OFFICE FOR PROTECTION OF HUMAN SUBJECTS |
According to the University's Federal-Wide Assurance (FWA) with the federal government, the University and the Institutional Review Board (IRB) must provide educational training in the protection of human research subjects. In an effort to be in compliance, the UO is now implementing the CITI education requirement. Previously education in human subjects research was recommended, but only enforced for researchers receiving NIH grants. CITI offers a convenient and user-friendly way for the University to meet the education requirement of its FWA.
On your first visit to CITI, you will need to register and create a username/password. After registering, you will select one of 5 Learner Groups. CITI will remember your password, learner group and "grade book score". Each time you log in, CITI's Grade Book will show you your status. After completing all the modules in your learner group, CITI will provide you with a certificate if your overall grade is 80% or higher. You are allowed to go back in the module to review and retake a quiz. The certificate will indicate which Learner Group you completed.
Before approval may be granted on any new or continuing IRB protocol (regardless of funding), you must complete the CITI educational requirement or submit your current NIH certificate. You can submit your protocol application without having completed CITI, but approval will not be granted until the training requirement is met. Completion of CITI will not be required for reseachers submitting a modification to an existing protocol.
All UO researchers (faculty, staff or student) and research personnel involved in human subjects research, regardless of whether the research is funded or not funded, will be required to successfully complete the CITI computer based training. This includes any investigators, research assistants, study coordinators and faculty advisors who are listed on the original protocol or have been formally added in a modification.
The Office for Protection of Human Subjects considers "research personnel" to include any investigators, research assistants, study coordinators and faculty advisors who are listed on the original protocol or have been formally added in a modification.
Yes, faculty advisors are considered "research personnel" and must successfully complete the CITI training course before their advisees' IRB protocols can be approved.
Only those people listed on the original protocol or formally added in a modification will be required to take CITI in order to receive approval on a new or continuing protocol. However, Principal Investigators are expected to provide their staff with appropriate educational training in the protection of human subjects. CITI is available to investigators for this purpose and its use is encouraged.
Current researchers holding an NIH training certificate will have a one-year grace period from the date of their NIH certificate in which to complete the CITI modules. After February 15, 2008, the old NIH training certificates will no longer be accepted.
You may contact the Office for Protection of Human Subject and we will secure a duplicate copy.
Yes. All CITI certificates expire 2 years from the completion date. At that time, you must take the refresher course. CITI will automatically contact you to remind you that it is time to take the refresher course.
Log on to CITI (https://www.citiprogram.org). Go to "Forgot Username or Password." They will give you your password information. CITI keeps your email and password information.
A Learner Group is a designation for UO researchers, research personnel, and students to be directed to the appropriate set of modules. There are 5 Learner Groups:
- Social/Behavioral Investigators - The majority of researchers at the UO should choose this group, which is designed for all researchers and research personnel who are conducting non-medical research.
- Human Physiology Investigators - This group is designed for researchers and research personnel who are conducting research of a biomedical nature. The majority of such researchers are in the Department of Human Physiology
- IRB Members - Social/Behavioral - This group is designed specifically for members of the UO's Social/Behavioral Institutional Review Board.
- IRB Members - Biomedical - This group is designed specifically for members of the UO's Biomedical Institutional Review Board.
- Data Analysts Only - This group is designed for researchers and research personnel whose role in human subjects research is limited to Data Analysis.
According to Amdur and Bankert, behavioral and social science are used interchangeably to mean "the study of human society and of individual relationships in, and to, society." Social and behavioral research is usually conducted in such academic disciplines as "sociology, psychology, anthropology, economics, political science, and history." (Amdur, R, and Bankert, E. Institutional Review Board: Management and Function, 2002, Jones and Bartlett Publishers, page 105.) Social and behavioral research is also conducted in areas such as education, epidemiology and public health, marketing, oral history, ethnography, criminal justice, religion, and social services. Social/behavioral science is distinguished from biomedical science, which focuses on human physiology, the treatment or understanding of disease, or "the application of the principles of natural sciences to medicine."
No. Once you register at CITI, you may proceed at your own pace. When you log off, CITI remembers where you left off. You can check your Grade Book for your status. CITI is available 24 hours a day, seven days a week, 365 days a year. Remember, however, you must complete the training course before you can receive approval for your study.
Each module is followed by a few short questions. Anticipate 2-5 hours to complete the required modules. The modules may be completed in multiple sessions. You do not have to complete them all at once. CITI will keep track of where you are each time you log out.
CITI is structured for the required modules to be taken in order, in many cases one module building upon the last. Once you complete the required modules, you may take any or all of the Elective modules in the sequence you prefer.
CITI keeps track of your progress in what is called a Grade Book. You can click on the Grade Book to see how many modules you have completed, your score, and the date you completed each one. Also, the Grade Book shows you which required modules you have yet to complete, and provides a list of elective modules you may complete after you have successfully finished the required modules.
In order to receive a CITI certificate, you must pass a quiz at the end of each module. An overall score of 80% or better is needed to receive your certificate. The completion certificate does not show your grade; only the Grade Book shows it. The Grade Book is available for you to view or print out.
You can re-take any of the quizzes as many times as you like, and CITI will always record your highest score. At the end of each quiz, CITI will provide an explanation of any item you responded to incorrectly.
Please keep a copy of the certificate for your files. If you lose your copy, CITI makes it easy for you to retrieve a replacement. Just login to CITI and print a copy. When you have completed the training requirement, CITI will automatically send an electronic copy of the certificate to our office. You do not need to provide us with additional copies.
When entering the CITI site, select either Social/Behavioral or Human Physiology as your learner group. The modules cover the basics of human subjects research. When you become an investigator on your own project, you will not need to complete the CITI modules again unless your certification has expired (after 2 years), in which case you will need to complete the refresher course.
Paper copies of CITI certificates will be accepted from UO researchers and staff who have completed CITI at another institution. The certificate will be considered valid for two years after the date of completion, regardless of how long the other institution considers it valid. When the certificate expires, UO researchers will be expected to complete the UO's version of CITI.
Investigators from other institutions who are named on a UO research team may submit documentation of training from their own institutions, provided that this training was completed or updated within the last two years. Alternatively, they may complete the UO's CITI modules.
CITI has modules in Spanish, French, Portuguese and Chinese. Modules in Russian are expected to follow. These modules will be of great use to your international collaborators and research personnel. The International modules are available at http://www.irbtraining.org.
CITI's homepage is located at https://www.citiprogram.org. CITI's FAQs can be found at https://www.citiprogram.org/citidocuments/faq.htm.
The following PowerPoint Presentation is available from the CITI website:http://www.citiprogram.org/citidocuments/admin/SACHRP1pb.ppt.
If you are having problems with the CITI site or course, contact the CITI Office at citisupport@med.miami.edu or at 305 243-7970. If you have questions about the UO requirements, contact the Office for Protection of Human Subjects at (541) 346-2510.