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 still uncertain, or if you’d like an official IRB determination, researchers can submit the SLU IRB Human Subjects Research Determination Form to email@example.com.
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.
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 firstname.lastname@example.org. The IRB will determine whether the training course is acceptable.
For CITI training, please register at the following site: http://www.citiprogram.org/
Complete one of the following courses as it relates to you/your research:
CITI registration instructions:
When registering, be careful to provide the SLUnet ID information requested to ensure the SLU IRB gets automated notification and access to your records. You should also save the training completion report for your records. Documentation of an approved educational program must be on file with the IRB Office before IRB review of 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." For NIH interpretation, see the clinical trial definition.
SLU researchers are able to 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.
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.
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 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 email@example.com 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*: