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HCCS009 - Human Subjects

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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