Collaborative IRB Training Initiative (CITI) Program

The Collaborative IRB Training Initiative (CITI) Program is an Internet-based course on the protection of human subjects. It is designed for individuals involved in the design, conduct, and analysis of any scientific activity that employs human beings as research subjects. A consortium of Institutional Review Board (IRB) professionals and human subjects researchers from universities and medical schools sponsors the Program. The University of Miami provides administration for the site.

Completion of the CITI training program is mandatory for all investigators and key personnel not previously certified by the Research Compliance Office (RCO). To comply with this federal requirement, the IRB does not approve research activity unless all key personnel are certified. The NIH policy defines “key personnel” to include all individuals “responsible for the design and conduct of the study.” NIH has further clarified that key personnel may include personnel from subcontractors (domestic and foreign), consultants, individual fellowship applications, or institutional training grant trainees if they are involved in the design and conduct of research involving human subjects. Scott & White has further clarified that for projects administered by S&W, key personnel includes nurse and study coordinators in clinical research, any individual with the title “study coordinator” who performs a similar coordinating or clinical function or those who conduct health or opinion surveys in the health-care setting. Members of the IRB, staff of the RCO and relevant administrative personnel should also meet this requirement. Certificates of training from other institutions may be acceptable as long as the training program is found to be equivalent. In this case, a copy of the existing certificate of training must be submitted to the RCO for review and acceptability prior to conducting the study.

IRB approvals of initial or continuing reviews of research projects will be delayed for lack of required education of any key personnel listed on a project.

The module topics for both courses are designated as required or optional. You are strongly encouraged to complete any additional modules that pertain to your research becauseresearchers are ethically obligated to understand the protection of human research subjects and should be familiar with the various topics.

Basic CITI Course

The course content satisfies the initial certification requirement and is organized into three groups for Biomedical and Social/Behavioral Researchers. Group 1 = Biomedical Research Investigator and Key Personnel, Group 2 = Social / Behavioral Research Investigator and Key Personnel. Group 3 = Biomedical Research and Social / Behavioral Research Investigator and Key Personnel. This third group is available for individuals who wish to complete both curriculums.

Each module will take 10 to 30 minutes to complete. The modules need to be completed in sequential order but you do not need to complete the course in one sitting. The “passing score” is 75%. This score is based on the overall calculation of your completed “Required Modules”. Certification of completion for the CITI training program is valid for three years at which time re-certification must be obtained. You will be notified when you are required to become re-certified.

Refresher Course

The course content satisfies the re-certification requirement for both the Biomedical and Social/Behavioral Researchers. The modules need to be completed in sequential order but you do not need to complete the course in one sitting. The “passing score” is 75%. This score is based on the overall calculation of your completed “Required Modules”. This recertification is valid for three years.

Course Completion

The University of Miami will notify the Research Compliance Office (RCO) upon your completion of this course. Please print a copy of the Certificate of Completion (link can be found at the finish of your last quiz question) to keep with your records as your official certificate.

Questions?

Should you have any questions regarding the CITI Training Program or you would like to inquire if an alternate education process meets our institution requirement, please contact Matt Ridley at 254-771-4854 or by email Send an e-mail.


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