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

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exemptions? Clearly in terms of a basic principle you do
not want the person who is performing the research, him or
herself, to be deciding that the research is exempt so
there has to be some level of review. Who does the review?
How much paperwork? Do you need to assist them? Do you
build in an incentive for a much larger system of for
profit IRB's? Do you build an incentive for a system where
you have pristine paperwork and you have lots of people
completing paperwork and reviewing things and filling out
forms? And the very serious ethical issues sort of get
lost in shuffle because you have diluted the effort so
much.
Do you have this -- I mean, I could imagine
developing an immaculate extensive system of paperwork that
had no meaningful ethical review in it. I have seen IRB's
function that were very, very good at the paperwork but
spent no time talking about what I think are the issues
that an IRB ought to grapple with.
So the question is would expansion divert
valuable resources and valuable energy and how do you avoid
that outcome? The danger is creating a burdensome possibly
profit driven rubber stamping system diluting attention to
the serious ethical issues.
I could go on about the problems that I ran