What is CITI?
Collaborative Institutional Training Initiative (CITI) certification is an institutional requirement for all personnel engaging in Human Subject Research (HSR). It includes three primary modules that are required by the institution to participate in conducting various types of research: Group 1: Biomedical Research, Group 2: Good Clinical Practice (GCP), and Group 3: Social & Behavioral Research.
Faculty, employees, students and other institutional representatives at UNMC, Nebraska Medicine, CHMC, and UNO are required to complete the Human Subjects Research (HSR) course via CITI if they will be working on a research project that involves human subjects. It takes approximately 1-2 hours to complete a Basic course. The training does not have to be completed in one sitting, but can be spread out over time if needed.
Instructions:
Instructions for how to access and use CITI can be found here.
Basic or Refresher?
The Basic course is designed to establish certification and should be taken when:
- No previous CITI training has been completed, or:
- Prior CITI certification has been expired for a period greater than three years
The Refresher course is designed to re-establish certification for three years and should be taken when:
- The Basic course of a particular group has already been taken, and:
- Recertification is required, but has not been expired for a period of three or more years
Course required based on type of research:
Group 1: Biomedical Research – Investigators conducting research about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods must take this course. Types of research:
- Clinical trial using a drug, medical device, technique or other intervention or strategy (including non-physical means, like diet, cognitive therapy, etc.) to diagnose, treat or otherwise study a particular condition or disease.
- Non-clinical biomedical research to study normal or abnormal physical or physiologic processes (for example: gait and balance testing, biomechanical assessments, etc.).
- Research involving medical records or data registries.
- Research involving human biologic materials.
Group 2: Good Clinical Practice (GCP) – Investigators conducting clinical trials funded by NIH, or utilizing an FDA regulated drug, device, or biologic must take this course. A clinical trial is defined as “a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.
***Investigators conducting these types of trials must also take the Biomedical course (Group 1).
***This GCP course meets the minimum criteria for training identified by some sponsors. (Check to see if your sponsor is listed.) If so, your CITI completion report can be supplied to the sponsor to meet their GCP training requirement.
Group 3: Social & Behavioral – Investigators conducting research performed with intent to study:
- Behaviors, attitudes, and interactions/social processes among and between individuals, groups, and cultures.
- Generally, this category of research has no intent of producing a diagnostic, preventative, or therapeutic benefit to the subject who is not seeking nor expecting a health benefit from the research.
- This course is primarily taken by students at UNO, although it is common for Nursing Program students to be required to take this as well.
Researchers/Students transferring from other institutions:
Please email all completion reports for previously completed CITI training courses to irbora@unmc.edu. CITI courses are unique from institution to institution and transcript comparison will be required. Only the completion report shows the modules required for transcript comparison. Once previous training has been updated, the IRB will determine if any additional training or Refresher courses will be required.
***It is highly recommended that you email the Completion Report prior to beginning the Refresher course.
***Please do not send completion certificates.
Collaborators with UNMC:
Any independent entity collaborating with UNMC for the purposes of research must also complete CITI training as required by the institution. When registering for CITI, please affiliate with UNMC/UNO and do not register as an independent learner.
If you need assistance with your username and/or password from an institution other than UNMC/UNO, you can contact CITI Support at (888)529-5929 (9:00 a.m. to 7:00 p.m. / U.S. Eastern Time / Monday – Friday). If you have more than one CITI account, you can request that they be merged by calling CITI Support. Once merged, all training completed will be available under one account.
For all questions regarding CITI training, please the IRB Office at (402) 559-6463 or email.
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