UF IRB Educational Courses
These group presentations can be arranged through the IRB Educator
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