardson presented that whole testimony in a monotone.
He never raised his voice, he never inflected a word. He just droned on
reading everything\--reading it off the back of his mind, I guess\--in
such a way that after 10 or 15 minutes, I looked around that hearing
room, people were falling asleep, their eyes were drooping. It was very
soporific, and he took all the fire out of that hearing, which I\--and I
later talked to his son who said it was a technique he learned for
diffusing really hot issues when the press and the Congress were
attacking it.

So that I found very interesting. I never knew that he was going to do
that. I never saw anybody else do that in all my years in government. So
he made it, as he took a very hot subject and transformed it into a
boring topic. On the other hand, he read with some vigor the very, or
pronounced with some vigor\--the very final part of that testimony was
that the government would take action.

After the hearing, we were invited back to his office, those few of us
from the legislative office at NIH, and he simply turned to us and said,

I don\'t know how to do this, but make it happen. Make those promises
come true.\" And so in a sense that was\--that changed my career at NIH.

So I continued in the legislative office for a while, but I got very
close to Dr. Don Chalkley, who was then the Director of the Office for
Protection from Research Risks. And we began to talk about how that
office which has become and even was at that time was the\--what was it
called?\--the Institutional Relations Branch, and it consisted of four
people over in the Division of Research Branch. And it had many other
duties besides protecting human subjects. So it was, for practical
purposes, ineffective. And we began to talk about how we could
strengthen that office and turn it into a force that would truly offer
genuine protection for human subjects.

Chalkley\'s original idea was to create committee which has since come
to be called the Institutional Review Boards, but that name came two or
three years later. But what he wanted was those committees to be\--to
review each piece of research, and a member of each committee would be
assigned to be a prosecutor, and another member would be assigned to be
the defendant. And the committee would serve as a jury so that the
research would be attacked and defended. The jury would decide whether
there was enough merit in the research to go forward, and the full of
that would be documented, and he wanted to get West Publishing, the
publisher\'s legal opinions, into the process so that when you argued a
case for or against a certain research protocol, you would argue from
precedent. And he wanted to build the whole system as a kind of
paralegal system that paralleled our civil court system. In fact, the
medical profession had little sympathy for that. He got no support from
Congress. He got no support from the medical profession, and very little
support from NIH. So those ideas lasted a few months and then, like a
lot of other ideas in the government, they\'re forgotten. But it is kind
of interesting to see what the original concept of an institutional
review board really was.

The idea of a committee had come from the NIH Clinical Center where Dr.
Felippe Cardone (ph), Phil Cardone, who was the Deputy Director of the
Clinical Center through the late \'60s and early \'70s, decided that,
well, even though\--and this was the concept at the time\--even though
patients were involved in the research, they were to be treated as
patients, and that equated to: therefore they have no self-determination
about how they will be treated. But he said he could not make the same
case for normal volunteers, and so he built the system within the
Clinical Center whereby normal volunteers would be presented with a
protocol; it would be explained to them, and they would be given a
choice of whether to participate or not.

That was a big departure for the Clinical Center because in the previous
decade most of the so-called volunteers were not really volunteers, they
were conscientious objectors to serving in World War II, and so they
were drafted to serve as research subjects. And they were ordered to
participate as research subjects in lieu of their military service. And
so there was in the medical profession a long history of telling
research subjects what they should do or not do because they were often
referred to as deserters, even though they were, technically, freed from
military service by the courts because they were conscientious
objectors. But there was such a sentiment for the war that these people
were not respected, their rights were not respected, and they were
treated pretty much without courtesy for a number of years.

But after the war, Cardone realized they\'re no longer here because
they\'re conscientious objectors, they\'re here because they
volunteered, and we have to treat them, we have to respect their consent
before we involve them in research that offers them no chance of direct
benefit. They don\'t need the research, they\'re merely volunteering for
the sake of society. So it was Phil Cardone and the NIH policy that
began, then, to model the first IRPs.

After the Tuskegee incident, all of NIH was buzzing, and the press was
buzzing, and Walter Reed Hospital, which was doing a lot of research and
other places in Washington were all buzzing with: How are we going to
regulate research? And so a number of bills were introduced. I think
five or six in the Congress, three or four in the Senate. The one that
got the most attention was a bill that was introduced by Senator
Kennedy, and his bill called for the creation of a regulatory agency
that was to be patterned after the Securities and Exchange Commission,
and that\'s where the term \"commission\" came from in the national
commission that finally emerged. But what he wanted was, technically, a
separate federal agency that would regulate the federal agencies that
actually fund or conduct research.

NIH, of course, was, and HEW later HHS, were not very happy about
falling under the regulatory control of another federal agency, so they
began to martial forces against the passage f the Kennedy bill, and so
they enlisted the aid of Congressmen Paul Rogers, who was in charge of
the corresponding committee in the House of Representatives. It had a
slightly different title, and I can\'t remember the name of the Rogers
committee. We just called it the health committee, but that wasn\'t its
full title.

In any case, Rogers then introduced a bill picking some of the language
out of the Kennedy bill, but turning it into an advisory commission
instead of a regulatory commission. And that was really the bill that
finally was enacted by Congress.

Now, lots of stuff was going on in between. The FDA, in the meantime,
had stopped the dissemination of thalidomide contrary to what happened
in Canada and in England thalidomide was administered to pregnant women
in hopes of preventing spontaneous abortions, and so women who in their
early stages, or earlier stages of pregnancy began to have contractions,
were given thalidomide, and no one understood that thalidomide would
cause limb anomalies in the offspring. What that meant was that babies
were born with no arms, no legs, or occasionally just little stumps.

Because television was just coming into vogue at that time, the first
medical hearings I ever remember seeing on television were seeing those
thalidomide babies, and they created an uproad. Frances Kelsey up at FDA
had reviewed the animal research on thalidomide, and she had picked up
the point that when it was administered to rats or mice\--I\'ve
forgotten which it was, that some of their offspring were born in a
deformed state, and she refused to approve thalidomide in this country,
and FDA saved what could have been an enormous scandal in this country.

And Frances Kelsey got a presidential award and all kinds of accolades
for taking a very courageous stand because she was vilified by the
company that wanted to sell this. And the argument was, they\'re using
it throughout Europe, they\'re using it in England, they\'re using it in
Canada, why can\'t we use this drug here?

It\'s going to help women who are pregnant, and why are we prejudiced
against women, and all that kind of stuff. Now, and then when the
scandal broke and it turned out she had saved many woman, hundreds,
perhaps thousands, and children from the heartache of deformity, she
became a heroine overnight.

So all that was going on, and it was very interesting. In the course of
that, Senator Jake Javitts, who was a republican senator from New York,
had insisted that from the time of the thalidomide study on, he had
forced amendments to the Food and Drug and Cosmetic Act that required
all drugs that were tested to be done so only after the subjects had
given informed consent. And that was a big change in the way drugs were
tested in this country. I think the public was largely unaware that
advancement simply went to physicians, gave them sample drugs, and paid
the physicians for testing the drugs on their patients, and the patients
never knew that the drugs they were taking from and were given them by
their physicians, not prescribed for them through the drug chain but
given to them and were actually experimental drugs. And probably most
families in America were subjects of drug research and never knew it.

And that had been going on since the \'30s in this country, and probably
all of us who lived at that time were research subjects without knowing
it because physicians never told their patients:

This drug is unproven, but I\'m going to give it to you anyway, and so
the physicians were double-dipping. They were getting fees in those
days, mostly directly from the pockets of their patients, not through an
insurance system. And they were also getting fees from the drug
companies for testing the drugs, so doctors were making very handsome
living conducting research and keeping the data, but it was an
unmentioned secret of the whole profession in this country for many,
many years. And it was Javitts who put that small amendment to the Food
and Drug Administration to the laws that required consent. And all of a
sudden, it upset the whole medical profession and interrupted the
practice.

But FDA had the little idea how to enforce it. This was a
well-established practice, and it was not then until we actually
codified the regulations for research in 1974 that we required research
not only to be carried out only after subjects had given informed
consent, but after it had been reviewed by an institutional review
board. And that that term appeared first in the Rogers bill, which was
the one that was largely enacted.

A little by-play occurred in between the Kennedy bill that would have
created a regulatory commission and the Rogers bill that created an
advisory commission.

And Kennedy said, \"I will drop my bill and support the Rogers bill if
the Department of Health and Human Services\--or at that time it was
still HEW\--if the Department will issue regulations for the protection
of human subjects.

The Department had had a policy since 1966 administered by Dr. Chalkley
and so on, but it had never been enforced with any rigor, and mostly it
was enforced by neglect. And Dr. Chalkley\'s way of dealing with it was
simply to write in longhand\--in those days we had Selectric
typewriters, but he couldn\'t type\--he would write in longhand nasty
letters to university\--I shouldn\'t tell you about it.

As the House and the Senate were jockeying for position, it became clear
that some kind of bill would be enacted.

*INTERVIEWER: Could you tell us a little bit about the background of the
National Research Act?*

DR. McCARTHY: The National Research Act, as you well know, was public
law 93-348, and it was signed into law on July 12, 1974. But it came to
be, because the Senate bills that were introduced by Javitts, by Senator
Mondale and others, were all being coalesced into one bill that was
drafted by Senator Kennedy and his staff. The House bills were gradually
being incorporated into a bill that was developed by Congressman Paul
Rogers and his staff, and there were three or four other health bills
that were included, one of which was by Congressman Ron Cowell (ph) from
upstate New York.

Ron Cowell had somehow got hold of some rather tragic pictures and
accused the NIH of carrying out research that the research was in
fully-formed abortuses, They were then beheaded, and their heads were
perfused, and the effort was to try to keep blood flowing through parts
of the brain so that outside the uterus the development of the human
brain could be observed. Ron Cowell got pictures of these heads, which
were, to say the least, unedifying, and circulated them to every member
of the Congress and the Senate. And the letter accompanying said: This
research is being conducted by the National Institutes of Health. This
is where your tax dollars are going.

Needless to say, it caused an uproar and a furor. This is about two
years after Roe v. Wade, and so both sides were upset on the
abortion\--of the abortion question. Anyway, we finally tracked it down,
and this was research actually being done by somebody in Finland; it was
not funded by the NIH, but an HIH grantee had gone over to Finland, met
the man and taken a couple of pictures. How they found their way to Ron
Cowell, I have no idea, but as a result one of the bills was to put a
ban on all federal funding for fetal research, and that, in itself, was
very controversial. But that was folded into the Rogers bill along with
the recommendation for a commission.

So Kennedy then went to Rogers. They were apparently pretty good friends
or at least not hostile to one another. And they worked it out that
Kennedy would accept the Rogers bill and drop his own if the National
Institutes of Health, or HEW, would issue regulations for the protection
of human subjects. NIH breathed a high sigh of relief because they did
not want a regulatory agency overseeing them.

So, suddenly, I received an order along with Jane Fullerton and
Charley\--and I\'m blocking on his name from the National Institute of
Child Health and Human Development\--yeah, I think it\'s Charley Lowe, I
think. Anyway, the three of us were to draft regulations as quickly as
possible. The Secretary dropped all the usual clearances for
regulations. Usually, it takes about two years for regulations to get
cleared. Public comment, all the rest, the Secretary waived all that and
said get those regulations out there.

And that was a very funny experience for me, because Charley Lowe and
Jane Fullerton, for whatever reason\--and I don\'t know what the reason
was\--wouldn\'t talk to each other.

So I was in a committee of three, and Jane would say, \"Please tell Dr.
Lowe such and such.\" And I would tell Dr. Lowe such and such, and he
would say, \"Please tell Ms. Fullerton such and such,\" and the three of
us are supposed to be drafting a regulation, and two of them are not
talking to each other. So we did produce some regulation based on the
old 1971 HEW policy which was referred to as the \"yellow book.\" It had
a picture of da Vinci\'s man on the front and so on, and it was widely
used.

It was a flawed policy, but given the conditions under which we produced
it, I think it was next to a miracle. It sailed right through. Normally,
a regulation would have to have sign-off from every department head.
That was all by-passed and went directly to the Secretary. It was
promulgated, Senator Kennedy said he was satisfied. Now, who reviewed it
for him I have no idea because it was full of shortcomings, but in any
case he said he was satisfied. He would support the Rogers bill, and so
the regulations required by the Rogers bill actually preceded the
enactment of the bill. So although the requirement came in July, the
regulations were published on May 30th of that year, and in the
succeeding weeks, then, the Rogers bill was enacted.

Now, that was also an exciting time because now Rogers had his
commission, advisory commission to the Secretary, HEW, and all of a
sudden he said, \"What is this commission going to do?\" And nobody had
filled out the responsibilities of the commission.

So I got a call one day from Rogers\' staff person, and he said, \"Can
you draft us some responsibilities for this commission and get them down
here by close of business today?\" This was around 2 o\'clock in the
afternoon. Well, we had been thinking about this stuff for a year or
two, but we had nothing on paper. And I just sat down and scribbled out
in longhand the responsibilities for the commission, sent them down,
which was, technically, dubious whether the executive branch should be
drafting legislation for the Congress or not, or whether that was
lobbying, and we could get different opinions from different people in
the department as to whether it was legal or whether it was lobbying or
whether it was simply providing technical assistance. But we liked to
call it \"technical assistance.\"

Anyway, we sent it down, and those words found their way into the bill.
So I actually drafted the responsibilities that the Commission was to
meet. And that\--and we put them all together to look into informed
consent, research involving pregnant women and human fetuses they were
to look in\-- and that was in response to Ron Cowell.

They were to look into such matters as psychosurgery, because in those
days it was fashionable to operate on the frontal lobes, and you may
remember the movie \"One Flew Over the Cuckoo\'s Nest\" was based on
that. And so the public was in an uproad about how mental patients were
being treated.

And some had to do with cognitively-impaired individuals and how they
would be treated an so on. We drafted all those, and when I read it over
I said nothing holds it together. This commission will issue a report on
informed consent on cognitively impaired, on fetuses, on pregnant women,
on children, and is there any common theme? And I began to think back to
my own training, and I had had considerable training in moral philosophy
and theology, and so I said, \"It looks to me as if a common set of
principles ought to underlie all these different moral issues that are
facing the research community and facing the country.

And so kind of as a last minute\--I remember about a quarter to 5:00,
and we had this old fax machine. It took six minutes to fax a page, and
so we\'re looking at the clock, and we have to get them down to Rogers\'
office, and we had about one minute left when we finished writing the
language for \"and there will be a study looking at the principles
underlying the research ethics.\" And I\'ve forgotten\--I don\'t have
them in front of me\--the exact wording of that in the bill now, but
that\'s what we put in it, and it went\--it sailed right through. The
bill was brought to the floor of the House the next couple of days, to
the floor of the Senate. It passed, and that was the beginning of the
Belmont Report.

So it came out of my head about five minutes at the end of a long, busy
day working under high pressure, and I\'m absolutely amazed that it
survived and nobody changed a word of it. So that\'s where the
responsibilities of the commission came from, and the bill was enacted
by Congress. I forget the day they passed it, but then it was signed on
July 12th.

*INTERVIEWER: Today some people think that the Commission\'s work is
mostly the Belmont Report itself. Is that how you saw it?*

DR. McCARTHY: I suppose I would say the most important thing the
Commission did was the Belmont, but I think perhaps it did a couple of
things that go along with that that are equally important. One is simply
by gathering all of the information about the ethics of research that it
could find in seven different languages and gathering all that
background literature, it really in many ways gave birth to, or at least
gave it an enormous boost to the whole field of bioethics.

Prior to that time, bioethics was limited to a handful of scholars, and
they were almost all morale theologicians, so there was virtually no
secular writing about the ethics of medicine, or health care, or medical
research. And the Commission almost single-handedly changed all that.

The brought every scholar in the country and many from overseas to
testify, and they also did a literature search into each of the topics
under consideration, and then they asked scholars to evaluate all that.
So it was a great shot in the arm to the whole field of bioethics, and
people still say today that the Commission saved the teaching of
philosophy because, usually, this is a branch of philosophy taught in
our universities. It saved the teaching of philosophy in America.

I don\'t know if that\'s true or not. I don\'t know how to evaluate that
statement, but, certainly, it gave an enormous impetus to the whole
world of ideas and principles and understandings, not just for research
but for philosophy in general and a whole principled approach to guiding
human life. And I think that part is probably not well appreciated, and
a lot of that was picked up by the Kennedy Institute. I mentioned them
earlier. They then got government grants to create the best library in
the world of ethical literature.

It\'s funded by the National Library of Medicine, but it actually is
housed at Georgetown University, and I think they now have articles in
ethics in about 28 languages, and they have a wonderful set of
librarians. All of that came out of the Commission. Whether they set out
to do that or whether that was an unexpected by-product I can\'t tell
you, but it did happen and I just think it\'s an invaluable contribution
to American culture and maybe to world culture. It\'s another kind of
favorite theme of mine that the big contribution that America has made
to world culture is in two areas: 1) jazz, and 2) in ethics and moral
theology, and not in government, not in all those other things, but in
these two areas I think we have led the world. And those are the things
I\'m most proud of to be an American.

*INTERVIEWER: Did you expect the Belmont Report to have the longevity
that it has in day-to-day lives of institutional review boards?*

DR. McCARTHY: I don\'t know that the question occurred to me one way or
the other. I saw so many drafts of it before it came out. I saw the
final draft. I never thought about: Is this going to still be guiding
people 40 years after it was written? I guess I just\--the question
didn\'t occur to me.

Later on when we \-- because I moved out of legislation into the Office
for Protection from Research Right Risks, which was the NIH predecessor
office to the Office of Human Research Protections. When I made that
move, one of the very first things we did was to take that clause in the
law that requires institutions carrying out research to assure the
government they will comply with the regulations. Those what we call
\"assurances,\" are really assurances of compliance with regulations,
and we put in there that the institution must have a set of principles.

And, of course, what we recommended was the Belmont principles. They are
free to choose Helsinki or some other set of principles, but I think
there are only two or three institutions in the country that don\'t
follow Belmont as the institutional guide. And that means for the first
time we had no common set of ethics for medicine in this country prior
to Belmont, and that move actually made every institution in the country
first think about what are our principles; and, secondly, can we live
with Belmont? And the answer to both questions was yes, we can live with
Belmont and we will adopt them as our principles.

So I think OPRR actually took Belmont Report off the shelf and put it
into practice, and that\'s been continued, of course, by OHOP (ph), but
I don\'t think OHOP really innovated anything; they just picked up what
was already in vogue.

*INTERVIEWER: We left off right as the legislation for the Commission
has become signed. And what was the next step?*

DR. McCARTHY: Well, the next six months were really organizational. One
of the\--I was still at that time working in legislation, and it was
customary at the time if you tracked a piece of legislation you were
responsible for getting it started. So we had to find curriculum vitae
of several hundred people who could possibly serve on the Commission and
send them down to the Secretary\'s office.

We had to find\--and, by the way, the bill provided no money. It\'s
typical of the Congress to write bills saying: Thou shalt do something,
but you don\'t have any money to do it. So we had\--we found space in
the old Westwood Building that was not being used. We borrowed furniture
from the used furniture that was turned in by government offices when it
was no longer usable, but we found we could get a little more mileage
out of it, and we began, then, to dun the institutes to provide us with
staff whose salaries were paid by the institutes.

So they were not very happy to give up paid employees to the service of
the\--but we were able to bring some pressure to the Secretary on the
institutes to give up employees to serve the Commission.

So all of that kind of scurrying around with the details, I\'d never
done anything like that, organize a body and try to find them offices
and typewriters, and staff and all of that kind of stuff. And I didn\'t
know much what I was doing, but we got a lot of help from the
Secretary\'s office, and we got a lot of help from the Director of NIH.
And if I could go into an institute and say, \"I\'m from the Director\'s
office, and the Director would like,\" we found we could get
cooperation.

And so it ran, really without budget, for the first year until we were
able to put a line item in the budget to support the Commission. NIH
institutes really coughed up the money out of their discretionary funds.

So that\'s what we did the first six months. What I only found out
recently was that Charley Lowe, who had drafted the \'74 regs., and
Duane Alexander and Barbara Mishkin had all been involved with the
Secretary\'s office in making the final selection from all of the CVs
that we sent down to them. And I hope you will interview them and find
out what criteria they used and why they made the selections they did,
because the Commission, with the exception of a couple of people, were
not nationally-known figures at the time. And people thought, oh,
ho-hum, they\'re just a bunch of also-ran writers and teachers from
around the country, and it was not thought to be a blue ribbon
commission at the time. Now, when people look back, of course, they
think it was the best commission ever put together. But that\'s
hindsight. Prospectively, it was not. It was thought to be a weak
commission.

*INTERVIEWER: Once the commission was formed, what was your interaction
with them?*

DR. McCARTHY: The Secretary asked for someone to serve as a liaison to
the Commission, and, I suppose because I had had a lot to do with the
legislation before it tasked, I was liaisoned to the Commission. And I
got very little instruction as to what that meant. Somehow you\'re
liaison to the Commission, but what do you do? I took it as my job to
alert all of the research components within the Department, and that
meant predominantly, but not exclusively, NIH. At that time mental
health was separate agency, so I got to know them very well, by the way,
because there were so many hearings about cognitive impairment and
mental health issues and the like, and so that was an education for me
to get to know those folks.

In any case, I kept them all informed of what the Commission was
deliberating about, what the rules were likely to be, and inviting them
if they had an disagreement or if they had points they wanted to make to
contact the Commission and testify. And many of them did, and so we got
lots of testimony from within the Department as well as from research
institutions all over the country and some\--a lot from England, a
little bit from the Continent, I think almost nothing from Asia, that I
recall anyway.

But I attended all of the meetings in Washington. As you might guess,
since you work in the bureaucracy, when the Commission traveled, I
couldn\'t get travel money, so I missed the meetings that were held
outside of Washington. Travel money didn\'t extend to following the
Commission; it was enough that I could read the transcript of what they
did then they were away; but I was present there and, occasionally, they
would ask me questions.

And, occasionally, they would have social events and invited me. And Al
Johnson, particularly, because he had been a Jesuit priest and I had
been a Paulist priest, and we had studied the same kind of curricula
together for a number of years. He and I got to be very close friends.
We would often have dinner together and argue out issues, and so I
suppose, indirectly, I had a small influence on the deliberations of the
Commission.

Ken Ryan, the chairperson, was a very pleasant person, and always very
courteous, but he was reluctant ever to tell you what he was thinking
until the meeting, so nobody knew what Kenny was going to say until he
said it in meetings.

Mr. Turtle was a lawyer on the Commission, a young lawyer, and he was
very suspicious of government, and so no matter what was suggested, he
would try to make sure that the suggestion would\--by the way, that the
government would have to implement the recommendations of the
Commission, and the reason it succeeded, I think, was because of the
forcing clause. There\'s a clause that I think came from Paul Rogers
himself\--I\'m not certain of that\--but the clause said the Secretary
must either accept the recommendations of the Commission or public in
[The Federal Register]{.underline} the reasons for not accepting them.

Well, no Secretary ever wants to go on record as saying, \"I disagree
with an ethics commission.\" So in the past they had buried
recommendations of ethics commissions, but this time they couldn\'t; by
this, this time they could not bury those recommendations. And I think
that\'s what made that commission different from virtually every other
advisory commission I know of. As far as I know, that clause has never
appeared again, and no government agency ever wants it because they want
to be free to reject and bury recommendations without having to give
their reasons.

And if you look at the current news today about the 9/11 Commission and
whether their recommendations are going to be buried or not, the
commissioners have said, \"We don\'t want our recommendations buried
like everybody else\'s are, so we\'re going to go out and stump for
them.\" And that will be headline news in tomorrow morning\'s paper.

But it was different with the National Commission. The Secretary could
not.

One of the funny things that happened when the bill that created the
commission was being developed was a time I was meeting with Senator
Javitts\' staff person, and we were meeting in an empty hearing room
down in the Rayburn Building in the House of Representatives. He wanted
to be as far away from the Senate as possible, and this was a secret
meeting because the Secretary of Health, by then seeing this bill coming
along, had told NIH to butt out and stay away from that, he was going to
take it over. And, of course, NIH said yes, yes, but they paid no
attention.

So we were kind of sneaking around doing this, but making sure or trying
to make sure the Secretary of Health would not know about it. So I\'m
meeting with Javitts\' assistant, and that was the day that Richard
Nixon announced that Agnew was being replaced by a new vice president.
And all of a sudden a press conference took place in that conference
room where we were meeting. And about 40 photographers first came in,
and they were snapping pictures right and left and center, and if you go
back to those pictures where Gerald Ford was announced as the new vice
president, you look in the back you will see two guys with their heads
in their hands hiding from the photographer. And so here we were trying
to be secret, and we made the front page of [The Washington
Post]{.underline}.

So anyway, that was just a funny incident, and I just died until I saw
the pictures the next day to see whether they got our faces or not, and
we got away with it. Nobody ever noticed who those two vague individuals
were in the back. And we couldn\'t get out of the room without going
right by the vice president\--he wasn\'t yet vice president, but the
nominee for vice president. But anyway, that was just a funny incident
that occurred, and we laughed about it many times about a private
meeting where only about 40 press people and the vice president were
present.

*INTERVIEWER: Once the Commission was formed, what was your\--you were
the liaison back to NIH, but how did that fit into your work life?*

DR. McCARTHY: Well, we could see the shape of what was to come. First
the Commission, since the Rogers bill had put a moratorium on fetal
research, the very first report the Commission addressed was fetal
research. And they first investigated, they got testimony from all over
the country and the world whether abuses of pregnant women were
occurring in the name of the research. And they got all kinds of
testimony, and finally concluded that, no, there was no serious abuse of
either pregnant women or human fetuses. And the bill read in such a way
that fetal research may not go forward until such time as the Commission
reports.

So that was the first report they issued and, once they issued it, then
I sat together with Charley Lowe and by this time Don Chalkley and
Barbara Mishkin, who had joined the staff of the Commission, and we
drafted the regulations for the protection of pregnant women and human
fetuses and got those promulgated in August of 1975, I think. So there
was a little over a year of moratorium on fetal research caused by Ron
Cowell and put in the bill, and we had to meet the conditions to get
that moratorium lifted.

So that is one of the things we did, and we had to pay close attention.
Fortunately, Barbara Mishkin and Charley Lowe, in their previous
existence, had already outlined a set of regulations for research
involving the human fetus, so we didn\'t quite have to start from
scratch. And we monitored everything that was said in the Commission and
read everything we could get our hands on. So it didn\'t take us very
long to draft those regulations.

But what is interesting to me now, looking back on them, is just the
cultural change that took place over a period of years because in there
we said that decisions about whether a fetus may be subjected to
research which ought to be made by the mother, the pregnant woman, and
the father if available.

And we got no criticism of any of that. Later on, the women\'s movement,
women\'s lib took over, and 10 or 15 years later we were getting all
kinds of complaints about that clause from NOW and other women\'s groups
that this is a woman\'s decision, and the father of the fetus, whether
it be her husband or anyone else, has no voice in making that decision.

So we saw a big cultural shift in that 10-year period that I found very
interesting, that all of a sudden we were pilloried 10 years later for
something about which women were silent at the time. So it showed me a
kind of evolution of authority and self-consciousness and
self-responsibility in women that probably was not present in the
culture\--maybe in rare cases\--but as a general rule at the time we
published the fetal regs. And that\'s since been modified, by the way.

But I thought that was kind of an interesting insight.

What else we were doing, we were\--I was still\--the Commission went
from \'74 to \'78. I was tracking them, I was still working in
legislation, and there were lots of other interesting issues, many of
them unrelated either to, directly, to research or to the Commission
that I worked on. There was no question of who should have access to the
information in the grant was hotly contested, and that had almost
nothing to do with the Commission.

But I drafted the brief for the government position that until such time
as a grant is funded, the intellectual property in the grant belongs to
the applicant, not to the government and, therefore, cannot be released
under the Freedom of Information Act. So I was doing stuff like that.

The staff of the legislative office was in many ways the staff of the
Director, so I chaired a lot of commission of different\--a lot of
meetings of committees of different institute directors and the like. I
was the Executive Director of the Directors Advisory Committee, and so I
had a lot of other duties besides tracking the Commission. And so it was
a busy time for me.

And then in \'78 a number of things happened. The Commission wound up
its work, and so it had extra meetings and was trying to get everything
published. Don Chalkley, the head of OPRR, had a stroke and suddenly was
forced to resign for medical reasons and Secretary Califano was
appointed.

And it was not well known, but in a previous existence I had been
Califano\'s confessor when he was one of MacIntyre\'s whiz kids in the
Department of Defense. And he was known as the \"enfant terrible\" of
the government. And so he decided to create a Secretary\'s Advisory
Committee, Ethics Advisory Committee, and so he selected me to be the
Executive Secretary of the Ethics Advisory Committee.

And the very day that he appointed me to that role was the day that I
was selected to be the Director of OPRR, so I got two full-time jobs the
same day. And both of them were\--I was informed of both of them by Tom
Malone, who was then the Deputy Director of NIH.

And I said, \"Tom, you know, this is great, but I can\'t do two jobs,
and Califano isn\'t going to last long, I don\'t want that job.\"

And he said, \"You can\'t say no to the Secretary.\"

And I said, \"What do I do,\" \'cause I really would like to succeed
Chalkley. I\'m really very interested in carrying out over the years
this thing, the mandates of the Commission, and I still feel that I had
promised the Secretary years before that we would make it happen.\"

So Tom said, \"Get yourself a good deputy and take the job as Executive
Director of the Secretary\'s Advisory Committee for a year or so, and
then resign that job and go back to OPRR full time.\"

And that\'s what I did. So, actually, it was 13 months with the
Secretary\'s Ethics Advisory Board. And we worked hand in hand then with
OPRR, and so Charles McKay was the Deputy Director of OPRR, and he ran
it for that year. And I used to get up there one day a week. But that
was as kind of an interesting dilemma.

I was in a meeting up at FDA\--I forget what that was about\--and,
suddenly, I was summoned by the Secretary\'s office, and by Malone\'s
office, and all of the phones started to ring off the hook, and I
didn\'t know what it was all about. And that\'s what it was about, so\--

And then in those days we always had an excuse. We didn\'t have any
metro at the time, and so when you get a call from the Secretary\'s
office to be down there in 30 minutes, and there was no metro, and rush
hour in Washington, I was simply able to buy some time by saying, \"I
can\'t make it, I\'m caught in a traffic jam. There\'s no way unless he
sends a helicopter, for me to get downtown.\" So I was able to buy
overnight, and I was able to work it out with Tom Malone how I was going
to take two jobs at one time.

*INTERVIEWER: And during that, after the end of the Commission, was OPRR
issuing regulations?*

DR. McCARTHY: Well, yes and no. We created the Public Health Service
Task Force to take each of the reports of the Commission and draft it
into regulations. So we worked about a year. There were some 125
different recommendations of the Commission that we had to work into a
redraft of the old \'74 regs. that we had drafted prior to the enactment
of the bill. And so we had representatives of FDA, and the FDA rules
were so different from the HHS rules, HEW rules\--HHS, I think, came in
\'83\--but anyway, they were so different that we had to persuade FDA to
change its rules dramatically.

And they were not mandated to do so by the bill, and so I spent half my
time at FDA trying to talk them into going along, and finally was able
to persuade them to put a competent, highly respected person on our
drafting committee. And that was John Petruchony, (ph) who later became
the director of FARMA (ph) and other things. Now he runs Cancer Research
Institute out in California.

But John was part of that committee, and he happened\--he helped us to
bring congruency between the HEW rules and the FDA rules that we\'d
never had before. And he did it over people at FDA, who were kicking and
screaming but finally\--finally agreed to do it. And we found every
different way we could think of to put pressure on FDA to do that.
Otherwise we would, all research committees, would have had two
disparate rules to follow in approving research. And we knew that
was\--would undermine the whole system.

So Petruchony is just one of my heroes. He stood up, and after it was
enacted, he was under such fire he asked for a leave of absence, and he
came over and worked in OPRR for about a year until the heat was off,
and then he went back and worked in the what was then the Division of
Biologics.

So that was some of what we were doing, but we drafted for two years. We
finally had a draft ready in December of 1980.

That was after the election but when Carter went out and Reagan came in,
but before Reagan had actually taken office. And Reagan had campaigned
with extravagant statements saying the government over-regulates
everything in the society. \"I\'m going to repeal all government
regulation.\" Well, that was\--you know, nobody really thought he could
do that, but everybody knew that this was not a time to try to propose a
new regulation when Reagan was coming into office.

So we gave a lot of thought. We had the regs. all drafted, and Patricia
Harris was going out of office. She had replaced Califano after Carter
fired him\--not for anything to do with human subjects or even the
Ethics Advisory Committee, but because he had campaigned against smoking
in both North Carolina and South Carolina in an election year. And he
lost both states for Carter, and Carter was furious. So that was the
sort of by-play that was going on at the time.

But we were trying to decide when is the appropriate time to get the
Secretary to sign off on the new regulations? They had already been
proposed, we had got comments from the public. We\'d incorporated the
comments. We wrote the preamble, it was ready to go. And then when is
the best time, \'cause Harris could care less whether they every got
published. So we talked to the transition team, and they said Reagan
will never allow new regulations to see the light of day, so if you\'re
going to get those out at all, you\'d better get them out before he
takes over.

So we\'re struggling with this problem, and the way we worked it out was
that\'s when we wrote, overnight one night\--brilliant inspiration\--we
wrote\--everybody stayed in the office, and we worked all night long,
and we wrote the exemptions to the regulations, and we also wrote
expedited review neither of which had ever been addressed by the
Commission. And that\'s where they came from.

Then we went to the transition team, and we said would the transition
team endorse regulations that are less stringent than the previous
regulations? And, of course, they weren\'t, but they looked like they
were because we wrote some exceptions. And so when we sent the package
down to Harris, we said \"Diminished Regulations for the Protection of
Human Subjects.\" And that was the title. And, of course, we knew nobody
down there in the last weeks of the Harris administration getting ready
to leave office would actually read it. So they didn\'t know what all
that was about, but they could read the title.

And so Secretary Harris signed that at her farewell party. She put down
her glass of champagne and signed the regulations on January 19, 1980,
and went out of office on the 20th. So we squeaked by. Those were some
of the adventures we had that were kind of harrowing for regulators, and
that\'s why some of the language in those exemptions is so convoluted
because it was really a first draft. But it survived and it\'s still in
there. And it makes some sense, but if we could rewrite the regulations,
we would run that through three or four more drafts and make them
crystal clear. They\'re less than elegant writing, whereas if you read
the rest of the regulation, I think you\'ll find sub-part A is very
well-written if you leave out the part about the exemptions.

So that\'s some of what we were doing. Does that make some sense to you?

*INTERVIEWER: Absolutely. Was there a reason the Commission did not
address exemptions or\--I\'m sorry\--expedited?*

DR. McCARTHY: I don\'t know. They were not looking to reduce or to
minimize regulatory burdens on the research community because their
hearings had led them to concentrate first on major invasive research.
And I don\'t think the Commission ever fully appreciated how much
research is carried out at minimal risk level. All the kinds of
psychological and survey research done by sociologist and by psychology
101 students and all that, there are hundreds of projects every year
that are pretty innocuous. They ask you questions like, \"Is your
favorite color blue, or gray, or red, or yellow,\" and they try to draw
some kind of psychological conclusions from that stuff. But it\'s really
minimal risk kind of stuff.

And the Commission wasn\'t\--I think all of these were focused on fairly
high-powered medical research and unaware that the regulations extended
to social science research. Their mandate, if you read the bill,
extended to social science research, but you cannot find a report on any
of that. A couple of mentions made indirectly in the Belmont Report, but
just in passing. So I think that was\--the Commission did a wonderful
thing, and it was a great commission. But I think it missed a major part
of its mandate in dealing with social science research. And I think
that\'s still a problem. It was a problem for OHARP (ph) and for OPRR.
It is a problem for OHARP. And until we find a better way to deal with
that, I think it\'s going to continue to be a problem

And for that I don\'t know whether to fault the Commission or simply say
they had worked very hard for four years, and they were exhausted, and
they were just not going to take on one more big issue. And so they
didn\'t, and they didn\'t fulfill their mandate in that regard.

And that\'s why one of the first things we did when I took over at OPRR
was publish a handbook on behavioral and social science research in the
IRB. And we got Joanie Seebert (ph) from\--I\'ve forgotten what school
she was with at the time, somewhere on the West Coast\--who was the
editor of that book, and we gave it wide publication to try to help
people in those fields.

And we had to decide when is legal research invasive of human subjects\'
rights; when is historical research invasive of rights? And so we had
lots of interpretation to do because the Commission never addressed
those kind of questions. All of that came from within our own office,
not from outside.

*INTERVIEWER: One of the issues or topics that I\'ve heard you speak
about before is the part of the Commission\'s work as well as the
subsequent regulations that dealt with prisoners. Could you tell a
little bit about it?*

DR. McCARTHY: Well, the report of prisoners was developed by the
Commission, at least in my judgment\--and others may disagree with
this\--but in my judgment it was the weakest of all the reports that the
Commission put out. They visited Jackson Prison in Michigan before
writing the report, and at Jackson Prison they found serious abuses.
First of all, they found that the prisoners were malnourished, that they
didn\'t get adequate medical attention, that they didn\'t get reasonable
amounts of exercise, that their sanitation was poor, that they were
overcrowded in the prison environment.

Just about every kind of malpractice for running a prison that exists
was there, and in that context the pharmaceutical houses came in and
offered to involve the prisoners in research.

And what that meant was in most cases one or two days a week they would
meet with somebody from outside, so the boredom was relieved a little
bit. It also meant that the incoming researchers would complain to the
prison authorities that the johns were filthy and the food was lacking
in nutrition. And so they found that research was a big boon to the
living conditions in Jackson Prison.

And when the commissioners went up and talked to the prisoners, that\'s
what they told them. They said, \"Do no take away research, because it
is the only place that keeps us\--the only thing that keeps us sane in
this place.\" And the commissioners came back and realized that the
Commission\--the prison environment was coercive. Those prisoners had
virtually no choice. If they wanted any kind of decent living
conditions, they had to agree to research, and much of it was very
invasive and dangerous, and the prisoners vied with one another to get
into those research studies.

One of them I recall was the study\--and it sounds innocuous
enough\--but it was a study on shampoos.

And so the way they studied it was simply to put together all different
kinds of hair shampoos, and then they would drop it in the prisoners\'
eyes to see which ones\--which of the soaps were so toxic that they
would blind the prisoners. And a number of prisoners were blinded in
those studies. That\'s one reason why to this day I won\'t use Johnson &
Johnson baby shampoo because the way it was developed caused terrible
blindness to a number of prisoners. And it just infuriates me when I see
it on the shelf. I want to throw it in the trash because it was not
necessary to do that.

But in any case, the Commission then came back and decided its mission
was really to reforms prisons rather than set standards for prison
research. And so they put\--if you read that report, they put: No
research may be done in prisons unless HHS has determined that the food
is good, the sanitation is good, the exercise is good, and all those
things that are outside of the jurisdiction of NIH or HHS, and,
consequently, nobody could meet any of those conditions, and it said
very little about the coercive atmosphere of the prison if it was well
run, if it was humanely operated.

And so it placed on the investigator a reforming role, if you want to do
research in there, you\'ve got to go reform the prison. And I think they
missed the whole point about that HHS, that the Justice Department has
the responsibility for federal prisons; the states have responsibility
for penitentiaries, and HHS has no legal or experiential responsibility
for any of that. And as a consequence they were trying to load onto
research the whole\--a whole prison reform movement, and the regulations
couldn\'t possibly carry that burden.

So we drafted the regulations leaving out as much of that as we could
while, nevertheless, we did invite Justice to come in and help us draft
so that they would understand these guys are telling you you\'re running
a terrible prison system, and you ought to change it. But we can\'t
change that by writing research regulations. And so we had\--that was
the second set of regulations written after the pregnant women and the
human fetuses.

A guy who was staff in ORPP, Norm Gulay (ph) drafted them, and I don\'t
want to say anything negative except he had little idea what he was
doing. Every office has somebody that should be put out to pasture, and
in that case it should have been Norm. And why he was assigned, it was
prior to Chalkley\'s demise, I think, because the Commission was still
going. I think it was \'77 when we drafted them\--and weren\'t they
published in \'78?\--so it was \'77 when we drafted them, and why
Chalkley assigned Delay to write them, I don\'t know.

But it was a terrible job. The Commission put pressure on us to get them
out there, and what I\'d like to do is retract them and rewrite them,
and I would like to see a kind of mini-commission look at prisons today.
The whole field has changed. HIV has changed the medical aspect of what
it\'s like to be a prisoner, dramatically, so that we\'re not even
dealing with the same kind of issues that we dealt with then. And I\'m
not quite sure what the prison regs. should be, but I know that they\'re
nearly impossible to implement, logically and consistently, in their
present form.

*INTERVIEWER: Okay, I just have a few more questions about your
experience with the commissioners. One of those is what topic do you
remember as having generated the most discussion among the commissioners
themselves?*

DR. McCARTHY: Oh, I think probably the classic debate over research
involving children was\--was just first of all they had the best
scholars in the country, and those scholars devoted major quantities of
time to addressing this, and the whole issue of whether a class of
citizens who are legally not competent to consent could be involved in
research was hotly debated. And the background, of course, is that
French, the French thing, any research involving a child is immoral, and
they make no bones about criticizing us. The Germans, after World War
II, were so sensitive about all the abuses of children they had
conducted that they banned children\'s research.

Here is NIH with its Institute of Child Health and Human Development,
and it was under attack. And there were several research projects that
I\'d have to go look them up to be sure now that were criticized that
were carried out in children. So the whole notion of allowing research
with children was under fire.

On the other side, Bob Cooke was one of the Commissioners, and he had
been the director of the Kennedy Foundation and part of the very reason
for establishing the commission was to see what kind of research could
be allowed that would improve the lot of children, and especially
handicapped children who were housed but not helped by any research
going on. And so Cook was arguing strenuously for research with
children, but he was arguing for it within the context of more animal
research. And that generated all kinds of ethical\--stimulated a lot of
criticism from the animal activists, so the Commission was getting some
fire from that side as well.

And Mr. Louisell, who is a lawyer who had practiced before the Supreme
Court, took the side that children cannot consent, and parents are
biased and therefore should not be able to consent on the children\'s
behalf, and therefore, you can\'t do much if any research with children.
He wanted to limit it only to that research where there was no standard
treatment available to a child, and it appeared to be in the best
interest of the child to participate. But no other research could go on
unless\--there was no standard treatment for anything that the children
might need.

And so it was\--it was hotly debated, and Dick McCormick, who was the
head of the American Catholic Theological Association at the time and a
Cardinal Spellman scholar, wrote an article in which he argued that it
is a parental duty to introduce the children to some form of civic
contribution. And one way to do that is for parents to volunteer their
children for low-risk research even when there was no direct benefit for
the individual child, but by learning to participate in society as a
whole, children themselves would be benefitted. And he argued that it
was part of a child\'s education and an obligation of parents to
volunteer the children to do some kind of social action and a
major\--and research would fulfill that obligation.

It is interesting that the Commission then came out with its
recommendations. They followed everything McCormick recommended, but
they left out of their report any theoretical justification, so it kind
of stands there, and if you were there you\'d say McCormick won that
argument against very strong opposition. But you can\'t find it anywhere
in the report.

And I can\'t tell you why the drafters did that.

I can guess that because it was coming out of Catholic moral theology,
they decided they didn\'t want to take on another critic. They didn\'t
want to get into trouble with the Protestant community in this country;
they didn\'t want to get in trouble with the secular people who said,
\"You\'re following religious arguments,\" so they just left it out
altogether, and there it stands, a beautifully modulated set of
recommendations with no justification.

And I don\'t know all that went on in that debate. I know you\'re going
to interview Bob Levine, or at least I think you are, and he did a lot
of this drafting of the Children\'s Report for the Commission. And he,
perhaps, can supply some of the rationale of that that\'s missing in the
report. But I think it was their finest hour in terms of the result, and
maybe the weakest in terms of justification of the whole Commission.

But that\'s my opinion, and I\'m not sure it\'s right. And I never
talked to Ken Ryan about that.

And Ken, of course, because he himself was a pediatrician, had a lot to
do with that. And as you recall, Louisell and I think maybe Turtle, also
\--I can\'t remember now\--but Louisell dissented and wrote his own
report, but it never went anywhere.

*INTERVIEWER: Were there other areas that the Commission did not touch
on that you felt might have or should have?*

DR. McCARTHY: Well, I mentioned the social science and behavioral
science side, and that really was a disappointment to me that the
Commission didn\'t do it, didn\'t address those questions. I think they
did poorly with the prisoners; I think they did well with the fetuses,
particularly under that was their first report, and it was rushed, and I
still think they did well. I think they failed to understand with
respect to\--what\'s the word that we used in the legislation that was
popular at the time?\--now it would be regarded as prejudicial\--for the
cognitively impaired. I think \"mentally infirm\" is what the
legislation said.

That report failed completely to understand the deep division that
existed at the time when we were coming out of the Freudian emphasis on
deep psychotherapy and moving towards treating mental illness by drugs.
And the field was deeply divided, I mean to the point where there were
threatened fisticuffs in meetings, psychologist and psychiatrists as to
which is the best way to treat the patients. And the Commission
seemed\--made almost no mention of that, and, as a consequence, they
really didn\'t ever distinguish kinds of research that might be carried
out with the mentally infirm, nor the climate in which the regulations
would, would come out if they were published.

So we published the proposed rules that reflected the Commission\'s
report, and they were eaten alive.

The two sides both rejected them because the regulations came out in the
middle, and neither side wanted them. And so the whole\--Adam taught the
whole Alcohol/Drug Abuse and Mental Health Administration refused to
sign off, and the Secretary said he wouldn\'t publish until they signed
off. And so that was a standoff.

On the side, civil rights lawyers said: You haven\'t sufficiently
protected the rights of incompetent\--and they linked everybody who had
a mental illness as being incompetent\--incapable of consent. You\'re
going to give them drugs, and they can\'t even consent for what, and
you\'re going to abuse them. And so we had a brouhaha, and as a result,
we were never able to get any Secretary to sign off on those regulations
\'cause it was fatal. You would always have two or three groups against
you and only one for you if you signed off, no matter what the regs.
were. And I think the Commission\'s failed to acknowledge some truth in
each of those camps and find a middle ground.

And so, as a result, we published proposed rules, and they were so
controverted that they have never\--the proposed rules have never been
withdrawn because no Secretary even wanted to withdraw them and attract
attention to them again by withdrawing and saying: We\'re not going to
implement them. So, in fact, they\'re there as sort of guidance rules,
but they\'re not implemented.

I don\'t know if we could do better today. We couldn\'t do any worse.
And so I thought that that was another place where the Commission was
weak.

*INTERVIEWER: You were telling about just some of the broader aspects of
finding humor during areas of hard work.*

DR. McCARTHY: We had lots of good people in OPRR, but not all of them
were good. Through the whole Reagan administration for eight years there
was a freeze on federal hiring, and, consequently, when somebody left or
retired or simply when\--when you need to expand because research was
expanding dramatically, we couldn\'t expand our staff. So I went around
NIH, and I went to each institute director and I said, \"I know you have
somebody on your staff that is causing you so much trouble you would be
willing to get rid of that person and give up the position.\" And so
OPRR became known \"refugium petratorum\" (ph), the refuge of sinners.
But if they were kicked out of every place else, and they were so bad
that people would give up the position, then we would hire them.

And so we had some pretty unreliable employees there for a while, and
trying to rehabilitate them and give them some responsibility of
morality and morale was a real management challenge. And we accomplished
a lot of that by simply fun. And, unlike OHARP today, OPRR had
responsibility for laboratory animals, so nearly half our staff were
laboratory animal people, and they were looking at all the
demonstrations against research with animals and so on.

But what I found is that veterinarians, particularly, are among the
earthiest people in the world. I suppose it\'s because they mostly grew
up shoveling manure out of barns. But in any case, we had lots of humor
going on, and Nelson Garneth (ph) and John Miller kept the office
laughing all the time, and so there was\--and Kay Duncan was herself a
comic. She would come into the office some days dressed as a witch with
the big, high black hat on. Some days she would black out every other
tooth in her head so that she looked like she had somehow been in an
accident. Sometimes she dressed up like a frontierswoman, and she\'d
come in with her little wooden gun. Today she probably couldn\'t get it
through security, but she came in with a little wooden gun, and she
would threaten people if they didn\'t line up. And she dressed for the
season; she dressed as a sort of female Santa Claus at Christmas time
and so on.

INTERVIEWER: Well, you know that all people in OHRP are going to laugh
when\--

DR. McCARTHY: Well, it\'s okay. Duncan was really a favorite. Kay also
had congestive heart failure for the last 20-some years of her life, I
think, and she handled most of the assurance documents, what we called
in those days \"general assurance documents.\" That\'s all been changed
in recent years, but every time she picked up the phone she first did
that kind of cardiac cough and clearing her throat. So there is not an
administrator in the country who didn\'t call in to OPRR, and the first
thing you\'d hear was this loud, crashing cough in their ears and
clearing of her throat, and expiration of the phlegm in her mouth, and
then she would start to talk. And she was just infamous all over America
for doing that to everybody she talked to\--and she talked to leading
people in every institutions in the country.

And so they started out by just being horrified and ended up falling in
love with her because she was such a great lady. She was truly a great
lady. And one of the funny things that happened, she came in my office,
slammed down her purse and said, \"I\'m quitting. I\'m not coming
back.\"

And I said, \"What happened?\" We had a summer employee\--that was
another way we supplemented the failure to be able to hire\--we had a
summer employee who found out she was an M.D. So he asked her to go in
the men\'s room with him and examine him for sexually-transmitted
disease, and she was insulted and furious, and came in and quit on the
spot.

And I didn\'t help matters very much because I laughed. But when she
calmed down even she could laugh about that stuff.

But we had Helen Gordon in the office. Helen never believed that\--that
computers were here to stay, and as a consequence she kept a copy of
every piece of paper that ever went in and out of OPRR until we had to
go in there at night and clean out her office by the truckload of stuff
because she would never\--no piece of paper was without its value as far
as Helen was concerned.

So we had some characters.

*INTERVIEWER: That\'s wonderful. Some people feel that the focus of
human subjects has shifted away from protecting from risk and towards
permitting access to innovations that may be helpful.*

DR. McCARTHY: Well, I think that happened, but I think the pendulum is
swinging back again. Initially, what the Commission felt needed
stressed, and partly because of Tuskegee and some of the other various
serious abuses that I mentioned, the commissions wanted to make sure
that the informed consent stressed the risks of participating in
research. And I think that was stressed to the point where the African
American community in this country is still very reluctant to be engaged
in research because they know the Tuskegee study and not much more, and
they don\'t realize that in many cases research holds out marvelous
benefits for them that they could not get anywhere else. So I think as
far as the African American community is concerned, they\'ve only heard
half of the story.

But in 1983, the AIDS virus was isolated, and for the next three or four
years there was virtually no treatment for AIDS, and, consequently,
those who had HIV infection or AIDS and no place to turn but to
research. And we had demonstrations demanding that we create more
research projects because it was the only way they could get their
disease treated or at least examined. And they could get the
accompanying care even if they got very little benefit from the therapy
in some of those early research projects. They could get the benefit of
care, and it was paid for by the government.

So the pendulum swung away from protecting against risk to offering us
the latest and best in care and service. And then I think the 13 or more
institutions around the country were shut down for research abuses,
mostly in the time of Gary Ellis when he was director.

And all of a sudden the risks of research began to be re-emphasized, so
I think we\'re now kind of back in a middle ground with the
opportunities to participate in research there, but also the risks are
not downplayed. And I think that is a happy balance. And right now I
think OHARP is playing both sides of that street very effectively and
very sensibly. So I\'m very pleased with the approach that looks to me
as if Dr. Schwetz is taking.

*INTERVIEWER: Do you believe that today\'s research environment is
overly restrictive?*

DR. McCARTHY: No, I don\'t think so. I think every new generation of
researchers\--and typically a generation only lasts about 10
years\--researchers study a long time, they get into the field,
they\--they have brilliant ideas, they work them out, they burn
themselves out, and then they either become administrators or go into
the practice of medicine or some other distantly related to medicine or
behavioral research.

So I think every new generation comes along, has to be re-educated, has
to be reined in. They have brilliant ideas, they\'re contributing
enormously to society, but unless we have a strong regulatory
environment I think they\'re going to abuse it again. And I don\'t think
that\'s ever going to stop because I think research, while people talk
about it as a life-long career, in fact their productive years in
dealing with sick people are often limited to five or ten years. And
those are times when they\'re so excited that they found a cure for AIDS
or for cancer, or for some other disease, they forget all about the
rights of their subjects, and they feel as if no one has ever had this
great insight before or ever will again, and there should be no
restraints on them.

So it\'s my feeling that they should\--that they need to be reined in,
and the IRB is doing an excellent job of not killing the research but
protecting the rights of the subjects.

It seems to me that medical schools in particular are\--their curriculum
is so full, and they\'re cutting corners everywhere they can to cut
costs, have left out of the curriculum how to do research. And,
consequently, I think the IRB has willy-nilly been drawn into the role
of the teacher of how to develop a clinical trial out of conducting
clinical trial, how to do good research. And so I think the IRBs have
become in the academic institutions of our country the only place where
a young investigator can get good training in how to do research, how to
make sure the results are properly\--have sufficient power, that the
statistics are right\--that the research is properly designed and all
the rest.

And so I think the IRBs are spending more time for protocol because the
young investigators are coming in and writing awful protocols. Nobody
taught them how to do it right. And the IRBs, I think, are maintaining a
tradition of sound research in this country that makes them invaluable,
not only for protecting human subjects but for continuing sound clinical
research.

*INTERVIEWER: So with this new generation of young Turks in every cycle,
do you think it\'s every possible that there would be another study like
Tuskegee?*

DR. McCARTHY: When I was in the government, I learned to say never say
never. I hope it\'s impossible, but a few times I have seen people who
seem to be somehow morally indifferent to the rights of others. And
that\'s\--I see that occasionally in the highway, I see it occasionally
in other parts of our society, and rarely but not\--not totally absent,
it\'s found in the research community itself. Every once in a while
there\'s a cowboy who is lawless, and I think the research community is
not totally immune from such rare individuals. Thank goodness they\'re
rare. I\'d like to see them so rare that they don\'t exist, but maybe
that\'s too much to hope for.

*INTERVIEWER: You mentioned in an earlier point about the changing
environment for research over the past 25 years, and one of the areas is
clinical trials and multicenter clinical trials and such. Could you talk
a little bit about that?*

DR. McCARTHY: Well, the whole system was based on the assumption that a
research investigator would be in an institution would recruit subjects
from the local catchment area, would conduct the research, report to the
IRB, and it would all be done locally. Those days are gone for the most
part. They\'re still a lot of small studies that are done, locally and
by individuals, but the larger and the riskier studies are almost always
multi-centered.

The lawyers have got into the act. They\'re so afraid of the
institutions being sued if anything goes wrong that they insist that
every institution carry out a full review of a project even though it
may be conducted in up to 125 other institutions. And that\'s, I think,
in our society with the cost of research, we cannot afford to duplicate
efforts 125 times when it offers minimal return, maybe no return to the
subjects. And it simply delays the research, adds to the cost, and adds
nothing to the protection of subjects, but it adds legal protection to
the institution.

And I think there are other ways to deal with them. I think we could
create some kind of an assumption of legal innocence until the standard
of proof abuse is very high and handle research violations of the rules
much as OHARP does anyway by simply shutting down projects that don\'t
meet the rules and limiting the legal liability of the institutions. And
that way I think institutions would accept one another\'s review. We
could cut down the review and have all the quick, maybe something like
an expedited review of these multi-centered trials, reduce the cost and
the human effort tremendously and not put subjects at any greater risk,
or very little if any. So that\'s an area where I think we need to work,
and we have to work with the legal community, not despite the legal
community, which has been the tradition in the research community.

They don\'t want anything to do with the lawyers, and the lawyers don\'t
want much to do with them, and the result is the lawyers have put up
some constraints that make research very difficult.

*INTERVIEWER: Do you think the regulations 45CFR46 appropriately
embodies the three ethical principles identified in the Belmont Report?*

DR. McCARTHY: Let me come back to \"appropriately.\" But, in fact, the
way they were written was simply to take each Belmont principle and then
write the rules to implement the principle. So the very heart of the
regulations are the Belmont principles. And when I teach them to our own
IRBs, what I teach is Belmont. And I say, \"Now, what are they? What is
informed consent,\" and read out of Belmont.

And then I say, \"How is that implemented in the regulations,\" and find
the whole section of 46-116 and the sequelae there to show how this
concretizes the principle of informed consent.

We do the same with the IRB responsibilities on the 46-111 for justice
and also for balancing risks and benefits. So I think, yes, they embody
Belmont. Whether\--I think you asked the question \"appropriately,\" and
here I think the climate at the time of the Commission and the focus of
the Commission itself was protecting the individual subject and
protecting his or her rights. We have now moved where you can scarcely
affect any subject without affecting that subject\'s family, without
affecting that subject if the person is an adult\--employment, health
insurance, all the rest.

And, therefore, I think we need\--and here I\'m going back to something
Jim Childress said at the recent symposium\--I think we need to
reinterpret those principles that can be read in such a way that they
apply to more than just the rights of the subjects themselves and apply
to the subject\'s families, employers, community and so on. I think it
will be a major undertaking. I wish I were 25 years younger because I
would\--I would try to get a grant somewhere and start writing about
this stuff. It excites me. It\'s not easy but I think it must be done,
and so, yes, Belmont in some sense has gone as far as it can go in
protect\--

I think the task of reapplying Belmont principles to more than just the
subjects is very difficult because it\'s hard to know if this is
stopping point. If you go beyond the subjects to their families, to
their communities, to their businesses, then Belmont will be used to
protect everybody. And if that occurs, it probably will protect nobody.
I don\'t think the system can support that much.

So finding ways to make them, their application wider without making so
diffuse that they\'re useless is going to be a major intellectual
enterprise, and I wish I were younger so I could undertake it.

*INTERVIEWER: Do you think that the Belmont principles are absolutes
that override all other considerations? Or do you see them more as
factors to be used in balancing the risk of harm?*

DR. McCARTHY: I guess I would want to rephrase the question. Certainly,
they\'re not absolutes, because even the Belmont Report itself says that
sometimes they\'re in conflict, and the conflict has to be resolved,
which means you can\'t follow them absolutely or you are contradicting
yourself.

So they are meant to be general value guidance, and they have to be
supported by reasonable understanding of factual situations, and that\'s
the way they\'re to be read. And if they are read that way, I think
it\'s very rare that they don\'t service well.

*INTERVIEWER: There\'s an area that we haven\'t touched on, the Belmont
Report\'s ethical framework in an international setting.*

DR. McCARTHY: Because Belmont, at least superficially, looks like the
work of Tom Beecham and Jim Childress, their ethical textbook, because
they identified three basic principles, and their vocabulary is very
close to, but not the same as Belmont. I think that book itself,
although widely endorsed in this country, is controversial overseas.

When I was in Scandinavia, they used to refer to it as that the \"George
with contempt,\" as the Georgetown mantra. And, unfortunately, because
of the superficial similarity, the criticism directed against Beecham
and Childress, even though I happen to think their book is very good,
the criticism directed against them gets directed against Belmont as
well. So that\'s the first problem with applying Belmont overseas is
that they mix it all up with Beecham and Childress, and that\'s unfair
but it happened.

Secondly, I think the Europeans, particularly the Scandinavians and the
Danes, and to some extent the British and French, have for years used
Helsinki. I think Helsinki in my judgment is inferior and far less
useful and much more prescriptive and less rational than Belmont.
Nevertheless, because they invested so much time, talent, energy over a
period of 40 or 50 years, the Europeans are reluctant to let go of their
system and adopt ours.

So I think Helsinki, we might be better off if they\'d never been
written, and that, itself, is a pretty controversial statement. But
it\'s my view, and I think the Europeans are somewhat unreasonably
hanging onto the Helsinki and setting it up as opposite to Belmont
whereas, in fact, I think the proper way to read Helsinki is in the
light of Belmont. So my view is that\'s why it\'s been slow to catch on.

The Japanese just want to please the westerners so they can get more
research dollars. They\'ll go along with any system of ethics as long as
the dollars come with it. And maybe that\'s too critical of the
Japanese, but in any case, I don\'t see really sound that I think\'s
coming out of Japan. Mostly, they\'re content to follow Belmont, and
they could do a lot worse.

*INTERVIEWER: Is there any other topic or area or issue?*

DR. McCARTHY: I\'ve been talking about two or three hours. Great. I
can\'t imagine any other area that ought to be addressed except to say
that as research changes, then I think the application of Belmont and
the rethinking of ethics must be a constant process. So I don\'t think
there is ever a point when you can say: Now we have it all figured out.
Belmont is not written as if it\'s rigid and to be applied, but, rather,
it is to guide our thinking. And as long as that thinking is creative
and imaginative and concerned for the rights of others, then I
don\'t\--do not fear for the research that is to come.

But that requires sound and well-educated people to understand the
spirit of Belmont and to be willing to do the intellectual hard work to
make Belmont realistic instead of simply an icon.

*INTERVIEWER: Tell me about stem cell research.*

DR. McCARTHY: Stem cell research really involves cells that are as yet
undifferentiated, and we\'re usually talking about stem cells that are
associated with fertilized ova. So they are other kinds of stem cells,
and I\'m not addressing those at the moment, but these cells are so
undifferentiated they have the full genetic code of a human being in
them. But if you divide them you will get two human beings. If you
divide them again, you get four human beings. They are not and cannot
be, by definition, unique human persons. Our whole debate about abortion
is the issue of whether the use of stem cells is somehow dealing with
the abortion question, and that\'s often defined in terms of, from a
conservative point of view, that you have a living human being from the
moment of conception. In fact, that cannot be true because you can take
that fertilized ovum and divide it, and then you\'ve got two living
human persons.

What the debate should be about is not about whether it\'s human\--it
certainly is human\--a fingernail is human, a skin graft is human, an
eyebrow is human. What the question is: When is this living piece of
human tissue, when does it become a living human person to which we
attach rights and dignity? And no one that I know of\--and I don\'t
think there is any side to the answer can tell you when that occurs, but
they can tell you when it cannot occur, and it cannot occur if you can
take this embryonic cell, or set of cells up to about 16 and divide them
and get twins, you cannot \--it cannot be a unique human person if it
can be divided. So the earliest point in the development of the embryo
where you could possibly make the case that you\'re dealing with a
unique human person is when the cells no longer can be divided and you
can get surviving duplicates, identical twins.

And that point comes when they begin to differentiate, and you begin to
get some kind of a nervous system. It\'s sometimes called the primitive
streak, and eventually it will grow into a spinal column and develop a
brain and other things. That\'s the earliest possible time. It comes
about 16 days after fertilization is complete. Fertilization itself
lasts about 18 hours, so there is no moment of conception. That\'s a
misnomer.

The notion that you have a unique human person from the moment of
conception makes no scientific sense, so the stem cell cannot be a
unique human person. Since it has the potential of becoming one, it is
not therefore worthless. It has value, but that value, it seems to me,
is respected by developing it into a stem cell and using\--or into a
cell line and using that cell line to improve or to cure disease. And
that seems much better, to me, than simply discarding stem cells and say
we\'re doing that because we\'re respecting their dignity.

So the argument for not creating cell lines and not using embryos seems
to me to be a very false one and scientifically untenable. Where I
would, as we can find this in the old HHS, Secretary\'s Ethics Advisory
Board, where we address the whole question way back in \'79 and
published a 100-page report and a thousand pages to back it up, stem
cells, embryonic stem cells, are discarded after almost every human
intercourse because approximately 60 percent of fertilized ova are
spontaneously aborted anyway. And if you say each of those is a unique
human person, then it seems to me you\'re getting into a position of
saying that 60 percent of the human race dies before 12 days old, and
somehow that seems to me to be defiant of human reason.

So we addressed all that stuff years ago because we knew it was coming
long before it was actually possible. And somehow I think the Bush
administration has simply closed its eyes and its ears to the scientific
facts surrounding this because they want to please the Right to Life
people. But the enlightened Right to Life people don\'t\--are not
opposed to stem cell research either.

A classic example\--I mentioned Dick McCormick before, the head of the
American Catholic Theological Association\--has supported exactly the
same position that I just argued for, and so it\'s not a matter of
religion or any of that; it is a matter of facing the facts about what a
stem cell is.

And so I feel very strongly that we\'re simply driving this research
overseas. It\'s cause a brain drain here. Eventually, we\'ll have a new
administration, and we\'ll be starting after the rest of the world, and
I think that\'s not a very wise public policy.

*INTERVIEWER: Thank you.*

--END OF INTERVIEW--