IRB Submissions
IRB Submissions The Auburn University Human Research Protection Program (AU HRPP) includes one convened Institutional Review Board (IRB). The convened IRB reviews health science related submissions and submissions from health science related disciplines and social and behavioral submissions from any college, school, or department. The process to submit for IRB review is the same regardless of the level of review (Convened IRB, Expedited process, and Exempt from certain federal regulations) or type of submission (renewal, modification, other). Meetings of the convened IRB
Process to submit for IRB Review Follow this process to submit all materials for IRB review prior to June 30, 2024:
Additional details will follow in July 2024 for the submission process in Endeavor. Order of Materials Submitted for IRB Review To facilitate the review process and ensure consistency, please note the following when submitting documents. If you experience difficulties when submitting your PDF application, contact your department IT representative. Original submission:
Revision submission:
A copy of all study materials must be included with all submissions. Combine documents as a single PDF. Forms may be converted to WORD for completion. Once all information is provided, convert back to PDF prior to submitting. Prior to submission review all study materials to ensure desired text is visible. The IRB has learned that printing a submission to PDF may strip some interactive functions. Rather than printing to PDF, the IRB suggests submissions be saved as a PDF. If problems remain, contact your departmental IT representative for assistance.
Protocol Forms Exempt Determinations – Projects reviewed prior to implementation of the revised Common Rule (January, 2019) no longer include an expiration date. Continuing review is no longer required; however, any changes to the approved project (personnel, procedures, documents, etc.) require review by the IRB before the changes can be implemented. Projects reviewed prior to January 2019 require continuing review, as indicated by the expiration date on the approved documents. Full Board and Expedited Protocols – Per federal regulation, protocols may not be approved for more than one year. Continuation of the project beyond the IRB approval period requires submission of a request for renewal and approval of the request by the IRB prior to the expiration of the initial approval. Any changes to the project must be submitted in the form of a modification request to the IRB for review and approval prior to implementation of the change(s). A Final Report will be required to close all Full Board and Expedited Protocols. For more detailed information on Exempt, Expedited, and Full Board processes, please refer to the IRB Procedures Section of our Website. All submission forms are provided on the Forms Section of our Website.
|
||