- Educational Program in Human Subject Protections:All staff who conduct research involving human subjects, either directly or through the use of human tissues or data, will be required to satisfy NYU Winthrop Hospital’s requirement for training in human subjects protections. This requirement may be satisfied by either completing the Collaborative IRB Training Initiative (CITI) Program (see link below), administered through the University of Miami or other training programs offered through the NYU Winthrop IRB. All certifications in the human subject protection training are valid for 3 years after the completion date. Other forms of training may be accepted, please contact the IRB Office.This web-based training program can be found at: https://www.citiprogram.org/
Effective, January 2, 2017 all investigators and key research personnel engaged in human subject Clinical Trials research (studies that involve drugs, devices, as well as interventional or behavioral treatments) must complete the online Collaborative Institutional Training Initiative (CITI) program for Good Clinical Practice (GCP) prior to IRB approval of a new or continuing review application.
This web-based training program can be found at: https://www.citiprogram.org/
- HIPAA and Research TrainingHealth Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that was enacted in 1996 and went into effect on April 14, 2003. The privacy rule requires researchers to address and maintain the privacy of research participant’s health information. All staff who conduct research involving human subjects is required to complete training in HIPAA and Research. In March 2003, three sessions were offered addressing HIPAA and Research. Those individuals who attended the March 2003 session have satisfied the HIPAA and Research training requirement. An announcement about NYU Winthrop Hospitals HIPAA policies and procedures with regards to research was distributed in a Letter to the Research Community on April 7, 2003. All researchers who have not taken the HIPAA training Course provided by the Institution are required to complete the Collaborative IRB Training Initiative (CITI) Module on HIPAA Training (see link below), administered through the University of Miami.https://www.citiprogram.org/
Regulations implementing the HIPAA privacy rule must be complied with for all health care providers who have access to identifiable health information.