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Short Form Consent Forms
Published on
· Last Updated 9 months 1 week ago
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 |
| Bengali: No special fonts are required for these forms | Bengali with FDA Language | Bengali | 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 |
| Dari: No special fonts are required for these forms | Dari with FDA Language | Dari | 1-8-19 |
| Farsi: No special fonts are required for these forms | Farsi with FDA Language | Farsi | 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 |
| Indonesian: No special fonts are required for these forms | Indonesian with FDA Language | Indonesian | 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 |
| Pashto: No special fonts are required for these forms | Pashto with FDA Language | Pashto | 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 |
| Romanian: No special fonts are required for these forms | Romanian with FDA Language | Romanian | 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 |
| Ukrainian: No special fonts are required for these forms | Ukrainian | 1-8-19 | |
| Urdu: No special fonts are required for these forms | Urdu | 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 |