U.S. Department of Health and Human ServicesHHS National Institutes of HealthNIH National Center for Advancing Translational SciencesNCATS

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Give Input On The Informed Consent Process

Overview

Informed consent allows clinical trial participants to understand what will happen during a clinical study, including the possible risks and whether participants will receive their personal results. Your patient group can provide input during the development of informed consent documents and help clinical trial participants better prepare for the consent process.

Resources

Consent Requirements
Informed Consent for Clinical Trials U. S. Food and Drug Administration (FDA) (link)
Informed Consent FAQs U.S. Department of Health and Human Services (HHS) (link)
Elements of Informed Consent SageBioNetworks (link)
Research versus Clinical Care
Clinical Research Versus Medical Treatment U. S. Food and Drug Administration (FDA) (link)
Return of results: ethical and legal distinctions between research and clinical care 2013 Published Article