Entire Transcript in Adobe Acrobat Format - National Reference ...
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297 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Thank you. DR. SHAPIRO: Thank you very much. Ms. Porter, is there anything you would like to add to what you told us last time, which was extremely helpful to all of us? MS. PORTER: I think I would like to address a little bit different focus that might help in making some decisions on where the best locus for a federal office to oversee and to regulate human subjects protections would be. I actually have a handout and some overheads that are very brief, mercifully and uncharacteristically, but I think they help. DR. SHAPIRO: Please. MS. PORTER: We did not collaborate before we came together today, the various presenters, but I think you will be struck by the amount of compatibility there is amongst the presentations even though the approach is somewhat different. (Slide.) I thought that it might be helpful to the commissioners to try to decide on what the goal of a federal office would be and then use those goals to inform the best location for the accomplishment of those goals.
298 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 I have put together two sets of goals. Goals that a human participant in research would expect the federal office for protection of human subjects to carry out and then the second overhead will give a list of goals that I think any entity regulated by a federal office for protection of human subjects would carry out. I did not address animal welfare issues in this particular presentation. (Slide.) First of all, what should a human participant in research or any other member of the public for that matter expect from a federal regulatory office for protection of participants in research? I think, first of all, and maybe these are not in my priority order, these are based on my values, there is considerable overlap between what an individual would expect and what an institution or an entity would expect from a federal office. Maybe you would choose to put different goals on here or take some of these goals off but I think it is the starting place. First of all, an individual participant in research would expect easy access to information on rights and welfare as research participants and some support in exercise of those rights. I think the person would expect
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297<br />
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Thank you.<br />
DR. SHAPIRO: Thank you very much.<br />
Ms. Porter, is there anyth<strong>in</strong>g you would like to<br />
add to what you told us last time, which was extremely<br />
helpful to all of us?<br />
MS. PORTER: I th<strong>in</strong>k I would like to address a<br />
little bit different focus that might help <strong>in</strong> mak<strong>in</strong>g some<br />
decisions on where the best locus for a federal office to<br />
oversee and to regulate human subjects protections would<br />
be.<br />
I actually have a handout and some overheads<br />
that are very brief, mercifully and uncharacteristically,<br />
but I th<strong>in</strong>k they help.<br />
DR. SHAPIRO: Please.<br />
MS. PORTER: We did not collaborate before we<br />
came together today, the various presenters, but I th<strong>in</strong>k<br />
you will be struck by the amount of compatibility there is<br />
amongst the presentations even though the approach is<br />
somewhat different.<br />
(Slide.)<br />
I thought that it might be helpful to the<br />
commissioners to try to decide on what the goal of a<br />
federal office would be and then use those goals to <strong>in</strong>form<br />
the best location for the accomplishment of those goals.
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