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DR. MURRAY: Right.
Harold was next.
DR. SHAPIRO: Just a small clarifying question.
The question of your recommendations on page 15 dealing
with retrospective samples. It was not clear to me and I
apologize, you may have said this and I may not have read
this quite carefully, not yet, that if -- excuse me. It
was not clear to me if there were any circumstances that
required new consent forms for -- or new consent, new
individual consent for material from retrospective studies.
I know they have to recontact IRB's under certain
situations and they may have to recontact people if they
are identifiable and so on. But is there any further
requirement under these recommendations for a new consent?
DR. OLD: These requirements do not
specifically say that. What they say is go back to the IRB
and presumably the IRB would say to do this study you would
need a new consent.
DR. SHAPIRO: So that is up to the IRB
according to this.
DR. OLD: But certainly the NHLBI cannot -- it
is controlled at the level of the IRB. It is not at the
government level. But --
DR. SHAPIRO: Thank you.