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HCCS009 - Human Subjects
A course in the "Research Compliance" Suite

Course Description

This course addresses the myriad rules, regulations, and ethical considerations pertaining to the use of human subjects in medical research. The course covers:

  • Types of research on human subjects
  • Protection of human subjects
  • Regulatory framework
  • Roles and responsibilities
  • Review processes
  • Implementation and management of a
    human subject research project
  • Budgeting and billing issues
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Target Audience
  • All Employees and Staff involved in conducting, managing, or supporting clinical or non-clinical research trials.
Course Outline
  • Ethical basis for compliance
  • Regulatory framework
    • FDA, HHS, and HIPAA regulations
  • Protection of human subjects
  • The informed consent process
  • Roles and responsibilities of investigators and Institutional Review Boards (IRB's)
  • Protection for vulnerable subjects of human subject research

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