Maryellen,

We are struggling with trying to get this into a streamlined policy as well.
Re:  OHRP requirements:  we accept on blind faith that if an institution
gives us an MPA number, they have an active assurance.  We have not had to
deal with a domestic organization which didn't have an MPA, but in that
case I suppose I'd ask for the number of the agreement and the date of the
FWA  as confirmation that they'd actually gotten the agreement finalized.
The old SPA's, of course, were not done until the grant was awarded and
usually took several months to process through OPRR.  We would (and do)
freeze an account until all approvals were in place.
Re:  NIH requirements:  we require some sort of certification for each
person in the consortium organization (i.e., appropriate Key Personnel)
that shows they have completed a human subjects protection training
program; e.g., a copy of the NIH web tutorial printed certification, or a
letter from their institution, signed by an institutional official.  So far
we haven't had any real problems except for frayed nerves due to the time
it takes to get this information.

More problematic are the international studies.  We have tried to be very
diplomatic and play down the "cultural imperialism" card, and so far have
gotten no refusals to going through a training program -- most opt to do
the NIH web tutorial, but we have had a few do the Chadwick/Dunn book and
pass the test.  We also have to make sure they have gotten an SPA or FWA
for the project, if federally funded.  We require a copy of the IRB or
equivalent approval.  Our investigators have been very helpful in being our
liaison to those institutions and helping us to get this information.
Hope this helps.
Jon Hart

At 09:41 AM 7/26/01 -0400, O'Brien, Maryellen wrote:
>I'm looking for info on OHRP compliance if you're willing to share it.
>We're wondering how other institutions  are monitoring compliance with the
>OHRP regs in their subcontracts.  Specifically, how are you insuring that
>subgrantees that are engaged in humans subject research have an active
>assurance?  Second, how do you monitor that the key personnel have completed
>the OHRP education requirements?
>
>Although this applies only to NIH, my university is applying this standard
>to all projects involved in human subjects research.  Are you doing
>likewise?
>
>Thanks very much,
>
>
>Maryellen O'Brien
>Grant/Contract Specialist
>Office of Research and Sponsored Programs
>Rutgers University
>
>
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Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel:  (212) 327-8054; fax:  (212) 327-8400

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