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.

NOTE:For ease of navigation, the additional consent elements required by the 2018 Common Rule are indicated in green font in the English short form.

Currently Available 2018 Short Form Consent Forms

2018 Short Form Templates
(in compliance with the 2018 Common Rule)
With FDA Language Without FDA Language Version
English: The English language short form plus any other languages required must be submitted together. English with FDA Language English 1-8-19
Albanian: No special fonts are required for these forms Albanian with FDA Language Albanian 1-8-19
Arabic: No special fonts are required for these forms Arabic with FDA Language Arabic 1-8-19
Burmese: Required font for these documents: ZAWGYI-ONE.TTF Burmese with FDA Language Burmese 1-8-19
Chinese (simplified): No special fonts are required for these forms Chinese with FDA Language Chinese 1-8-19
French: No special fonts are required for these forms French with FDA Language French 1-8-19
German: No special fonts are required for these forms German with FDA Language German 1-8-19
Gujarati: No special fonts are required for these forms Gujarati with FDA Language Gujarati 1-8-19
Haitian Creole: No special fonts are required for these forms Haitian Creole with FDA Language Haitian Creole 1-8-19
Hakha Chin: No special fonts are required for these forms Hakha Chin with FDA Language Hakha Chin 1-8-19
Hebrew: No special fonts are required for these forms Hebrew with FDA Language Hebrew 1-8-19
Italian: No special fonts are required for these forms Italian with FDA Language Italian 1-8-19
Japanese: No special fonts are required for these forms Japanese with FDA Language Japanese 1-8-19
Karen: Required font for these documents: KNU.TTF Karen with FDA Language Karen 1-8-19
Korean: No special fonts are required for these forms Korean with FDA Language Korean 1-8-19
Polish: No special fonts are required for these forms Polish with FDA Language Polish 1-8-19
Portuguese (Portugal): No special fonts are required for these forms Portuguese with FDA Language Portuguese 1-8-19
Russian: No special fonts are required for these forms Russian with FDA Language Russian 1-8-19
Somali: No special fonts are required for these forms Somali with FDA Language Somali 1-8-19
Spanish: No special fonts are required for these forms Spanish with FDA Language Spanish 1-8-19
Turkish: No special fonts are required for these forms Turkish with FDA Language Turkish 1-8-19
Vietnamese: No special fonts are required for these forms Vietnamese with FDA Language Vietnamese 1-8-19

Currently Available Pre-2018 Short Form Consent Forms

Pre-2018 Short Form Templates
(Pre-2018 Common Rule)
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: This document is in PDF format. Burmese 4-28-11
Burmese with FDA Statement: This document is in PDF format. 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
Georgian with FDA Statement: This document is in PDF format. Georgian with FDA Language 4-28-11
German: German 8-16-16
Gujarati:This document is in PDF format. Gujarati 4-28-11
Haitian-Creole: Haitian Creole 4-28-11
Haitian-Creole with FDA Statement: Haitian Creole with FDA Language 4-28-11
Hakha Chin with FDA Statement: Hakha Chin 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
Japanese with FDA Statement: No special fonts required for this document. Japanese with FDA Language 4-28-11
Karen with FDA Statement:This document is in pdf format 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
Polish: Polish 11-16-17
Polish with FDA Statement: Not yet available N/A
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
Somali: Somali 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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