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

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I think that you have to focus on the goals of
protecting subjects from risk, the unwitting participation
aspects, and again on the focus of informed consent an
independent review where you know that there is a danger of
risk.
So then the question is how do you reach that
within the available resources consistent with reality.
The paradigm that I think is applicable that I use in
thinking about a lot of the problems that I deal with is
one that was first introduced -- actually I heard Bud
Relman give a presentation probably 15 years ago and he
used the term "low incidence, high severity problem."
The serious problems do not occur very often.
When they do occur they are very, very serious.
So what is the low incidence, high severity
problem of this nature? What sort of response does it
suggest?
To my thinking of low incidence, high severity
problem the most sensible approach is that you put almost
all of your resources into education. Most people most of
the time want to do the right thing and you have to make
sure you know what it is. We do not have adequate
resources in our system for that right now.
The second thing you have to do after education