In accordance with Federal regulations and IRB policy, Investigators and study staff conducting clinical research are required to receive appropriate training in the protection of human subjects. Individuals must provide the IRB with a copy of their training completion prior to receiving IRB protocol approval or initiation of research activities. An individual will not be considered trained in the protection of human research subjects until the IRB receives a copy of an accepted training completion certificate.
The IRB conducts and/or sponsors periodic training sessions for investigators who are members of the Saint Francis Hospital Medical, Dental, and Nursing staff, research coordinators, research staff and IRB members. Currently, the IRB provides and accepts CITI training:
- The Collaborative Institutional Training Initiative (CITI) on-line training program located at http://www.citiprogram.org
This training takes an average of 4-6 hours to complete. Training modules may be broken up over several work sessions because the system remembers which module was last completed. The exam at the end of each module must be completed in order for the system to remember that the module has been reviewed and completed. Once all modules and exams are completed, the individual and IRB Program Coordinator will receive a copy of the completion certificate.
For Investigators and Study Staff:
Good Clinical Practice (GCP-US FDA focus), Human Subjects Research (Group 1 or 2) and Conflicts of Interest (COI)
The CITI training and completion certificate expires after 3 years.
New users should choose "Saint Francis Hospital and Medical Center-Hartford" as their participating and affiliating Institution. **This Institution must be selected or the IRB will not automatically receive a copy of your training completion certificate.
It is up to the discretion of the IRB whether it will accept a CITI training certificate from an outside Institution. The IRB will verify if the CITI training contains the minimum module requirements to conduct research at Saint Francis Hospital and Medical Center.
The IRB offers CITI training free of charge to members of the Saint Francis Hospital Medical, Dental, and Nursing staff, research coordinators, research staff and IRB members. CME and CNE credits are available for each training option and must be requested at the time of initial training by the individual completing the training. The IRB does not reimburse individuals for the costs of CME and CNE credits.
Subsequent to the initial training, the IRB requires all investigators, study coordinators, and research staff to complete a CITI refresher course via http://www.citiprogram.org The refresher course is to be completed every 3 years.