What is CITI training? CITI training refers to web-based courses offered through the Collaborative Institutional Training Initiative (CITI) Program, a leading provider of research ethics and compliance education. Many institutions—including universities, hospitals, and government agencies—use the CITI Program to ensure that researchers and staff receive training on key topics such as Human Subjects Protection (HSP), Good Clinical Practice (GCP), and HIPAA privacy standards. These self-paced courses help ensure that all personnel understand how to conduct research ethically and in compliance with applicable regulations.
Do I need to take CITI training? Investigators and study personnel doing research involving human subjects must take CITI training before receiving IRB approval, and become re-certified at minimum every three years.
If my study is exempt, am I still required to complete CITI training? Yes. Even if a study is exempt, CITI training is required.
How long does the training take to complete, and does it need to be taken all at once? The training takes about 1.5 to 4 hours to complete, and you can start or stop at any time—your progress will be saved.
What is the passing score? A passing score of 80% is required. You may retake module quizzes to improve your score.
What if I have already taken CITI training at another institution? CITI training completed under another institution may be transferable. To transfer previously completed modules GU will need to be added as an affiliated institution to your existing CITI account. Once added you will need to sign up for the GU required course and CITI will automatically pull over the completed modules from your past institution giving you credit for any modules that align with the GU CITI requirements. You would then need to complete any outstanding GU CITI required modules. More information on how to update your affiliated institution in CITI can be found on the CITI Support page.
How do I register for CITI training? Investigators and key personnel can access CITI training by going to their website at: https://citiprogram.org
Which CITI courses do I need to take?
The list below displays all of the CITI modules that are potentially required. Expand the accordion to read more about who is required to complete that module and how often.
Who does this apply to? All members of a research team that meet the definition of “engaged in research” are required to complete human subject protection (HSP) training. An individual is “engaged” in human subjects research when the individual, (i) intervenes or interacts with living individuals for research purposes; or (ii) obtains individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].
Note: The Responsible Participant (student’s mentor/advisor) is considered to be a member of the research team and must fulfill all required training.
Which CITI modules fulfill the HSP training requirement? There are two Human Subjects Protection (HSP) training courses, organized by research category. The required HSP course is determined by the specific study or protocol. Study teams should complete the course that most closely aligns with the type of research being conducted (reference bullets below). If a study team is involved in multiple protocols that span different research disciplines (e.g., one biomedical and one social-behavioral), team members must complete both corresponding HSP courses.
Biomedical Research: Biomedical research is patient-oriented and involves the study of the mechanisms of human disease, therapies or interventions for disease, clinical trials, and development of new technology. Biomedical research includes oncology research. If your research fits in this category, complete the Biomedical Comprehensive Human Subject Protections Course.
Social-Behavioral-Educational Research: Social and Behavioral research applies the behavioral and social sciences to the study of humans. This research is conducted by many academic disciplines to include but not limited to education, sociology, anthropology, economics, political science, and history. If your research fits in this category, complete the Social-Behavioral-Educational Human Subject Protection (SBE) Comprehensive Course.
Note: The HIPAA and Human Subjects course has now been combined with the HSP training courses.
Recertification and Renewal: Human Subject Protection training must be renewed every three years.
Who does this apply to? All National Institute of Health (NIH) funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials. The policy applies to all active grants and contracts, at any point in the life cycle of the clinical trial.
Definitions:
NIH Clinical Trial – A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions [defined below], on health-related biomedical or behavioral outcomes.
Interventions – A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as surveys, education, and interviews.
Which CITI modules fulfill the GCP training requirement?
Biomedical Research:
GCP Drugs and Devices FDA
Social and Behavioral Research:
GCP – Social and Behavioral Research Best Practices for Clinical Research
Recertification and Renewal: Good Clinical Practice training must be renewed every three years.
Who does this apply to? Investigators who receive PHS funding (NIH, FDA, etc.) or cooperative group funding must also undergo conflict of interest (COI) training before engaging in the funded research.
Recertification and Renewal: FCOI training must be renewed every four years.