IRB1 and IRB2 - Protocol Assignment
The Auburn University Human Research Protection Program includes two IRBs. IRB1 reviews all health science related protocols in addition to other protocols from health science related disciplines. IRB2 reviews primarily social and behavioral protocols from any college, school, or department not otherwise assigned to IRB1. Assignment of protocols to an IRB for review is conducted by the IRB Chairs or their designee.
Each IRB meets once a month to review protocols. IRB2 meets on the second Wednesday of each month and IRB1 meets on the third Wednesday of each month. The deadline for submission to both IRBs is the last Wednesday of the month preceding the meeting for which the protocol is submitted for review. The IRB makes every effort to maintain scheduled meeting dates. However, due to member availability, university holidays, or other unusual circumstances, meeting dates are subject to change on occasion. Meetings are rescheduled as close to the original date as possible. In addition to meetings involving protocol review, the IRBs conduct joint meetings at least annually to discuss programmatic topics.
Order of Materials Submitted for IRB Review
To facilitate the review process and ensure consistency, please note the following when submitting documents via IRBsubmit@auburn.edu. Documents may be converted to WORD format to complete and converted back to PDF for submission. If you experience difficulties when submitting your PDF application to IRBsubmit@auburn.edu, contact your department IT representative.
- 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.
- 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).
Please note a copy of all study materials must be included with all submissions. Combine documents as a single PDF and submit via IRBsubmit@auburn.edu. Forms may be converted to WORD for completion. Once all information is provided, convert back to PDF prior to submitting via IRBsubmit@auburn.edu. 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.
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.
Protocol Process Overview
1. The Principal Investigator (PI) submits a completed application including all signatures to IRBsubmit@auburn.edu.
2. Complete submissions will begin the review process. Submissions requiring Full Board review will be placed on an IRB Meeting Agenda with respect to deadlines for meeting agendas. Submissions for Expedited Review and requests for Exempt Status Determinations may be submitted anytime and will be processed on a continuous basis.
3. Reviewer(s) are assigned by an IRB Chair or designee and submissions are reviewed by the reviewer(s).
4. The ORC will provide written communication to the PI regarding the committee’s or reviewer’s action on the submission.
5. The PI responds to all comments and requirements from the reviewer until the submission is approved. Any items not resolved between the PI and the reviewer(s) or IRB Chair will be referred to the full IRB for review, determination, and final resolution.
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. All submissions for IRB review should be submitted via IRBsubmit@auburn.edu.
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.
- Faculty / Advisors / Mentors
- AU ORC Staff & Website
- IRB Members
- IRB Chairman
Small Group Presentations
Short (approximately one hour) educational programs can be presented to small groups, such as graduate or undergraduate research classes. These programs are provided to assist researchers in obtaining a better understanding of the history of human subject protections, requirements and procedures associated with conducting human subject research, and the protocol approval process at Auburn University.
Please email requests or comments to IRBAdmin@auburn.edu.
The IBC formulates policy and procedures related to the use of biohazardous agents, including human, animal, and plant pathogens, other infectious agents, toxins, and rDNA. As mandated by the National Institutes of Health, experiments involving human gene therapy, formation of transgenic animals or plants, and the generation and/or use of rDNA must be reviewed and approved by the IBC. Auburn University also requires IBC review and approval for use of all Risk Group 2 or higher biohazardous agents.
The IACUC oversees the use of all live vertebrate animals at Auburn University, whether for research, instruction, demonstration, production, or maintenance purposes. Investigators/instructors using vertebrate animals in such activities are required to submit an Animal Subjects Review Form (ASRF) or an Animal Production/Maintenance Facility Standard Operating Procedures Form (APMF) for IACUC review and approval prior to project initiation.