Amy Gutmann, Ph.D.
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DR. GUTMANN: Good afternoon, everybody. I'm
Amy Gutmann, and I'm President of the University of
Pennsylvania, and Chair of the Presidential Commission
for the Study of Bioethical Issues.
On behalf of our Vice Chair Jim Wagner, who's
President of Emory University, and myself, I welcome
everyone to this, our Sixth Meeting of the Commission.
It is -- before we continue, let me note the
presence of our designated federal official, Commission
Executive Director Valerie Bonham. Val, will you
please stand up so people can recognize you? Thank
We, as a commission, are now well into our
work responding to President Obama's charge on the
topic of human subjects protection. As you'll recall
last Fall, we learned that the United States Public
Health Service conducted intentional exposure studies
involving STDs, sexually-transmitted diseases, with
vulnerable populations in Guatemala between 1946 and
Following this revelation, President Obama
charged us to do a study of both the historical and the
contemporary situation with human subjects research.
So there are two tasks.
One, to do a thorough fact-finding
investigation in to the events in Guatemala to
determine what happened and also to decide what our
ethical position is on what happened, and the second is
to determine if contemporary human subjects protections
adequately guard the health and well-being of
participants in scientific studies supported by the
We're pleased to report that the historical
investigation is near completion. The Commission staff
has devoted the last nine months to conducting
comprehensive independent research into the Guatemala
studies. This is and will be, when we bring it out,
the most comprehensive study of this series of
experiments to date.
During this time period, they reviewed over a
125,000 documents. They also created an inhouse
document library of over 13,000 documents that inform
most of the facts in this report.
The staff reviewed documents compiled from
nine archives, three libraries, and five government
agencies. Source included institutions, such as the
National Archives and Records Administration,
PanAmerican Health Organization Headquarters Library,
and the Bureau of Prisons.
From all of that information, this report was
drafted and today we'll discuss some of the answers
we've uncovered to key questions about the studies in
Guatemala. The best thing we as Americans can do when
faced with a dark chapter in our government's history
is to bring it to light. It is important that we
accurately document this clearly unethical episode of
We also have called on our sense and
sensibility, if you will, about bioethics and added a
careful and, I would say, unvarnished ethical analysis
to the historical investigation. We do this, to put it
as simply as possible, to honor the victims and to make
sure it never happens again.
Before we turn to the historical
investigation, which will be the topic for the meeting
today, I'd like to take a moment to talk about the
Commission's other activities.
The second part of the President's charge on
human subjects protection is to review current rules
for human subject protection and determine if these
rules, coupled with the practices that accompany them,
protect people participating in federally-funded
research from harm and unethical treatment.
In carrying out this part of the human
subjects assignment, the Commission has done a number
of things since we last met. An international research
panel was set up as a subcommittee to the Commission.
That panel consisted of international experts on human
subjects protection standards and international
research. The panel members came from all over the
Since the Commission's last meeting, the
international panel held its second and third meetings
and it's poised to complete its work. The panel has
reported its findings and recommendations to the full
Commission in the form of a report entitled Research
We have sent this report to be published in
the Federal Register and we look forward to taking
public comments on it. The panel report will be on our
I'm very grateful to Commission Members John
Arras, Christine Grady, and Nelson Michael, who sat on
the international research panel, and they will report
to us. Christine and Nelson will take the lead and we
will have a report tomorrow on the panel and its work
and a discussion on it, as well.
We're also collecting data from government
agencies that support research involving human
subjects. What we're going to do with this information
is to be able to describe to the President the
landscape of human subjects research that is supported
by the Federal Government, domestically and
There is no such set of empirical data
available at the moment and there is nobody in the
process of collecting it. So we decided this was a
very important first step which will accompany our
investigation into the adequacy of the rules and
practices concerning human subjects research.
In December, we will complete the second part
of the President's human subject protection assignment
and we will deliver our report about contemporary human
subjects research to the President in December.
Finally, we're making progress on our next
project, called Genes to Genomes: Collecting, Using
and Governing Genome Sequence Data.
This project will address how the growing
amount of collected and available genetic data raises
the bar on data protection, privacy, consent, issues of
individual counseling, among other important issues,
and we will devote the Fall and Spring to this subject
and produce a report next summer.
Following this project, so when I said
finally, I was not telling the truth, I will
now -- since I'm a truth-telling person, that was
penultimately, following this project, a project we
haven't started working on, so it's true that I've just
said everything that we've been working on to date, but
following this project, we are going to begin another
topic called Neuroimaging and The Self which focuses on
advances in neuroimaging and the implications for moral
and legal responsibility. So we have a very full year
Unfortunately, due to the hurricane this
weekend, Dr. Rafael Espada, Vice President of
Guatemala, who was planning on being with us, planning
on flying up yesterday, you can understand why he was
unable to travel to Washington to be with us as
scheduled. He sends his regrets.
I am very sorry that he couldn't be with us
today. We have enjoyed a very good working relationship
with Dr. Espada throughout our investigations. We very
much appreciate all that he has shared with us.
I would like to say a few words about how we
will take comments from the audience at this meeting
before we get started.
We are -- we have a lot to accomplish today
and tomorrow and a short amount of time to do it. So
what we've done at the Registration Table out front,
there are comment cards and we ask that anyone who
wishes to make a comment write down any comments you
have on the cards, hand the card to any staff member,
and they're all wearing badges. Would staff members
stand up so people can recognize you? Okay.
So any staff member can take a card and the
staff will give Jim and me cards throughout the session
and, time permitting, we will read them aloud and we
will engage in responses. All I ask is that any
questions or comments you make be relevant to the
sessions that we are engaged in.
And with that, I think we've done all the
preliminaries. We know our beginning. I'm going to
turn to Jim Wagner, our Vice Chair, and see if he has a
few opening remarks.
Thank you all for being here, and let me just
thank -- there will be opportunities later, and I will
thank the staff for the incredible work they've done,
especially on the historical report, but let me also
thank all the commission members who traveled to get
here today, for getting here. Somebody once said 90
percent of success in life is showing up. Well, I'm
glad you've showed up. We have a lot more to do
besides that, but thank you for being here.
DR. WAGNER: Very good. Amy, thank you so
much. Let me also thank the staff for the hard work on
what we're about to discuss, the historical report of
the Guatemalan incident, and thanks to all the
commissioners for all of their work, mostly offline
This is an opportunity this afternoon to be
overheard as we talk to ourselves about the -- thank
you -- as we talk to ourselves about the report now in
draft form and, as you heard Amy say, that we want to
discuss the facts and, as well, as have some
conversation about our ethical analysis.
In fact, the ethical analysis will be the
second piece in Session 2. Now we're going to spend
some time talking about the historical investigation
into the inoculation studies in Guatemala. Our
investigation is to document a couple things, a number
of things, but it documents the actual events, first
and foremost, and tries to explain these events in the
context in which they occurred.
It's important to understand not only the
details of the work that Dr. Cutler and colleagues did
but also how the study in Guatemala fit into the wider
context of what was going on in venereal disease
research at that time.
To set the stage, we know that syphilis,
gonorrhea, and other venereal diseases were among the
most serious public health problems of that day and
researchers leading these efforts were at the time some
of our nation's very best scientists. So what happened
is the first question and why, and then the second
question in our second session is about the ethical
appropriateness of that.
I think, Steve, you're going to lead us, are
you not? Steve Hauser is going to lead us in an
initial discussion on the facts where we'll talk. We
hope to touch on such things as what were the
scientific questions involved, what methods were used,
what populations were involved, was the methodology
sound, and not just by our standards but all in the
context of the standards of that day.
So if you'd open our first session with your
comments, Steve, I'd appreciate it.