HealthStream Brands

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

1 to 100 Learners?

Number of Learners:

More than 100 learners?

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

Target Audience

  • All Employees and Staff involved in conducting, managing, or supporting clinical or non-clinical research trials.