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 uncertain, or for an official IRB determination, researchers can submit the SLU IRB Human Subjects Research Determination Form to firstname.lastname@example.org.
Determine what IRB to Use: SLU researchers are assumed to require review by the SLU IRB; however, some studies may seek approval to rely on a Central or External IRB. The IRB Reliance Agreement Determination Form can be submitted in situations where multiple institutions are collaboratively conducting a minimal risk research study to determine whether SLU IRB or an External IRB could serve as the single IRB to review the study. Additionally, certain multi-site clinical trials may qualify for use of a central IRB. See the Use of Central/External IRBs webpage for more information about use of External (non-SLU) or Central IRBs (in place of doing a full IRB submission to SLU IRB).
Complete Required Training: Ensure that all research team members 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, and the IRB highly recommends that researchers take Good Clinical Practice (GCP) training, which is mandated by many sponsors and for anyone conducting an NIH-sponsored "clinical trial", which can include behavioral interventions looking at health-related outcomes. GCP training focuses on quality standards for designing, conducting, recording and reporting research to help assure the safety and integrity of studies, thus is beneficial for all researchers aiming to perform studies in accordance with best practice.
The IRB hosts voluntary training sessions on the IRB submission system, submission process, and research conduct requirements. Upcoming classes are listed on the workshop calendar.
Select and Prepare the IRB Application: If submitting to the SLU IRB, 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:
To complete the appropriate applications (except for HUD, Emergency Use, or central IRB 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 at email@example.com 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 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. Review status is displayed on the investigator home page in eIRB, but the IRB may be contacted if there are questions/concerns.
For new studies, please plan to receive initial feedback from IRB review in:
Note: this is not necessarily the timeline for official approval. Often, changes to the materials may be requested and will be need to be addressed in order to gain full approval. A notification will come from the IRB letting you know the review outcome including any next steps. See next section for additional detail.
Respond to IRB Requests: Commonly, initial IRB review results in requests for revisions prior to issuance of full approval. The timeline for review of PI responses is typically shorter than that for initial review. Researchers can enable the most efficient follow-up review of the study by carefully and completely addressing all IRB requests, and are welcome to work with IRB staff and Chairs to do so.
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.
An e-mail will be sent from the eIRB system letting you know when the study has been approved. IRB approval is documented by a full approval letter which is accessed in the eIRB system. Do not start your research project until the approval letter has been issued.
Responsibilities after IRB Approval: Conduct the study in accordance with the approved protocol and IRB guidelines. Importantly, researchers are expected to carry out their research using the procedures and materials approved by the IRB, and any deviation from that will require approval by the IRB prior to implementation of the change(s). Please be aware of reporting requirements post IRB approval. The following activities require further submission to the IRB:
Investigators are encouraged to work with the IRB throughout the submission process and while conducting their study. Please do not hesitate to use the support in place for investigators conducting human subjects research at SLU.