IIHE Education, Epidemiology IV Notes
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Human Subjects Considerations

Objectives of Session

1. Residents will become familiar with issues involved in conducting research in human populations.
2. Residents will learn about the process used within HFHS to apply for human subjects' approval for research studies.
3. Residents will be exposed to the applications required for Institutional Review Board review.

Outline

1. I. Institutional Review Board (IRB) overview
   • Jurisdiction
2. Expedited review
   • Criteria
   • Forms
   • Example of expedited review application
3. IRB full board review
   • Criteria
     • Drugs
     • Biological agents
     • Devices
   • Components of application
     • Transmittal form
       • Who, what, where
       • Abstract
       • Description and source of population
       • Time commitment of subjects
       • Cost/payments to subjects
       • Consent process
     • Drug Form, Device Form, Radiation Form
     • Study protocol

Study Questions

1. What is the role of human subjects committees?
     
     
     
     
   
2. What are the categories of Institutional Review Board applications?
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4. What are the criteria for expedited Institutional Review Board applications?
     
     
     
     
     
5. What is the process for receiving approval for an expedited application?
     
     
     
     

 

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