It seems you are going down a slippery slope. One of the primary
responsibilities (outside of subject protection) is to avoid risk or
at the very least manage it. Being silent on an indemnity clause does
not infer consent and in those cases where it does it is very limited.
I would not recommend it.

I would recommend that you refer that matter to an attorney/risk
manager on the best strategy. Being silent is like sticking your head
in the sand...your backside is still exposed.

Robert Gregory Miller
Charles R. Drew University of Medicine and Science
Div. of Endocrinology, Metabolism and Molecular Science
Administrative Director/Research Administrator
xxxxxx@cdrewu.edu
Office: 323.563.5961
Fax: 323.563.5966

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-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On
Behalf Of Brandi Boniface
Sent: Tuesday, May 24, 2005 2:40 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] Indemnification Question

Dear Colleagues:

We are currently reviewing our internal procedures regarding
indemnification on clinical trial agreements.  We have walked away
when a sponsor has not been willing to indemnify on sponsor initiated
trials, but are taking a second look at our stance on this issue.  At
this time, our office is processing a number of sponsor initiated
clinical trial agreements, 1 investigator initiated clinical trial and
2 third party initiated clinical trials (neither the PI nor the Pharma
partner have developed the protocol).  In all three of the non-sponsor
initiated agreements neither the Pharma nor third party are willing to
indemnify us, but are willing to remain silent on indemnification.
Are there instances when you would remain silent on indemnification
under clinical trials.  If so, with which type of trial (sponsor
initiated, investigator initiated or third party initiated) and under
what circumstances?

On and off-line responses would be greatly appreciated.

Sincerely,

Brandi Boniface, CRA
Sr. Industry Contracts Manager
Industry Contracts Unit
University of South Carolina
901 Sumter Street, 5th Floor
Columbia, SC  29208

P:  (803) 777-6420
F:  (803) 777-4136

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 subscription information and a web-searchable archive, are available
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