This is one on which I wish someone from OHRP would weigh in.
If you expedited this instead of approving an exemption then evidently the data is of a sensitive nature - but export control? Data use agreement for de-identified data? Is this really necessary?
Sharon McWhorter
Associate Director
Research Services and Sponsored Programs
The University of Akron
Akron, OH 44325-2102
-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Dawnmarie DeFazio
Sent: Thursday, January 22, 2009 8:42 AM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] IRB Question - Foreign Collaborator Involvement - UIA Needed??
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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