meetings

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

Date

Wed, 11/16/2011

TRANSCRIPT: Meeting Six, Conclusions on the Ethics of the Experiments

            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

Date

Mon, 08/29/2011

TRANSCRIPT: Meeting Six, Session 2

             

            DR. GUTMANN:  So that's a good segue, right?

  We are going to talk now in this session addressing

  directly the ethical standards of the day and, in

  particular, here are the questions we want to address.

            Did the researchers try to keep the

  experiments secret?  What standards did the researchers

  employ to protect human subjects in an earlier

  experiment conducted in Terre Haute, Indiana, in a

  federal or state penitentiary there?  I think it was a

Date

Mon, 08/29/2011

TRANSCRIPT: Meeting Six, Concluding Remarks

DR. GUTMANN:  So, on behalf of Jim Wagner and

  myself, I want to thank all of our speakers and

  everybody who attended today's and yesterday's

  meetings, who have given their time, their energy, and

  their thoughtfulness.

            We have taken questions as they have come up.

  But I should urge you, because it's really important to

  us, that we welcome questions between our meetings, or

  comments between our meetings, as well.  You can go to

  our website, bioethics.gov, to submit your comments.

Date

Tue, 08/30/2011

TRANSCRIPT: Meeting Six, Session 7

            DR. GUTMANN:  Welcome back, everybody.  We are

  now in session seven of this two-day commission

  meeting, and I am very pleased to welcome our two

  guests, Ruth Macklin and Robert Temple.  And I

  would -- will briefly introduce both of them.  They are

  widely known and respected, and will present us with

  two different views on the topic of trial design and

  international standards.

            Ruth Macklin is Professor of Bioethics in the

  Department of Epidemiology and Population Health at

Date

Tue, 08/30/2011

TRANSCRIPT: Meeting Six, Session 6

            DR. WAGNER:  Let me invite Michelle Groman and

  Jeremy Sugarman to the table.  This next session will

  be around our commission receiving a staff report.

  Michelle Groman is senior policy and research analyst

  for our commission, and has served as a lead staffer on

  this project.  But we are going to hear first from

  Jeremy.

            Jeremy Sugarman is going to report to us about

  the empirical project, as we have been calling it, that

  the staff has been conducting to collect data from

Date

Tue, 08/30/2011

TRANSCRIPT: Meeting Six, Session 5

            DR. GUTMANN:  If I could ask everybody to

  please take a seat, we are going to reconvene.

            It is my pleasure now to introduce our panel

  on community engagement.  I will introduce all the

  speakers at the beginning, and then ask each to speak,

  and then we will open it up for questions and comments.

  And I want to thank everybody who has given us comments earlier this morning for really excellent comments.

            Our first speaker will be Carletta Tilousi.

Date

Tue, 08/30/2011

TRANSCRIPT: Meeting Six, Opening Remarks

 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

Date

Tue, 08/30/2011

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