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81 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 but "must," and it is not just seeking advice but actually having representatives of the people who are going to be studied participate in the design, planning and actually be part of the steering committee or whatever. So my first question is if you could discuss with us sort of exactly how much participation you thought was desirable and useful. DR. OLD: Sure. DR. LO: The second issue has to do with the consent for new prospective studies. I like very much the layered approach and the idea that we should try and make it work and see what works and what does not but err on the side of giving people more choices rather than fewer. However, I am concerned that we are putting again so much emphasis on the consent document, the form, and not on the process of discussion, and I think, you know, with the successful large prospective trials it is a relationship, it is a process, it is not a consent form. I am wondering how we can sort of get away from our obsession with getting the words right on the page to really getting investigators in studies out to talk to patients in ways that they will understand, which is, you know, just a lot harder than getting a model form on the web which everyone can copy but that is not the same as the consent process.
82 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 DR. OLD: No, you are right. Let me go to your first point and that is community involvement. NHLBI has in the past for our epidemiological studies has large participation from community involvement. We have a Strong Heart Study which is with the American Indians and they are part of the steering committee. They are part of the process of deciding protocols. They are very active participants and I think one of the reasons that this is in here is due to having special communities like that involved already in our epidemiological studies. We expect them to have also input in our genetic studies. We are currently in the process of setting up a study exclusively in African Americans in cardiovascular disease. They are also part of the process of defining the protocols, the study cohort, and on the steering committee. So NHLBI has already taken that step in terms of including the community in setting up a study and involvement. I think on some of our studies where we are looking at a much -- we deal pretty much exclusively with complex diseases on -- not exclusively but a large number or things that are complex diseases and who exactly is the community of people with hypertension and where do you go to get community involvement and how do you study
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81<br />
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but "must," and it is not just seek<strong>in</strong>g advice but actually<br />
hav<strong>in</strong>g representatives of the people who are go<strong>in</strong>g to be<br />
studied participate <strong>in</strong> the design, plann<strong>in</strong>g and actually be<br />
part of the steer<strong>in</strong>g committee or whatever.<br />
So my first question is if you could discuss<br />
with us sort of exactly how much participation you thought<br />
was desirable and useful.<br />
DR. OLD: Sure.<br />
DR. LO: The second issue has to do with the<br />
consent for new prospective studies. I like very much the<br />
layered approach and the idea that we should try and make<br />
it work and see what works and what does not but err on the<br />
side of giv<strong>in</strong>g people more choices rather than fewer.<br />
However, I am concerned that we are putt<strong>in</strong>g aga<strong>in</strong> so much<br />
emphasis on the consent document, the form, and not on the<br />
process of discussion, and I th<strong>in</strong>k, you know, with the<br />
successful large prospective trials it is a relationship,<br />
it is a process, it is not a consent form. I am wonder<strong>in</strong>g<br />
how we can sort of get away from our obsession with gett<strong>in</strong>g<br />
the words right on the page to really gett<strong>in</strong>g <strong>in</strong>vestigators<br />
<strong>in</strong> studies out to talk to patients <strong>in</strong> ways that they will<br />
understand, which is, you know, just a lot harder than<br />
gett<strong>in</strong>g a model form on the web which everyone can copy but<br />
that is not the same as the consent process.
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