Luke’s Health System
Human Subject Protection Training
Mandatory Training in Human Subjects Protection
Federal regulations require documented evidence that research personnel, IRB members and other individuals involved in human subject research are qualified and have the expertise needed to protect human subjects. To meet this requirement, St. Luke’s requires all key study personnel, IRB members and St. Luke’s Research staff to receive human subject protection training. St. Luke’s uses the Collaborative Institutional Training Initiative (CITI) web-based human subject protection program to satisfy this requirement. Training must be completed prior to receiving initial or continuing IRB review of research.
CITI offers both basic and refresher courses. Completion of a CITI basic course is required to become certified to conduct human subject research at St. Luke’s. After completion of a basic course, researchers who continue to have active studies must take a refresher course (a shorter version of the basic course) every 3 years.
CITI course work completed at another institution may count towards St. Luke’s requirements, although additional modules may be required to become CITI certified at St. Luke’s.
Note: See CITI Questions and Answers for additional information on how to transfer training completed at another institution to St. Luke’s.
I. CITI Human Subject Protection Learner Groups (Basic Course)
A learner group is a designation for researchers to be directed to the appropriate set of training modules. St. Luke’s has 4 learner groups: Biomedical Researcher, Social Behavioral Researcher, IRB Member/St. Luke’s Research Staff, and Research using Data and Specimens only. Selection of a learner group should be based on the type of research to be conducted and the following criteria:
Group 1: Biomedical Researcher: This is your group if you are involved in research with any of the following and you may have direct contact with subjects or their protected health information (PHI).
- Clinical trials
- Drug or device trials
- Tissue or specimens
- Retrospective chart review (with PHI)
- Any other investigation that is medically oriented
Group 2: Social Behavioral Researcher: This is your group if you are involved in research with any of the following and you may have direct contact with subjects or their protected health information (PHI).
- Surveys, questionnaires, interviews
- Focus groups, forums, observation
- Psychological or cognitive testing
- Educational interventional
- Quality of life studies
Group 3: IRB Member and St. Luke’s Research Staff: This is your group if you are an IRB Member or St. Luke’s Research staff. The course consists of a combination of biomedical and social behavioral modules.
Group 4: Research Using Data and Specimens ONLY: This is your group if you have no direct contact with subjects or their protected health information (PHI).
- Pre-existing data, records or specimens
- Retrospective chart review (No PHI)
- De-identified data analysis
Note: If you select this learner group and your future research involves direct contact with subjects or their protected health information, you will be required to complete additional modules. It may be beneficial for you to complete Group 1 or Group 2 if you plan to conduct additional research in the future.
II. CITI Human Subject Protection Learner Groups (Refresher Courses)
Group 1: Biomedical Researcher Course
Group 2: Social Behavioral Researcher Course
Group 3: IRB Members and ORA Staff
CITI Instructions for First Time Users (Basic Course)
CITI can be accessed at www.citiprogram.org. Follow the directions for first time registration. Save your username and password. Use this username and password for subsequent entry into CITI. Designate your affiliation with St. Luke’s Health System - Boise, Idaho. To take a basic course, choose a learner group appropriate to your activities in human research.
CITI Registration for Returning Users (Refresher Course)
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. Re-entry into CITI can be accessed at www.citiprogram.org. Login with the username and password you created when you first registered with CITI. If you don’t remember your username and/or password, do not create a second account, click on “forgot login information” and CITI will email your username and/or password. On the main menu page, click on the red link (Enter or Re-Enter) to begin or continue a refresher course.
CITI offers additional courses that are optional. Once St. Luke’s affiliation has been established, you may take any of the optional courses available on the St. Luke’s CITI curriculum selection page. While certificates are awarded for completion of these courses, they DO NOT fulfill the human subject protection training requirements. The optional courses include:
- Health Information Privacy and Security (HIPS)
- Good Clinical Practice (GCP)
- Responsible Conduct of Research (RCR)
Continuing Medical Education (CME or CEU): 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
CITI Questions and Answers
1. What is CITI?
The Collaborative Institutional Training Initiative (CITI) is a web-based training program in human subject protection. The CITI courses consist of a series of modules. Most modules have a short quiz. You must achieve a complied score of 80% to pass the course. A running tally is compiled in the grade book. If you want to improve a score, you may repeat any quiz. Upon completion of all required modules, you may print a course completion certificate as proof that you have met the requirements.
2. Who is required to take the CITI human subjects protection training?
St. Luke’s requires all individuals engaged in human subject research (including exempt research) to complete the training. Additionally, IRB members and St. Luke’s Research staff are required to complete CITI training. Examples of those who must complete the training include, but are not limited to: investigators, sub-investigators, research nurses, research coordinators, study coordinators, general assistants or persons who have 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. Identifiable data is information that would allow the identity of a subject to be readily recognized.
3. What are the objectives of the CITI human subject protection training program?
The program is designed to: a) assist investigators and research 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.
4. How long will it take to complete the course?
Depending on your experience with human subject research, the basic course (with the exception of learner group 4) can take 4-6 hours to complete. Course work does not have to be completed in one sitting. The program automatically saves your work as you complete the series of modules in the course.
5. How often is training required?
Certification is valid for 3 years from the date of initial training completion. CITI offers refresher courses that must be completed every 3 years. Research personnel receive a reminder notice from St. Luke’s Research 60 days prior to the certification expiration date.
6. I have forgotten my username and /or password for the CITI website. What do I do?
Automatically retrieve your username and/or password by clicking on “Forgot login Information” on the CITI main page. You may also contact the Research Compliance Coordinator at 208-381-2715 or email@example.com.
7. Are individuals reminded when their human subject protection training is due to expire?
The CITI website emails automatic reminders to individuals 90 days prior to their CITI expiration date. St. Luke’s Research also sends reminder notices 60 days prior to CITI expiration.
8. If I’ve completed CITI training at another institution can I transfer it to St. Luke’s? Yes, but only if the modules completed at another institution have not expired. The transfer period for St. Luke’s is 2 years. The software will automatically merge the required curriculum from all institutions and present the curriculum in the St. Luke’s grade book. To transfer your completed modules from another institution to St. Luke’s, log in to your previous CITI account and click on the “Affiliate with another Institution” link. Choose St. Luke’s Health System - Boise, Idaho from the dropdown menu and follow the registration process. On the St. Luke’s curriculum page, select the same course you most recently completed at the other institution. For example, if you most recently completed a Basic Biomedical course, select Group 1 Basic/Biomedical Researcher course. If you most recently completed a Social/Behavioral Refresher course, select Group 2 Social/Behavioral Researcher course. You will receive automatic credit for any modules duplicated. The modules must be identified as the same module by the unique modules ID number. Because each institution determines which modules are available in their courses not all modules will transfer. Those modules which transfer will be displayed as “Complete” in the grade book. You will only need to take those St. Luke’s required modules that are displayed as “Incomplete.”
9. Is CITI training tied to IRB approval?
Yes. New protocol applications, continuing reviews, and changes to research personnel will be reviewed by the IRB, but will not be granted final approval until CITI training has been verified for all research personnel.
10. Who do I contact if I have questions?
It is important that researchers select the correct learner group or additional modules may be required to satisfy the training requirements. Contact the St. Luke’s Research Compliance Coordinator at 208-381-2715 or at firstname.lastname@example.org. For technical problems or help with log in information, contact the CITI office at 305-243-7970 or email@example.com.