What is CITI?

The Collaborative Institutional Training Initiative (CITI), founded in March 2000, was developed in collaboration with the University of Miami to provide a web based training program in human research participants protection. In addition to the "Basic" content offered in social/behavioral, biomedical, clinical trial and responsible conduct of research areas, the CITI model provides the opportunity for institutions to post additional instructional materials specific to their institution.

Why was CITI chosen to replace the NIH training certificate previously accepted?

CITI is the most effective and comprehensive training program for the ethical conduct of research. As of October 2007, more than 830 institutions around the world utilize the CITI program. Investigators can log in to the system at their leisure and complete the training at their own pace. Additionally, institutions can incorporate their own materials and/or policies, tailoring the training to the institution's requirements.

When will the CITI training requirement begin?

Effective September 1, 2008, all key personnel (researchers/co-investigators/assistants and faculty sponsors) involved in human participants research investigations must complete the CITI training program (basic course). As of November 1, 2009, all individuals must complete a course in Responsible Conduct of Research (basic course) as well. The NIH training certificate will no longer be accepted as valid training in the protection of human participants in research. However, individuals applying for NIH grants must complete NIH  training in addition to the CITI requirement. 

Who is required to take the training?

As of September 1, 2008, all key personnel including researchers and faculty sponsors involved on any human participants research protocol must complete the CITI training. This includes all faculty, staff, assistants and students who are engaged in the planning, conduct, or analysis of the research, regardless of funding of the project. Board members and administrative staff of the IRB are also required to complete human participants protection training through CITI.

As of November 1, 2009, all individuals must complete the Responsible Conduct of Research training as well.

If I have previously completed the NIH training, do I still have to complete CITI?

Yes. As of September 1, 2008, the NIH training certificate will no longer be valid.

Do I have to complete the CITI training if my research qualifies for exemption?

Yes. Investigators and all key peronnel engaged in research which qualifies for exemption are bound by the same training requirements. 

What does "institutional affiliation" mean?

To complete the CITI training program, an individual must designate institutional affiliation. This means that the trainee is conducting research as a representative of a particular university or other institution which subscribes to CITI's training site. Additionally, completion certificates will be forwarded to the designated administrative official at the affiliated institution.

Institutional affiliation for Marywood faculty, students, and staff involved in research projects should be with Marywood University. This ensures that researchers complete the appropriate training modules required by Marywood University.

What is a "learner group"?

A Learner Group is a designation for all researchers and key personnel to be directed to the appropriate set of training modules. Currently, Marywood has established 5 learner groups:

• Social & Behavioral
• Biomedical
• Clinical Trial Researcher/Good Clinical Practice (GCP) - Clinical Trial researchers and staff only
• IRB Members & Staff - IRB personnel only
• Laboratory Animal Welfare (IACUC) - Animal lab researchers and staff only 

In addition to the appropriate learner groups shown above, all researchers and key personnel must complete training in Responsible Conduct of Research. 

NOTE: The Laboratory Animal Welfare (IACUC) and Good Clinical Practice (GCP) learner groups were specifically designed for researchers working in animal labs or clinical trials research. Unless you've been instructed to do so by the IRB office or your sponsor, it is not necessary to complete these learner groups.

Which learner group should I choose?

New users should select basic courses, not refresher courses.  Refresher courses are for those who've previously completed CITI training and need to renew their certificate. At this time, renewals are not required. Most researchers should choose the Social & Behavioral or Biomedical learner group.  

CHOOSE One of these learner groups AND Responsible Conduct of Research:

• Social & Behavioral: This learner group is designed for social and behavioral research which examines human society and the intrapersonal/interpersonal relationships that take place within that society. Social and behavioral research projects commonly involve surveys, questionnaires, interviews, focus groups, etc., for data collection.
  
  
• Biomedical: This learner group is designed for Investigators who are involved in biomedical research, with a focus on normal or abnormal physiology and development. Biomedical research is designed to evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and may involve any invasive procedures (e.g. collection of saliva, tissue, urine or blood samples, bone density scans, dietary manipulation, exercise studies, etc.). *
  
  
• Clinical Trial Researcher/Good Clinical Practice (GCP):  This learner group is designed for investigators who conduct human research trials regulated by the FDA.
  
  
• IRB Members & Staff: This learner group is designed for current or newly appointed members of the IRB, in addition to IRB administrative and support staff. Student researchers and faculty sponsors are not eligible for the "IRB Members & Staff" group.
  
  
• Laboratory Animal Welfare (IACUC) :  This learner group is designed for investigators and staff who plan to use laboratory animals in their work, or for IACUC Committee members.
  
  If you still have questions or are unsure which learner group to select, please contact Kristie Congdon at 570-961-4778 or Ann Loyek at 570-340-6031.
  
  (*biomedical information obtained from Penn State University, IRB)
  

How long will it take to complete the course?

According to CITI, the average learner spends 4.5 hours completing the Basic Course training modules. 

Do I have to complete all the modules at once?

No. CITI allows for multiple sign-ins, so you can complete the training at your convenience. CITI will keep track of your place each time you log out of the system.

Is there a passing score for the training modules?

Marywood University's IRB office requires a minimal, cumulative passing score of 80%. Please remember that a quiz may be repeated to increase your score, but it must be done in one sitting.

Do I have to send the IRB a copy of my completion report once I have completed training?

Please upload a copy of your completion report on the IRBNet system when you submit an application.  Log into the CITI site, under 'Completion Reports', click print completion report twice.  At the next screen, you'll see a report which shows all of the completed modules. Choose 'file' and 'save as'.  Save the certificate to your hard or flash drive as an .html document. It may then be uploaded to IRBNet. 

If you've previously completed CITI training and your certificate is on file in the IRB office, include the date training was completed in the appropriate section of your IRB application.  

I received an e-mail from the IRB office stating that I completed the wrong training modules. How do I change my learner group, and will I have to complete additional modules for the correct learner group?

You can change your learner group at any time in the CITI program. Log in to the program; click on "Add a course or Update Learner Groups," then click on the "update group" link. Select the appropriate learner group. The content of the training modules and quizzes are specific to each learner group. If there are any modules that weren't completed as part of the original learner group, you may have to complete additional modules to satisfy training requirements. If the "IRB Members & Staff" training was completed, there are no additional modules required for certification under the "Social & Behavioral" or "Biomedical" Research groups. Your training will be updated automatically and a confirmation e-mail will be sent to you from our office.

I forgot my CITI password. Can I obtain my password from the IRB office?

No. The IRB office does not have a record of passwords. However, CITI keeps your email and password information on file. Log on to CITI (http://www.citiprogram.org), go to "Forgot Username or Password" and follow the directions to obtain your user information.

I have previously completed CITI training while at another institution. Is my training certificate acceptable?

Yes, provided the training was completed within the past 2 years. Please submit a copy of the completion report along with your application.

Who can I contact if I am having trouble with the CITI site or course?

The CITI site is limited to 1500 concurrent users. If you try to sign in but experience difficulty, please try again at an off-peak time, such as an evening or weekend.

If you continue to experience problems, contact the CITI Office at citisupport@med.miami.edu or (305) 243-7970. If you have any questions about specific training requirements, contact Ann Loyek at ahloyek@marywood.edu or call (570) 340-6031.