Ernest D. Prentice, Ph.D., and Bruce Gordon, M.D., IRB co-chairs, have issued the following memo to all investigators and participating study personnel regarding required training in the protection of human subjects.
The Institution which includes UNMC, The Nebraska Medical Center and UNO requires all investigators, study personnel, and protocol coordinators engaged in human subjects research to undergo training in the protection of human subjects utilizing the collaborative IRB training initiative (CITI). This requirement was initiated in September of 2000.
1. CITI certification renewal
Certification for training using the CITI course is valid for three (3) years from the original date of completion. Certification must be renewed at that time for any personnel who submit a new IRB application. Certification renewal is available through the CITI Continuing Education Course. To renew CITI training:
- a. UNMC and Nebraska Medical Center investigators must complete either the Biomedical Continuing Education course, or retake the initial Biomedical course which has been revised.
- b.UNO investigators and study personnel engaged in exercise science studies must complete either the Biomedical Continuing Education course, or retake the initial Biomedical course which has been revised.
- c.All other UNO investigators and study personnel must complete the Behavioral/Social Science Course. (The continuing education course for Behavioral/Social Sciences will be developed at a later date.)
NOTE: CITI certification renewal is required only when an investigator submits a new IRB application or a 5-year re-submission. Before final approval and release can be issued, all personnel listed on the IRB application must have a valid CITI certification. This is effective as of Sept. 15, 2003.
2. Citi training tracks
- a.Biomedical: To be completed by all investigators and participating study personnel at UNMC, the Nebraska Medical Center, and UNO personnel engaged in Exercise Science studies.
- b.Behavioral/Social Science: To be completed by all investigators and participating study personnel at UNO. (Note: As an exception, UNO investigators who conduct Exercise Science studies must complete the Biomedical track.)
3. Student research
All students conducting research under the jurisdiction of the UNMC IRB must complete CITI training prior to initiation of the research. This includes Exempt Behavioral and Social Science research.
4. Minimum passing score
As of Sept. 15, 2003, the IRB will require a passing score of 75 percent for both the Continuing Education Course and the CITI initial training courses. The quizzes in the initial training courses are now open-book. This will facilitate access to course content to assist in answering quiz questions.
Individual test scores are confidential. The webmaster and staff supporting the distance learning software at the University of Miami where the data are processed and stored have access to individually identifiable quiz scores. However, each of these staff members has signed confidentiality pledges and will not disclose individually identifiable quiz results or aggregate institutionally identifiable results. Staff of the Office of Regulatory Affairs (ORA) at UNMC, who have access to individually identifiable test scores, have also signed confidentiality pledges. Aggregate, anonymous quiz data may be used by course faculty to help improve course content and quiz questions.
5. New personnel added to IRB-approved research
All employees added as investigators, participating personnel, or research coordinators must comply with the training requirements.
6. External investigators or subcontract recipients involved in UNMC, The Nebraska Medical Center, or UNO studies
The IRB will accept certificates of training from other institutions when key personnel include external investigators, or subcontract recipients who have been trained elsewhere. A description of the training and a copy of any certification must be provided to the Office of Regulatory Affairs (ORA).
7. Access to the CITI training program
The CITI web-based training course in human subjects research may be accessed through the UNMC IRB Web site (www.unmc.edu/irb) at the “CITI Training” tab.
If you have questions regarding the CITI Training program, e-mail Jodi Hume or call her at 559-6463.