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Human Subjects Division (HSD)

Announcements

The Office of Sponsored Programs has released an important Reminder & Update about Industry-Sponsored Clinical Trials.

Dec 8, 2008 at 1:54pm

The Office of Sponsored Programs (OSP) is responsible for negotiating and finalizing all UW research agreements, including those relating to clinical trials and similar clinical research studies.  Because this is a subject that has received a fair amount of recent attention, we thought it would be useful to update you on a number of matters:

 

1.      The UW's Human Subjects Division has recently clarified that the UW's own program for providing compensation for subjects experiencing injuries as a result of participating in clinical research does not apply to industry-sponsored clinical trials.

 

2.      It should be noted that the foregoing clarification of the UW's subject injury program has no effect on our long-standing indemnification requirement for sponsor-initiated clinical trials.  For contracts covering these trials, the UW will continue to require that a financially responsible party (other than the federal government) agree to indemnify the UW for all claims by subjects who allege they have been injured as a result of participation in the trial.  However the UW will not require indemnification to the extent the claimed injuries are the result of the UW's failure to perform its responsibilities under the contract and protocol.

 

3.      Because the UW has clarified that its subject injury compensation program is not available for subjects injured in industry-sponsored clinical trials (see #1 above), the UW will generally require that the industry sponsor make appropriate arrangements for such a program.  The UW will waive this requirement only under limited, special circumstances and for good cause.

 

4.                  All provisions in the UW's clinical trial agreements (and any other arrangements with sponsors of clinical trials) pertaining to either reimbursement or submission of insurance claims for injuries by subjects participating in clinical trials will be consistent with all applicable laws, rules and regulations.

If anyone has any questions about this, please feel free to contact OSP directly - (206) 543-4043.