I think it's a good issue for the list.

It would seem to me from the 45 CFR 46.109, that if their IRB approved the
research, and if their IRB has been accepted by HHS, you'd be clear in terms
of human subjects assurances regardless of location.  There may be something
buried somewhere that I'm missing, and I'm sure the good folks at HHS and/or
the listserv will correct me, but I think I'm on good ground here.

In terms of the use of a P.O. or subcontract, I'd prefer the sub route.
Subcontracts would stand a better chance in court if things go awry.  Also,
the terms and conditions are specifically stated (or should be).  You can
reiterate IRB Certifications and a requirement that they be maintained.  You
would also want to have the foreign institution pay the subjects and RA.
You can also limit your liability better with a sub.  A subcontract is
better suited for this application.

Greg Schmidt

-----Original Message-----
From: Farnsworth, Franci <xxxxxx@JAGUAR.MIDDLEBURY.EDU>
To: xxxxxx@hrinet.org <xxxxxx@hrinet.org>
Date: Tuesday, November 16, 1999 2:44 PM
Subject: Human Subjects Research at Foreign Sites

>I need help identifying the budget/institutional issues for the following
>project and I'd like to know more about using purchase orders to buy
>services from another institution, rather than using a subaward.    Because
>this is such a specific situation, please reply directly to me
>(xxxxxx@middlebury.edu); I'll forward replies to anyone interested.
>
>A faculty member is proposing to collect data from human subjects at an
>institution in the U.K. as part of a longer research project based here.
>He wants to hire a part-time research assistant for the 6 months he'll be
in
>the U.K.    I know that we can't hire the research assistant through our
>payroll and I doubt if we can pay the human subjects directly.    Can we
use
>a purchase order to the host institution?   Do we need to do a subaward?
>Total U.K. cost will be no more than $25K (total award will be less than
>$100K).     How do we provide assurances that these human subjects
>(recruited for other purposes) are handled according to US regs?
>
>Thanks in advance.
>
>Frances Vinal Farnsworth
>Coordinator of Sponsored Research
>MIDDLEBURY COLLEGE
>Munford House
>Middlebury, VT 05753
>Tel:  802-443-5889
>Fax: 802-443-2081
>Email:  xxxxxx@middlebury.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")
>======================================================================
>

======================================================================
 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")
======================================================================