Amy Gutmann, Ph.D.
James Wagner, Ph.D.
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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.