Guidance

Research and Non-English Speaking or Reading Subjects

IRBMED
Sep 5, 2005 1:30 pm

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be taken to assure informed consent is obtained. This does not simply mean that a form is signed, but rather that steps are taken to assure the study and voluntary nature of research are understood by the participant. A translator may need to be on hand for the informed consent discussion and a translated document may be needed. Further, the IRBMED may require the investigator to submit a certified* back-translation of the informed consent.

  • Instructions for studies occasionally recruiting non-English-speaking subjects

    Submit the following with a new project or amendment application:

    1. A written summary in English of the oral presentation to be conducted with the subjects.The written summary can be the English version of the informed consent document used for the study (recommended). If a different template is used, it must cover all the required elements of consent captured in the IRBMED template.
    2. A copy of the 'short form' consent document written in English (available here).
    3. A 'short form' consent document written in the foreign-language of the anticipated subjects.
    • Use the foreign-language short form templates posted on the IRBMED webpage:
      • Where indicated by blank lines on the form, ask the translator assisting in the informed consent process to insert (hand write or provide electronically) the appropriate names, numbers, and contact information.
    • When using a foreign-language short form other than one posted at the IRBMED website include in the application:
      • Reasons for not using an IRBMED template (e.g. the needed language was not available).
      • Documentation of the credentials of the translator(s) who provided the foreign-language translation(s). Detail the translators' qualifications to write the consent form (e.g. the translation is certified* or the translator is a fluent speaker of the foreign language and has the medical or scientific background appropriate to understand the study [specify] and research concepts).
  • Consenting and Record-keeping Requirements when using a 'Short Form' Informed Consent Document

    Per the Office of Human Research Protections (OHRP) the following steps must be followed after IRBMED approval (or before IRB approval if there is urgent health care need in a particular case).

    1. Conduct the subject's informed consent process with the researcher and a translator fluent in English and the foreign-language present (a family member or others may also attend as long as no concerns regarding undue coercion from them on the subject is known)
    2. The subject signs a 'short form' informed consent document written in the appropriate language if agreeing to participate
    3. The researcher signs the written summary (which may be the currently approved informed consent document [ICD] in English)
    4. The witness (fluent in both languages) signs BOTH the short form and the written summary/ICD. (Note, the translator may also serve as the witness or the investigator, but not as the investigator and the witness and the translator).
    5. The subject is given a copy of BOTH the signed short form and signed written summary/ICD
    6. Provide the written summary/ICD even though the subject may not understand English.
    7. Copies of BOTH signed documents are maintained in the study records.
    8. Copies of both signed documents should be included in the subject's medical records if that is the standard practice for this particular study.
    9. Note on Previously Approved Projects:  Submit an ORIO report (protocol deviation) when a subject is consented and enrolled prior to obtaining IRBMED approval for the foreign language short form consent document.
  • Instructions for studies recruiting a significant percentage of foreign-language-speaking subjects

     Submit with the following with a new project or amendment application:

    1. English version of the full (IRBMED template) Informed Consent Document(s)
    2. Foreign-language version of the full (IRBMED template) Informed Consent Document(s)
    3. Back-Translation(s) of the full (IRBMED template) Informed Consent Document(s)

    Studies with a 'minor over minimal,' moderate or high risk level

    • The "back-translation" must be performed by a certified* individual and/or organization listed as having the expertise and competency to translate medical information contained in the informed consent.

    Studies with a risk level of 'no more than minimal'

    • The translation from English to a foreign language does not require a certified "back-translation" if a consultant is available to provide endorsement that the translation is accurate. Detail the consultant's qualifications to provide the endorsement (e.g. for a Chinese language document, the consultant is a native Chinese speaker and has the medical or scientific background [specify] appropriate to understand the study).
      • If the investigator is unable to provide a consultant's endorsement the investigator is required to submit a certified translation or back-translation.
    • The investigator and/or study budget is responsible for the costs associated with the translation and back-translation (if required).

    Consenting and Record-keeping Requirements with Translated Long Form

    1. Conduct the subject's informed consent process with the researcher and a translator fluent in English and the foreign-language present (a family member or others may also attend as long as no concerns regarding undue coercion from them on the subject is known)
    2. The subject signs the informed consent document (ICD) written in the appropriate language if agreeing to participate
    3. The translator (or other witness fluent in both languages) signs the ICD
    4. The subject is given a copy of ICD
    5. Copies of signed documents are maintained in the study records
    6. Copies of signed documents should be included in the subject's medical records if that is the standard practice for this particular study
  • Federal Regulations and Guidance

    According to the guidance from the Food And Drug Administration (FDA):

    To meet the requirements of 21 CFR 50.20, the informed consent document should be in language understandable to the subject (or authorized representative) . . . When the study subject population includes non-English speaking people . . . the IRB should require a translated consent document to be prepared and assure that the translation is accurate. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. In the case of non-English speaking subjects, this would be the translated document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.

    If a non-English speaking subject is unexpectedly encountered, investigators . . . must rely on oral translation. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent required by 21 CFR 50.25 were presented orally. The required signatures on a short form are stated in 21 CFR 50.27(b)(2).

  • Certified Translations

    A certified translation requires the following:

    • English-language version of the document
    • Foreign-language version of the document
    • Back-translation of the document
    • A signature of the person or company doing the translation that guarantees the accuracy of the translation. Certification for IRB purposes must also address the required medical/scientific/regulatory expertise of the translator.

    Refer to the commercial services (provision of these links does not constitute a formal endorsement of said companies) listed below or contact the UMHS Interpreter Services or foreign language department in LSA for other recommended translation services.

    K-International

    Lingua Graphica, Inc. 

    Medical Translation GmbH

    Do not use computer programs that translate documents.

     

    For more information about related regulations or IRBMED procedures when translation is needed, contact irbmed@umich.edu .

    9-5-05

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: May 10, 2018 2:00 PM