Glossary Term

Informed Consent

Participant Protections

Also known as: consent form, consent process, ICF, informed consent form

The process by which a prospective participant voluntarily confirms willingness to participate in a study after being informed of all aspects relevant to the decision.

Informed consent is both a document and a process. It must be documented (unless waived) and must include the required elements in 45 CFR 46.116 and, for FDA studies, 21 CFR 50.25.

Required elements include

A statement that the study involves research and its purpose
Reasonably foreseeable risks and discomforts
Benefits, alternatives, and confidentiality protections
Compensation and treatment for injury (if applicable)
Contacts for questions and a statement that participation is voluntary

The 2018 Common Rule revisions added a concise 'key information' section at the top of the form to help prospective subjects make an informed decision.

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