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

135
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
consents. I do not think it is a complex -- I do not think
it is any more complex than we would like to use your
tissue for research to say are there certain things that
matter to you about how we use your tissue.
I think that the compromise here was a
practical one from the medical community's point of view
and again it was our belief that we wanted to give patients
an opportunity to participate. They do not have it now in
a knowing way. So this was step one to give them a way of
knowingly participating.
DR. MURRAY: Thanks, Pat.
Zeke?
DR. EMANUEL: Like my fellow commissioners I
want to thank you for an excellent and spirited discussion.
I would like to identify -- I found many areas
in which your approach is very consonant with the
subcommittee's approach. I think overall there is very
little disagreement and actually a lot of agreement,
including the issue of standardization of rules for IRB's
trying to create a framework that is uniform to minimize
exceptions so that people know what the rules are while
recognizing that in some cases there may be extraordinary
reason.
This issue of ownership is one you did not hear