Lesson 2: Human Subjects Protection and Informed Consent

Overview
Examine the reasons why there are protections for human participants in research studies and how permissions are collected from the candidates. Then use what you’ve learned to evaluate patient profiles for inclusion or exclusion in a possible trial.
Objectives
  1. Describe the general history of clinical research
  2. Explain the importance of clinical research and informed consent
  3. Define CFR and ICH and describe their importance in clinical research
  4. Make informed decisions on possible test candidates based on available data
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