As per the Northwell Health policy, GR085 Training Requirements for the Human Subjects Research Protection Program, all individuals involved in research with human subjects (investigators, coordinators, research assistants, etc.) must complete the following:
- Researcher Registration Form
- Required Human Subjects Research Training
Tutorial Completion Dates – click this link to find CITI Program training completion dates for Northwell Health.
Researcher Registration Form
The Researcher Registration Form is only required once. UPDATE 12/2013: The form is now incorporated into the CITI Program course for required human subjects research training. Anyone who completed CITI Program training after 12/1/13, does not need to complete a separate researcher registration form. The date of completion of the researcher registration form will be the same date of completion of the CITI Program course.
For those who need to complete the paper form: After the form is completed, it should be printed and signed. Researchers should keep the original signed registration form with their other compliance documentation. A copy of the completed signed form should also be forwarded to the IRB by email (preferred) at firstname.lastname@example.org. Hard copies can be faxed to 516-321-2125. All copies will be kept on file at the Office of the IRB.
Required Human Subjects Research Training
To meet our federal human subject protections educational requirements, Northwell Health requires:
- ALL Northwell Health clinical research investigators and staff are required to complete the following CITI Program courses via www.citiprogram.org:
- Northwell Health Human Subjects Research Course (must be renewed every 3 years)
- Conflict of Interest Course (must be renewed every 4 years
- Northwell Health sponsor-investigtors and staff are also required to complete a Good Clinical Practice (GCP) training. The GCP training must be approved by the Health System’s Human Research Protection Program. GCP training must be renewed every 3 years. Available options include:
- CITI Program Good Clinical Practice Course (Sponsor-Investigator Responsibilities)
- 2-Day Navigating Clinical Research at Northwell Health class
- TransCelerate Member GCP Courses
- TranCelerate Accredited GCP Courses
- Northwell Health physicians and their staff, who are listed on the IRB HUD application, are required to complete the following course when using a HUD within its approved labeling:
- CITI Program Humanitarian Use Device (HUD) Course (must be completed once, unless otherwise directed by the IRB)
Accessing CITI Program
Click here to watch a video tutorial on how to register as a new user, affiliate with Northwell Health as an existing user, and to add a course or update your learner group in CITI. More information and detailed instructions on accessing the CITI Program can be found by clicking here.
Additional Training Opportunities
It is highly recommended that clinical researchers also take optional courses on Good Clinical Practice (GCP) and ICH and the Responsible Conduct of Research (RCR) even though they might not be required. For guidance on other optional research training that may benefit your research team, click here.
CME/CEU credits are available for CITI Program courses through the University of Miami for a fee. Contact CITI Program for more information about CME/CEU credits.
Please email the Office of Research Policy and Training at RPT@nshs.edu with any questions and concerns. Thank you for your cooperation and we look forward to continuing to work with you in the advancement of human subject research.