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Re: Fulbright Hays program and IRB compliance Rosemary H. Ruff 10 Feb 2004 16:03 EST

Frances,

A couple of things come to mind.  Maybe one or the other will help you out.

Can your IRB meet by teleconference prior to the fellow's departure
date?  Effective March 28, 2000, IRB meetings conducted via telephone were
recognized as "convened meetings" provided that each participating member
1) has received all pertinent information prior to the meeting, and 2) can
actively and equally participate in the discussion of all protocols
reviewed at the meeting.  There are some other restrictions but none are
onerous.  The  URL for the implementation letter is at
http://ohrp.osophs.dhhs.gov/references/irbtel.pdf.

Another possibility — have the person at your institution responsible for
making the decision as to the designation of either "exempt" status or
requiring "expedited"  or "full board" review by the IRB talk to the fellow
directly.  It is possible that the  project will fit in either the "exempt"
or "expedited" category and the IRB will not have to convene at all. In
that case a single designated person (or as otherwise outlined in your
IRB's F-W Assurance) can approve the project/research protocol.  Research
where the human subject interaction is restricted to a survey with minimal
risk to the participant often meets the requirements for "exempt"
classification or "expedited" review.

Good luck

Rosemary

At 01:35 PM 2/10/2004, you wrote:
>The Dept of Education's Fulbright Hays Faculty Research Abroad program
>requires that any human subjects research involved in a FRA fellowship be
>approved PRIOR TO THE START OF THE FELLOWSHIP (meaning before the faculty
>member leaves the US).     The project in question (economics/business)
>involves a survey which won't be administered  until a few weeks or more
>into the fellowship period but is still being finalized by the fellow and
>his overseas collaborators (who are the hold up).     He's scheduled to
>leave next week and our IRB can't meet before then -- in fact, he still
>doesn't have the final version.     The Fulbright Hays program officer has
>said he has to change his travel plans.      I'm hoping there are other
>solutions.
>
>I'm looking for anyone with relevant experience -- FHA fellows whose
>projects did not get IRB approval until AFTER they were abroad,
>conditional approval strategies that would allow us to submit Travel Request
>Forms (on line now) that say the project has been approved, or any other
>suggestions.
>
>We're a small liberal arts college ... IRB meets monthly, has only very
>part-time staff, handles mostly social science protocols, and has its own
>internal policy of full board review for all grant-funded research.
>
>Frances Vinal Farnsworth
>Coordinator of Sponsored Research
>Munford House
>Middlebury College
>Middlebury, VT 05753
>
>Tel:  802-443-5889
>Fax:  802-443-2081
>Email:  xxxxxx@middlebury.edu
>Web:  http://www.middlebury.edu/~grants/
>
>
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Rosemary H. Ruff
Associate Director, Review and Compliance
Biological Research Facility
139 Mell Street
Auburn University, AL  36849
(334) 844-5965 Voice
(334) 844-5938  Fax

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