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 > > > > > > ====================================================================== > Instructions on how to use the RESADM-L Mailing List, including > subscription information and a web-searchable archive, are available > via our web site at http://www.hrinet.org (click on "Listserv Lists") > ====================================================================== ********************************************************************** This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the West Penn Allegheny Health System Help Desk at 412 330-4357. ********************************************************************** ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================