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

264
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
At the moment I think it is too soon to reach
conclusions and we need to hear from each of the agencies
about their own response. Some of the problems are obvious
ones but there is one which stands out and that is the lack
of an authoritative office to deal with these issues in the
federal government.
(Slide.)
So the question that we determined to look at
as a whole commission is the one is there a need to have a
government-wide human subjects office. We sought advice on
this from Charles McCarthy, who is the former director of
OPRR, and John Fletcher, who was the first in-house
ethicist at the Clinical Center and then went on to be
professor at the University of Virginia where he has now
recently become emeritus.
We also received additional expert advice from
Joan Porter, who reported at our last subcommittee meeting
and who is here today again. And from Tina Gonsalus, whose
views we have not actually heard yet, who was looking at
the additional question that was raised by David Cox, which
is whether this opportunity ought to be seized if we are
talking about a government-wide effort to say it should
also encompass the research which is not federally funded.
(Slide.)