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299 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 adequate and timely information to and education for those entities regulated concerning protection of human subjects in research. They would expect that the organizations carrying out the research had been informed about what they were supposed to do and guided in what they were supposed to do. I think the individual would expect adequate and consistent -- at least minimal protections in research regardless of the source of funding or support. Obviously we see that this is a major issue. How far is this office going to regulate? As far as it does now or is it going to take on all research regardless of resources, or support, or funding? I think we have to start thinking in this direction. I think in this day and age it is not appropriate to ask individuals to try to sort out is it federally funded research or is it under a state law or is someone looking after my rights and welfare, or is it one of those seven categories which were alluded to that simply fall between the cracks. I also think that the individual would expect timely and consistent investigations of allegations of noncompliance with human subjects protections by both regulated entities and the investigators. And then, of
300 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 course, responsible follow-up -- follow-through on findings of noncompliance with human subject protections by regulated entities and investigators. Then I would believe that the individual would want an office that was there to carry out actions that would be consistent with promoting protection of human participants in research in an as political a manner as possible. That is an office that would stand as a champion of human subjects rights and welfare above other goals that might be competing and that were inconsistent with that goal. For example, we heard this morning a discussion of the use of tissue samples and the idea that, oh, it would be a tragedy to lose this important invaluable research but it may also be a tragedy to collect information or use information that represented a violation of the rights and welfare of individuals. So there has to be some office that is a champion for human subjects protection in the milieu of larger competing issues or different competing issues, or resource demands. (Slide.) Likewise, I think, what would an entity that was regulated by a federal central office expect? I think they would expect many of the same things, of course. They
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adequate and timely <strong>in</strong>formation to and education for those<br />
entities regulated concern<strong>in</strong>g protection of human subjects<br />
<strong>in</strong> research. They would expect that the organizations<br />
carry<strong>in</strong>g out the research had been <strong>in</strong>formed about what they<br />
were supposed to do and guided <strong>in</strong> what they were supposed<br />
to do.<br />
I th<strong>in</strong>k the <strong>in</strong>dividual would expect adequate<br />
and consistent -- at least m<strong>in</strong>imal protections <strong>in</strong> research<br />
regardless of the source of fund<strong>in</strong>g or support. Obviously<br />
we see that this is a major issue. How far is this office<br />
go<strong>in</strong>g to regulate? As far as it does now or is it go<strong>in</strong>g to<br />
take on all research regardless of resources, or support,<br />
or fund<strong>in</strong>g?<br />
I th<strong>in</strong>k we have to start th<strong>in</strong>k<strong>in</strong>g <strong>in</strong> this<br />
direction. I th<strong>in</strong>k <strong>in</strong> this day and age it is not<br />
appropriate to ask <strong>in</strong>dividuals to try to sort out is it<br />
federally funded research or is it under a state law or is<br />
someone look<strong>in</strong>g after my rights and welfare, or is it one<br />
of those seven categories which were alluded to that simply<br />
fall between the cracks.<br />
I also th<strong>in</strong>k that the <strong>in</strong>dividual would expect<br />
timely and consistent <strong>in</strong>vestigations of allegations of<br />
noncompliance with human subjects protections by both<br />
regulated entities and the <strong>in</strong>vestigators. And then, of