TRANSCRIPT: Meeting Six, Conclusions on the Ethics of the Experiments

Date

August 29, 2011

Location

Washington, DC

Presenters

Amy Gutmann, Ph.D.

Commission Chair

James Wagner, Ph.D.

Commission Vice-Chair

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Transcript

            DR. GUTMANN:  Alas, because of time, and I

  know we're pressed for time, I'm going to wrap this up

  and ask Jim to make some concluding comments, as well.

            Our discussion was sobering to say the least

  but necessary to bring facts to light and what we're planning on putting forward publicly as our report.

            Let me try and not in any way comprehensive

  way but to outline some of the things on the ethical

  analysis side that we have agreed upon as a commission

  and you'll see that in the report we do this in a much

  more detailed way, drawing upon some of the historical

  facts that we've just in a very summary way have just

  brought to light.

            So a civilization, we've said, can be judged

  by the way it treats its most vulnerable individuals

  and it is our moral responsibility to care for those

  who cannot protect themselves and clearly in this

  history, we failed to keep that covenant.

            The research specifically included populations

  that were vulnerable and thereby deserving of

  additional safeguards to ensure their adequate

  protection.  The researchers knew that that was the

  case, as indicated in the Terre Haute experiments.

  Prison inmates in Guatemala, institutionalized and

  mentally-disabled individuals and children were among

  the groups most frequently included in the Guatemala

  experiments.

 Federal regulation, international codes and

  the ethics literature all acknowledge that research

  involving these groups raises unique issues requiring

  additional attention.

            That said, many of the institutional codes and

  federal regulations that exist today did not exist at

  the time, although the Nuremberg Code had

  contemporaneously come out, and I'll say something more

  about three of the standards that were articulated in

  that Code which are not unique to Nuremberg but are

  really ethical standards that have been with us for

  centuries.

            The research team in Guatemala and their

  immediate supervisors appear to have had considerable

  latitude in the design and conduct of individual

  experiments with no evidence of substantive independent

  review of the conduct of the research.  Again, as Raju

  has pointed out, there could have been more review than

  there was.

            On the contrary, substantial evidence reflects

  efforts by the researchers to limit knowledge of the

  Guatemala activities as much as possible outside of those conducting it or directly authorizing it.

            The experimenters in Guatemala, both the

  Americans and their local colleagues, consistently

  failed to act in accordance with minimal respect for

  human rights and morality in the conduct of research.

  It's even more disturbing for us as a commission to

  find that the blame lies with medical doctors and

  scientists who hold professional positions that carry

  with them special privileges and responsibilities,

  expected to do no harm, and to abide by the highest

  professional standards of ethics.

            In the Commission's view, the Guatemala

  experiments involved basic violations of ethics, even

  as judged against the researchers' own recognition of

  the requirements of the medical ethics of the day,

  although some of those researchers clearly rejected

  those requirements.

            Many of their actions violated principles

  widely accepted as applicable at the time as well as

  the standards of our own time that are embodied in the

  ethics and regulation of biomedical research today.

  These standards include the following:

First, treating people fairly and with

  respect.  The voluntary consent of human subjects is

  absolutely essential.  That is the first sentence of

  the Nuremberg Code.

            Second, one ought not to subject people to

  harm or risk of harm, even with their consent, unless

  the risk is reasonable and there is a proportionate

  humanitarian benefit to be obtained.  Careful and

  scientifically-sound research is an essential condition

  for medical ethics.

            And third, one ought not to treat people as

  mere means to the ends of others.  Subjects must not

  only give informed consent but they also must be free

  to withdraw and they certainly ought not to be deceived

  unless they have been informed of possible deception

  and consented to that.

            The Guatemala experiments could not be

  approved under current human research protections for

  U.S.-funded research.  That is clear.  Widely-discussed

  cases in the post-World War II era with some similar

  features have led to a greater appreciation and

  articulation of the moral principles underlying medical research.

            We hasten to add that in judging and assessing

  these experiments as morally wrong and assigning blame

  to the individuals, we in no means, by no means mean to

  say this was the only example, far from it, of

  unethical experiments and blameworthiness not only in

  the 1940s but in the '50s, '60s and forward.

            A clear consensus has emerged that medical

  research must not violate human dignity or undermine

  the very human flourishing it seeks to advance in

  future patients.  The Guatemala experiments and other

  troubling violations of this norm that have come to

  light in the last 60 years shock the conscience.  They

  should shock the conscience, not in spite of their

  medical context but precisely because of it.

            It is clear that many of the actions

  undertaken in the Guatemala experiments were grievously

  wrong and that the individuals who approved, conducted,

  facilitated, and funded these experiments are morally

  culpable to various degrees for these wrongs.

            Although some individuals are more blameworthy

  than others, the blame for this episode cannot be said

  to fall solely on the shoulders of one or two

  individuals.  The unconscionable events that unfolded

  in Guatemala in the years 1946 to 1948 also represented

  an institutional failure of the sort that modern

  requirements of transparency and accountability are

  designed to prevent.

            In the final analysis, institutions are

  comprised of individuals who are expected to exercise

  sound judgment in the pursuit of their institutional

  mission.  This is all the more important when those

  individuals hold privileged and powerful roles as

  professionals and public officials.

            One lesson, just one lesson of the Guatemala

  experiments is never to take ethics for granted, let

  alone confine ethical principles, confuse ethical

  principles with burdensome obstacles to be overcome or

  evaded.

            This lesson should be a sobering one for our

  own and all subsequent human research experiments.  We

  all know of rules that feel burdensome to comply with

  and we all believe that rules shouldn't be any more

  burdensome than they need to be to protect us from

  unethical experiments, but we should be ever vigilant

  to ensure that such reprehensible exploitation of our

  fellow human beings is never repeated.

            In the charge to the Commission last November,

  President Obama said, and I quote, "While I believe the

  research community has made tremendous progress in the

  area of human subjects research protection, what took

  place in Guatemala is a sobering reminder of past

  abuses.  It is especially important for this Commission

  to use its vast expertise, spanning the fields of

  science, medicine, policy, ethics, and moral and

  religious values to carry out this mission.  We owe it

  to the people of Guatemala, to future generations of

  volunteers at home and all around the world who

  participate in medical research."

            As a commission, we shall report back to the

  President with our findings on the research and our

  analysis of the ethics of this shameful piece of

  medical history.

            That's all I have to say for now and I would

  like to turn the floor over to Jim Wagner for some

  concluding comments before we adjourn.

            DR. WAGNER:  Amy, there's very little that

  needs to be added to that statement.  Thank you so

  much.  But maybe to highlight one point or two.

            The purpose for doing this was not simply to

  put a moment of history to bed so that it could be

  sealed with some form of sealing wax that says we've done it, we

  understand it, and we condemn it, but, rather, it's to

  inform what we need to do going forward and what we

  recommend going forward, and, of course, that will be

  the purpose of our conversations tomorrow.

            The challenge, of course, is how to implement

  the kinds of principles that you spoke about, Amy, in

  such a way that they are for the well-intentioned

  researcher seeking how to pursue viable research, that

  they are an illuminating aid and not, as you said, some

  sort of onerous burden.

            On the other hand, for the other kind of

  individual or group of individuals, who understand

  somehow intrinsically that the value of their work is

  so meritorious that it is to be -- it can rise above

  restraints and restrictions and ethics, these do need

  to be horribly burdensome, in fact impenetrable, if

  possible, and how do you do all of this without unduly

  restricting the imperative that we have to pursue

  biomedical research in the service of humanity, I

  think, is the big challenge.

            And I'm pleased to be working with this group,

  to roll up our sleeves and take that as our next move

  going forward.

            So thank you very much.

            DR. GUTMANN:  Thank you.  I would like to ask

  the staff members of the Presidential Commission for

  the Study of Bioethical Issues who have worked on the

  historical report and they've worked assiduously, the

  125,000 pages of documents doesn't even come close to

  capturing all of the work and the drafts which we are

  still refining but will soon be put out there for the

  public to read, if you would all stand up so we can

  thank you for your work, I'd really appreciate it.

            (Applause.)

            DR. GUTMANN:  Tomorrow, we will reconvene and

  we will discuss contemporary human subjects protections

  standards.  This will be our third meeting addressing

  this subject and we will look forward to a full day of

  speakers and discussion.

            I want to thank everyone who's attended again

  and we will reconvene tomorrow at 9 a.m.

            Thank you very much.

            (Whereupon, at 3:13 p.m., the meeting was

  adjourned, to reconvene tomorrow morning, Tuesday,

  August 30th, 2011, at 9:00 a.m.)

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