St. Luke’s Health System
Human Subject Protection Training

CITI Requirements
Investigators and key research personnel* who participate in human subjects research must complete the Collaborative Institutional Training Initiative (CITI) web-based training. For researchers, this requirement applies to all human subjects research including research classified as expedited or exempt. Initial and continuing education (recertification) is required every 3 years.

CITI training must be completed prior to receiving initial or continuing IRB review of research protocols.

New Users
The Basic Human Subject Course is required for investigators and key research personnel who have not previously completed a CITI course. There are 3 learner groups for the Basic Course; Biomedical, Social Behavioral, and IRB Member. You should choose the group most closely matching the research in which you are involved. Each CITI module has text to read and most include a quiz.The average learner requires approximately 4-6 hours to complete a Basic Course. The modules do not have to be completed all in one login session. A minimum aggregate score of 80% is required to pass a Basic Course.

Login Directions for the CITI Site

Go to http://www.citiprogram.org/

1. Click on Register Here.
2. Select St. Luke’s Health System-Boise, Idaho under Participating Institutions
   (drop down box)
3. Select your Username and Password
4. Complete CITI Member Information Page
5. On Select Curriculum Page, by question 1, select group appropriate to your research activities
6. On the Main Menu page, check under My Courses - Status, and click on the
   "Not started-Enter" link
7. Complete the "Integrity Assurance Statement"
8. Complete the modules and quizzes
9. When all modules are completed with an overall score of 80%, CITI will issue you a completion certificate. A copy will be sent to your institutional administrator

Returning Users

A Refresher Course is required for investigators and key research personnel every 3 years as continuing education in human subject protection. Completion of a CITI Basic Course is a prerequisite to taking a Refresher Course. There are 3 learner groups for the Refresher Course; Biomedical, Social Behavioral, and IRB member. The CITI program will automatically assign you to the same learner group for a Refresher Course that you selected for the Basic Course at 90 days of your certification expiration date. The average learner requires approximately 2-3 hrs to complete a Refresher Course. A minimum aggregate score of 80% is required to pass a Refresher Course. You will be notified by Research Administration when it is time for you to recertify.

Login instructions for returning users who wish to take a Refresher Course:
Go to http://www.citiprogram.org/

1. Login with the username and password you created when you first registered with CITI. If you don't remember your username and/or password click on "forgot login information"
2. On Main Menu page, check under My Courses - Status, and click on the "Not started-Enter" link
3. Complete the "Integrity Assurance Statement"
4. Complete the modules and quizzes
5. Print or download a Completion Report as proof that you have completed the educational requirements to conduct human subject research. A copy will be sent to your institutional administrator so you do not need to submit a copy to the IRB

Optional Courses

Once you have established your affiliation with St. Luke’s, you may at any time take any of the optional courses available on the curriculum selection page, question 3. While completion certificates are awarded for successful completion of these courses, they DO NOT fulfill the human subject protection education and training requirements. Currently, the optional courses offered include:

• Health Information Privacy and Security (HIPS)
• Good Clinical Practice (GCP)
• Responsible Conduct of Research (RCR)

Equivalent CITI Training at another Institution

Research staff who have completed equivalent CITI training at another institution within the past 3 years should contact Research Administration at 208-381-2715 for more information.

Continuing Medical Education

You may be eligible to receive continuing education credits for completing the CITI course work. For information on continuing education credits, click on this link. https://www.citiprogram.org/citidocuments/cme/index.htm

*Key research personnel:  All persons identified as study personnel in the research application who are involved in the design or conduct of research or persons who may have significant contact with a research subject, subject identifiable information or subject data during the course of the study.

CITI FAQ’s

Q. What are the objectives of the CITI human subject protection training program?
A. The program is designed to: a) assist investigators and their staff in their understanding of the special requirements associated with the use of human subjects in research b) clarify the responsibilities of those involved in research and of the Institutional Review Board c) increase recognition of the basic ethical principles for the use of human subjects d) provide education on the protection of human subjects as mandated in the federal regulations.

Q. Who is required to complete the training?
A: If you are involved in the design or conduct of the research involving human subjects, you must complete the training. This would include any person who has significant contact with subjects such as consenting, interviewing, providing interventions, etc. It also includes any person who has significant contact with subject identifiable information or data about a subject during the course of a study. If you don’t have contact with research subjects or their identifiable data, then you don’t need to take the training. Identifiable data is information that would allow the identity of a subject to be readily recognized. Examples of those needing training include, but are not limited to: investigators, sub-investigators, research nurses, research coordinators, study coordinators, general assistants, etc.

Q. How often is training required?
A. Both initial and re-certification training is required. Re-certification is required every three years. Investigators and research staff will be notified 3 months in advance of their re-certification due date. Re-certification will include completion of refresher courses.

Q. Is human subject protection training required for exempt studies?
A. Yes. Human subject protection training applies to all protocols that involve human subjects regardless of the risk level. Therefore, principal investigators and key personnel named on these protocols are required to complete the training.

Q. What if I have completed the CITI Course at another institution?
A. If you have previously completed the CITI Basic Course, contact Cathleen in the research Administration (208-381-2715) to determine whether the training meets St. Luke’s requirements.

Q. Will the education course be tied to my protocol approval?
A. Approval of new protocols and continuing reviews will not be issued until the principal investigator and key research personnel have successfully completed CITI training.