Training and Education Requirements Education is a key component in the protection of human subjects in research. It is essential that all key personnel engaged in human subjects research understand the regulations that govern research that involve the use of information and specimens obtained from human subjects. Thus, all Albert Einstein College of Medicine, Montefiore Medical Center, and White Plains Hospital investigators, clinical research coordinators, research staff, and IRB members are required to complete the required Human Subjects Protection (HSP) training mandated by the terms of our Federal Wide Assurance before they can submit their protocols in iRIS. Please refer to the OHRA CITI Training Support Page for instructions on how to access the HSP course and obtain a copy of your training certification Note: All investigators must renew their CITI training certifications every 5 years in order to be certified in Human Subjects Protection (HSP) training. The Einstein IRB will not issue approval for a research protocol if any key personnel has not satisfied this requirement. Good Clinical Practice (GCP) Education The training of investigators and research teams to conduct clinical research is crucial to successful translation of novel drugs, devices and interventions. In order to secure comprehensive competency-based training for clinical research personnel, we will require certification of training in Good Clinical Practices (GCP) for all investigators and personnel directly involved in new and ongoing clinical studies that involve the testing of drugs or devices, including all FDA-registered studies as well as investigator-initiated protocols. This requirement applies to studies reviewed by both the Einstein IRB, as well as approved external IRBs (e.g. BRANY, NCI CIRB, etc.). GCP training is available through CITI; please refer to the OHRA CITI Training Support Page for information on how to add the course to your profile Note: GCP training for investigators and clinical trial staff must be renewed every three years (for more information on the NIH notice regarding GCP training, see NOT-OD-16-148) Documentation of Human Subjects Protection Training for NIH-funded Studies The NIH requires that all Key Personnel on NIH-funded human subjects research fulfill their HSP training requirement and that documentation for meeting this requirement be provided to the Institute/Center funding the project before the award will be issued. Please be sure to send a copy of your completion certificate to your administrative support team so they have this information available as needed. Directions for how to obtain your completion certificate are available on the OHRA CITI Training Support Page Useful Links: iRIS Training Navigate to the CITI website to complete your Human Subjects Protection Certification Watch OHRP educational videos on a variety of topics related to human subjects protection
