Saint Louis University has established three Institutional Review Board (IRB) committees, supported by an administrative team in the research integrity and safety group within the Office of the Vice President for Research, to review and oversee human research studies conducted at SLU or by SLU researchers.
Researchers are assumed to need SLU IRB approval if they are conducting human research unless the use of a central or external IRB has been approved.
Email email@example.com to join the IRB listserv and receive updates about training opportunities, policy changes and other notifications.
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.
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 firstname.lastname@example.org.
Note: Publication of five or fewer cases may not require IRB review. See the SLU IRB Guidelines for Case Reports for more information.
If you are doing research involving PHI from deceased persons, complete the Notification of Decedent Research; IRB review is not required.
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. Research cannot be approved without it.
SLU uses the Collaborative Institutional Review Board Training Initiative (CITI) Human Subjects Training. Investigators who have completed a training course other than CITI may provide a copy of their training certificate to the IRB with their IRB application or to email@example.com. The IRB will determine whether the training course is acceptable.
For CITI training, please register at www.citiprogram.org.
Complete one of the following courses as it relates to you and your research:
Training Documentation: Save the training completion report for your records. If CITI training is taken with your SLU email address and Banner ID, the IRB will also have record of your training. Documentation of an approved educational program must be on file with the IRB office before research on human subjects may begin.
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.
The NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials (NOT-OD-16-148, effective date January 1, 2017), mandates GCP training every three years for all investigators and study staff of NIH-funded clinical trials. A clinical trial is defined by NIH as, "A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
SLU researchers can take the CITI GCP training (GCP basic or GCP refresher training) to satisfy these requirements (see CITI registration instructions above). Comparable courses may also be accepted, such as:
Documentation of comparable training must be submitted to the IRB for review/acceptance and to enter into our database so training will automatically appear in eIRB Applications. Note: GCP course completion does not count toward the mandatory IRB/Human Subjects Protections education requirement outlined above.
Research with team members found out of compliance with training requirements may be asked to halt activities until compliance is restored.
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:
Certain multi-site clinical trials may qualify for the use of a central IRB. Saint Louis University has established partnerships with the following central IRBs:
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 IRB Director Melissa Fink at firstname.lastname@example.org or 314-977-9814 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:*
*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.