- Determine if IRB Review is Required
- Complete Required Training
- Select and Prepare the IRB Application
- Submit the IRB Application
- IRB Review/Timelines
- Respond to IRB Requests
- Responsibilities after IRB Approval
Determine if IRB Review is Required: The following guidance documents can assist in determining whether an activity is human subjects research requiring IRB review: Is Your Project Human Subjects Research? and Checklist: Human Research Determination. If in doubt, please confer with the IRB office at email@example.com or 977-7744.
For studies involving multiple sites or non-SLU collaborators, you may contact the IRB office to see if an agreement can be reached to rely on an external IRB's oversight rather than submitting to the SLU IRB, or to have SLU have oversight for all sites involved.
Complete Required Training: Ensure that all investigators have completed mandatory IRB training. See the Training and Education page of the website for additional details. Note that investigators are also expected to have taken other necessary compliance training, such as conflicts of interest or environmental health and safety trainings.
The IRB Office hosts voluntary, introductory training sessions on the IRB submission system and submission process. Upcoming classes are listed on the workshop calendar.
Select and Prepare the IRB Application: There are three types of IRB review: exempt, expedited, and full board. Tips on choosing the appropriate application for these types of research can be found here:
- Tips for Choosing the Appropriate IRB Application
- Checklist: Eligibility for Exempt Review
- Checklist: Eligibility for Expedited Initial Review
To complete the appropriate applications (except for HUD, Emergency Use, WIRB or CIRB applications), please go to eirb.slu.edu. Instructions for completing the form can be found within the application itself, and additional guidance for use of eIRB can be found on the eIRB web page. Please contact the IRB office at firstname.lastname@example.org or 977-7744 if questions arise regarding eIRB and call your department's IRB coordinator if you have questions about your study.
Note: Forms for applications not in eIRB, such as consent templates and other forms, can be found on the Forms and Instructions page of the IRB website. Please use the consent and recruitment templates and customize for use in your research. IRB Guidelines and Checklists covering various topics are available to assist you in planning and conducting your research.
Submit the IRB Application: When the IRB application is ready to be submitted, click on submit to begin the pre-review process. Applications must be reviewed by a department chair or faculty advisor pre-reviewer prior to submitting to the IRB office. Unfunded research (except biomedical exempt applications) must also receive scientific pre-review (see Guidance).
Once pre-reviewers have completed their review, the PI can view their comments, edit the protocol as needed, and MUST SELECT submit form again in eIRB in order for the IRB to receive the submission. To see a video demonstration of the process, click here. Notifications will auto-generate from the IRB system alerting you of progress in the process. Contact the IRB office with any questions.
Investigators submitting for full board review (not exempt or expedited) should be aware of IRB meeting dates and corresponding deadlines.
IRB Review/Timelines: The timing of IRB review depends on the type of application. For exempt applications, expect to receive feedback from the initial IRB review within two weeks and for expedited applications, within 3 weeks. Full board application initial review responses may take up to two weeks following the board meeting in which the application was reviewed. Note that this is not necessarily a timeline for official approval, as some changes to the materials may be requested and will be need to be addressed in order to gain full approval (see next section). Review status is displayed on the investigator home page in eIRB, but the IRB office may be contacted if there are questions/concerns. An e-mail notice will be sent via the eIRB system when the initial IRB review is complete, and it will inform the investigator whether there are additional requirements prior to full approval. IRB approval is documented by a full approval letter. Do not commence research until this letter has been issued.
Respond to IRB Requests: Most commonly, the initial IRB review results in requests for revisions prior to issuance of full approval. Please follow instructions in eIRB for responding to any requests for revisions in order to receive full approval. Revisions must be submitted to the IRB in eIRB by clicking the "Submit to IRB" button, as they are not automatically sent when completed. The timeline for review of PI responses to IRB requests for revisions is typically shorter than the timelines for initial review.
Responsibilities after IRB Approval: Conduct the study in accordance with the approved protocol and IRB guidelines. Please be aware of reporting requirements post IRB approval. The following activities require further submission to the IRB:
- Amendments: Any modifications to the study must be approved by the IRB prior to implementation.
- Continuing Review: IRB review is required at least annually for all non-exempt research unless a shorter approval period was determined by the IRB.
- Reportable Events: Serious Adverse Events, Unanticipated Problems, Protocol Violations and other events must be reported as detailed in the IRB Guidelines.
- Study Closure: Studies should be closed in accordance with the SLU IRB Closure Guidelines. Please note record retention requirements specified in that guidance.
Investigators are encouraged to work with the IRB Office throughout the process. Please do not hesitate to use the support in place for the investigators conducting human subjects research.