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UF IRB Educational Courses

These group presentations can be arranged through the IRB Educator, Ivana Simic

Fundamentals of Human Subjects Protections and the IRB review process: 60 minutes

  • Also called IRB101
  • Covers a brief history of human subjects research
  • Covers regulatory guidelines of human subjects research
  • Gives an overview of the local submission process (currently includes paper and electronic submission process)
  • A separate variation for IRB-02
  • Overview of PI Responsibilities

Informed Consent 101: 60 minutes

  • Also called How to Write an Informative Informed Consent
  • Gives the 8 mandatory elements of consent required by the Federal regulations
  • Gives the 6 additional elements that may be required
  • Gives an overview of the Items of the IRB-01 Informed Consent Template and how they assist Investigators meeting the required elements of consent
  • Suggestions on converting “Protocol” language to language appropriate for the targeted populace

Informed Consent 102: 60 minutes

  • Also called How to Obtain Informed Consent
  • Describe the difference between the Consent document and the consent process
  • Provide general tools for documenting the consent process
  • Overview of tools for Investigators involved in the informed consent process
  • Overview of delegating the informed consent process to study staff and the difference between delegating the duty and study responsibility
  • Suggestions for determining who is appropriate to delegate the consent process to on the study team

Project Revision: 60 minutes

  • Overview of difference between major and minor revisions
  • Overview the risk/benefit ratio and consideration with revisions
  • Recommendations to keep documents consistent

Adverse Event Reporting: 60 minutes

  • Definitions related to adverse events
  • Overview of the adverse event flow chart
  • Suggestions in balancing sponsor requirements and UF IRB requirements

Study Recruitment: 60 minutes

  • Overview of general recruitment methods
  • Considerations for determining recruitment methods based on subject populace
  • Overview of do’s and don’ts for recruitment methods
  • Considerations for flyer creation
  • Considerations for delegation of study recruitment to study staff

Continuing Review: 60 minutes

  • Explains when continuing reviews are necessary
  • Explains why continuing reviews are necessary
  • Overview of considerations when requesting continuation of an existing study
  • Consideration of adverse events, revisions, unanticipated problems, and deviations during continuing review submission

Specialized talks as requested by the research community and as needed based on the Board’s determinations.

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