Electronic Transmission of IRB Approvals
I. PURPOSE / BACKGROUND
The University of Louisville Human Subjects Protection Program Office (HSPPO) is responsible for the development and transmission of all University of Louisville Institutional Review Board (IRB) communications. The University is currently implementing an IRB software management package that will require the entire submission, approval and oversight process exist only in an electronic medium. The use of the University e-mail system is a temporary measure that allows for the reduction in transmission time for approval and correspondence documents from the IRB.
Transmitting paper documents by regular or University mail resulted in additional days lost for the investigator and the HSPPO while each waited for documents to arrive from the other. In response to investigator concern over this lost time and, occasionally, lost documents in the mail, the IRB directed the HSPPO to implement an electronic process of transmitting approval documents and other correspondence to researchers using the University e-mail system. This process began on December 1, 2004.
The University e-mail system is a secure system and the approval documents and other correspondence are transmitted only by staff assigned to the HSPP Office. Documents are saved and backed up through the University’s Information Technology Service. Most documents are transmitted as .pdf file attachments but e-mails will provide specific information on what approvals have been granted. The e-mails cannot be edited once received. All transmissions are saved as word documents in the HSPPO electronic files and as a paper document in the HSPPO study file. The original e-mails are saved in the University e-mail archive system.
The University of Louisville Institutional Review Board will transmit all approval documents and other correspondence, utilizing the University’s e-mail system, to investigators and others. The only exception to this policy is for correspondence utilizing the BRAAN2 software.
III. PROCEDURE FOR POLICY
The HSPPO will prepare and transmit, utilizing the University’s e-mail system, all approval documents and other correspondence for those studies utilizing paper to investigators and others. Refer to the HSPPO Policy & Procedure for Preparation, Transmission and Storage of electronic documents for a full explanation of the procedures for this policy.
Subject: Transmission of Institutional Review Board Approvals and Correspondence| Policy and Procedure | Author: Institutional Review Board | Original Effective Date: 12-1-2004 | Last Revised Date: 6-06-2012