Core course:

• Human Subjects Protection

  Overview:

  This course gives researchers the practical advice they need for working with human subjects, but also helps them understand why research with human subjects is special and is afforded particular attention. It includes how human subjects protection regulations evolved and why we need them, what role the IRB plays and how you should approach your application to the IRB, and other considerations to take into account before, during and after your research.

• Module 1: Basic principles and responsibilities

   

  • Introduction
  • Past abuses and current problems
  • Global principles
  • US principles
  • The regulatory life of a human subjects project
  • Must my project be reviewed and approved?
  • Module 1 Summary

   

• Module 2: Preparing a proposal for review

   

  • Introduction
  • Developing a research plan/protocol
  • Providing additional information
  • Explaining the scientific or scholarly importance of your project
  • Obtaining informed consent
  • Protecting privacy
  • Data protection
  • Looking ahead to review
  • Module 2 Summary

   

• Module 3: IRB review

   

  • Introduction
  • Establishing the need for review
  • Is it research?
  • Are they human subjects?
  • Is the research exempt?
  • Expedited review
  • Full board review
  • Major issues
  • Project review
  • Module 3 Summary

   

• Module 4: Continuing review and responsibilities

   

  • Introduction
  • Recruiting and record keeping
  • Audits
  • Reporting events to your IRB
  • Continuing review and ending your project
  • Module 4 Summary

   

• Closing

   

  • Resource bank
  • References
  • Course quiz