transcripts

Amy Gutmann:  So here's what I—yes, here's what I suggest—we segue to Dan Sulmasy, who will introduce the topic of compensation on behalf of the commission and the thinking today about it.  And—

James Wagner:  [Inaudible]. 

Amy Gutmann:  —Daniel and Karen, if you would like to stay at the table, we would be happy to include you in the discussion.  I see nods, right?  Good. 

James Wagner:  Let's do that. 

Amy Gutmann:  Thank you. I'm going to wait until Mr. Ken Feinberg arrives, and I know he's here so–so let me set the context for this session, and we are extremely pleased to have a special guest with us, and here's the context.

James Wagner:  Good morning and commissioners, welcome back, guests, welcome to the second day of our what did we say this is, the seventh meeting? 

Amy Gutmann:  Yes. 

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.

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.

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.

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.

Amy Gutmann:  Yes.

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

            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