Use of Non-English Speaking Subjects in Research

Investigators are strongly encouraged to recruit and include all segments of our diverse community in research, including individuals whose primary language is not English. Participants who do not understand English must be presented with a consent document written in a language understandable to them. Please see below for more information on how to properly consent non-English speaking subjects.

What Must Be Provided To The Participant During The Consent Process?

The following are required during the consent process:

A qualified medical interpreter fluent in both English and the subject’s spoken language must be provided during the consent process to ensure the subject understands the consent document and is able to freely ask and receive answers to their questions.
An impartial witness fluent in both English and the subject’s spoken language must be present during the consent process. The interpreter may serve as the witness.
A written consent document in a language understandable to the research participant.

What Are My Options For Translating The Consent Form?

Depending on the research, the written consent document can be either:

A translation of the entire English version of the BRI IRB-approved consent document OR
A “short form” consent document stating that all of the elements of informed consent have been fully presented orally OR
Contact Virginia Mason Translational Services (for VMMC/BRI personnel only)

The following translations options are accepted:

Professional Translation: Use of a professional translations service, such as Dynamic Language. A BRI Translation Certificate must be completed by the person providing the translation service and submitted to the IRB with the translated document(s).
Certified Translation: Use of a qualified individual who is fluent in both English and the language of translations, or other non-professional methods. A summary of qualifications of the individual who translated the document(s) or other method of translation must be submitted to the IRB with the translated document(s). For an individual this should include any credentials, certifications, education, native language fluency, etc.
Translated Short Form Consents: Use of an IRB-approved short form consent template that has already been translated into the appropriate language (see below).

Which Consent Form Option Should I Use?

When non-English speaking subjects are being targeted or will otherwise make up a portion (>5%) of eligible subjects in a study, a translation of the entire consent form in the appropriate language(s) is the preferred method of translation prior to IRB approval. This approval must occur in advance of use.

When the majority of study participants are English speakers, but there may be an occasional person who does not understand English, a short form consent in the participant’s language may be used.

What Should I Submit To The IRB?

If you know you will be accruing non-English speaking participants of a particular language at the time you submit a new IRB application, a translation of the entire consent form in the appropriate language(s) and a translation certificate should be included in your IRB application packet.

If you have an existing study and the opportunity arises to consent a non-English speaking participant, submit a "Study Modification Form" along with the above documents for IRB approval.

If you unexpectedly encounter a potential non-English speaking participant, and there is not sufficient time available to submit documents for IRB-approval before enrolling, proceed with the short form consent method. Study personnel must report to the IRB all uses of this method in the next Continuing Review submission.

Short Form Consent Process

The consent process must include oral presentation of the entire IRB-approved English version of the consent form in language understandable to the potential subject. A witness proficient in English and in the research subject’s language must be present throughout the entire consent process. When the subject is assisted by an interpreter, the interpreter may serve as the witness. The following signatures are required:

The research subject signs the short form.
The witness signs the short form and the English long-form consent document.
The study staff member obtaining consent signs the English long-form consent document.

Copies of the short form and English long-form consent documents will be given to the research subject.

Which Languages Have A Prepared Translated Short Form Consent?

The IRB has created several translated short form consent documents based on the most common languages spoken in King County. These documents are translations of the OHRP sample short form consent.

Important Notes For The Use Of The Short Form Method

Routine use of the short form consent method is not permitted.

The types of studies for which the short form consent method are appropriate are limited. Examples include:

A therapeutic study for a subject whose language was not anticipated and for which there is not sufficient time to translate the consent form.
A minimal risk study for which there is a short window to enroll a subject and for which there is not sufficient time to translate the consent form.

In order to use the short form consent method, your study protocol must be approved with non-English speaking subjects marked as “Possible Inclusion.”

Should I Translate Other Study Documents?

The IRB may require translation of additional study documents, including full consent form, recruitment materials, questionnaires/surveys, or any other documents provided directly to the subject.

For more information, see the Translation SOP for contact the BRI Research Protections Department directly.