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

Investigators are responsible for ensuring all study team members have completed training before submitting an application to the IRB.    

 

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.”

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

 

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.

Investigators and research staff must also complete training on Conflicts of Interests as described in the following section. 

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 and Training requirements

Investigators and key personnel must comply with the University of Miami COI policy. The Office of Disclosures and Relationship Management (DRM) and the UM COI Committee (COIC) are charged with determining whether relationships with an external entity create a situation that could introduce bias into a research project conducted at the UM or by UM investigators; and, when this bias could occur, to manage it.  Additional information is located on the Disclosures and Relationship Management (DRM) website pages. 

Investigators are responsible for ensuring all study team members have submitted financial disclosure information and  completed training before submitting an application to the IRB.    

 

The DRM shares information about the financial relationship and the determinations made by the COIC with the IRB.  The IRB will then review the research and the information provided by the DRM to determine whether risks to subjects continue to be minimized and are reasonable in relation to anticipated benefits to the subjects or others.  

Investigators and research team members must complete financial conflicts of interest training when joining the UM and:

  • Every four years;
  • When financial conflicts policies are revised in a manner that changes investigator requirements
  • When found non-compliant with financial conflicts policies and procedures

The training focuses on the federal policies that apply to research and externally funded scholarly activities performed at UM. Additional information including a schedule of seminars to be held on the Gables, Medical and RSMAS campuses can be found in the ULearn System (keyword search “conflict of interest.”)