Required Human Research Subjects Protection Training | NYU Langone Health

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Institutional Review Board Courses & Training Required Human Research Subjects Protection Training

Required Human Research Subjects Protection Training

Participation in the Collaborative IRB Training Initiative (CITI) program is required for everyone listed on a study involving human subjects. This online training takes approximately three to six hours to complete. To receive credit, set your affiliation to “NYU School of Medicine.” If you have previously taken the CITI training while affiliated with a different institution, you can update your affiliation in your CITI account.

Experts in the institutional review board (IRB) community developed the CITI program, which consists of two basic courses in biomedical research, as well as a course in social and behavioral research. The CITI program also offers case-based refresher courses for continuing education.

Login and Registration Information

All users should create their accounts by registering and logging in via the Single Sign-On method. This ensures that your CITI certification status appears in the Research Navigator system. Additional information and instructions are available.

Required Courses

Each course includes reading material that can be read on screen or printed, as well as a brief online quiz. The format is open book—you may refer back to the text at any time while taking the quiz. An important note: Your sponsor or principal investigator (PI) may require completion of additional modules. Please check with your PI to ensure you obtain certification in all relevant training modules.

Basic Courses

All researchers and staff from the NYU Langone research community are required to take the basic science modules:

  • For the biomedical research community: complete the Biomedical Research basic course (19 modules).
  • For the NYU Langone Social Behavioral Research community: complete the Social/Behavioral Research basic course (17 modules).
  • For NYU Langone researchers conducting data or specimens research only: complete the Research with Data or Laboratory—Specimens–Only course (10 modules). Please note that if you have completed the Biomedical Research basic course, you do not have to complete this course section.
  • For students conducting no more than minimal risk research: complete the Students Conducting No More Than Minimal Risk Research course (24 modules).

Refresher Courses

The refresher course (a shorter version of the basic course) must be completed every three years.

Additional Courses

The CITI Good Clinical Practice (GCP) Course (14 modules) may be required if you are involved in the conduct, oversight, or management of clinical trials funded by the National Institutes of Health (NIH) or other sponsors. Otherwise, this course is optional.

If you are conducting social behavioral research funded by the NIH or another sponsor that requires completion of this GCP training, please review this article for guidance on the GCP requirement.

Please note: This GCP course may be completed after completing the basic biomedical course requirement as outlined above. The GCP course is not to be completed in place of the basic biomedical course. To access the GCP module, at main learner menu, select “change group” and “CITI Good Clinical Practice Course.”

Access the CITI program modules on the CITI website.

Certification Expiration

Once the required modules are completed, the certification is granted and remains active three years past the date of completion.

Completion of the refresher course is necessary. Once the refresher course has been taken, you will be prompted to complete the full course again upon expiration.

Your CITI certification must always reflect the type of research you are currently carrying out. Should the type of research you are conducting change (e.g., from social/behavioral to biomedical), you must update your CITI profile and take the course that is relevant to your current research type.

How Certification May Impact Review

After Friday, April 12, 2019, IRB Operations will review CITI certification status as part of the pre-review process. All study teams are strongly encouraged to ensure that their CITI training requirements are current before this date.

The following requirements will be in effect after Friday, April 12: 

  • For PIs with missing or expired CITI certification, any IRB submissions (initial studies, modifications, or continuing reviews) will not be approved until the certification requirement has been met.
  • For other study personnel with missing or expired CITI certification, the PI or primary contact will either require the individual to complete the training and advise the IRB once it is completed, or the PI or primary contact will remove the individual(s) from the list of study team members and submit a modification to add them back once they have completed the training.

Addressing Certification Date Issues in Research Navigator

If your CITI certification date indicated in Research Navigator is incorrect, find guidance on how to link your CITI account (make sure to use your correct Kerberos ID).

To avoid delays with your IRB submission, all study team members are encouraged to review their CITI status and ensure that their certification is current before Friday, April 12.

If you have any questions or concerns, please contact IRB Operations at irb-info@nyulangone.org.