human subjects protection

TRANSCRIPT, Meeting 7, Session 4

James Wagner:  I’ll tell you what.  Maybe we will get rolling.  Dr. Hauser will join us in just a moment.  Welcome back everyone and Commissioners.


Wed, 11/16/2011

TRANSCRIPT, Meeting 7, Session 1

Amy Gutmann:  Good morning, everybody.  I’m Amy Gutmann.  I’m Chair of the Presidential Commission for the Study of Bioethical Issues, and it’s my pleasure along with our Vice Chair,   Jim Wagner, who is President of Emory University and my partner with our colleagues here.  It’s my pleasure to invite you to the seventh meeting of the commission’s deliberations.  This is day one of our seventh meeting.


Wed, 11/16/2011

TRANSCRIPT, Meeting 7, Session 5

James Wagner:  Good point.  So we are a rare situation of finishing a session ahead of schedule, so why don’t we just move into—


Amy Gutmann:  So we are going move into our next discussion which is Study Design.  Steve Hauser is going to introduce our thinking on this.  Again, we will open it up for broader discussion of the Commission and our participants in the public.



Wed, 11/16/2011

TRANSCRIPT, Meeting 7, Session 6

James Wagner:  I believe the commission is present and assembled, so let us get underway. In this next hour and 15 minutes, we will be addressing three subjects. It is interesting. All are sort of the place-based considerations. They have to do with place where research is done. The three subjects are equivalent protections, community engagement, and site selection. Christine, I don't know.


Wed, 11/16/2011

TRANSCRIPT, Meeting 7, Session 2

James Wagner:  We’re going to continue our session or meeting by talking about human subject protections as professional standards.  We have heard in meetings and public comment that at times there is tension that exists between the importance of regulation to keep human subject safe and the burden that some researchers feel to meet them.  We recognize that regulations alone do not necessarily ensure or make for ethical practice.  A researcher embodies research ethics as a professional code will carry those ideas into the work whether it’s mandated as a condition of federal funding or simpl


Wed, 11/16/2011

Agenda for Meeting Seven: November 16-17, 2011, in Boston, MA

New Research Building at Harvard Medical School
The Joseph B. Martin Conference Center
77 Avenue Louis Pasteur, Boston, MA 02115

Wednesday, November 16 – Meeting in the Rotunda Conference Room

9:30 – 9:45 a.m.  Welcome and Opening Remarks

Amy Gutmann, Ph.D.
Commission Chair

James Wagner, Ph.D.
Commission Vice-Chair

TRANSCRIPT: Meeting Six, Session 3


                      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


Tue, 08/30/2011

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


Mon, 08/29/2011


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