CITI Training

Training requirements for Investigators and Research Staff

This section describes the training requirements imposed by the HSRO. You may have additional training imposed by other federal, state, or institutional policies.

Basic Courses in Human Subject Research Training 

All personnel involved in human subject research must complete human subject research training before engaging in human subject research activities.  This requirement is referred to as becoming “CITI-Certified.  The following classes of individuals must complete the required training:

• Investigators
• Sub-investigators
• Research team members listed in the eProst application
• Individuals named as the contact person in the informed consent document and recruitment materials

The PI and research team members should complete the required training before submitting an application for a new study to the IRB for review.  New members of the research team must complete the training before engaging in research activities, including access to and analysis of private identifiable data.

CITI offers the following courses:

• Group 1: HSR Series for Biomedical Researchers - Required for all personnel involved primarily in biomedical research; and for all personnel performing both biomedical and social/behavioral research.
• Group 2: HSR Series for Social-Behavioral-Educational Researchers Basic Course - Required for all personnel involved primarily in social and behavioral research.

Trainees should select the courses most applicable to the types of human subject research conducted at their site.  The IRB reserves the right to make this course a requirement for research personnel involved in both biomedical and social/behavioral research.

Recertification is required at three-year intervals for all courses discussed above. The CITI Program offers refresher courses to meet the training requirements. Principal Investigators must ensure that all study team members hold current CITI certification. Failure to maintain such certification is noncompliance with University requirements for the conduct of human subject research.

Training for Clinical Trials 

In addition to the above courses, investigators and research team members involved in the conduct of a clinical trial must complete training in Good Clinical Practice (GCP).  Below is the definition of “clinical trial.”

GCP training is a regulatory requirement for NIH-funded clinical trials, including clinical trials with that focus on social-behavioral issues. GCP training consists of basic and refresher courses provided by CITI tailored to different types of research, including:

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (FDA focus)
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
• GCP for Clinical Investigations of Devices
• GCP – Social and Behavioral Research Best Practices for Clinical Research

Trainees should select the courses most applicable to the types of human subject research conducted at their site.  As with the basic courses, retraining is required at three-year intervals for all courses discussed above. The CITI Program also offers refresher courses to meet the retraining requirement.

For questions or concerns related to this issue, please contact the Human Subjects Research Office at 305-2433195 or email our Help desk at hsro@med.miami.edu.

Financial Disclosure requirements

Investigators and key personnel must comply with the Conflict of Interest, Conflict of Commitment, Foreign Influence, and Institutional Conflict of Interest policy. The role of the Disclosures & Scholarly Activities Management (DSAM, formerly the DRM) and the UM COI Committee (COIC) is to determine whether an investigator’s relationship with an external entity creates a situation that could introduce bias into a research project conducted at UM or by UM investigators, and, where this occurs, to manage it.

Additional information is located on the UDisclose website pages.