January 2021

What are requirements for including non-English speakers in a study?

As required by The Department of Health and Human Services (DHHS) regulations (45 CFR 46.116 and 45 CFR 46.117) and FDA regulations (21 CFR 50.25 and 21 CFR 50.27):

Unless written consent has been waived as a requirement for the study, the participants who do not speak English must be provided with:

• A written consent document in a language understandable to them AND
• An interpreter fluent in both English and the participant's spoken language to aid in the consent process

Is there more than one type of written consent form for non-English speakers?

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

• a translation of the entire English version of the JHM IRB approved consent document OR
• a “short form” consent document stating that the elements of consent have been fully presented orally

When is a translation of the JHM IRB full English version consent form required?

If more than an occasional person speaking the same non-English language will be enrolled in a study, then a fully translated consent form is required.  Examples of situations that require a translated consent form:

• Investigator is targeting a non-English speaking group
• Research will be done in a foreign country
• Investigator anticipates that more than a few participants who speak the same non-English language will want to enroll in the study

Does the JHM IRB have to approve the translated version of the JHM IRB approved full English version consent form?

Yes. Investigators must submit a translated version of the JHM IRB approved entire English informed consent document along with a Certificate of Translation.  

When should the investigator submit the translated version of the full English version consent form?

The investigator may submit both the English version of the informed consent document and any translated informed consent documents needed for the study along with a Certificate of Translation.  However, since any changes made by the JHM IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators are advised to have the translation completed after JHM IRB approval of the English version of the informed consent document. 

What are short forms?

A short form is a written document, in the participant’s language, stating that the elements of informed consent required by 45CFR46.116 have been presented to and are understood by the subject or the subject’s legally authorized representative.

When can a short form be used?

A short form may be used when the majority of study participants are English speakers, but there may be an occasional person who will not be able to understand the consent form written in English. A short form, in the participant’s language, can be used in these instances to obtain consent ensuring equal access for potential participants.

How do I use a short form?

A short form may be used in conjunction with an oral presentation of the full English version consent form to the participant with the assistance of an individual fluent in the participant’s language (as required by 45CFR46.116).

The participant must receive a copy of the signed and dated short form consent and a copy of the signed and dated approved JHM IRB full English version consent form (signed by a witness and a consent designee). The witness must be fluent in both languages and must be unaffiliated with the study. The witness may also be the interpreter (unless the interpreter is affiliated with the study as an investigator or study team member).  

What are the required signatures with short forms?

• Study participant must sign the short form consent.
• Witness/Interpreter must sign the short form consent and the approved JHM IRB full English version consent form.
• Consent designee must sign the approved JHM IRB full English version consent form.

HELPFUL HINT: Each person should sign the consent forms they understand.  The non-English speaking participant signs the short form consent in their language.  The consent designee signs the English version full consent.  The witness understands both languages, so signs both.

What must be approved by the IRB?

• Justification of the use of short forms
• JHM IRB full version English consent form
• Translated short form if the JHM IRB has not already approved the translation

Where do I find a short form?

The JHM IRB has approved translations of the short form document in several languages. These approved translations are posted on the IRB website. If you require a short form consent in a different language, you must have the English version short form translated into the required language and submit it, with a Certificate of Translation, to the JHM IRB for approval.

English version of the “short form” and the following approved translations of the “short form” (Arabic, Chinese, Haitian, Italian, Korean, Polish, Portuguese, Russian, Spanish, Vietnamese).

Is translation of other study-related documents required?

If more than an occasional non-English speaker will be enrolled in a study, the JHM IRB requires that all study-related documents are written in a language that is understandable to the participant population(s). This means that all study-related documents must be translated into the required language(s) and submitted, along with a Certificate of Translation, to the JHM IRB for approval.

What is meant by “study-related documents”?

Such documents can include but are not limited to:

• recruitment material (flyer, brochure, poster, telephone recruitment/screening script, etc.)
• survey or questionnaire(s)
• focus group/interview guide(s)

When should the investigator submit the translated version(s) of the study-related documents?

The investigator may submit both the English version of the document(s) and any translated document(s) needed for the study along with a Certificate of Translation. However, since any changes made by the JHM IRB to the submitted English version of the document(s) must be included in the translated document(s), investigators are advised to have the translation completed after JHM IRB approval of the English version of the document(s).

Are there resources available to assist researchers?

Yes. Centro SOL offers a comprehensive research consultation service to promote culturally competent research inclusive of Latinx populations, especially those with limited English proficiency (LEP). Services offered include planning, study staff recruitment, material review, translation, and participant recruitment. For more information about Centro SOL’s research consultation please visit our website at https://www.jhcentrosol.org/research-and-policy

See our online guide on Instructions for Requesting Interpretation Services through Language Access Services.

Contact Information for Language Services:

Phone: 410-614-4685 (follow the prompts for any language services’ needs), para español 1-844-765-9930
Email: [email protected] (for any interpretation requests)
Web link to request in-person interpreter: https://jhmiportal.force.com/LASWebRequestFormInterpretation
Translations: [email protected]
Requests to become a Qualified Bilingual Staff Member: [email protected]