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Re: IRB Question - Foreign Collaborator Involvement - UIA Needed?? Dawnmarie DeFazio 22 Jan 2009 08:42 EST

Barb,

I would do the agreement although and add the co-investigator to your IRB protocol. I think you have to consider export control issues as well (not sure if you have any issues but you should check to be sure the data isn't a concern) and also do a data use agreement. This will then limit the use of the data that your institute owns - if not it is a gift and they can do what they want with it (no strings attached).

If you don't do the IRB agreement, you can do just a data use agreement as he is only receiving de-identified data. However, to make it easier, I would do both agreements, check export control, have him follow your training policy and take your training and be on your IRB protocol. That seems the best solution.
Good luck,

--

Dawnmarie DeFazio, CIP
Director, Clinical Research and Regulatory Affairs
Allegheny General Hospital/Allegheny Singer Research Institute
320 E. North Avenue, 1532 ST
Pittsburgh, PA 15212
phone: 412.359.3043
fax: 412.359.3130
xxxxxx@wpahs.org

>>> On 1/21/2009 at 5:45 PM, in message <012c01c97c19$e76cbea0$b6463be0$@edu>,
Barbara Gray <xxxxxx@VALDOSTA.EDU> wrote:
> Our PI (Psychology faculty) has a collaborator in the UK.  Our PI will
> collect the data from participants in the US.  The protocol will receive
> expedited review because our PI will be able to associate personal responses
> with participant identities (face-to-face data collection).  The
> collaborator will only receive de-identified data for analysis.  Must we
> enter into an Unaffiliated Investigator Agreement with the collaborator and
> have him complete our training program?  On one hand, it seems like a
> reasonable practice if the collaborator is going to co-publish and
> co-present, but, on the other hand, the data he receives is anonymous, and
> so where is the risk to the participants?  Thoughts?
>
> Thanks.
>
>
>
> Ms. Barbara H. Gray
>
> Director of Grants & Contracts
>
> Valdosta State University
>
> 1500 North Patterson Street
>
> Valdosta, GA  31698-0429
>
>
>
> Telephone:  229-333-7837
>
> Fax:  229-245-3853
>
> Email:  xxxxxx@valdosta.edu
>
>
>
>
>
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