TRANSCRIPT: Meeting Six, Opening Remarks


August 30, 2011


Washington, DC


Amy Gutmann, Ph.D.

Commission Chair

James Wagner, Ph.D.

Commission Vice-Chair

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 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

  first speaker from near, and some of our other speakers

  from far.  I look forward to everybody's presentations

  and our discussions.

            Today we will focus on the second part of the

  President's charge on human subjects protection.  This

  is what we have been calling the forward-looking part

  of our project.  Yesterday, as you know, we had an

  in-depth discussion of our historical findings on

  Guatemala, a dark chapter in our history, and also we

  had a discussion of our ethical analysis of that

  chapter in our history.

            The commission's task in this case is to

  review current rules for human subjects protection to

  determine if these rules protect people participating

  in federally-funded research from harm or unethical

  treatment.  President Obama asked the commission to

  convene a panel of international experts to seek

  independent advice on the effectiveness of current U.S.

  rules and international standards for the protection of

  human subjects in scientific studies that are supported

  by the U.S. Government.

            The international research panel included

  experts on medical ethics, on science, and clinical

  research.  They were truly an eminent and very

  dedicated group.  We met three times.  We will publish

  the proceedings of that panel.  This panel hailed from

  many countries, including Argentina, Brazil, China,

  Egypt, Guatemala, India, Russia, Uganda, Belgium, and

  the United States.

            The panel has reported its findings and

  recommendations to the full commission in the form of a

  report entitled, "Research Across Borders."  This will

  be published in the Federal Register, and we look

  forward to taking public comment on it for 30 days,

  once it is published.  The panel report will also be on

  our website as of this afternoon.

            Christine Grady and Nelson Michael will report

  to us this morning on the panel and its work.  But

  before we get underway, I would just like to ask if Jim

  Wagner wants to say a few words.

            DR. WAGNER:  I think you've covered it all;

  let's get underway.

            DR. GUTMANN:  Okay.  We're going to get

  underway.  So, this first session is on human subjects

  protection, as this whole day's meeting will be on.

  And, as many of you know, our work on human subjects

  protection dovetails nicely with the reform work

  already underway by the U.S. Government.

            The Advanced Notice for Proposed Rulemaking

  released last month reflects many of the

  concerns -- not all, but many -- that we have heard in

  our prior meetings, and the public comments submitted

  to us about the current human subjects protection

  system, let us call it.  I use the word "system"

  loosely, because it is a web of rules and regulations.

  I think we will hear about this in a moment.

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