Introduction to Clinical Research: Part 2 – Human Subjects Protection and Informed Consent

Human Subjects Protection and Informed Consent


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.

Learning 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
Explore the federal and international regulations that protect human participants in research... more
Learn more about the Belmont Report as the foundation for the Institutional Review Board, an... more
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research... more
See how clinical trials of a research drug or medical device are conducted and managed.