Consent of Non-English Speaking Persons

Enrollment of non-English speaking participants

The Washington DC metropolitan area is home to a substantial population of non-English speaking persons, with Spanish being a common first (and only) language for many.  At NIH, we frequently enroll persons from all over the world that speak a diverse array of languages.  Study teams should prospectively consider whether it is likely that they will encounter persons who are not native English speakers.  Based upon their knowledge and experience with the population typically enrolled, if it can be reasonably anticipated that for example, Spanish speaking persons will be enrolled, it is advisable to obtain a Spanish translation of the informed consent document and relevant study instruments ahead of time. 

This does not mean that study teams are obligated at the initiation of any study to translate the consent document into every possible language that might be encountered.  Typically, at the time a clinic appointment is made, the study team will be aware that a potential participant does not speak English and that an interpreter is needed.  At this time, the study team should have the informed consent translated into the language of that person.  The prospective participant’s appointment may need to be delayed to obtain the translated document, unless it is clearly in the prospective participant’s best interest to not delay and proceed with enrollment using the short form process. 

When the short form process must be used, the limitations of this process can be mitigated in part by translating the consent promptly after enrollment and providing it to the individual that was consented using the short form.  FDA guidance on informed consent indicates that this is an expectation of the FDA any time a short form consent process is used. 

In the guidance document below are the step-by-step instructions for enrolling non-English speaking persons onto studies in the NIH Intramural Program. 

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Both HHS and FDA regulations allow for consent to be documented using a process referred to as the “short form” process. (45 CFR 46.117(b)(2)) (21 CFR 50.27)(b)(2)).  In brief, the short form process allows for an oral presentation of the information that is contained within the full written English consent document, and for written documentation of consent to be obtained by having the participant sign a form that lacks any study specific information (the short form).  Typically, the short form has only generic headers that correspond to each of the required elements of consent, with no information about the actual study in which the person is enrolling. 

Although the regulations do not specify under what circumstances the short form process can be used, it has been commonly used to enroll non-English speaking persons when there is no written consent document in the language of the participant.  When used in this way, the participant receives no written study specific information in their own language.  Therefore, they have no documentation to refer to as they decide whether or not to participate or, if they do enroll, to refer back to during the course of the study.  Given the ethical and regulatory requirements for obtaining valid informed consent and ensuring the safety of subjects, in many if not most cases, the short form process falls short. 

The intent of permitting the short form process has been to provide a mechanism for the unanticipated or unexpected enrollment of non-English speaking individuals when there is no IRB approved translated full consent document, and when it is clearly in the participant’s best interest to enroll prior to obtaining a translated consent.  Given the known inadequacies of the short form process, the expectation has always been that use of the short form would be infrequent. 

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.