Re: IRB Membership Rhodes, Kris E 13 Nov 2003 10:31 EST
Alexander, What no one has brought up so far, is perhaps what is at the essence of your question. Does the sponsored research office's involvement/participation/financial support of IRB activities constitute a conflict of interest. I don't think there is a definitive answer, but it is a question that institutions must consider in evaluating the structure, support, and reporting chain for the IRB and IACUC. Does the role of the sponsored research office in which external funding is typically an assessment measure and a basis for the institution's budgeting decisions for the department create a conflict in objectivity? Does the role of the sponsored research office in supporting/ensuring programmatic performance meets the expectations of the sponsor create a conflict? These are not simple questions and neither are answers, which are impacted by institutional resources, scope of the institution's research protocols, and the organization's reporting structure. At the University of Kentucky the Office of Research Integrity, which administers the institution's IRBs and IACUCs, reports directly to the Vice President for Research. The sponsored research office has a cooperative working relationship with the office, but does not control the office's resources, nor are we in any way involved in the protocol review or decisions. I like the UK model, but part of this is based on the quality of the UK's leadership in the Office Research Integrity - Ada Sue Selewitz. Conversely, having observed other organizational structures where there was not an adequate linkage between the sponsored research office and protocol review, where protocol review seemed less than adequate, I could probably equally argue that the office should be involved. The answer is institution specific , but the potential for conflict must be evaluated in the decision. Kris __________________________________________ Kris E. Rhodes, MS CRA Associate Director Office of Sponsored Projects Administration University of Kentucky 213 Kinkead Hall Lexington, KY 40506 Phone: 859-257-4826; Fax 859-323-1060 -----Original Message----- From: Schoen, Alexander [mailto:xxxxxx@WINTHROP.ORG] Sent: Wednesday, November 12, 2003 9:25 AM To: xxxxxx@HRINET.ORG Subject: [RESADM-L] IRB Membership Good Morning, I am interested in knowing how many Sponsored Programs / Grants personnel are involved in their institutions' Institutional Review Board. Does your Sponsored Programs/Grants office administratively run the IRB? Is a representative of the Sponsored Programs/Grants a member of the IRB? Does a representative of the Sponsored Programs/Grants sit in on the meetings for informational purposes? Does your Sponsored Programs/Grants office have no involvement with the IRB? In our institution, I am not a member of the IRB, but attend meetings and provide information on related clinical trial agreements as needed. I look forward to your responses. Thank you, Alex ----------------------------------------- Alexander Schoen Director, Office of Sponsored Programs Winthrop-University Hospital 222 Station Plaza North, Suite 510 Mineola, NY 11501 Phone: (516) 663-8997 Fax: (516) 663-9718 xxxxxx@winthrop.org CONFIDENTIALITY NOTICE: This transmission is intended only for the individual or entity to which it is addressed and contains information that is confidential. If you have received this communication in error, please notify the sender at the email address above and delete this email immediately. This information has been disclosed to you from confidential records and is protected by federal and state law. This information may include confidential mental health, substance abuse, alcohol abuse and/or HIV related information. Federal and state law prohibits you from making any further disclosure of this information without the specific written consent of the person to whom it pertains, or as otherwise permitted by law. Any unauthorized further disclosure in violation of the law may results in a fine or jail sentence or both. A general authorization for the release of this information may not be sufficient authorization for further disclosure. ====================================================================== 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") ======================================================================