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Module 1: Lesson 1
Understanding Informed Consent
A comprehensive introduction to informed consent in clinical research, exploring its ethical foundations, required elements, the consent process, and special considerations for vulnerable populations.
What you will learn
By the end of this lesson, you will be able to:
The ethical foundation: why informed consent matters
In Module 2, you learned about the Belmont Report and its three core principles: Respect for Persons, Beneficence, and Justice. Informed consent flows directly from the first principle.
Respect for Persons holds that individuals should be treated as autonomous agents, capable of making their own decisions about their lives and their bodies. In the context of clinical research, this means that people have the right to decide for themselves whether to participate in a study. No one should be enrolled in research without their knowledge. No one should be coerced or manipulated into participating. And everyone who participates should truly understand what they are agreeing to.
This was not always the case. The Tuskegee Syphilis Study, the Nazi medical experiments, and other research abuses happened in part because researchers did not respect the autonomy of their subjects. Men in Tuskegee were never told they had syphilis, never told they were in a study, never given the choice to participate or refuse. The consent process exists to ensure that such violations never happen again.
Good Clinical Practice (GCP)
Full course · Clinical Research Foundations