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Required Elements of Informed Consent FDA: 21 CFR 50.25

Summary: Required Elements of Informed Consent
Based upon
FDA: 21 CFR 50.25
DHHS: 45 CFR 46.116
General Requirements
Must be obtained from the subject or subject's legally authorized rep.
Process must allow sufficient opportunity to consider whether or not to participate
Process must minimize the possibility of coercion or undue influence
Must be in a language understandable to the subject or representative
Must not waive or appear to waive any of the subject's legal rights
Must not release or appear to release the investigator, sponsor, institution, or its
agents from liability for negligence
Basic Elements
1. State that study involves research
Explain purpose
Expected duration
Describe procedures
Identify procedures which are experimental
2. Describe foreseeable risks
3. Describe benefits


Source: Arslan, Hüseyin - Department of Electrical Engineering, University of South Florida


Collections: Engineering