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
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- Review processes
- Implementation and management of a
human subject research project
- Budgeting and billing issues
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- See Sample Screenshots -
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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