Training and Education

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 (HIPAA) must be learned through understanding the law and its implementation at the Icahn School of Medicine at Mount Sinai.

All educational requirements are completed through the CITI Program.

Note: Requirements for human subjects' education apply to anyone listed on a project in RUTH who has a role where they are involved in the design, conduct or reporting of the research study.

Administrative-Non-FCOI Role:

For those who are assigned the Administrative non-FCOI role, human subjects education requirements are not required but encouraged nor are they required to make an FCOI disclosure*.  The role of Admin non-FCOI should be used very infrequently and only for the following team members:

  • Team members who are solely providing administrative support and
  • Team members are not ever involved in interacting with potential or enrolled human subjects (including managing reimbursements, acting as the contact for the project for subjects, etc.) and
  • Team members are not ever involved in collecting, analyzing or managing data. 

Keep in mind research coordinators should not be listed in this role and the role should not be used as a “back up” in case one someone listed on the project is not available.  All team members can perform all tasks except submit a project in RUTH. This role is to help when there are few study team members listed on a project. Only three (3) members of the team may be listed for this role on any project.  

*This role does not negate the FCOIC's requirement for meeting their education requirements in the CITI Program. 

Primary Contact:

Anyone assigned an employee number at Mount Sinai, regardless of whether they are an approved study team member, can be assigned the Primary Contact role of a study. Unless otherwise noted as a study team member, the  Primary Contact is required to follow the same guidelines as the role of Admin non-FCOI. Unlike the PI proxy role, only one Primary Contact is allowed per project. 

*This role does not negate the FCOIC's requirement for meeting their education requirements in the CITI Program.  

While completing the CITI course work is required prior to submitting to the PPHS office, copies of the educational certificates do not need to be attached to your RUTH submission. To facilitate proper linking between CITI, RUTH and Sinai Central, be sure to set up your CITI account as indicated below. Please note that completion certificates from other institutions will not be accepted.

When setting up your CITI account:

  • Affiliate with Icahn School of Medicine at Mount Sinai
  • Use your legal name as recognized by Human Resources
  • Use your Mount Sinai email address
  • Add your Mount Sinai Life Number to your profile

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 Icahn School of Medicine at Mount Sinai 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.

  • HUMAN SUBJECTS RESEARCH COURSES
    • Investigators/Research Staff Basic Course: Comprehensive basic foundations course. Required of study team members before involvement in human subjects research.
      *Valid for three years but must be taken once*
    • Investigators/Research Staff Refresher Course:  Case-based course designed to reinforce understanding of core issues related to human subjects research.
      *Valid for three years but only acceptable after completion of the Investigators/Research Staff Basic Course*

  • HIPAA COURSES
    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 *Course does not expire*
    HIPAA for Research Update *Course does not expire*

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 COURSE
    This course is required of researchers and staff conducting FDA-regulated research or when obligated by contract or other agreement.
    Industry sponsors often require GCP training for investigators and the research team. Check with your funding agency regarding their GCP requirements and refreshers.

    The required GCP Course can be completed through the CITI training program’s website at CITIProgram.org. 
    *Refresher is recommended at least every 3 years*

    For additional information, researchers and staff can attend a training course conducted by the Office of Research Compliance entitled “Research Compliance GCP Course."  Please see the Research Roadmap for information on how to sign up for this supplementary course.

  • RIGOR, REPRODUCIBILITY AND ETHICAL BEHAVIOR IN BIOMEDICAL RESEARCH COURSE
    This course is required for all faculty, fellows, residents and students at the institution.
    *Refresher is required at least every 3 years*

IRB University

IRB University is ideal for all new ISMMS faculty and research staff who are preparing to make their first submission to the IRB. It is also recommended for any ISMMS faculty and research staff who need a refresher on making submissions to the IRB. IRB University comprises IRB 101 and IRB 201.

  • IRB 101 introduces ISMMS faculty and research staff to the IRB. In this course, you will learn exactly what types of research are reviewed by the IRB, details of the IRB’s review process, and gain insight and knowledge on how to make successful submissions to the IRB. This course is a pre-requisite for IRB 201.
  • IRB 201 provides deeper detail regarding the content of your IRB submissions. Using examples and exercises, you will learn how to complete required forms, create a protocol and consent form for your submissions.

You can find the video courses in PEAK by searching IRB. If you have further questions, please send a message to the IRB@mssm.edu mailbox.

PPHS In-Service

The In-service option is an opportunity for departments or research groups to schedule a tailored IRB training session for their staff. If you are interested in scheduling some time with us for your department or group, please send a message to the IRB@mssm.edu mailbox.

IRB Virtual Office Hours

The PPHS Office offers virtual Office Hours providing ISMMS faculty and staff the opportunity to consult with the IRB. During these consultations, the PPHS staff can assist with all questions related to the IRB submission process.