Under 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2), the short-form documents that all required elements were presented orally. A witness must be present, and the witness and subject sign the short form while the witness and the person obtaining consent sign the full English summary.
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Glossary Term
Short-Form Consent
Participant Protections
Also known as: short form consent, short-form written consent
An abbreviated written consent statement, used with an oral presentation of the IRB-approved long form, often to consent non-English-speaking participants.
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