I think many IRBs would object to this language as being exculpatory.

Bob Bienkowski

--
Robert S Bienkowski, PhD
xxxxxx@att.net

 -------------- Original message ----------------------
From: Carole Knight <xxxxxx@SLU.EDU>
> Hi everyone,
>
> We are attempting to negotiate a contract with a pharmaceutical company
> for a clinical trial.  The contract contains the following clause which
> we have been advise not to accept.  However, the company stands firm in
> that they will not delete it, and says that "everyone accepts this."
> I'm wondering if you do, and if you see liability red flags as we do.
> I'd appreciate any advise or suggestions as to how to proceed.
>
> "Sponsor agrees to pay for the cost of reasonable and customary medical
> treatment of any illness or injury sustained by a Study
> subject.....provided however, that Sponsor's obligations under this
> Article...shall not apply to the extent that any such costs or such
> illness or injury is attributable to.....(d) the Study subject's failure
> to comply with instructions contained in the Informed Consent executed
> by such subject or communicated to the subject by Study personnel."
>
> Any thoughts?  Thanks everyone.
>
> Carole
>
>
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