Ethics in Research Involving Human Subjects: Informed Consent and Asessing Risk

Lauren Wollman

Module 3 of a 3 part series.  There is a consensus regarding the importance of informed consent. As mandated by the Code of Federal Regulations (CFR), informed consent should protect human subjects and volunteers, ensure that study subjects clearly understand the benefits and risks associated with their participation in a study, and provide possible study subjects with all information needed to reach a decision on their potential participation in a research study. This module outlines the informed consent requirements as stipulated by the CFR, how to obtain informed consent, exceptions from informed consent, the various assessments of risk surrounding participation in research, and how to minimize and manage risk.  Keywords: Code of Federal Regulations (CFR), informed consent, risk

Interactive Version (Flash)

Lecture (video version)

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