I would have several questions/issues with this.  First, I'm not sure that
it is legal or would be approved by your IRB.  You may want to clear this
with them before you spend a lot of time on it. Second, it is too vague - if
a patient forgets to take pill, would that constitute negligence? Third, for
a master agreement, it would be very difficult to define correctly.  Since
each study will have a different population with diverse abilities and
problems (children, Alzheimer's patients, etc.) it would be a mine-field.

Deb Birgen
206.543.4043

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of
Beyea, Donna L.
Sent: Tuesday, 02 Aug 2005 06:11 AM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] Research Subject's negligence in clinical trials

We are having extreme difficulty in getting some pharmaceutical sponsors to
delete reference to the study subject's negligence in the indemnification
language in their clinical trial agreements.  We have been rather successful
in getting out language that implies the reseach subject must follow
directions, however, we've run into some other road blocks.

Specifically, Novartis and a couple of other sponsors include language that
states that they will indemnify us provided:   Such liability, claim, action
and/or suit does not arise out of the negligence or willful malfeasance of
any Indemnitee, or any other person on the Institution's property, exclusive
of [the sponsor's] employees;

We have specifically been told by Novartis that this is meant to include the
research subject.  Hence my question - does your institution accept this
language and thereby accept responsibility for the study subjects negligence
in addition to the negligence of your own employees?  Have any of you been
successful in negotiating a Master Clinical Trial Agreement with Novartis in
which they have agreed to remove this language or stipulate that it doesn't
include the research subject?

Any additional arguments I can gather would be greatlly appreciated.

Thanks

Donna
**********************************
Donna L. Beyea
Senior Research Administrator
University of Rochester
Office of Research and Project Administration
509 Hylan Building - Box 270140
Rochester, NY  14627
Phone:  585-275-8037
Fax:  585-275-9492
email:  xxxxxx@rochester.edu

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