Section V:

Education and Training

WPP #: V-1

Title 1:

Investigators and Research Personnel

Effective Date:

07-29-14

Revision History:

06-20-00; 09-20-01; 06-07-04; 06-21-06; 02-25-14

Policy Statement

All principal investigators and other research personnel engaged in the conduct of human research must complete initial training in human subjects protections and fulfill continuing education requirements.

Procedures and Guidance

The investigator/faculty training program consists of multiple components that target varying degrees of involvement with human subject research at VCU.

  1. Institution-Wide and Community Education:

    The ORSP supports effort to provide for the basic informational needs of all faculty, staff, and students who are part of the VCU community. ORSP sponsors a series of workshops each semester to address educational needs pertaining to obtaining IRB approval and conducting human subjects research according to best practices. ORSP also offers and/or facilitates in-services and presentations throughout VCU, as planned or requested. Presentations, programs and workshops for diverse segments of the research community at VCU offer networking with research colleagues and a forum for questions.

    Additional education pertaining to the conduct of human subjects research is sponsored by the Center for Clinical and Translational Research (CCTR). The CCTR offers programs for investigators and research coordinators on topics such as good clinical practice and conducting community engaged research, as well as a clinical coordinator certification study program.

  2. Investigator Education and Training:

    VCU requires that investigators and engaged research personnel complete the Collaborative IRB Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research prior to participation in human subjects research. A passing score of 80% for the CITI program is required. The IRB may consider alternate training arrangements for certain kinds of research where access to the CITI training is unavailable or a customized training would be more appropriate for the engaged personnel. Investigators and engaged personnel are required to maintain current CITI training by completing the CITI Refresher module every two years.

    1. Monitoring of Education Requirements

      The Office of Research Subjects Protection verifies at the time of initial submission and continuing review that the principal investigator has completed the appropriate CITI training requirements. This includes ensuring that a relevant Basic Course in Human Subjects Protection (biomedical or social behavioral) has been completed and that a Refresher course has been completed within the past two years, if applicable. Principal Investigators are responsible for assuring that all other engaged research personnel, as identified in the IRB submission, maintain current CITI training. CITI completion by engaged personnel is subject to random verification by ORSP staff and will be verified during a post approval monitoring visit.

      New protocols (including ‘exempt’) and continuing reviews submissions will be forwarded for IRB review only after the principal investigator’s completion of the CITI Biomedical or Social-Behavioral Course has been verified by ORSP staff. In rare circumstances, IRB review may commence prior to completion of CITI requirements; however, IRB approval will not be granted until training requirements have been met.

References

CITI Training Requirement Details