For research participants who do not speak and/or read English, a short-form consent can be used [45 CFR 46.117(b)(2)); 21 CFR 50.27(b)(2)]. The short-form is used to document that the elements of informed consent were orally presented to the research participant by a qualified interpreter. Both the short form and a written summary, which may also be the IRB-approved English-language informed consent document, must be submitted to the IRB.
NOTE: You must receive IRB approval to use these forms to consent participants.
There are two versions of the short-form consents are available, please use the version appropriate for your study.
- 2018 Requirements version: For use by studies approved by the IRB on or after January 21, 2019.
- Pre-2018 Requirements version: For use by studies approved by the IRB before January 21, 2019.
2018 Requirements
Click below to access the version of the short-form consents for all research studies that were approved by the IRB on or after January 21, 2019.
Pre-2018 Requirements
Click below to access the version of the short-form consents for all research studies that were approved by the IRB before January 21, 2019.