Saint Louis University faculty, staff and students who plan to conduct research involving human subjects must obtain Institutional Review Board (IRB) approval before the research can be conducted. An IRB is an ethics committee composed of scientists and non-scientists who serve as advocates for human subjects in research.
Saint Louis University has established three IRBs (two with regular meetings and one ad hoc) to review and oversee human research studies conducted at SLU or by SLU researchers. Researchers are assumed to need SLU IRB approval if conducting human research unless use of a central or external IRB has been approved.
The following guidance documents can assist in determining whether an activity is human subjects research requiring IRB review:
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).
Ensure that all research team members have completed mandatory IRB training. 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 also recommends that researchers take Good Clinical Practice (GCP) training, which is mandated by many sponsors and for anyone conducting an NIH-sponsored clinical trial that 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.
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), visit 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. Contact the IRB at firstname.lastname@example.org or 314-977-7744 if questions arise regarding eIRB and call your department's IRB coordinator if you have questions about your study.
Forms for applications not in eIRB, such as consent templates and other forms, can be found on the IRB website. 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.
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.
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. View a video demonstration of the process. 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.
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 or concerns.
For new studies, please plan to receive initial feedback from IRB review in:
Note that 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.
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.
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.
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 changes. 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. Do not hesitate to use the support in place for investigators conducting human subjects research at SLU.
Submission deadlines pertain only to items that require full board review, primarily new full applications. Exempt or expedited protocols need not be submitted according to these deadlines.
Note that while normally IRB review of submissions will take place according to deadlines and meeting dates below, in some cases, such as capacity issues or incomplete submissions, review may be moved to subsequent meetings, as needed. Investigators are encouraged to submit in advance of the deadline date, as reviews will make the meeting agenda on a first-come, first-serve basis.
Deadline for submission is noon unless otherwise noted.
|IRB Submission Deadlines||Meeting Dates|
|Aug. 21||Sept. 5*|
|Sept. 4||Sept. 19†|
|Sept. 18||Oct. 3*|
|Oct. 2||Oct. 17†|
|Oct. 23||Nov. 7*|
|Nov. 6||Nov. 21†|
|Nov. 20||Dec. 5*|
|Dec. 4||Dec. 19†|
The eIRB system is open to all Saint Louis University investigators. All new IRB protocols and requests for continuing review should be submitted in the eIRB system. Amendments and safety reporting submissions should take place in eIRB for electronic protocols and using paper forms for paper protocols. Study closures can be submitted in eIRB using the final report form.
Note that Emergency Use, HUD, WIRB and CIRB Applications are still being accepted on paper forms.
For support, contact 314-977-7744 or email@example.com. To submit feedback, access the eIRB System Feedback Form.