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
The Convened IRB meets on the third Wednesday of every month. The deadline for submissions is the last Wednesday of the month preceding the meeting for which the protocol is submitted for review. Only university holidays or other unusual circumstances cause meeting dates to change from the third Wednesday; if a change is needed, the meeting of the convened IRB will be scheduled for the second Wednesday of the month.
 

IRB Meeting Schedule 2021

IRB Meeting Schedule 2022
 

Process to submit for IRB Review

On October 11, 2021, a change to the submission process will become effective. The change is designed to simplify the submission process.

Follow this process to submit all materials for IRB review

  • Convert all study materials to PDF.
  • Combine all PDF study materials to a single PDF.
  • Complete the IRB Submission Page
  • Drag the single PDF to the designated space at the bottom of the new IRB submission Page
  • When all areas of the IRB Submission Page are completed and the single PDF is loaded, press Submit.
  • When the submission process is completed as described an email documenting successful submission is sent to the Principal Investigator.

 

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:

  • Application;
  • Consent documents (consent form, information letter, etc.);
  • Recruitment materials (flyers, emails, telephone script, etc.;
  • Study instruments (survey, questionnaire, etc.);
  • Other study documents (data collection form, additional information, etc.):
  • Agreements/other IRB approvals; and
  • CITI training documentation.

 

         Revision submission:

  • Memorandum addressing IRB reviewer’s requested clarifications and revisions;
  • Revised documents (as listed above) “highlighting” all requested revisions;
  • “Clean copy” (as listed above) of all revised items; and
  • Other study materials (as listed above).



         When completing the Protocol Review Form:

  • Item 8.A - Appendix A should include a summary of relevant research findings leading to the research proposal;
  • Item 12.B - Appendix B should include a copy of all recruitment materials (emails, flyers, ads, etc.,); and
  • Item 13.C - Appendix C should include copies of all surveys, questionnaires, and other data collection instruments.

     

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 
All protocol forms for submissions to the IRB can be found on the Forms Section of our website.  All forms were revised as of February 2, 2014. Always check the Forms page on this website to ensure you are using the latest version.  Prior versions will not be accepted.

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.


 

 

Human Subjects Research

IRBADMIN@AUBURN.EDU

540 Devall Drive, Suite 200

Auburn, AL 36832

Phone: 334.844.5966