human subjects protection

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

9:45 – 10:30 a.m. - Session 1: Human Research Protections as Professional Standards

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

TRANSCRIPT: Meeting 5, Session 6

DR. WAGNER:  Where is Steve and Barbara? In order that we maximize the time that we have available, I think we ought to get going. This is the public comments session. You know, a couple of process issues, first of all, to remind folks that the Commission staff published an inventation prior to this meeting in the Federal Register inviting comment. I understand there was something on the order of 300 people who wish to offer comment.


Wed, 05/18/2011

TRANSCRIPT: Meeting 5, Session 5

 DR. GUTMANN:  We are going to make a seamless segue into a panel discussion so I'd ask everybody who has presented to come on up and I think we'll add perhaps a few seats to the table.
  First of all, thank you all for joining us, and it’s a great privilege for us to have you here to share your wisdom with us on a set of very thorny and important issues. So, we’ve made a practice of this, and you’ve got to trust us, it works, even though it’s going to impose a discipline on you.


Wed, 05/18/2011


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