IRB consent form templates
If you have any questions about a particular form, please contact your local IRB office
Document Translation/Foreign Language Interpreting Services are available here.
Consent forms
NOTE: We have updated our adult consent form template, hopefully making some of our directions and suggested language easier to follow. One new requirement is included. Updated regulations require that for any study that is a clinical trial registered on Clinical Trials.gov the following language must be inserted no later than March 1, 2012. This language must be provided verbatim in the section addressing privacy and confidentiality (template page 5): *
If the study is a clinical trial, the following must be included:
"A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time."
* Clarifications from the Federal Register Vol. 72. No. 2, January 4, 2011
- Must be included in translated “short form”
- Only for clinical investigations initiated on or after the compliance date
- Reconsent is not necessary
- Only required if the clinical trial is an “applicable clinical trial”
FDA Issues Guidance on New Informed Consent Requirements (click here for details)
UPDATE: We have revised the Adult Consent form template slightly; a signature line has been added to the future use section for the individual obtaining consent.
| IRB Forms |
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| Adult Consent Form Template version 4_20_2012 |
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| Assent Form |
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| Short Form Consent - English |
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| Surrogate Consent ** See guidelines prior to usage |
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Short Form Consent - Alternate Languages
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Form |
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| Arabic |
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Italian |
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| Chinese |
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Polish |
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| Dutch |
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Portugese |
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| French |
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Russian |
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| Greek |
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Spanish |
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| Haitain Creole |
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Vietnamese |
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