Short Form Consent Forms

The Short Form Consent process is an alternative to using a translated consent form. The process is intended for use when few non-English speaking subjects are expected or when few subjects who speak a particular language are expected (if at all). The short form consent is a document, translated into the subject's native language, that contains a description of the required elements of informed consent and notes that these elements, as they pertain to the study, will be presented orally to the subject or legally authorized representative.

Currently Available Short Form Consent Forms

Short Form Templates Download Version
English: The English language short form plus any other languages required must be submitted together. English 4-28-11
English with FDA Statement: The English language short form plus any other languages required must be submitted together. English with FDA Language 4-28-11
Albanian with FDA Statement: No special fonts required for this document. Albanian with FDA Language 4-28-11
Arabic: No special fonts required for this document. Arabic 4-28-11
Arabic with FDA Statement: No special fonts required for this document. Arabic with FDA Language 4-28-11
Burmese: Required fonts for this document include: zawgyi1. Burmese 4-28-11
Burmese with FDA Statement: Required fonts for this document include: zawgyi1. Burmese with FDA Language 4-28-11
Chinese: Required fonts for this document include: SimSum and SimHei. Chinese 4-28-11
Chinese with FDA Statement: Required fonts for this document include: SimSum and SimHei. Chinese with FDA Language 4-28-11
French: French 4-28-11
German: German 8-16-16
Haitian-Creole: Haitian Creole 4-28-11
Haitian-Creole with FDA Statement: Haitian Creole with FDA Language 4-28-11
Hebrew with FDA Statement: Hebrew with FDA Language 04-28-11
Hindi: This document is in pdf format Hindi 4-28-11
Hindi with FDA Statement: This document is in pdf format Hindi with FDA Language 4-28-11
Italian: Italian 4-28-11
Italian with FDA Statement: Italian with FDA Language 4-28-11
Karen with FDA Statement:Required fonts for this document include: KNU Karen with FDA Language 4-28-11
Korean: Required fonts for this document include: Batang Korean 4-28-11
Korean with FDA Statement: Required fonts for this document include: Batang Korean with FDA Language 4-28-11
Portuguese: Portuguese 4-28-11
Portuguese with FDA Statement: Portuguese with FDA Language 4-28-11
Russian: No special fonts required for this document. Russian 4-28-11
Russian with FDA Statement: No special fonts required for this document. Russian with FDA Language 4-28-11
Spanish: Spanish 4-28-11
Spanish with FDA Statement: Spanish with FDA Language 4-28-11
Turkish: Turkish 4-28-11
Vietnamese: No special fonts required for this document. Vietnamese 4-28-11
Vietnamese with FDA Statement: No special fonts required for this document. Vietnamese with FDA Language 4-28-11

Signature Page for Study Summary Documents

In addition to the Short Form Consent form, the standard written consent must be revised to create a Study Summary Document. The directions for doing are on the Short Form Consent page.

Signature Pages for Short Form Consent Download Version
Short Form Consent: Study Summary Document Signature Page
The Study Summary document is used in place of the consent form when using a Short Form Consent process. The signature block is signed by the member of the investigative team obtaining consent and the witness instead of the parent/subject. The signature block may be modified to meet the circumstances appropriate to the study. See information about the short form consent process below.
Summary Document Signature Blocks 3-11-15

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