TRANSCRIPT: Meeting Six, Welcome and Opening Remarks

            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

  you.

            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

  1948.

            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

  Federal Government.

            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

  historical injustice.

            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

  world.

            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

  Across Borders.

            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

  website tomorrow.

            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

  internationally.

            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

  coming up.

            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.

            Jim.

            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

  work.

            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.