> ![](media/image1.emf){width="1.5in" height="0.38055555555555554in"}
>
> Oral History of the
>
> Belmont Report and the
>
> National Commission for the Protection of Human Subjects
>
> of Biomedical and Behavioral Research
>
> Interview with
>
> Duane Alexander, M.D.
>
> Director, National Institute for Child Health and Development
>
> National Institutes of Health
>
> Bethesda, MD
>
> July 9, 2004
>
> Belmont Oral History Project
>
> **INTERVIEW**
>
> *Interviewer: Patricia C. El-Hinnawy, Office for Human Research
> Protections Staff*
>
> *INTERVIEWER: Dr. Alexander, to begin, could you give us your name and
> your degrees, and the current title that you have?*
>
> DR. ALEXANDER: I\'m Dr. Duane Alexander. I\'m the Director of the
> National Institute of Child Health and Human Development at the
> National Institutes of Health in Bethesda, Maryland. My degree is an
> M.D.
>
> *To start off, could you tell us why the Commission was formed?*
>
> DR. ALEXANDER: The Commission was established by Congress, I think, in
> large part to get the debate on biomedical ethics issues off the floor
> of the Congress and provide a cooling-off time while the Commission
> could deliberate the issues in public but without the political
> pressures the Congress was having placed on them.
>
> At the time, they were dealing with the issues of the Tuskegee
> syphilis study, psychosurgery, research with prisoners, research with
> people who had mental impairment, and then the crowning blow was fetal
> research\...research on the human fetus after abortion.
>
> And there was so much time being taken up in discussion and debate on
> the floor of both the House and Senate on these issues that they
> needed to try to get a resolution off the floor and move this to a
> commission for discussion -- fact-finding -- rather than legislating
> in haste to put bans on all kinds of things, which we were facing,
> that could have been harmful in the long run.
>
> So the Commission was the perfect solution. It got these issues off
> the floor of the Congress. It got them into the realm of a commission
> of people with expertise in the area; respected scientists and
> civilians and ethicists who could deliberate these in public, but
> without the political pressures on them that the members of the
> Congress felt, and come up with recommendations.
>
> The other thing that was going on at the time was the Department
> acting to develop regulations for the protection of human subjects.
> And they were proceeding, also, very hastily under the pressure of
> these things happening on the floor of the Congress. And by requiring
> the Department to respond to recommendations from the Commission, with
> either regulations or saying why they were not going to do these
> things for each topic to be studied by the Commission, this also took
> some of the pressure off the Department for its regulatory process for
> the subgroups of human subjects.
>
> So that combination of trying to get the debate off the floor of the
> Congress and trying to allow the development of regulations by the
> Department to proceed in a more orderly fashion, I think was the
> impetus for establishing the Commission and I think, really, it was a
> very, very wise move.
>
> *What was your role\--how did you come to be a part of the
> Commission?*
>
> DR. ALEXANDER: When issues first arose, they focused really on the
> NIH. And as they focused on children and then on fetal research, they
> came to the National Institute of Child Health and Human Development
> for a response.
>
> And I was, at the time, the assistant to the Scientific Director of
> the NICHD, Dr. Charles Lowe, who got the assignment of preparing NIH
> responses to issues of fetal research, and then research on children,
> and then, broader issues of protection to human subjects.
>
> We had worked with the scientific and ethics community to get advice
> in how we might best respond\...and were working in this area when the
> Commission got established. The Department then came to NIH and to Dr.
> Lowe and asked him to be the first Executive Director of the
> Commission. And he asked me to come with him in this role to work on
> the staff as the physician on the staff.
>
> Because we\'d been working on this together and because I had a very
> special interest in the issues of research with children and research
> on the human fetus, in particular, I agreed to do that
> enthusiastically.
>
> *And what brought about your interest in research with children and
> research on the fetus?*
>
> DR. ALEXANDER: I\'m a pediatrician, so, obviously, I had a vested
> interest in the issue of research on children. I had spent several
> years here at NICHD involved in research of various types\...and was
> very keenly professionally and personally committed to making sure
> that research with children would not get banned, that it would be
> allowed to go forward in an ethically acceptable way so that we could
> gain the knowledge we needed so badly to improve their health and
> development and well-being.
>
> There was great concern at the time that impediments could be placed
> in the way of getting this research on children done, to the detriment
> of children. Sometimes we protect people to their harm. And there was
> a very real risk that this could have happened with children; with
> other population groups; particularly, others that couldn\'t give
> consent.
>
> And I was committed to trying to do what I could to provide
> information to people who were in decision-making positions that would
> try to make the case for the importance of this research going ahead.
>
> *You mentioned this slightly, about the political climate or the
> political environment at the time that the Commission was formed.
> Could you tell us a little bit about that?*
>
> DR. ALEXANDER: Biomedical ethics had rarely received the attention
> from the public and from the Congress ever before that it was
> receiving at the time the Commission was established. This came about
> because of revelations of some kinds of research that had been
> published claiming some research had proceeded unethically -- research
> on prisoners, research on dying patients, research on persons with
> mental retardation or mental disability, and then, particularly,
> research on the African-American men from the Tuskegee syphilis study.
>
> But the crowning blow, really, was the issue of research on the
> aborted fetus. This took on a very special significance because it
> came just after the *Roe v. Wade* Supreme Court decision on abortion.
> And opponents of that decision and opponents of abortion looked for
> any ways they could to cast abortion in a worse -- even worse --
> light.
>
> And one of those things that happened to provide fuel for that fire
> was the report of a study conducted in Scandinavia in which fetuses
> after abortion had their heads severed and were used for research on
> brain metabolism.
>
> This was a study that was distasteful to just about anybody and could
> be used maximally to create a distaste in the public, as well as the
> Congress for this kind of research and to further the concern about
> trying to put an end to this research.
>
> So there were calls for bans on research on children, calls for bans
> on research on the fetus after abortion, calls for banning research on
> prisoners\...all these coming together.
>
> So, this was a highly charged political issue. Then getting it off the
> floor of the Congress and into the hands of a commission that was to
> deliberate, initially, for two years and then for four years as they
> got extended, was a very wise move that I think helped to prevent a
> significant amount of that research from being stopped permanently.
>
> As it was, we had a moratorium on research on the human fetus after
> abortion for four months or until the Commission had made its report,
> which it did in five \[months\]. But after that report was issued,
> that moratorium was lifted and that research, under the regulations
> that the Department developed, was allowed to go ahead.
>
> *Do you think that studies like the ones you\'ve cited could happen
> today?*
>
> DR. ALEXANDER: I think the likelihood of studies like the Tuskegee
> syphilis study or the research -- some of the research on patients
> without them even knowing they are research subjects, or research like
> some of the fetal research after abortion -- is highly unlikely to be
> able to get done today\...not just in the United States, but virtually
> anywhere in the world.
>
> Times have changed considerably, partly because of the work of this
> Commission; partly because of the work of other bodies in Europe and
> under the auspices of the World Health Organization, World Medical
> Association, and others, that I think make it highly unlikely that we
> will again see abuses of human subjects in research like we had seen
> in the past.
>
> *We\'ll step back in time a little bit to the Commission. Today, some
> people think of the Commission\'s work as being represented entirely
> by the Belmont Report. Is that how it looked in 1974 to 1979?*
>
> DR. ALEXANDER: The Commission\'s work is represented by far more than
> just the Belmont Report. The Belmont was one thing, almost a
> sidelight, at the time that the legislation was put together compared
> to their major tasks, which were to produce recommendations for how
> research on human subjects should be conducted in general and then how
> it should be conducted on sub-populations who were at particular risk
> or were particularly unable to give consent for
> themselves\...children, persons with mental illness or retardation,
> and other groups, the fetus.
>
> And so those were really the key reports on which the Department was
> required to develop regulations\...either accepting *in toto* the
> recommendations of the Commission or saying why they weren\'t going to
> and developing some regulations, instead.
>
> And that was another beautiful part of the legislation that created
> the Commission -- that it was not a report or a series of reports from
> a Commission that could just get received and people say thank you and
> put it on a shelf.
>
> By law, the Secretary had to respond within a certain number of days,
> I think it was 180 days by either issuing regulations, putting into
> place the recommendations of the Commission saying why they weren\'t
> going to do that.
>
> And so those things that got translated into regulation actually had
> more direct impact than the Belmont Report itself did. The Belmont
> Report was sort of overarching guidelines and principles on which
> these other regulations really relied for their fundamental
> principles.
>
> But the immediate impact of the Commission\'s recommendations in these
> other areas was really greater than the Belmont Report. So the public
> probably associates the Belmont Report with the Commission more than
> anything else. But we shouldn\'t forget that every regulation that
> exists for research on the fetus, research on children, research on
> prisoners, research on people in general\....all that had its origin
> with the recommendations from the Commission.
>
> *A very powerful responsibility, then?*
>
> DR. ALEXANDER: Yes.
>
> *As you look back on your experience with the Commission, is there any
> part that stands out more in your memory than others?*
>
> DR. ALEXANDER: I guess the part that stands out most for me was the
> work on the report on the fetus. That\'s the one that I had the most
> extensive involvement on, probably because I had been working in this
> area at NIH, before I went with the Commission, completely. And
> second, because it was done with such enormous visibility and under
> such an incredibly tight timeframe.
>
> The law gave the Commission four months from the time they were
> established to come up with a report on recommendations on the
> fetus\...and imposed a moratorium on that research until the report of
> the Commission was delivered. And the Department would act on it.
>
> So, we had a very, very incredibly short timeframe, in order to gather
> the information for the Commission. And we worked very quickly, we
> worked as fast as federal regulations and rules would allow us to do,
> to form several different groups that provided information on various
> aspects of the topic: literature reviews on what research on the fetus
> had been done and reported in the world literature and descriptions of
> those various categories.
>
> Another group had looked at survivability and viability -- what was
> the lowest birth rate and the lowest gestational age at which a fetus
> had ever been born and survived. And another review of world
> literature and hospital experiences was done by this group\...and then
> ethical issues with regard to our research on the fetus.
>
> All these were put in place and done and reports delivered to the
> Commission in record short time. And we worked very, very hard to get
> that done. The Commission worked very, very hard to get it done; and
> they didn\'t quite do it in four months, but they did it in five. And
> they delivered the report and the Department responded, also,
> extremely rapidly. Basically, right after they got the report, they
> had regulations developed and published and the moratorium lifted. So,
> it happened very, very quickly.
>
> It was an exciting time. It was a high-pressure time, the stakes were
> big here. And the Commission responded beautifully based on the
> information that they got. They took into account, you know, some of
> the emotional overlay and concern, as well\...and recognized the kind
> of importance of the public policy that they were representing with
> their recommendations. But they also paid attention to the facts;
> believing, as Ken Ryan \[ph\], their chairman often said, good ethics
> begins with good science and good facts.
>
> And they were determined that they were going to make their report
> recommendations consistent with the scientific information and the
> ethics advice that they got. And they did a really good job.
>
> That was an exciting time and probably the thing that I remember most
> about the Commission.
>
> *Which of the topics generated the most discussion among the
> Commissioners and the staff?*
>
> DR. ALEXANDER: Well, this was a discussing commission. There\'s not
> much that they didn\'t discuss pretty extensively. But they were very,
> very thorough. They were extremely conscientious.
>
> They took their jobs very, very seriously. They met every month,
> flying in from all over the country for these two, sometimes two and
> a-half, three-day meetings. And they really pursued every issue in
> depth.
>
> They wanted to be sure that they got the science; that they got the
> ethics opinions and the full range of ethics opinions and that there
> was not a source of information that went untapped to get them what
> they needed.
>
> And then they discussed, deliberated with each other in depth. So
> there really wasn\'t anything that got neglected. As to what they
> probably spent the most time on, they spent a lot of time on the
> fetus. They probably would have spent more time had they not been
> under such a short deadline.
>
> They had a real hard time grappling with the issue of prisoner
> research. There was a lot of division there. Not so much when they
> started as when they came to debate at the end because of the
> information that they had gotten from site visits to a prison where
> research was being done, from site visits to a different kind of a
> set-up that used a reward system for good behavior in a particular
> way, to other information that they had gotten in interviews with
> prisoners with drug company officials, and so forth.
>
> And they really had a hard time grappling with that one. But every
> issue that they dealt with, they did in depth. The discussed it
> thoroughly and they worked extra hard, trying to reach consensus.
>
> As, Ken Ryan said, right at the outset, as chairman, if we issue a
> report that has five different dissenting opinions among 11 Commission
> members, nobody\'s going to pay attention to it. And so that kind of
> set the stage for a very conscientious effort on the part of the
> members to try and understand where each other was coming from, to
> understand and reason together the various principles on which any
> recommendations would be made, to understand the science as well as
> the ethical issues and concerns\...and to try and -- by reasoning
> together -- reach a consensus to the fullest extent possible. And they
> really succeeded in doing that in just about everything.
>
> The report on children has a couple of dissenting comments from
> several members, but that\'s the only one that has anything in terms
> of any extensive dissent, other than, maybe the one on the report on
> the fetus. But they really did a good job of reaching consensus.
>
> *It would be hard to imagine something like that today?*
>
> DR. ALEXANDER: Well, it\'s still possible. The other thing that they
> did was -- they got to know each other socially and individually.
> Every meeting, a different Commission staff member would host a dinner
> or a reception in the evening that went on into the night for the
> members and the staff. And we really got to know each other and
> respect each other very much.
>
> Our Commission members would go to an ice hockey game together or a
> basketball game. When we would be in other cities, one of the
> Commission members, if they happened to live in the area, would host a
> Commission reception at their home.
>
> Ken Ryan, when we were visiting the **Frenault \[?\]** State School,
> an institution for mentally retarded individuals near Boston, had the
> whole Commission to his home for a dinner that evening. Some of the
> Commission members would host an event for the other when we were in
> their area.
>
> So people got to know each other socially. They respected each
> other\'s views and all that worked together to create a very positive
> working atmosphere among these eleven individuals, that they really
> wanted to get consensus to the fullest extent possible. And it worked.
>
> *As a Commission staffer, what did you feel was your most important
> contribution to the work of the Commission?*
>
> DR. ALEXANDER: Well, I think probably what I would consider my most
> important contribution was helping get the report on the research on
> the fetus done within the timeframe that the Congress had set out.
>
> Getting that information to the Commission and really, by those
> actions, helping to set the tone for future reports that we were going
> to get them every bit of information they would like to have, to the
> extent that was possible, so that they would be able to make their
> recommendations based on the best information possible\...and have it
> a fact-finding Commission and a factual basis action Commission.
>
> So I think that was important, partly because of the content and
> partly because it kind of set the tone for the approaches that we
> would take with future reports and topics.
>
> I think that was important. I think the work on children\--the
> children\'s report -- was important. And I think those were the major
> contributions.
>
> *All this was done before the Internet and e-mail?*
>
> DR. ALEXANDER: And before typewriters that you didn\'t have to use
> WhiteOut and CorrectType for. That was\--that was how we did it. We
> had one of the first computer-based typewriters at NIH, helping to get
> the work of the Commission done, when they were just coming into use.
>
> *If you could go back in time to the Commission is there anything you
> would do differently?*
>
> DR. ALEXANDER: That\'s an interesting question. You know, I can\'t
> think offhand of anything we would have done differently because we
> had time. If we had been held to two years, as the original
> legislation proposed, the Commission\'s work would have been far less
> thorough and professional. But extending it to give that Cassure that
> the products were sound, well-thought out, well reasoned and, really
> excellent, in terms of their quality. So that helped a lot.
>
> Maybe giving it four years at the outset would have been useful, maybe
> giving six months instead of four months for the fetal research report
> might have been helpful. I don\'t think the outcomes would have been
> different, it might just have been a little less hectic. But all in
> all I think the Commission did its job well. I\'m not sure what I
> would have done different.
>
> I think the membership on the Commission was terrific. It was a very
> representative, balanced group of people who really cared about what
> they were sent out to do as their task.
>
> *And do you know how the Commission members were selected?*
>
> DR. ALEXANDER: The final decision was with the Secretary who was
> Casper Weinberger, at the time. NIH had the task -- the lead task --
> in putting together a slate and we contacted a wide variety of
> organizations, professional societies in medicine, in ethics, in other
> areas, as well as, you know, the National Academy of Sciences. We got
> many recommendations from members in Congress. And then these were
> vetted at the NIH and within the Department and a slate of possible
> people went to the Secretary, who made the final decisions.
>
> But there was a very broad effort made to tap a very representative
> group. The law prescribed that the majority of the Commission be
> non-scientists, so we had three medical scientists and two behavioral
> scientists and the others were from law, ethics areas and public
> policy. And so it was a minority of scientists prescribed by law. And
> it worked out very, very well.
>
> *Good lesson.*
>
> DR. ALEXANDER: Yes.
>
> *Were there any issues or ideas that you felt the Commission could
> have addressed but didn\'t?*
>
> DR. ALEXANDER: I think the tasks set out for the Commission by the
> legislation were pretty comprehensive. I don\'t think that they needed
> any other topics to address. I don\'t think they asked for anything
> else to address.
>
> One thing that did come up right at the end of their tenure was the
> birth of Louise Brown through *in vitro* fertilization (IVF). So that
> came to a subsequent body, a successor body to the Commission to deal
> with -- with recommendations with regard to *in vitro* fertilization.
> The Commission never really dealt with that one because efforts were
> being made but had not yet been achieved for a successful human IVF. I
> think people knew it was bound to come but since it had not occurred
> yet the Commission didn\'t deal with that. They had plenty of other
> things to do.
>
> And so, their successor body the President\'s Commission dealt with
> that issue.
>
> *In a somewhat broader sense, since the time of the Commission\'s
> work, what changes have you seen in human subject protections?*
>
> DR. ALEXANDER: The changes that have occurred have really been
> minimal. Even though groups have been set up to look at the
> regulations, very little has been recommended in terms of change.
> Sometimes interpretations have been required. A particular case in
> point involved the children\'s regulations, where the issue of what
> constitutes minimum risk and minor increase over minimum risk was
> interpreted differently by different groups.
>
> Mainly, it revolved around whether minimum risk was an absolute or a
> sliding scale, such that minimal risk for a very sick child might be a
> greater risk than minimal risk for a well child. This was never the
> intent of the Commission, but some people started interpreting it as a
> sliding scale.
>
> And the actions that have been taken since that time by the advisory
> groups that have been asked to look at it have re-enforced the
> original concept of the Commission that this is an absolute -- that we
> mean minimal risk for a healthy child and it does not change what
> minimum risk is if you\'re really sick.
>
> So, that, I think has been clarified. The only real change in the
> regulations themselves, that was Subpart B -- Research on Pregnant
> Women and the Fetus -- and the wording has been changed there just a
> little bit but not a whole lot, with the subsequent revised Subpart B.
>
> And I think that the change that we have seen really relate to people
> being more comfortable with extending research to people, perhaps with
> less capacity to consent or with, perhaps, some greater risk, than was
> envisioned that was possible, really, at the time the Commission did
> its work. And I credit the Commission\'s work and the regulations that
> were put into place as reassuring an anxious public that research was
> going to be done in an ethically accepted way, that there were
> standards in place, that the ethical principles from the Belmont
> Report were guiding this research, that there were regulations that
> were providing for protection, that there was an institutional review
> board wherever research was done that was looking at research -- each
> individual project -- and passing on whether it was acceptable to do
> as proposed or needed to be modified.
>
> With this reassurance of an anxious public, I think that the general
> perception of research gradually changed from something that posed
> great risk to people and a burden to be avoided, to a benefit to be
> desired. And the actual reflection of that change took place, I think,
> first with the AIDS epidemic. And as AIDS appeared and spread, people
> recognized that the only way that there was going to be any
> development of treatment, of prevention or cure was going to be
> through research. And that research, even if you were dealing with
> some vulnerable people or not, needed to be done.
>
> And holding back research for people was doing far more harm to them
> as individuals and groups, than offering research far more broadly.
>
> And I think it was, in my perception, it was the onset of the AIDS
> epidemic and the people who were the leaders in the AIDS movement to
> recognize research as their only potential salvation; and as a benefit
> eagerly to be sought, rather than avoided, did help to start the real
> swing of the pendulum from extreme protectionism to a more liberal
> approach to enrolling subjects in research.
>
> That was followed by the women\'s health movement. And we saw women
> clamoring to be included in research. Men were in the studies, women
> need to be included, too. And so women, again, as a group saw research
> as a good, rather than a risk to be avoided.
>
> The same thing happened with minority populations. The
> African-American population, said, hey, we have disparities in our
> health. We\'re not doing as well as the white population in this
> country. We need to know why and we need to have our people eligible
> to participate in research and encouraged to participate in research
> for the benefits that accrue to them from research. Directly as
> individuals and as a group.
>
> And so when minority populations, who had felt so threatened because
> of the Tuskegee revelations -- even there -- we began to see research
> viewed in a positive light, rather than a negative one.
>
> And then, the last to join in this group -- and it came after Congress
> passed legislation requiring NIH to include women and minority groups
> in our clinical research studies -- children, then, came to be
> included, as well. And the pressure came here, as well.
>
> You can protect children to their harm, if you protect them from
> conservatism on institutional review boards and people being unwilling
> to give approval to projects without enormous information being given
> to people in the consent process. But that\'s not based on the
> regulations.
>
> Where that comes up is in terms of institutional protection, rather
> than subject protection. And I think what happens sometimes is that
> institutions get so concerned about protecting themselves against
> claims of inappropriate research conduct or whatever, from subjects,
> that they go to extremes in requiring what people must be told or how
> they may be selected, or whatever, as a condition for approval for the
> project to go ahead.
>
> This is just intrinsic to a system. Any time you have groups assigned
> to do these kinds of tasks, there is a risk of them becoming
> excessively protective of the institution or their role as
> individuals, rather than mainly assuring that people get the essential
> information that they need.
>
> So this is the main concern that I think we see raised by people who
> have complaints about the system being excessively restrictive. And
> it\'s not the regulations themselves. It\'s not the ethical principles
> themselves, it\'s how these may be carried out in various
> institutional settings that go, perhaps, beyond the letter and the
> intent of the regulations themselves and forget who the primary group
> is to protect, which is the subject.
>
> *Do you feel the subjects are at any greater risk today than they were
> 25 years ago?*
>
> DR. ALEXANDER: I think subjects are at far less risk today than they
> were 25 years ago, because of what\'s in place to provide assurance of
> their protection.
>
> First is the knowledge and awareness of investigators of what has to
> be done to make sure the subjects understand that they are in research
> and what that research involves and that they have a choice in whether
> or not to participate, and the precautions that have to be taken
> during the course of research. And I think subjects themselves are
> more aware of research and what it requires and what it doesn\'t
> require\...and how they can act to protect themselves, by asking
> questions, by getting information and they have the authority to
> withdraw at any time.
>
> The system of institutional review boards that we have in place adds
> to this protection which starts with the investigator and the subject.
>
> But then we have the institutional processes involved, as well, that
> enhance that protection. So I think that subjects are at far less risk
> today\...both because these are in place and because we monitor their
> participation in research and we monitor the impact of any
> interventions that we do, much more closely than we did 25 years ago.
>
> *We\'re going to take a slight side step. When we look at children\'s
> research in international settings, how do you think the ethical
> standards that were developed for this country apply in those
> international settings?*
>
> DR. ALEXANDER: Countries vary greatly in their inclusion of children
> in research and in the protections and oversight they provide when
> children do participate in research. And this variation is within
> Europe, it\'s within developing countries as well.
>
> Many countries are much less permissive than the U.S. is, when it
> comes to involving children in research. Many do not do it at all.
> Many do it with only for what we would call highly therapeutic
> research, when it\'s highly likely that that individual subject is
> intended to benefit but not at all for research where there is not
> that benefit to the child, regardless of risk.
>
> But most of them have protections in place comparable to what we do in
> terms of the principles of informed consent, of permission of parents,
> of institutional review board equivalence, whatever.
>
> In developing countries, the situation is quite different. Many of
> them are still developing the concepts of what is research, what does
> it mean to participate in research, is there an IRB, is there only one
> for a whole country?
>
> And so, in developing countries, the situation there varies widely,
> but the reach of the United States roles for what we support, goes
> wherever the researcher goes and wherever the U.S. dollar goes that
> supports that research\...so that, if we are going to conduct research
> in a developing country, there must be that kind of process, an
> institutional review board process, or whatever.
>
> We\'re involved in research in a developing country at the present
> time within NICHD in a global network for maternal and child health,
> where we\'re studying ways to improve the process of labor and
> delivery to make them safer.
>
> Research is a foreign concept -- women having any say about what they
> do themselves, rather than their husbands having the control -- is a
> totally foreign concept, yet we have to find a way to get review of
> that research in that country\... to get some acceptable means about
> informing the women about what\'s going to be done and that it is
> research and that they have a decision role to play in whether they
> participate in that or not.
>
> So, even in the most underdeveloped of developing countries, if the
> U.S. is involved in that research, our rules pertain. And while they
> may not have the sophisticated IRB that we have here or they may not
> have subjects who are as sophisticated about a consent process, the
> elements of an ethics review in that country and the elements of
> telling people what they\'re going through and that they have a choice
> whether to do it or not, still apply.
>
> *Do you think that the HHS regulations appropriately embody the three
> ethical principles of the Belmont Report?*
>
> DR. ALEXANDER: I think that the regulations really reflect and are
> built upon the basic principles for research in the Belmont Report.
> They find their expression in the concept of informed concept; in the
> concept of balancing research risks and benefits; and in subject
> selection. All the three cardinal principles of the Belmont Report for
> Research. So they embody those, but they go beyond those and extend to
> cover other ethical principles, as well. But the foundation is still
> those three.
>
> *I\'d like to ask you how your work with the Commission has impacted
> the rest of your career since then?*
>
> DR. ALEXANDER: Well, the work with the Commission is one of the most
> enjoyable things that I have ever done professionally. It was a
> wonderful group of people to work with. It was a very significant task
> to be engaged in with the government and the public sector.
>
> It was, I think, an important contribution to medical research in this
> country and the world. And to improving the health of people worldwide
> because we facilitated the continuation of research being done in an
> ethically acceptable way, rather than putting such prohibitions on it
> that we couldn\'t gather the knowledge we needed to improve people\'s
> health.
>
> So, I just look back on it with very fond memories of what the
> contributions were and of the pleasure that we had in working with the
> Commission members and the other staff members. All of whom brought
> special skill sets and special personalities and wisdom to this
> subject.
>
> Since that time, I\'ve continued to be involved in ethical issues,
> particularly with regard to research with children and research during
> pregnancy.
>
> What I learned as a result of that experience has stood me in
> incredibly good stead as director of the Institute of Child Health and
> Human Development, that deals more than any other with issues of
> research in pregnant women; research in women\'s health; research in
> children\'s health; research on the fetus; research on the embryo.
>
> All these issues, are particularly significant and have their own
> nuances. And the understanding and the depth of knowledge that I
> gained as a consequence of my experience with the Commission, have
> been very, very valuable to me in dealing with these issues that the
> institute has had to deal with.
>
> In addition to that, it\'s been my privilege during the last 10 or so
> years to be the representative from the United States to the Council
> of Europe\'s Committee on Bioethics, which is dealing, for the
> European countries with the same issues in biomedical research and
> practice that we have dealt with here in the United States.
>
> We\'re dealing with the same things contemporaneously now in Europe
> and in the United States. And it\'s been a very interesting process to
> see how members of this committee have worked through trying to come
> up to solutions to the very same ethical issues that the Commission
> grappled with and that we\'re grappling with now, in contemporary
> biomedical ethics. So that has been an opportunity that I would not
> have had without my involvement with the Commission.
>
> I\'ve also continued to be involved with the evolution of the
> Department\'s regulations, participating in revisions of Subpart-B, as
> well as taking the lead responsibility when the issue of the inclusion
> of children at NIH research came to the fore. That was handed to me as
> a lead person and gathered, again, following the Commission model,
> gathered information on what was happening with inclusion and
> exclusion of children in the clinical research that came to the NIH;
> putting a group of people together for a conference to address this
> issue and come up with recommendations and then come up with
> finalizing the NIH guidelines for this.
>
> So, that was another activity that I got responsibility for where the
> experience with the Commission was extremely valuable.
>
> *Is there anything else you would like to add?*
>
> DR. ALEXANDER: One of the best things about the Commission was the
> interactions that we had with the commission members themselves and
> with the staff.
>
> This was an extraordinary group of people who were on the Commission
> and the staff members. They came from vastly different backgrounds,
> but they all had their own expertise, their own ideas, their own
> commitments to bring to the issues that they were to address.
>
> So, it was just such a pleasure to have the opportunity to interact
> with them in this four-year period. And since the dedication and
> commitment that they brought to this issue and I think their sense of
> public service in trying to help the U.S. government, the U.S.
> behavioral research community, deal with this in a way that would
> assured a worried public that research was going to be done in an
> ethically acceptable way that was going to provide benefit to them and
> not ut them at undue risk of harm.
>
> And the fact that the work of the Commission has really stood the test
> of time and that those basic principles from the Belmont Report are
> still the basic principles, that the regulations that the Department
> issued based on the recommendations of the Commission have stayed
> almost unchanged during that period of time -- I think is a pretty
> good tribute to the good work that the Commission did.
>
> *Dr. Alexander, thank you very much.*
>
> DR. ALEXANDER: Thank you, my pleasure.
>
> -- END OF INTERVIEW --