St.
Luke’s Health System
IRB
CITI Human Subjects Protection Training
Federal regulations require all clinical investigators, co-investigators, sub-investigators, key research personnel, and IRB members to complete training in human subjects 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. Examples of key research personnel include: research nurses, research coordinators, research assistants, general assistants, physician office personnel, technicians, students, etc.
Human Subject Protection Course
CITI (Collaborative IRB Training Initiative) is the only approved human subjects protection course at St. Luke’s. CITI is an on-line computer based program that was developed by experts in the "IRB community" and consists of two “Basic” courses in the Protection of Human Research Subjects for Biomedical as well as for Social/Behavioral research. CITI also offers a Refresher Course for continuing education. Individuals conducting research at St. Luke’s are required to take one of the basic courses. The courses contain modules that include reading material that can be read on the screen or printed. A brief on-line quiz follows each module. The format is “open-book” so you may refer back to the text at any time while taking the quiz. Completion of the CITI program takes approximately 4-6 hours, however; the program 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.
Log-on Directions for the CITI Site
- Go to http://www.citiprogram.org
- Select “Register for the CITI course.”
- Select St. Luke’s Health System-Boise, Idaho under “All Others” drop-down box
- Select your Username and Password
- Complete CITI registration page
- Review information from your institution and then select the learner group. If the research you will be conducting is biomedical then select learner group #1. Select learner group #2 for social behavioral research.
- Select Basic Course under the Learners menu and complete modules and quizzes.
- Print or download a Completion Report as proof that you have completed the educational requirements to conduct human subjects research. A copy will be sent to your institutional administrator.
Training records are maintained in the IRB office.
If you have any questions, please contact Cathleen Isaacs in the IRB office at 208-381-2715 or by e-mail at isaacsc@slrmc.org.
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 (IRB) 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 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, co-investigators, sub-investigators,
research nurses, research coordinators, research assistants,
study coordinators, general assistants, technicians, students,
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 when they must re-certify.
Re-certification will include completion of the online
CITI courses.
Q. Is human subjects protection training required for exempt
studies?
A. Yes. Human subjects 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 IRB Office to determine whether the
training meets St. Luke’s requirements.
Q. Will the education course be tied to my protocol approval?
A. Approval for new protocol submissions will not be issued
until the principal investigator (PI) and key research
personnel have successfully completed CITI training.
Q. Who should I contact if I have questions about training?
A. Cathleen Isaacs in the IRB Office at 208-381-2715 or isaacsc@slrmc.org.
