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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

F. William Dommel, Jr., J.D.

NIH Liaison to the National Commission

National Institutes of Health

Bethesda, MD

September 16, 2004

Belmont Oral History Project

**INTERVIEW**

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

*INTERVIEWER: Just to start, Bill, could you give us your name, your
current position, your academic training, and your role in the 1970s,
the start of the National Commission.*

MR. DOMMEL: Sure, I\'d be pleased to. My name is Bill Dommel, F. William
Dommel, Jr., and my current position is that of consultant to, an
advisor to medical schools, research organizations, sometimes drug
companies, in the development and enhancement of programs of protection
of human subjects in research. And I come from a background of
on-the-job training and absorption of medicine and research by being
employed at NIH from 1965 until 1998.

My formal education is in political science and the law. I graduated
from American University Law School, but my graduation occurred while I
was working for NIH and, in fact, while I was doing some work with the
National Commission and some of my very early activities at NIH
involving other than automatic data processing, because I had begun my
career in automatic data processing in the government, and then when I
was about to graduate from law school, I had an opportunity to work as
what was called a program analyst in the Federal Government at NIH, and
some of my first work was with the National Commission. And I still use
that work today in my current assignments in my own business.

*INTERVIEWER: When the work of the Commission began, what was your
role?*

MR. DOMMEL: The Commission\--in 1974, I was approached by Dr. Charles
McCarthy, who was working with the National Commission as a consultant;
even though he was a federal employee, he was doing some work with the
Commission. And at that time, the Commission was assessing the use of
fetuses in research, which was truly its first assignment from Congress.
And the greatest ethicists of the time assessed the status of fetal
research in the country and made determinations from their points of
view of what research with fetuses could and could not, should and
should not be done at the request of the National Commission.

They were asked to keep their reports to about ten pages, and they each
averaged about 30 pages. And then the Commission had a need to have
these 30 pages reduced to one paragraph for each ethicist. And that was
the project that I first worked on for the National Commission, was
reducing these great works to paragraphs that I\'m sure did not come
near to doing them justice so that they could fit into the publication.

*INTERVIEWER: Could you tell us a little bit about the political climate
at the time?*

MR. DOMMEL: At the very beginning of the Commission\'s work, the
political climate was volatile. There had been hearings in Congress
about the study conducted by the Public Health Service in Tuskegee,
Alabama, involving rural, poor black males who had syphilis and were
being assessed but really not treated in a study that went on for nearly
40 years. And Congress had taken up this rather abusive study, this
activity conducted by the Public Health Service itself, as well as other
breaches of ethics carried out during research involving human subjects,
and had public hearings on them in the context of developing legislation
creating the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, and assigning to that Commission a
number of evaluations of vulnerable populations and creation of the
Belmont study as well.

*INTERVIEWER: Since you brought up the Tuskegee study, do you think a
study like that could happen today?*

MR. DOMMEL: I don\'t\--well, yes, it could, but not by the U.S. Public
Health Service, not by a federal agency, although we do have an Animal
Welfare Act that applies to all research that involves animals, as well
as many other things involving animals, but provides for the general
welfare and care of laboratory animals, regardless of the source of
funding for the activity.

In human subjects, we only have protections at a federal level that
emerge from the funding or the conduct of the research by a federal
agency. And so I think with the establishment of Institutional Review
Boards, what we all call IRBs, we know that such a study as Tuskegee
could never pass any IRB. It would just be recognized far too quickly.
So\--and the conduct of a study of that size and that duration in the
absence of an IRB approval at an organization that required IRB review
and approval would be very unlikely, perhaps even impossible.

But outside of the regulations that protect human that emerged from the
Belmont Report and other activities of the National Commission, we
certainly have\--I lost my train of thought.

*INTERVIEWER: You were comparing the Animal Welfare Act just covering
all animals and --*

MR. DOMMEL: Right. Okay. The Animal Welfare Act provides protection for
all animals that may be involved in research, protection in the form of
appropriate care and use of these laboratory animals. And it applies to
all research involving animals regardless\--all those protected by the
act, regardless of the source of funding for the research activity.

On the other hand, the provision of protections for human subjects
emerges not from a statute that protects human subjects, but from
regulations established by the individual agencies, the federal agencies
that provide a basic core of regulations protecting humans that are
involved in research, but only if that research involves federal
funding. And in the absence of federal funding, perhaps you could have a
study like Tuskegee today because you wouldn\'t have the requirement for
Institutional Review Board\--IRB\--review and approval, and such a study
like Tuskegee could never pass an IRB doing its duties. And I think
someone who were\--was attempting to avoid the IRB review and approval
deceitfully at an institution that was under the federal regulations
would be unlikely to succeed in carrying out a study of this magnitude
and duration.

So I think, no\--in brief, no, it couldn\'t occur today at a federally
funded agency or institution. But, yes, I think it could occur at an
institution where there are no protections of human subjects by federal
law.

*INTERVIEWER: Today, some people think that the Commission\'s work is
represented by the Belmont Report. Is that how you saw it at the time?*

MR. DOMMEL: I didn\'t see it at the time because the Belmont\--the
publication of the Belmont Report came subsequent to much of the other
work of the Commission. So what I saw emerging from the Commission and
what I was involved in myself in the work of the Commission was much of
the detail of protection of human subjects that later, when the Belmont
Report emerged, we could see fit nicely into these overall principles
established by the Belmont Report, set forth in Belmont.

So, but once published in the late \'70s, in 1979, I saw the Belmont
Report as a magnificent document that would withstand the test of time,
that didn\'t have the detail of regulatory description that would make
it be obsolete after 5, 10, 20, 30 years. I can see something like
Belmont lasting for a century as a set of principles that would
withstand the test of time because it contains the flexibility to do so.

*INTERVIEWER: And was that insightful perception shared by a lot of
people at the time?*

MR. DOMMEL: Oh, I think not. I think we\--we had people working very,
very hard, people who were dedicated to the protection of human
subjects, often as lifetime pursuits, who saw and recognized an
opportunity to make a contribution that could have an immediate effect.
And certainly they wished to design something that would work not just
today but tomorrow. But I\'m certain that they could not have imagined
that it was as magnificent as it has turned out to be. And I\'m sure
that they\'re joyful that it has.

*INTERVIEWER: As you look back on your experience with the Commission,
what stands out in your memory?*

MR. DOMMEL: Oh, many things. The\--in my own memory, the first\--the
opportunity to work with such an august body, and I certainly recognized
it as such immediately. And then to work with, on my first assignment,
the evaluation of the statements relative to fetal research put forth by
the greatest biomedical ethicists of the day was heady wine, if you
will, for a young man about to graduate from law school. And so that
stands out in my mind that I could even contribute one or two sentences,
and I actually contributed significantly to many paragraphs in the fetal
report.

But I guess what stands out almost as much is the translation of the
important work of the National Commission in its establishment of
recommendations and principles, translation of these into regulations,
which became my responsibility subsequently. And at the time that I was
doing my early work with the Commission, I didn\'t know my role would be
to translate to regulations subsequently, but indeed it turned out to be
an assignment that I was honored with and value to this day. And so to
this day, I still use the work of the Commission and the translation of
that work into regulations in assisting institutions throughout the
country in enhancing or developing programs to protect human subjects
and to establish their IRB reviews and approvals.

*INTERVIEWER: What topic or topics generated the most discussion among
the Commissioners?*

MR. DOMMEL: I think those that even today would be seen as the most
politically turbulent did bring about the greatest discussion and debate
among the Commissioners, for example, research involving fetuses,
research involving vulnerable populations, research involving *in vivo*
fertilization and embryos and pregnant women, and indeed whether
pregnant women were vulnerable populations as defined by the statute.
That indeed was a point of major debate because I think by virtue of
being a woman and being pregnant does not make one vulnerable in the
sense of the other vulnerable populations identified\--children,
mentally infirm, prisoners who were not allowed to exercise their
autonomy. Pregnant women really aren\'t vulnerable populations, but
indeed they require special consideration because of their pregnancy.

So debates about the nomenclature at the time were\--were stimulating,
to say the least.

*INTERVIEWER: And was that--did the staff have similar debates on
similar topics?*

MR. DOMMEL: I would think it was almost mirror-like, that what we being
discussed by the Commissioners you would see exactly the same thing
discussed, sometimes beforehand, by the staff because the staff would
recognize what would be of major concern to the Commission and to
individual Commissioners in the staff\'s attempt to provide sufficient
information for Commissioners to carry out these discussions thoroughly
and to have the resources available they needed at that point.

*INTERVIEWER: What do you believe was your own most important
contribution to the work of the Commission?*

MR. DOMMEL: My own most valuable contributions I would think would be
the two that I have mentioned, and that is, the work that I did
evaluating the reports of the ethicists on fetal research, the reports
on fetal research, and developing summaries that were published by the
National Commission and found satisfactory by the Commission to provide
the sufficient information on the positions of these ethicists. And I
worked closely with Dr. Charles McCarthy on that project, and that was
my introduction.

And then, subsequently, my tangential work to that of the Commission in
that my responsibility became take the recommendations of the
Commission, translate this work into regulations using my legal
training, and publish in the manner required by federal agencies\'
proposed rulemaking and evaluating public comment in light of the
comment of the public on the National Commission\'s reports and the
comment of the public on the proposed regulations, merging all of this
into a set of regulations which have withstood the test of time, not
quite as well as Belmont has, I think, and certainly won\'t in the
future to the extent that Belmont will, in my own opinion, but that have
served, I think, well to protect human subjects in federally funded
research.

*INTERVIEWER: Having spent such a large part of your professional career
right in the heart of human subject protections, as you look back at the
work of the Commission, is there anything you think it would be useful
to do differently?*

MR. DOMMEL: I don\'t think I would choose something to point to and say
the Commission might have done this differently because I think the work
they did and the outcome of all of their hard work has been of such
extraordinary value that it\'s the kind of thing that I wouldn\'t
suggest tinkering with. Even if I had the ability to go back in time and
tinker with it, I hope I would have the reservation not to because the
outcome is just so fine, it is so magnificent, and in an area that I
view as so important and so much so that I dedicate my career to it. So
I wouldn\'t touch what they\'ve done. I would perhaps suggest that
others who look at the work of the Commission revisit some of their
recommendations and say in\--in light of our experience subsequent to
the reports of the Commission, perhaps the Commission was more wise than
we recognized when they said that the Congress should by statute require
that these protections apply to all human subjects in this country and
not just to those in federally funded or regulated research.

And one other that I think I might revisit, not the Commission\'s work
but the translation in regulation, would be when one establishes minimal
criteria for the membership and actions of an Institutional Review
Board, an IRB, one should be cautious that the minimum doesn\'t become
the standard. And the minimum, I believe, has become the standard in
many circumstances, and I would offer as an example the requirement that
at least one member be not affiliated with the institution.

I do not think that in its recommendations the Commission was looking
for IRBs to only have one member not otherwise affiliated with the
institution other than their membership on the IRB.

And yet often the case is there\'s one member not affiliated and an
alternate for that member, so that someone else could be present.

Similarly, the requirement that at least one person whose primary focus
is not in science be a member, and the standard perhaps is to make sure
there is at least one member, and one member who meets this requirement
present, because that requirement flows even to approval and that you
may not approve a project unless there is someone who is not a
scientists, if you will, present at that meeting in the review and
approval.

So I think that I would as a federal regulatory agent present those
requirements in a different way and make sure that we recognize that the
minimum should not become the standard and do what would be required to
see that that didn\'t happen.

*INTERVIEWER: At the time of the Commission, were there any ideas or
issues that you felt should have been addressed in the Commission\'s
work but weren\'t?*

MR. DOMMEL: I would like to have seen the Commission address with\--with
more detail the requirement for compensation of injured research
subjects. And what the Commission decided to do was to pass that on to a
subsequent commission that might emerge, and one did, the President\'s
Commission for the Protection of Human\--let\'s see. The President\'s
Commission for\--wow, I forget it now.

*INTERVIEWER: Everyone just says the President\'s\--*

MR. DOMMEL: Right, because that\'s the one that includes medicine as
well as research, unlike the National Commission. But the
President\--the subsequent commission, the President\'s Commission,
addressed compensation and sort of passed that on to the federal
agencies to pick up on. And the federal agencies were not in a position
to\--to bring such an enormous project to fruition. And so although
attempts went on and I was involved in those for more than a dozen
years, they were never successful. And although recommendations went
forward to our Secretary, my Secretary, Department of Health and Human
Services, other agencies did not even reach that point. And the
recommendations of a task force that I worked with regarding provision
of compensation in the event of injury simply did not get full attention
of any of the Secretaries at the time that they went forward.

So I would like\--if this National Commission was so effective that if
it had taken that topic up with the thoroughness that it did its others,
I think that it would have provided a program that would be in place
today.

*INTERVIEWER: Even the 2002 Institute of Medicine on the protection of
human subjects took up the topic yet once again.*

MR. DOMMEL: Yes, a good point. Thank you.

*INTERVIEWER: What impact do you feel that your work on the Commission
has had on the rest of your life?*

MR. DOMMEL: Oh, I couldn\'t overstate the enormity. It really was the
beginning of my career. From a personal standpoint, I came to work for
the Federal Government at the age of 17 as a\--as a clerk typist, and I
was a Grade 3 and a Grade 2, and then I was able to find a position as a
trainee in automatic data processing. And then I went into the Navy for
four years around the time of Vietnam, and we won\'t get into
discussions about my Vietnam role in the service because too many others
are under discussion today. But we\'ll let mine pass.

But I did get an honorable discharge after four years and then returned
to the Federal Government in automatic data processing, and then using
my veteran\'s benefits and while working for the National Institutes of
Health, I was able to proceed through college and law school. And about
the end of my law school years, somewhere near my third or fourth
year\--because I went part-time to law school, so I had four years\--I
was tapped by Dr. Charles McCarthy to work on two projects: one, the
fetal research, and another, a task force on compensation for injuries
in research, human.

And at that time I was searching for a role. I had always wanted to be a
lawyer, but I was now 15 years in the Federal Government and I didn\'t
see a role as a lawyer in the Federal Government that I really desired
strongly. Most of what I wished to do in the law at that time was
outside of the Federal Government. But given my commitment to a federal
career at that point with 15 years, I was exploring opportunities, and
my opportunity came in an area that I wasn\'t familiar with at all\--the
protection of human subjects\--right at the time the Commission was
beginning its work.

And so blessed by my selection by Dr. Charles McCarthy and timing, that
I was available when the Commission had a need, we were sort of\--my
professional career and the work of the Commission and the Federal
Government in addressing thoroughly the protection of human subjects
occurred at about the same time, in the mid-\'70s.

*INTERVIEWER: Because you have spent your life, professional life, so
much in the heart of this issue, what changes have you seen in human
subject protections over time since then?*

MR. DOMMEL: I\'ve seen the development of a profession similar to my
own, a profession occupied by individuals who devote careers to the
protection of human subjects in research, something which in 1975 very
few ethicists even addressed biomedical and behavioral research ethics.
Those that did, few, very few had a total career based on just the
biomedical and behavioral research. And certainly there weren\'t
individuals in other professions\--law, the analyst, Federal Government
analyst profession\--where programs were evaluated for with an eye
toward meeting Federal Government needs, that there weren\'t those who
focused on the protection of human subjects. But, indeed, with what came
forth from the National Commission, a whole profession, if you will, of
those with this dedication emerged. And today we have\--there were a few
Bill Dommel\'s in the mid-\'70s, and now there are thousands who are
much better and much more highly trained and far more qualified and
brighter and who meet the needs of the Federal Government in\--in
whatever arm the Federal Government uses, whether establishments of its
own commissions or requests to the Institute of Medicine for further
evaluations of protection of human subjects. Now there are many who are
available who are well qualified and can hit the ground running, if you
will, on these very types of activities that at the time of the National
Commission everyone was sort of a novice, and today we have really,
really highly qualified and trained professionals who can contribute,
and do enormously. It\'s a big change.

*INTERVIEWER: You just \[inaudible\] the field.*

MR. DOMMEL: I was there.

*INTERVIEWER: As the Commission defined the three ethical principles for
the protection of human research subjects, was more weight given to one
principle over the others?*

MR. DOMMEL: Always. There was always more weight giving to one\--given
to one principle over the others. But what\'s amazing, what\'s wonderful
about the Commission\'s work and its recommendations and its
establishments of the principles of beneficence and respect for persons
and justice is that, as needed, you may apply different weights to these
principles. And it\'s been my experience\--and I don\'t recall offhand
if the Commission spoke precisely to the point. But there always seems
to be an equal distribution that shifts among the three. So if you said,
well, each has 33 percent, but if you give away the 40 percent to one
under a given circumstance, you will have to take something away from
the others.

More positively spoken, anytime you must diminish your\--your focus on
one of the principles by a particular need, for example, then you should
enhance your focus on another of the principles so that you come forward
with a 100-percent ethics assessment, if you will, applying these three.
So indeed they do shift, and they shift, I think, rather successfully.
And one major occurrence which could be\--could be properly\--I\'d like
to stop here for a second because what I want to talk about at this
point\...

For example, in the 1980s, when those who spoke most loudly for those
affected by AIDS, those who spoke most loudly were demanding access to
research drugs that were not yet deemed as safe and efficacious and were
still under research. But the research protocols themselves were
generally closed to much of this population that was in need of access
to new drugs or viewed themselves as being in need of access to these
new drugs. And at that time, little treatment of HIV/AIDS was available
outside of research. So the cry went forward: We\'re willing to take the
risk, let us decide the risks.

Well, much of what had happened and was seen as abuse of human subjects
had occurred under circumstances where someone thought that the need was
so great that attention to the principles set forth in Belmont could be
superseded by this need to provide for treatment for life-threatening
diseases.

Well, in the absence of Belmont, perhaps one would just unilaterally
begin to try these experiments on individuals while doing research. And
this was not acceptable. What was assigned to the National Commission
was seen as a search for answers to circumstances such as this where the
need was great, we needed to do the research, people had serious
illnesses, but we needed to protect their rights as well. And what could
we do, how could we\--how could we accomplish that?

Well, if you looked to Belmont and you say, well, you have a principle
of beneficence, that risks must be reasonable in light of anticipated
benefits, that you maximize benefits and minimize risks.

Well, if you don\'t know what the benefits are and you aren\'t even sure
what all the risks are, how can you allow someone to go forward into
such an activity without limiting greatly the activity? And that\'s what
we do in our research protocols, and we have IRBs approve them. But when
you had many who couldn\'t get into these studies and they said, \"We
want access, anyway,\" what could you turn to that was recommended by
the National Commission to provide adequate protection? And you could
turn to the Belmont principles, and you could say we will heavy-up, if
you will, on the principle of respect for persons and autonomy and
informed consent and the exercise of autonomy, and say in circumstances
where we\'re unable to determine the risk and benefit but where many are
in need of some sort of new treatment or they will die before a new
treatment that is deemed safe and efficacious comes forward, that in
that circumstances if we fully explain that to the individuals and we
say we don\'t know what the risks and benefits are here, we\'re still
studying it, but because of this great need if you completely understand
this, consider all of the information which is provided in greater
detail than in any other kinds of research study, then we think that it
would be ethical to go forward with this.

And so Belmont, the recommendations of the National Commission, and the
principles set forth by the National Commission lent themselves well to
this new demand and provided an opportunity for access to research at a
point where there really hadn\'t been such access previously. And it
could be done in a way that I would see as ethical.

*INTERVIEWER: Excellent. Do you think the HHS regulations, 45 CFR 46,
appropriately embodied the three ethical principles\--principles
identified in the Belmont Report? (Respect for persons, justice,
beneficence)*

MR. DOMMEL: Yes, I do. I think the\--the recommendations of the
Commission that actually led to all of 45 CFR 46, the regulations
protecting humans, that those recommendations really are embodied in a
living way in the regulations. However, regulations are regulations, and
regulations leave not a great\--a great deal of room for change,
for\--they\'re far more inflexible than the recommendations of the
National Commission. The National\--the National Commission could speak
in terms of \"should\'s,\" \"it would be best if,\" and appropriately
so. But when developing regulations, one must be very cautious in
leaving that sort of flexibility.

But these regulations probably, in my opinion, have more \"should\'s\"
or \"ought to\'s\" than most any other regulation I know that came from
a federal agency. And the trick to doing it was to provide for the
autonomy of IRBs. Institutional Review Boards could be presented with
regulations that said \"should\" because we knew we had a body of
individuals that brought forth a number of views that recognized an
extraordinary responsibility, and when assessing a \"should\" really did
assess it rather than dismissing it as being not a requirement.

So earlier in our discussion, I criticized the\--inherently I think
it\'s the institutions for adopting the minimalist approach to
representation on IRBs. Contrarily, I think IRBs do not take on a
minimalist role in making decisions about \"should\'s.\"

I think they feel a \"should\" is a \"really ought to be\" unless
there\'s a good reason not to. And since IRBs do, in my opinion, act
that responsibly, then I think the \"should\'s\" and the \"ought to\'s\"
in the 45 CFR 46 actually work in a way that they probably wouldn\'t in
other statutes and regulations.

*INTERVIEWER: How interestingly put. This goes a little bit back to your
answer a couple of moments ago. Over time, some feel that the focus has
shifted from protecting human subjects from risk and toward permitting
access to innovations that may be helpful. Do you agree with that?*

MR. DOMMEL: Yes, I think that this shift occurs at times, and at times
it shifts back, and that the changing needs of those who benefit most
from research and those who carry out research will\--will cause an
emphasis that might be greater at times than was previously the case.
And so I think that in the \'70s, when we established regulations that
provided enormously strict requirements for vulnerable populations, that
subsequently a concern for not involving in a sufficient way a number of
these individuals deemed as vulnerable came\--came to result in the
detriment\--resulted in a detriment to these protected groups. And so
one could look to the regulations and the exceptions permitted in the
regulations and say, How can we involved children, for example, in\--in
research when the restrictions on the involvement\--involvement of
children are so great as to make outcomes not very valuable? And\--and
that still the risks occur to children in or outside of research,
depending on when an experimental drug is introduced into the population
of children, for example, but that if we turn to these regulations and
the recommendations of the Commission, we\'re sort of stuck. We\'re
stuck with this very protective body of rules and guidelines that came
forth in a period where those\--where the abuses were such that these
stringent rules and guidelines were appropriate.

I think today they aren\'t needed quite as much, that there are other
mechanisms that are used to open opportunities to do research with
vulnerable populations that an interpretation of the rules in the \'70s
might not have permitted, but that an interpretation today might; that,
yes, the change has occurred. I don\'t view that change as
inappropriate. I think that there is a balance shift here, and that if
one looks at the overall protection and provides adjustments in the
circumstance of limiting ethical provisions in one area but enhancing in
another, that the system works. And I think that it works well.

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

MR. DOMMEL: No, I don\'t think the research environment is overly
restrictive at all. I think that it\'s underregulated when federal funds
are not involved and that the extent to which this occurs is\--I would
speculate is significant, that there is a great deal of research going
on not receiving any federal funding; therefore, not subject to the
federal regulations; and if not stringently assessed, perhaps not
subject to FDA\'s regulations, because licensing may not be involved,
introduction of new products might not be involved; and that great risks
are there. And I think you might find this more in behavioral research
than in others.

*INTERVIEWER: Do you think subjects are at greater risk today than they
were 25 years ago?*

MR. DOMMEL: I think I wouldn\'t want to\--to\--to suggest one way or
another in\--in that regard. I think that, in general, subjects are
appropriately protected. The extent to which they were inadequately
protected in the \'70s, they were inadequately protected in the \'70s to
a significant degree. However, today, there are far more experimental
products available, and so the\--the opportunities for abuse are perhaps
far greater, at least in numbers, and the amount of money that is
available to carry forward such research might suggest that\--that the
opportunity for abuse is greater today.

But I wouldn\'t want to suggest that\--that subjects are not adequately
protected today simply because I might say that the difference between
today and the \'70s is such to suggest that. So I would rather say I
think subjects are adequately protected and can be protected far better.

*INTERVIEWER: Are there any changes you feel would be needed or possible
in today\'s human subject protections environment?*

MR. DOMMEL: I think there is an opportunity for the establishment of a
commission similar to the National Commission that we\'ve been
discussing that would serve the public well if the Commission were
assigned the review of protections provided individuals who are in some
way compromised, either by virtue of their economic status, their mental
capacity, the seriousness of their disease, which so many serious
diseases have treatment only in\--or in the majority of the cases in a
research setting that we almost forget at times to focus on their
vulnerability by virtue of the disease from which they are suffering.

And so I would like to see a commission of the stature of the National
Commission that would be presented with the opportunity to evaluate in a
deliberate fashion the adequacy of employing the guidelines set forward
by the National Commission and the subsequent regulations, and assessing
their effectiveness today with a special eye toward those who are
vulnerable and with a particular focus on those who suffer from the most
serious diseases and their ability to consent, to fully understand that
to which they are consenting. I would love to see that assessed today.

*INTERVIEWER: Do you think a second edition of the Belmont Report is
needed?*

MR. DOMMEL: No. I think\--to repeat myself on something that I\'m
delighted to repeat myself on, I think Belmont is a masterpiece and a
treasure, if you will. And if\--if one were to develop ethical
principles that supplemented Belmont, they ought to have a name other
than Belmont so that Belmont can stand for what it is, for its
thoroughness, for its capacity to function well in guiding individuals
25 years later in times that have changed in an extraordinary fashion
where research today is\--is\--the enormity of that which is occurring
in the name of research today is just\--you can hardly compare it to
what was going on in the \'70s. And yet here is a set of principles that
function as well today for this enormous project that occurs in the name
of research as well today as it did in the \'70s, and in the \'70s and
\'80s it just\--it fit the bill and today it fits the bill just as well.

So I think the changes that would occur would be outside of the
principles. It would be how better to employ the principles, how better
to write the regulations, how better to establish and provide for the
proper functioning of our Institutional Review Boards, IRBs. But I think
we got the principles right.

*INTERVIEWER: At the time the Belmont Report was written, the prevailing
view was that vulnerable individuals such as children should be
protected from research. However, currently there are requirements, such
as the Children\'s Health Act, to conduct more research involving
children. What are your thoughts about this?*

MR. DOMMEL: I think this is an expression of\--I think that this is an
expression of the natural tendencies for the\--the weights applied to
the principles in Belmont to shift this natural tension that exists
among these principles. And so we have a principle that says an
individual must be permitted to exercise their autonomy, to the extent
that they can. \"Informed consent\" we call it. And in children, we
attempt to get an informed consent that we call \"assent\" in the
regulatory world, as well as a legally binding consent from a legally
authorized representative of\--representative of the child, usually the
parents.

However, we have needs for children to benefit from the successes in our
research projects, but to translate research which is only carried out
in adult populations to treatment of children outside of a research
context is extremely difficult to do. So it was recognized that because
there were stringent rules involving the conduct of research that
included children, that fewer and fewer children were involved in
research.

And, indeed, the outcomes of research with adults was carried forward to
little adults called children. And so the weight\'s different, let\'s
decrease the amount of the experimental product, which, of course,
doesn\'t take into consideration metabolism differences that might call
for just the opposite, that you would use more of a product in a little
person, a young child, than you would in adults.

So there indeed was a great danger to children occurring because of the
stringency of the regulations protecting children. And what was needed
in order to encourage those in the research enterprise was a benefit to
including children in your research activities. And I think the act you
designate was one attempt at doing this. I think there are other means,
that the regulations provided those means for carrying out the research
involving children, but really didn\'t bring forward a benefit and\--to
the organization for including children.

Well, if you say your benefit is going to be that you will be able to
identify this product for children and you won\'t be able to if you
don\'t include children in the project, or you will be able to receive
federal funding to help you carry out this research but you won\'t
receive that federal funding if you don\'t involve children is a move in
the right direction.

In the absence of IRBs, I wouldn\'t want to see that move at all, but
understanding that IRBs take their \"should\'s\" even more seriously
when they recognize that there\'s a pressure on researchers to include
children, where they might really not even wish to, makes their research
more difficult to do.

And so IRBs say, well, with that pressure going on, we need to give
special attention to this, and I think that works \[inaudible\].

*INTERVIEWER: Do you think there\'s a need to make any changes to the
regulatory protection for vulnerable populations?*

MR. DOMMEL: I\'m sure there are. I haven\'t thought about ones that I
might wish to identify as in some sort of urgent need. But\--but
certainly the\--the provisions of the regulations that limit the conduct
of research with pregnant women are still in need of special assessment.
And because they are a political firecracker, it\'s very difficult to go
through an alteration of these regulations. I actually chaired the
Public Health Service committee that developed the most recent revision
of Subpart B, I believe it is, protection of pregnant women and fetuses
and embryos. And w knew at the time that we could only go so far in our
recommendations, that there were other areas that we would like to
provide suggestions to the Secretary and others for modification that
would have killed the revision if we had addressed them. And so we had
to be reserved.

But we were federal employees. I think other bodies can take this on
with greater success, not easily, because there will always
be\--anything that mentions fetuses, embryos, will be subject to a great
deal of attention and always a great deal of misunderstanding about what
they\'re doing. But I think they are in need of attention, and I think
the other regulations are, too. And I think the prisoner regulations are
really outdated. I think they\'re rather restrictive in their
opportunity for prisoners to participate in research. I think greater
participation in federal prisons could and should be occurring, but only
with special protections that would be in place. And they\'re so
stringent now that prisoners are generally excluded.

*INTERVIEWER: Many would also agree with you on that. Do you think
additional protections are needed for other populations, such as the
decisionally impaired?*

MR. DOMMEL: I do. I think that IRBs and institutions are not provided
with adequate federal guidance on the inclusion of those who are
decisionally impaired, mentally disabled. The National Commission\'s
terminology was \"mentally infirm.\" And the Federal Government, when
attempting to issue regulations, changed that to \"institutionalized as
mentally disabled,\" which was a much larger population then than today,
because most who are\--are challenged in this way are not
institutionalized. So even the proposed rule, which some institutions
say we used the proposed \"institutionalized as mentally disabled\" as
our guidance for the conduct of research with decisionally impair
individuals, well, it doesn\'t really serve that because it only
addresses those who are institutionalized.

So I think there are many who could benefit from an addressing of
this\--the needs of this special group again.

*INTERVIEWER: Excellent. How do you think the ethical standards that
were designed for this country apply in international settings?*

MR. DOMMEL: I think sometimes they apply very well, and in terms of
numbers, most of the time they don\'t work. We rely very heavily on a
rather complex informed consent process that, as a part of it, must be
in writing considering that most of our population can read or have
access to individuals who can read and help them understand what it
says; and that in other cultures these capabilities may not exist or
they may not be recognized as being as important as they are in our
culture. In some cultures, decisions are not made by individuals.
They\'re made at a group level, and this indeed is how that society
functions. And to enter that society and say, well, we need individual
informed consent when nothing else in that society calls for individual
consent is something that won\'t really work. You need to translate that
into something else. And our regulations don\'t really provide an
opportunity for that except in the form of a rather complex waiver of
informed consent, which isn\'t really what we want to do. What we want
to do is adapt the consent process to the cultural design, if you will,
of another society and how they go through a consenting.

And so we aren\'t able to change our consent in that way, or we don\'t
know how to, to meet what would be the traditions and the mandates of
another society. So often our regulations, although required by law in
foreign societies where our dollar is involved or our researchers are
involved, it\'s really not working in\--in practice. And so I think a
thorough review of this with perhaps the United States taking a lead
role but with an emphasis on meeting the needs of other countries, we
could then be the mediator and the designer, having the needs expressed
to us, and because of our experience in translating this to principles,
guidelines, and regulations, we could be of great assistance to other
countries.

*INTERVIEWER: Excellent. Do you think that the Belmont principles are
absolutes that override all other considerations? Or are they factors to
be used in balancing the risk of harm to individual subjects against the
societal benefits of increased knowledge?*

MR. DOMMEL: It sounds like a trick question because I think absolutely
we must consider the principles of\--of Belmont. But as I mentioned
several times, the principles are flexible and they permit providing a
greater weight to one over the other. But to fail to properly assess
them I think should be absolutely prohibited. And to properly assess
them will be to apply them, I think, in every circumstance.

And so perhaps in some national emergency one might conclude that the
only way you can save the nation is to go forward with something that
violates the principles, well, if you assess the principles thoroughly
and with an eye toward we\'ll make these principles work in this
emergency situation, and if the principles simply can\'t be applied,
then does the emergency outweigh it? Does the national need? Does the
potential wiping out of the entire country by some virulent virus
that\'s spreading rapidly that such emergency circumstances might call
for ignoring the principles in order to save the nation? But to ignore
them should only occur after an attempt to\--to apply them.

*INTERVIEWER: Excellent. Do you think the regulatory approach to
vulnerability should continue to be based on vulnerable populations
rather than the types of vulnerability that are applicable to individual
subjects?*

MR. DOMMEL: I think not. I think to identify the vulnerable populations
that we did in the \'70s was appropriate at the time because these were
populations that we\--where we saw abuses occurring. And as I mentioned
earlier, I believe, I think there are other vulnerabilities that are
even more important to focus on today. They\'re mentioned in the
regulations.

They\'re mentioned at Belmont. But the seriousness of a disease and the
inability\--and the extraordinary ability of humans to deny things so
that when presented with evidence of a rapidly approaching death, we
often can\'t hear it. And so we go into denial and come back to revisit
that later when we think we can handle it. So we may have been told that
we\'re going to die soon, but we can\'t accept it.

Similarly, and more\--more applicable to\--to research would be we\'ve
accepted that we\'re going to die soon and we\'re told someone wants to
do research on us that might help other people in similar circumstances
in the future but won\'t help us. And we may not hear the \"won\'t help
us.\" And so we enter into the research under a misunderstanding. And I
think that to identify the needs for communicating this information
adequately, sufficiently to this particularly vulnerable group with
life-threatening diseases is worthy of special assessment today, whether
you categorize that and say Subpart F, to provide additional protections
and assessments for persons suffering from life-threatening diseases
which often include a denial on the part of individuals in assessing
informed consent, no, I think not. I think what we do is we take
provisions that we already have in the regulations and in the guidance,
and we bone up on them. We begin to focus on them more and find better
ways to advise our IRBs, our institutions on how to provide information
in a way where it will be adequately understood before a consent occurs,
for example, and many other valuable outcomes, I think, of focusing on
the needs of today. Where are our problems in research today? And I
think we\'ve spoken about a couple of them, and they aren\'t so much in
the case of violation of the rights of children.

I think children are\--it\'s worth\--I think it would be a worthwhile
pursuit if we were to spend the money and the time of this vast field of
professionals that exists today and of which there were so few, I think,
in the \'70s. And we got all the great ones and put them on our
commissions then. And we have great ones today. And to ask a group of
these individuals to assess the\--the use of the term even, \"vulnerable
populations,\" and special subsections protecting children and pregnant
women and prisoners and whether there\'s a need for institutionalized
mentally disabled or mentally challenged individuals having special
protections, to assess all of these categories with a focus on the
special category of those who really are challenged in the consent
process because of inability to fully comprehend, not always because of
intelligence or knowledge but perhaps because of our very nature as
humans that we deny things for periods of time that we can\'t handle at
that moment, information that we just simply don\'t choose to believe at
that time or to absorb. To assess the needs of all of these groups today
in terms of our experiences over the last quarter century would be a
worthwhile endeavor. I would recommend it.

*INTERVIEWER: Is there anything else that you would like to add?*

MR. DOMMEL: Very little I would add. I would take that open opportunity
to refer to Belmont as a masterpiece again, to\--to stand in awe of the
work of the National Commission as just an extraordinary achievement
that even the regulations are deserving of some praise for translating
adequately, I think, pretty close to adequately the recommendations of
the National Commission and keeping those regulations within the
principles of the Belmont are all worthy of commendation.

And then institutions who carry out our research today and the IRBs who
play the critical role of protecting humans and assisting our
investigators in protecting humans in an adequate and perhaps specially
honorable way are all worthy of commendation of their achievements over
the last 25 years. And I think, sure, there\'s room for improvement.
There are opportunities for improvement and enhancement, and I don\'t
think that we would have much objection to that if we came forward with
revisions that would improve the system. But the system works.

INTERVIEWER: Excellent. Thank you so much, Bill.

MR. DOMMEL: You\'re welcome. Thank you very much for inviting me.

-- END OF INTERVIEW --