Institutional Review Board Education & Training
NYU Grossman School of Medicine offers various opportunities for investigators to learn more about institutional review board (IRB) policies and procedures, federal regulations, and the ethical issues surrounding human subjects research and protection. Select the options below for information regarding required and recommended training:
- Required Human Subject Research Protection Training
- Required Courses
- Recommended Courses and Training
- On-Demand Training Videos for Minimal Risk Research
The Collaborative IRB Training Initiative (CITI) program prepares research investigators to conduct studies that involve human participants. All NYU Langone researchers conducting research in humans are required to complete the course.
Experts in the 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.
Participation in the 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 Langone Health.” If you have previously taken the CITI training while affiliated with a different institution, you can update your affiliation in your CITI account.
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.
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. It is important to note that 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.
All researchers and staff from the NYU Langone research community are required to take one of the following 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).
Your CITI certification must always reflect the type of research you are currently carrying out. Should the type of research you are conducting change (for example, from social/behavioral to biomedical), you must update your CITI profile and take the course that is relevant to your current research type.
The refresher course (a shorter version of the basic course) must be completed every three years.
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 the article “New NIH Clinical Trials Policies: Implications for Behavioral and Social Science Researchers” for guidance on the GCP requirement.
Please note that 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.”
After the required modules are completed, you will receive the certification, which 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.
How Certification May Impact Review
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 submitting their human subject research studies for IRB review.
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 or individuals 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).
If you have any questions or concerns, please contact IRB Operations at email@example.com.
NYU Grossman School of Medicine offers the following courses and training opportunities to support the educational needs of our research community:
- weekly courses covering both fundamental and advanced topics
- quarterly information sessions and ad hoc sessions on special topics
- invited presentations and training for individuals and groups; issues covered include presenting to your staff during grand rounds or holding a meeting on a topic of interest to your research team
- IRB outreach, in which investigators can meet one-on-one with an IRB scientific manager, who can help navigate a new or difficult IRB submission
- on-demand Research Navigator training
To schedule an outreach session or an invited presentation or training session, please email firstname.lastname@example.org.
Registration via FOCUS Learning is required for all of the below offerings. Date, time, and location are subject to change at any time. You must register using the FOCUS Learning system for time and location details and to receive alerts regarding updates and cancellations (Kerberos ID and password required).
Register for the upcoming sessions of your choice by viewing one of the registration links or locate the sessions in the FOCUS Learning system by searching for each course by title.
Fundamentals of the IRB
IRB fundamentals sessions are in-person, instructor-led courses generally held on the first, second, and third Mondays of every month. There are three separate sessions that cover the submission requirements for the five major applications the IRB reviews. To obtain a description of each and to register, please view the links below.
Register for upcoming New Submissions sessions.
Register for upcoming Reportable New Information sessions.
Register for upcoming Continuations, Modifications, and Closures sessions.
Advanced Topics of the IRB
IRB advanced topics sessions are in-person, instructor-led courses generally held on the fourth Monday of every month. These sessions focus on the development of required study-related documents and processes. To obtain a description of each and to register, please select one of the links below.
Register for upcoming How to Write a Protocol sessions.
Register for upcoming Writing an Informed Consent that Informs sessions.
Register for upcoming Informed Consent Process sessions.
Quarterly Information Sessions
The IRB hosts quarterly information sessions to keep the research community informed of IRB requirement changes that may impact their human subjects research. This session provides an open forum for researchers to come together, ask questions, and meet members of the IRB Operations team.
- View recording for the summer 2021 information session
- View recording for the spring 2021 information session
- View recording for the winter 2021 information session
The IRB offers customized presentations to meet the needs of research teams and classes. Past topics have included the history of ethics in human subjects research, primary investigator and research team responsibilities, IRB submission requirements, and common submission pitfalls and solutions.
IRB Outreach Program
The IRB outreach program gives research investigators an opportunity to meet with a scientific manager and review their IRB proposals before submitting to the IRB for formal review. At your session, you receive help with the development of new protocols, informed consent writing, and the best approach toward getting your IRB submission approved.
Individuals can schedule a 30-minute, one-on-one appointment with a scientific manager. Appointments can be scheduled to accommodate work schedules.
On-Demand Research Navigator Training
All initial human subjects research studies and follow-up applications must be submitted using the Research Navigator system. A range of on-demand training videos are available to demonstrate how to use the system properly (Kerberos ID and password required). Topics covered include the following:
- Research Navigator submission orientation
- submitting a human subject research application for regulatory review
- reportable new information, continuations, and closures
- IRB modifications
- responding to IRB request for clarifications
- adding a CV to a Research Navigator person profile
The following videos have been developed to help researchers determine what activities meet the definition of “research,” understand what category of exempt or expedited review their research may fall under, and understand the submission requirements for each minimal risk review type.
Access the online courses below (Kerberos ID and password required):