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OFFICE FOR PROTECTION OF HUMAN SUBJECTS


The Collaborative IRB Training Initiative (CITI)

Frequently asked questions:


Why is education being required now?

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.


How does CITI work?

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.


When do I need to do CITI?

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.


Who must take the CITI training modules?

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.


What is meant by "research personnel"?

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.


Do faculty advisors on student research projects need to complete the CITI training?

Yes, faculty advisors are considered "research personnel" and must successfully complete the CITI training course before their advisees' IRB protocols can be approved.


I have a very large research staff. Do they all have to take CITI?

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.


Is my NIH training certificate still good?

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.


I lost my old NIH certificate. What do I do?

You may contact the Office for Protection of Human Subject and we will secure a duplicate copy.


Does the CITI certification expire?

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.


I forgot my CITI password. What do I do?

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.


What is a Learner Group? Which Learner Group do I select?

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:


What is meant by Social and Behavioral Research?

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."


CITI is time consuming. Do I have to do it all at once?

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.


How long will it take to complete the CITI modules?

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.


Some modules look more interesting than others. Why can't I do them in the order I want to? I would like to skip around.

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.


What is the Grade Book?

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.


What am I being graded on?

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.


What if I don't receive a passing score?

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.


Do I need to keep a copy of the certificate?

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.


My professor said I must do CITI as part of my coursework. How do I do it?

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.


I completed CITI at another institution. Do I have to take it again?

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.


Are non-UO researchers/collaborators required to complete 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.


Is CITI available in any languages other than English?

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.


How do I find CITI?

CITI's homepage is located at https://www.citiprogram.org. CITI's FAQs can be found at https://www.citiprogram.org/citidocuments/faq.htm.


How do I get more information about CITI?

The following PowerPoint Presentation is available from the CITI website:http://www.citiprogram.org/citidocuments/admin/SACHRP1pb.ppt.


Help! Whom can I contact?

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.