It is essential that all investigators and their staff understand the regulations that govern research that involves human subjects. Appropriate education is seen as the first building block in the protection of human research subjects. Similarly, appropriate efforts toward protection of patient privacy and data confidentiality via the Health Insurance Portability and Accountability Act must be learned through understanding the law and its implementation at the Icahn School of Medicine at Mount Sinai.
All education requirements are completed through the CITI Program. When setting up your account, affiliate with Icahn School of Medicine at Mount Sinai. Use your work email account, your name as recognized by HR, and your life number (or its equivalent) for your profile. These steps will enable your credits to register under this account and will provide easy access to viewing which courses you have completed.
While completing the course work below is required prior to submitting to the PPHS office, copies of the education certificates are not part of your submission. The PPHS office tracks completion electronically. To facilitate proper tracking, be sure to set up your account/profile as indicated above. Please note that completion certificates from other institutions will not be accepted.
For Investigator/Research Staff, following are required courses:
- Basic: Comprehensive basic foundations course. Required of Research personnel before involvement in human subjects research. This must be taken once.
- Refresher: Case base course designed to reinforce understanding of core issues related to human subjects research. This course is due once every three years. (This course is first due three years after completion of the Basic Course.)
- HIPS: Both courses must be taken to receive credit. These courses are designed to cover institutional policies as well as regulatory considerations.
- Data Security and HIPAA Training Course
- HIPAA for Research Update
- Note: All HIPAA for Research requirements are accessed through CITIProgram.org. To fulfill HIPAA requirements for the Health System/Hospitals, required for all employees, please visit https://peak.mountsinai.org or contact the HIPAA Office at 646-605-7130 for further information.
- Good Clinical Practice: Required of researchers and staff conducting FDA-regulated research or when obligated by contract or other agreement. Researchers and staff have the option of completing the GCP course through the CITI program or attending the training course conducted by the Office of Research Compliance entitled “Clinical Research: Are You Doing It Right?”
Instructions to affiliate existing CITI account with Icahn School of Medicine can be found here. If you have an existing account that is affiliated with another institution, please add ISMMS as an affiliated institution rather than creating a new account. Any previously completed modules that overlap with the ISMMS requirements will not be required again, but all new ISMMS requirements must be completed.