Yes, we have them cover the quality of the drug itself, as they manufacture
the drug.

scott

Scott Davis
Sponsored Programs Administrator
University of Oklahoma Health Sciences Center

Tel:     405.271.2090
Fax:    405.271.8651
email:  xxxxxx@ouhsc.edu

-----Original Message-----
From: Valerie A. Blake [mailto:xxxxxx@NSHS.EDU]
Sent: Tuesday, August 07, 2001 1:04 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] Research Agreements with Industry

Dear Colleagues:

This question is directed to those Research Administrators who review and
negotiate investigator-initiated clinical trial studies with industrial
sponsors.  This pertains to studies that attempt to evaluate the
effectiveness of a new use for an FDA-approved drug.   In cases such as
these, our Investigators are asked to seek an IND for their proposed new
use.  If the study yields positive results, then the new use will be jointly
owned by the Institution and the Sponsor, with the Institution granting the
Sponsor a royalty-free license.    Under these circumstances, do you
request/require indemnification and subject injury coverage from the
Sponsor?

Valerie A. Blake
Assistant Director
North Shore-Long Island Jewish Health System
Office of Grants and Contracts
5 Dakota Drive, Suite 307
Lake Success, NY  11042
Phone:  (516) 719-3100
Fax:  (516) 719-3110

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