In accordance with federal regulations and SLU policies, training on the involvement of human subjects in research is mandatory at Saint Louis University.
All faculty, staff, students, and collaborating researchers who conduct human subjects research must complete the course of instruction offered by the Collaborative Institutional Review Board Training Initiative (CITI) Human Subjects Training at the website given below or provide documentation of having completed a comparable human subjects research training course.
Investigators taking the CITI training must complete all required modules, regardless of where the research is being conducted. Investigators who have completed a human subjects research training course other than CITI may provide a copy of their training certificate to the IRB Office with their IRB application or to email@example.com. The SLU IRB will determine whether the training course satisfies the mandatory education requirement.
For CITI training, please register at the following site: http://www.citiprogram.org/
There is a course for biomedical research, a course for social/behavioral research, and a course for external collaborators (non-SLU collaborators who don't routinely do research, but are helping to conduct a particular study). Please complete at least one of the courses as it relates to you/your research. You must satisfactorily complete all modules and quizzes in order to pass the course.
CITI Registration Instructions to create a new account (if never had a CITI Account): click here.
CITI Registration Instructions to link existing CITI account to SLU (if took CITI through another institution): click here.
CITI Registration Instructions to take an additional CITI course: click here.
Training Documentation: After you complete the online CITI course, you should print a completion report for your records. CITI will email the completion report to the SLU training coordinator so that the IRB will have a 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: Mandatory for NIH-Funded Biomedical or Behavioral Health Clinical Trials
While not required for all researchers, many industry sponsors mandate the completion of GCP training with refresher training every three years. In addition, 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, click here.
SLU researchers are able to take the CITI GCP training (GCP Basic or GCP Refresher Training) to satisfy these requirements. See CITI Registration Instuctions above. Comparable courses may also be accepted. Current acceptable courses include the National Institute of Allergy and Infectious Disease (NIAID) GCP Training (see registration instructions), and the National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice. 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.
Importantly, investigators who are subject to the NIH GCP Training Policy and are found to be out of compliance may be asked to halt activities on NIH trials until compliance is restored.
Researchers outside of a mandate are also encouraged to take the GCP Course in CITI to learn about the importance of using good clinical practice in the conduct of research. NOTE: GCP course completion does not count toward the mandatory IRB/Human Subjects Protections education requirement noted above.
In-Person: Customized sessions or presentations, from a 15-minute "Who We Are" IRB introduction to a lengthier session or series of sessions fully tailored to your unit's needs can be requested. Instructors interested in scheduling an IRB education session for your students, or departments interested in scheduling a session for faculty or staff, please contact the IRB at 977-9813.
Online: Online workshops are routinely offered and are open to all SLU affiliated research personnel (including faculty, staff and students).