Getting Started with Human Subjects Research
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.
Follow these steps to determine if IRB review is required for your project and how to get the appropriate IRB training.
To help you determine whether IRB review is required, review Is Your Project Human Subjects Research?
If you are still uncertain, or if you’d like an official IRB determination, you can submit the SLU IRB Human Subjects Research Determination Form to irb@slu.edu.
Note: publication of five or less cases may not require IRB review. See the SLU IRB Guidelines for Case Reports for more information.
If doing research involving PHI from deceased persons, IRB review is not required. Instead, please complete the Notification of Decedent Research.
If IRB review is required, make sure that all research team members have completed mandatory human subjects protection training before forms are submitted to the IRB.
HSR/CITI Training
SLU uses the Collaborative Institutional Review Board Training Initiative (CITI) Human Subjects Training. Investigators who have completed a Human Subjects Research (HSR) training course other than CITI may provide a copy of their training certificate (with listed course modules) to the IRB with their IRB application or to irb@slu.edu. The IRB will determine whether the training course is acceptable.
GCP Training: Mandatory for NIH-Funded Clinical Trials
Good Clinical Practice (GCP) training focuses on quality standards for designing, conducting, recording and reporting research to help assure the safety and integrity of studies. The IRB recommends all researchers train on the principles of GCP and industry sponsors may require it, but the course is only mandated for investigators conducting NIH-funded "clinical trials."
Please note, GCP course completion does not count toward the mandatory IRB/Human Subjects Protections education requirement noted above.
Research with team members found out of compliance with training requirements may be asked to halt activities until compliance is restored.
To learn more about IRB training requirements, see the Training and Quality Assurance page.
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, or may request to use the SLU IRB as the single IRB for a collaborative project.
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.
Single IRB review can only proceed if there is an IRB Authorization Agreement (IAA, also called a Reliance Agreement) with the External IRB.
Common scenarios include, but are not limited to studies under the following conditions:
- SLU and the External IRB's organization are conducting research jointly;
- One IRB is deemed to be more able to review the study than another;
- There is a sponsor or other mandate to use a single/external IRB; or
- All human subjects research has been subcontracted to one of the site’s.
Certain multi-site clinical trials may qualify for use of a Central IRB. Saint Louis University has established partnerships with the following Central IRBs:
- NCI CIRB
- Quorum Review IRB
- Advarra IRB (formerly Schulman Associates IRB (SAIRB))
- StrokeNet IRB
- Western IRB (WIRB) and Affiliates (Copernicus Group, Aspire, Midlands, & New England)
These are the only central IRBs that SLU researchers can use at this time. If you have a study that requires reliance on another IRB, please contact the SLU IRB Office at 314-977-7744 or irb-reliance@slu.edu to discuss the possibility of an exception.
A clinical trial may be eligible for submission to a central IRB if it meets all of the following criteria*:
- Is an industry-sponsored, multi-center clinical trial, partner NIH trial, or has been granted an exception to use a central IRB;
- Has already been pre-reviewed or approved by a partner central IRB (submitted by sponsor or another site);
- Procedures take place at an authorized site (SLU, SSM Health SLU Hospital, and SSM Health sites);
- SLU investigators do not hold the IND or IDE ; and
- Study was not previously reviewed by SLU IRB.
*NCI CIRB serves studies sponsored by the National Cancer Institute and is limited to SLU- and CIRB-approved Principal Investigators and CIRB-approved studies. The list of eligibility criteria does not apply to NCI CIRB.
All requests from external researchers (researchers who are not affiliated with SLU), including but not limited to requests to recruit SLU students, staff and/or faculty, contact SLU alumni, use SLU facilities and/or receive data from SLU for research purposes must be reviewed by and given permission from the SLU IRB beforehand. This procedure constitutes an administrative review, not an IRB review.
After the SLU IRB has reviewed the request, external researchers must then also obtain permission from the appropriate SLU authority (college, department or office).