On Sun, 14 Oct 2007, Marc Carter went:

My major concern would be that the IRB is stepping into issues that
don't concern it -- it's not the job of an IRB to meddle with issues
of design that do not impact the rights and welfare of the
participants.

I'm on an IRB, and I side with the school of thought that says a badly
designed study is less ethical than a well-designed study because, as
the science deteriorates, the risk:benefit ratio approaches infinity.
So I have no problem with an IRB's dispensing scientific suggestions.
I see it as another layer of quality control, and I'm grateful if it
improves one of my own studies.

However, in cases like this, where the IRB apparently doesn't know
what it's talking about, I feel that there should be a mechanism
available for a smackdown (or, you know, an appeals process, to phrase
it more politely).  The absence of such a mechanism was the subject of
a fascinatingly bitter little symposium at this year's APA
(presentation titles included "IRBs as Bioethical Industrial Waste for
Both Research and Society").

--David Epstein
  [EMAIL PROTECTED]

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