21 CFR 50.25 - Elements of Informed Consent

What it says

The informed consent given to each subject must include required elements, such as a statement that the study involves research, an explanation of its purposes, duration and procedures, a description of foreseeable risks and discomforts and of expected benefits, disclosure of alternative treatments, a statement about confidentiality of records, information on compensation and medical treatment for injury, whom to contact with questions, and a statement that participation is voluntary and the subject may withdraw at any time. Additional elements apply where appropriate.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A consent form missing a required element is a deficiency, even if the discussion with the subject covered it.
• Language must be understandable to the subject and must not ask them to waive legal rights.
• Contact information should be current so subjects can reach someone with questions.

What FDA inspectors look for

• Whether the consent form contains every required element.
• Whether the version signed was the IRB-approved version.
• Whether subjects were given enough information and time.

Related regulations