meetings

            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

            DR. GUTMANN:  So that's a good segue, right?

  We are going to talk now in this session addressing

  directly the ethical standards of the day and, in

  particular, here are the questions we want to address.

            Did the researchers try to keep the

  experiments secret?  What standards did the researchers

  employ to protect human subjects in an earlier

  experiment conducted in Terre Haute, Indiana, in a

  federal or state penitentiary there?  I think it was a

DR. GUTMANN:  So, on behalf of Jim Wagner and

  myself, I want to thank all of our speakers and

  everybody who attended today's and yesterday's

  meetings, who have given their time, their energy, and

  their thoughtfulness.

            We have taken questions as they have come up.

  But I should urge you, because it's really important to

  us, that we welcome questions between our meetings, or

  comments between our meetings, as well.  You can go to

  our website, bioethics.gov, to submit your comments.

            DR. GUTMANN:  Welcome back, everybody.  We are

  now in session seven of this two-day commission

  meeting, and I am very pleased to welcome our two

  guests, Ruth Macklin and Robert Temple.  And I

  would -- will briefly introduce both of them.  They are

  widely known and respected, and will present us with

  two different views on the topic of trial design and

  international standards.

            Ruth Macklin is Professor of Bioethics in the

  Department of Epidemiology and Population Health at

            DR. WAGNER:  Let me invite Michelle Groman and

  Jeremy Sugarman to the table.  This next session will

  be around our commission receiving a staff report.

  Michelle Groman is senior policy and research analyst

  for our commission, and has served as a lead staffer on

  this project.  But we are going to hear first from

  Jeremy.

            Jeremy Sugarman is going to report to us about

  the empirical project, as we have been calling it, that

  the staff has been conducting to collect data from

            DR. GUTMANN:  If I could ask everybody to

  please take a seat, we are going to reconvene.

            It is my pleasure now to introduce our panel

  on community engagement.  I will introduce all the

  speakers at the beginning, and then ask each to speak,

  and then we will open it up for questions and comments.

  And I want to thank everybody who has given us comments earlier this morning for really excellent comments.

            Our first speaker will be Carletta Tilousi.

 DR. GUTMANN:  Good morning, everybody.  I

  would ask people to be -- please to be seated.  Thank

  you.  I am Amy Gutmann.  I am president of the

  University of Pennsylvania, and chair of the

  Presidential Commission for the Study of Bioethical

  Issues.  On behalf of myself and our vice chair, Jim

  Wagner, who is president of Emory University, I would

  like to welcome you to day two of our meeting.

            We welcome in particular our speakers, who

  have traveled from near and from far to be here:  our

DR. WAGNER:  In our -- thank you, Zeke.  In

  our next section we get to hear from a couple of our

  commission members, Christine Grady and Nelson Michael.

  They served along with our chair, Amy Gutmann, and John

  Arras, on the international search panel, which, as

  Amy noted before, was set up as a subcommittee of this

  commission.  On behalf of the entire commission, thanks

  to the four of you for being engaged in that.

            Now, Christine and Nelson will report to us on

              DR. HAUSER:  Thank you, Jim.  Delighted to.

  Fellow Commission Members and audience, my name is

  Stephen Hauser from the University of California, San

  Francisco.

            I would like to just briefly describe the

  details of the experiments that were carried out in

  Guatemala during this two-year period between 1946 and

  1948 and maybe as a prelude just very briefly discuss

  the scientific environment and milieu at this time.  I

  think without that, it's harder to understand the

                      Our next speaker -- our first speaker

  today -- is Dr. Ezekiel Emanuel.  Zeke was one of the

  driving forces behind this effort while he was working

  at the White House last year.

            Dr. Emanuel is the former head of the

  department of bioethics at the clinical center of the

  National Institutes of Health, and he is an oncologist

  who also has a Ph.D. in a field that is dear to me as

  well, political philosophy.  Dr. Emanuel has published