Entire Transcript in Adobe Acrobat Format - National Reference ...

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best I can and then we try to go on, and then we try to
look at and review and improve, if possible, both the
policies and the structure that were in place when the
train wreck occurred to try to prevent future such events.
So that is my professional interest and how I come to be
here.
I also served on the United States Commission
on Research Integrity, which also informs my view on
perhaps some of the actions that you should take or not
take, and I will come back to that at the very end of my
remarks.
I was asked to look at the possible unified
government's federal and private human subject research
under an OPRR-like structure. Let me just discuss some of
the issues of the OPRR-like structure. I understand that
you as a commission unanimously passed a resolution in May
that no person should be enrolled in research without the
protections of informed consent and an independent review
of the risks and benefits of that research.
I understand that you have had a form of
Presidential endorsement of that concept by saying that no
American should be an unwitting guinea pig in
experimentations putting them at risk.
Conceptually, therefore, I think that where I