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> 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 ************************************************************* ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================