Training of Investigators and Study Staff

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 and IRB members.  In addition, the IRB conducts quarterly training mailings for individuals currently involved in research and those who wish to receive the informational materials.

The IRB accepts two types of training:

1. 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 Administrator will receive a copy of the completion certificate. 

   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.

2. Reading the book Protecting Study Volunteers in Research, completing the exam and evaluation forms enclosed in the back of the book and returning the exam to the IRB office to be sent out for grading.  The IRB sends exams to the University of Rochester for grading.  Exams are batch graded by the University, therefore the turn around time for certificate return can be one to three months.  This training option is not recommended if training is needed in a short period of time.

The IRB offers these trainings free of charge to members of the Saint Francis Hospital Medical, Dental, and Nursing staff, research coordinators 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.