Michelle -- I put the question to the research administrators list I monitor
and here is the first reply, from my "friend" (I've never met him) Bill
Campbell at Univ Wisconsin-River Falls.   I have a lot of respect for his
opinions and he's been in the research administration game quite awhile.
One reason he says we should count it as HS research is to protect the
institution and I remember that rationale being presented at the first
compliance workshop I ever attended.    Also, the reaction of Nancy Heller
(IRB staff at UVM) was YES (but she's doing some research for me).

So, I guess we better check YES on the NIH form after all and prepare to do
a Single Project Assurance if Bob gets the money.    I'll ask Ann to send
him the paperwork.

Franci

> -----Original Message-----
> From: William Campbell [SMTP:xxxxxx@UWRF.EDU]
> Sent: Wednesday, January 20, 1999 7:21 AM
> To:   xxxxxx@hrinet.org
> Subject:      Human Subjects question -Reply
>
> Franci, what an interesting question.  My initial reaction is yes.  Here's
> why:
> the IRB should definitely review the protocol to protect both the subject
> (folks need to be protected from themselves, sometimes) and the
> institution
> (imagine the headlinesin the National Inquirer--"Middlebury vampire
> collects
> own blood for 'scientific' experiments").  Since the IRB is involved, I
> think
> you'd have to check yes on the NIH cover page.
>
> This raises some more questions, of course: is collecting his own blood
> really
> integral to the project, i.e. can't he use some samples he buys from a
> supply
> house?  Are there some hidden, negative consequences from checking yes on
> the
> cover page?  And--most interesting to me, of course--what's it all about
> anyway?  Probably you can't say anymore.  Oh well.
>
> Regards, Bill
>
>
> ==========================================================================
> ===

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