Research > Institutional Review Board (IRB) > Education Requirements

Education Requirements

All individuals involved in human subject research have an obligation and responsibility to protect the rights and welfare of human subjects.  Training of Department of Research Staff, investigators, research staff, and IRB members is critical to protect the rights and welfare of research subjects in a consistent manner throughout the LBH research community.

    a.     Department of Research staff and members of LBH IRB will receive initial and ongoing training regarding the responsible review and oversight of research and LBH policies
            and procedures.  IRB Chairs will receive additional training in areas germane to their additional responsibilities.

    b.     Valid research certification is required to conduct human subject research at LBH (including research exempt from IRB review as set forth in the LBH General Department of Research and
             IRB Administration Policy).  All investigators on a research study conducted at LBH must have completed the human subject research certification process prior to submission of a
            research application to the Department of Research, and the certificate of completion must be on file with the LBH Department of Research.  The current research certification
            process requires investigators to complete the CITI program and HealthStream modules assigned by the LBH Department of Research.  Research certification is valid for 3
            years, at which time recertification must be obtained.

    c.     The Institutional Official will receive ongoing training in areas germane to his/her responsibilities.

    d.     All training and education shall be documented and kept on file in the Department of Research office.


The Collaborative IRB Training Initiative (CITI)

The CITI human subjects research educational program consists of a basic course of 17 training modules for Biomedical investigators and a similar number of modules specifically prepared for investigators conducting Social/Behavioral research. Each module was developed by experts in the "IRB community", focuses on different aspects of bio-ethics and human subjects research, and has an associated quiz. Software maintained at the University of Miami compiles the quiz scores. When the user completes the required materials (which takes ~20 minutes/module), the learner can print/download a Completion Report that details the learner's accomplishments. A copy of the report is e-mailed to the institutional LBH IRB administrator. Click here for CITI training LOGIN directions.

CITI training program can be found at: www.citiprogram.org

Requirements:

    a.   Principal Investigators and Clinical Research Coordinators


          1.     Individuals  involved in biomedical research are required to complete the CITI Program "Group 1" training consisting of 12 modules prior to initiating any research activity.

          2.     Individuals involved in Social and Behavioral Research training are required to complete the CITI Program "Group 3" consisting of 12 modules prior to initiating any
                  research activity.

    b.   Co-Investigators and Research Staff

          1.     Individuals involved in biomedical research are required to complete the CITI Program "Group 2" training consisting of 8 modules prior to initiating any research activity.

          2.     Individuals involved in Social and Behavioral Research training are required to complete the CITI Program "Group 4" training consisting of 8 modules prior to initiating any
                  research activity.

    c.   LBH IRB Members, Designated Alternates, and IRB Staff

          1.     For new appointments - The CITI Program "Group 1" training consisting of 12 modules is required within 120 days of appointment.

          2.     For current appointments -  The CITI Program "Group 1" training is required to be maintained by completing the CITI Program within three (3) years of their last
                  completed training session.       

Alternatives and Additional Resources

This is not an IRB requirement, but a convenient option for those that are required to have this training. To register you would log onto CITI as usual and then click on "Add a Course or Update Lerner Groups". Go to "Question 2" and pick from one of the following:

  • Good Clinical Practice Course, US FDA Focus
  • Good Clinical Practice Course Trials Involving Medical Devices (International Focus)
  • Good Clinical Practice Court for Clinical Trials Involving Investigational Drugs (ICH/International Focus)

For "Group 1 and Group 3 Training Requirements"

The CITI Program completed at another institution may satisfy LBH IRB training requirements within three (3) years from the date of the documented completed training session. Alternate coursework provided by appropriately certified educational, regulatory or governmental entities or professional societies may be substituted for the CITI Program, subject to approval by the Research Office.

Failure to complete required certification as outlined above by the indicated dates will result in the following actions:

Consequences for Failure to Comply with the Education and Training Policy:

  1. Refusal to accept new research applications from the non-compliant Investigator and staff by the LBH IRB office.

  2. Suspension of the non-compliant Investigator and staff from participation in further research until the requirements are met.

  3. LBH IRB Members who do not comply with deadlines imposed will have their status changed to a non-voting member with a one-(1) month extension to fulfill the requirements unless the LBH IRB chairperson allows the member additional time to complete training. If the requirements are not met, the member will be removed from the LBH IRB committee.