St. Luke’s Health System IRB
CITI Human Subjects Protection Training

St. Luke’s requires all clinical investigators, co-investigators, sub-investigators, key research personnel, and IRB members to complete training in human subject protection.  For researchers, this requirement applies to all human subject research including research classified as expedited or exempt. Documentation of training must be received before research studies receive approval.  Human subject protection training must be renewed every three years.

Definition of 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. This would include any person who has significant contact with subjects such as consenting, interviewing, providing interventions, etc.   Examples of key research personnel include: research nurses, research coordinators, research assistants, general assistants, physician office personnel, technicians, students, etc.

Human Subject Protection Program
CITI (Collaborative IRB Training Initiative) is an online computer based program and is the only approved human subject protection educational program at St. Luke’s. The CITI program consists of both Basic and Refresher courses.  The Basic course is a prerequisite to the Refresher course.

A.  Basic Course has the following learner groups:

• Group 1   Biomedical Researchers
• Group 2   Social/Behavioral Researchers
• Group 3   IRB Member
• Group 4   Exempt Research (may only be selected once the IRB Office has determined your research study to be exempt).  
• IRB Reference Resource (Do not select this group – it is a reference resource only) 

Note: Select the learner group that is appropriate to the type of research you will be conducting. It is important that you select the correct learner group or you will have to take additional modules in order to receive a completion certificate!   Please check before proceeding if you are uncertain as to which group to select.  

B.  Refresher Course has the following learner groups:

• Group 1   Biomedical Research Investigators
• Group 2   Social/Behavioral Research Investigators
• Group 3   IRB Member

Important:  You must complete the basic course before you can take the refresher course.  The refresher course is designed for individuals who have completed the basic course and are seeking re-certification.  Re-certification is required every 3 years. 

The Basic course learner group modules take approximately 4-6 hours to complete. The IRB member module is longer and takes approximately 8 hours to complete. The Refresher course modules take approximately 1-2 hours.  The course work does not need to be completed at one time. You can sign off at any time and pick up where you left off when you next sign on.  CME’s and CEU’s are available through the University of Miami – the host site.  Information on completing the course and acquiring CME’s and CEU’s is available at the CITI site.

Login Directions for the CITI Site 
For first time users who have not completed a CITI basic course:

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 registration page
5. On Select Curriculum Page, by #1, Select group appropriate to your research activities
6. On the Learner’s menu screen click on “Not Started – Enter”
7. Complete the modules and quizzes
8. 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   

For returning users who have completed a CITI basic course and wish to take the Refresher course:

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

1. Click on returning users – if you don’t remember your username and password click on link.
2. On Learner’s menu page, click on Add a Course or Update your Learner Groups for St. Luke’s Boise, Idaho.
3. On the Groups Page click on Update Groups (Red type)
4. On Select Curriculum Page, by Question 1, select “I have completed the basic course”
5. Question 2, select the appropriate learner group
6. Click on Go Back to Learner Main Menu
7. Under Status in the center of the page click on Not Started-Enter (Red type)
8. Complete the modules and quizzes
9. 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.   

There are optional modules listed on the curriculum page (Groups 3&4) which you may take voluntarily, but they will not count towards the required certification.

If you have any questions, please contact Cathleen Isaacs in Research Administration/IRB at 208-381-2715 or by e-mail at isaacsc@slrmc.org.

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’ve 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.