Short Form Consents

The Short Form Consent process is an alternative to using a translated study consent form. The process is intended for use when you have unexpected enrollment of a non-English speaking subject and there is no translated consent.  If you expect to enroll subjects who do not speak/read English (e.g., Spanish speaking persons), or you have time to translate the consent for a person who does not read English prior to them enrolling, then you should have the IRB-approved English long form consent(s) translated into that language in advance.  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.

The IRB maintains a library of short form consent documents that can be used for non-English speaking subjects.  These posted consents have already been approved by the IRB for use in any IRP protocol that does not require the subject speak/read English as an eligibility requirement. You do not need to obtain specific approval to use one of these posted short form consents for your protocol.

The IRB expects that you will use the appropriate IRB-approved study consent as the basis of translation during the short-form consent process. If you do not plan to use the study consent for this purpose, then you must seek prior approval from the IRB for the written summary about the study, that will be used by the interpreter during the short form consent process.

If you need a short form that is in a language which is not available on this website, then you must obtain a translation of the appropriate English short form version.  A resource for obtaining a translation is the NIH Library.   Once you receive the translation, submit the translated short form and the certificate of accuracy to the IRB via PROTECT using the Modification form.   Once approved, we will post newly translated version(s) to this website for future use by the NIH Intramural Research Program (IRP) research community.

The below consent templates are NIH approved translations of the short form consent document, as well as the English language version of the short form.

Please Note: The short form templates have been updated to comply with the Revised Common Rule. If your study was approved prior to or on 01/21/2019 and you wish to use a short form, please select the short form from the Common Rule table listed below. If your study was approved after 01/21/2019, please select the Revised Common Rule table listed below.