Human Subjects Research

            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

            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

DR. WAGNER: We’ve got forty-five minutes to talk about the European perspective – we’re going to take our whole forty-five minutes because we expect to be just as rich as the prior conversation was.

DR. GUTMANN:  Thank you all very much. As you know, the subject of our present investigation is human subjects research, and specifically, the protection of human subjects, both national and international, with the particular focus on the international dimension. And this panel is brought together to discuss transnational standards of human subjects research and we’re going to begin with John Williams.