We follow the same logic as Bill describes here. It is all part of making
sure subjects are provided with ALL information relevant to the study. And
yes it can have an impact ,even when it is not a humongous amount of
industry funding, not only on confidentiality issues but indemnification
issues as well. Kari
----------
From: Caskey, William PhD. [SMTP:xxxxxx@CMH.EDU]
Sent: Tuesday, March 21, 2000 11:07 AM
To: xxxxxx@HRINET.ORG
Subject: Re: IRB -- consent forms
We require that the consent form includes a statement indicating
source of
project funding (internal and external). Our rationale is: (1) the
notice
provides additional information to the subject about the nature of
the
research (i.e., therapeutic drug development for potential profit
can be
totally different from research to understand the nature of a
disease), (2)
source of funding impacts confidentiality (especially for
industry-sponsored
projects) when the sponsor has access to medical records, CRFs,
etc.), and
(3) source of funding affects handling of research-related injuries
to the
subject.
Bill Caskey, PhD
Director, Research & Grants Administration
Children's Mercy Hospital
2401 Gillham Road
Kansas City, MO 64108
Voice:(816) 234-3879
FAX:(816) 855-1982
E-mail: xxxxxx@cmh.edu <mailto:xxxxxx@cmh.edu>
This communication is intended only for the use of the addressee.
It
may contain information which is privileged or confidential under
applicable law. If you are not the intended recipient or the agent
of
the recipient, you are hereby notified that any dissemination, copy
or
disclosure of this communication is strictly prohibited. If you have
received this communication in error, please immediately notify The
Children's Mercy Hospital at 816-234-3879 or via return Internet
electronic mail at xxxxxx@cmh.edu <mailto:xxxxxx@cmh.edu> and
expunge
this communication without making any copies. Thank you for your
cooperation.
-----Original Message-----
From: Mary T. Spina, CRA [mailto:xxxxxx@IIT.EDU]
Sent: Tuesday, March 21, 2000 9:44 AM
To: xxxxxx@HRINET.ORG
Subject: IRB -- consent forms
A question to those of you involved in your institution's IRB
committee:
If a project is supported by external funding, does your IRB
require/request that the consent form include a statement indicating
this,
informing the research participant of the funding agency? If so,
why? If
not, why not? Our IRB is discussing the pros and cons.
Thanks for your help on this.
- Mary Spina
*************************************************************
Mary T. Spina, CRA
Director, Sponsored Research
Illinois Institute of Technology
3300 South Federal Street, MB/301
Chicago, IL 60616-3793
Phone: 312.567.3035
Fax: 312.567.6980
email: xxxxxx@iit.edu
http://www.iit.edu/colleges/grad/sresearc.htm
*************************************************************
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