Re: IRB -- consent forms Hastings, Kari L 21 Mar 2000 12:06 EST

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>

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 -----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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