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.

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.).

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.

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