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Consenting Subjects Who Do Not Read, Speak or Understand English

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Overview - Consenting Subjects Who Do Not Read, Speak or Understand English

The purpose of this guidance is to explain how researchers should obtain and document informed consent for subjects who:

  1. Are non-English speakers and require an interpreter and translated consent materials, or
  2. Understand English but cannot read due to blindness or illiteracy, or
  3. Understand English but cannot talk or write due to incapacitation.

Because the Orange County area is a diverse region of many cultures and languages, investigators who enroll research subjects in Orange County must consider the likelihood of encountering eligible subjects with limited English proficiency. A look at the populations served by UCI Medical Center and satellite clinics will help investigators anticipate the languages spoken by potential subjects.

The governing principles of human subject research: respect for persons, beneficence, and justice, require that researchers not exclude subjects based solely on their inability to read, speak or understand English. Investigators need either to communicate directly with subjects, or to provide a reliable alternative to ensure that:

  1. Study participation is voluntary, as indicated by free and truly informed consent (respect for persons); and
  2. Study schedules, procedures, and risks are accurately communicated, and subjects have ongoing opportunities to express concerns and ask questions, in order to minimize risks to subjects (beneficence); and
  3. There are fair procedures and outcomes in the selection of research subjects so that risks and benefits of research are shared in society (justice).

Federal regulations enforced by the Office for Human Research Protections (45 CFR 46.116) and the Food and Drug Administration (21 CFR 50.20) state that informed consent "shall be in language understandable to the subject or the representative," and 45 CFR 46.117, along with 21 CFR 50.27 describe how the informed consent is to be documented. In addition, for all studies that pose a real or foreseeable risk of biomedical harm, California state law (Health and Safety Code section 24172) requires that the Experimental Subject's Bill of Rights be provided to all subjects "written in a language in which the subject is fluent."

This guidance incorporates the federal and state regulatory requirements into the following two methods for obtaining and documenting informed consent for research subjects who do not read, speak, or understand English:

  1. The preferred method is to provide consent forms written in the subject's language. For biomedical research, the Experimental Subject's Bill of Rights must also be provided in the language in which the subject is fluent.
  2. For the occasional and unanticipated non-English-speaking subject, an alternative "short form" method is allowed [21 CFR 50.27(b)(2) and 45 CFR 46.117(b)(2)]. For biomedical research, the Experimental Subject's Bill of Rights must still be provided in the language in which the subject is fluent. Moreover, routine use of this method is strongly discouraged by the University and federal regulators.

Important Notes:

  • Section 5 of the IRB Protocol Narrative must describe the consent process for non-English-speaking subjects.
  • Section 5 of the IRB Protocol Narrative may also describe the consent process for unanticipated non-English speakers for whom translated consent forms have not been prepared.
  • Informed consent is an ongoing process throughout a study. For non-English speakers, the investigator should address the means for providing continued, qualified interpretive services. Likewise, for those who understand English but cannot read, talk, or write, the investigator should be prepared to provide the necessary support to ensure the subject's ongoing comprehension of new information that may become available during the study.

Ethical and Legal Considerations

As part of each consent discussion, investigators have an ethical and legal obligation to assess the subject's understanding of the consent information to ensure that the consent is truly "informed." When the investigator and subject do not share a language, the investigator must depend on the accuracy of the translated consent documents and the working relationship with the medical interpreter. The investigator's familiarity with the subject's culture ("cultural competency") or lack of familiarity affects the communication.

Clinical Investigations and Biomedical Studies

The medical and technical information discussed during the initial consent discussion, as well as ongoing, study-related information, can be very complex and should be communicated to non-English speaking-subjects through an interpreter with training and understanding in medical terminology. In addition, an individual with a professional commitment to maintain strict confidentiality should handle the private medical issues discussed with subjects.

Working Effectively with Medical Interpreters: The field of medical interpretation is evolving and although protocols are being developed, standardized practices do not exist. Investigators may want to discuss some or all of the following topics with the interpreter before participating in an interpreter-mediated consent discussion.

  1. Will the medical interpreter serve as patient/subject advocate as well as interpreting the consent material?
  2. If the English version of the consent form is orally interpreted for the alternative "short form" method, how will the interpreter incorporate cultural considerations into the consent information?
  3. How transparent will the interpreted conversation be? With three people communicating (subject, investigator and interpreter), will everything said by each person be translated?
  4. How will the investigator and interpreter determine whether the subject truly understands the consent information?
  5. Informed consent is an ongoing process. How will the investigator ensure that the subject will understand ongoing study-related communication? If the subject has questions about continuing in the study, how will that be communicated to the researchers?

Anticipating the Need for Written Translations

As part of the IRB application process, investigators should estimate the likely proportions of non-English-speaking-people who may be encountered as eligible subjects for a proposed study. The United States Census Bureau provides overall demographic characteristics of counties and areas served by the UCI research community.

Preparing Translated Consent Materials: The English version consent and study materials submitted to the IRB should be written at the 8th grade level or lower. Translations are prepared after IRB review and approval of the English version.

Translation Requirements:

Greater than minimal risk studies: a professional or certified translation of the consent/assent form(s) and recruitment material(s) is required for studies that pose more than minimal risk to subjects (i.e., studies that require full committee review), unless the IRB has granted a waiver of documentation of informed consent.

For a professional translation the LR must provide the qualifications of the individual who translated the informed consent documents and recruitment materials. Include any credentials, certifications, education, native language fluency, etc. For a certified translation, a copy of the certification from the translator or translation service should be attached to the translation of any informed consent documents and recruitment materials.

Minimal risk studies: Studies that are eligible for expedited review also require translation of the consent/assent forms; however, certified translation is not required. The IRB will accept documents translated by an individual fluent (i.e., can speak, read and write) in a given language. The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents. As noted above, include any credentials, certifications, education, native language fluency, etc.

Differences between an interpretation and a translation: For purposes of research informed consent, an interpretation is a verbal exchange between two parties and the person serving as interpreter is fluent (can speak, read and write) in English and the language of the subject. A translation is the process of translating a written document (e.g., consent form) from one language into another, assuring the language of the translated document has the same meaning as the written document in the first language.

The following documents should be translated before enrolling non-English speaking subjects on a study:

  • The IRB-approved English informed consent/assent document(s)
  • California Subject's Bill of Rights (when applicable). Several translations are available on the on the Applications and Forms Page.
  • Authorization for the Use of Personal Health Information for Research (when applicable). Translations are available in Spanish & Vietnamese on the Applications and Forms Page.
  • Self-Certification of Surrogate Decision Makers for Participation in Research (when applicable). A translation is available in Spanish on the Applications and Forms Page.

Cost of Translation:

The cost of translating written consents is the investigator's responsibility. These costs may be quite high, particularly for large studies where multiple translations are needed and/or studies with relatively complex consent information that may require additional time by a skilled professional. Investigators should include the costs of written translations as well as medical interpreter services on grants and contracts. Industry sponsors are often willing to pay the costs of translating consent forms.

The Experimental Subject's Bill of Rights

California law requires the "Bill of Rights" to be part of the informed consent process for all biomedical studies. If additional translations of the Bill of Rights are needed, contact the Office of Research Administration at (949) 824-1558.

The Informed Consent Discussion with Non-English Speaking Subjects

As with all consent discussions, sufficient time should be allowed for explaining each section of the consent and for the subject to ask questions. Working with an interpreter to explain complex topics such as randomization, placebo control, dosing schedules and invasive/noninvasive procedures may require additional time and/or subsequent discussions. See How to Consent for detailed information.

IMPORTANT NOTE: It is the investigator's responsibility to judge the subject's comprehension of the consent information including the understanding that participation is voluntary and that the subject has the right to withdraw at any time during the study. If the investigator doubts the subject's consent comprehension, he/she should not enroll the subject in the study. The subject's autonomy must not be jeopardized due to a language barrier.

Preferred Method of Obtaining Informed Consent from Non-English Speaking Subjects:

The UCI HRP supports the policy set forth by the Office of Human Research Protection (OHRP) and strongly encourages investigators to provide a written consent document in language understandable to the subject.

If the investigator anticipates a substantial portion of eligible subjects to be non-English-speaking people, translated consent forms in the common languages should be prepared in advance.

In addition, for all biomedical studies, California law requires the Experimental Subject's Bill of Rights to be provided in a language in which the subject is fluent. Several translations are available on the on the Applications and Forms Page.

See the flowchart that summarizes the consent discussion using the preferred method.

Alternative Short Form Method of Obtaining Informed Consent from Non-English Speaking Subjects:

The alternative "short form" method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking subject in a study for which no consent form in the subject's language has been prepared. The short form method should not be used for Spanish speaking participants, given the demographics of Orange County and more specifically the patient census of UCI Medical Center.  Should a researcher believe that enrollment of Spanish speaking participants is not expected due to the disease or condition being studied and the anticipated study enrollment, study specific justification must be provided to the IRB in Appendix Q.

  • Translations of the short form consent are available on the Applications and Forms Page.
  • Only those study team members who are approved by the IRB to obtain informed consent from research participants may obtain short form consent.

Procedures for the Alternative Short Form Consent Method:

  1. The investigator requests a short form consent process by completing Appendix Q of the IRB application. In general, the short form method should not be used for Phase 1 clinical trials, research that includes vulnerable subject populations such as children and pregnant women, and for ‘true’ placebo-controlled studies.
  2. If IRB approved, the investigator consents non-English speaking subjects using the translated short form and approved English consent document. Note: the translated short form is generic, not study specific.
  3. The subject will read the short form consent in his/her chosen language.
  4. An interpreter, in the presence of the Lead Researcher or qualified Co-Researcher (approved by the IRB), will orally translate the English version of the IRB-approved consent document and will facilitate the question and answer phase of the informed consent process between the potential participant and the researcher.
  5. A copy of the Experimental Subject’s Bill of Rights should also be provided to all research subjects considering participation in a medical experiment, per California Health & Safety Code.  These are available at the following website under Foreign Language Translations. Additional Experimental Subject’s Bill of Rights translations may be requested by contacting the HRP office at 949-824-1558. 
  6. A witness will be present during the oral presentation of the English version of the IRB-approved consent document.
    • Note: The witness must be an adult, fluent in both languages, who is not a member of the study team (i.e., is not listed in the protocol narrative). The interpreter may serve as the witness.
  7. The following signatures will be obtained on the short form consent and the English version of the IRB-approved consent:
    • The subject will sign and date the short form consent; and
    • The witness and researcher will sign and date both the short form consent and the English informed consent document.
  8. A copy of the English informed consent document and the short form consent will be given to the participant.
  9. Once the subject has consented and eligibility is confirmed, the English version of the IRB-approved consent form must be translated into the subject’s language by a professional or certified translator and provided to the subject within one month from the subject’s initial consent. 

The Informed Consent Discussion with Legally Blind Subjects

If you are enrolling subjects who cannot read the consent materials due to blindness, or the subject's legally authorized representative is legally blind:

  • It is recommended that an impartial witness observe the consent process.
  • The UCI IRB approved consent form and Subject's Bill of Rights should be presented orally.
  • Sufficient time should be allowed for questions to be asked and answered, both by the subject, and by the person obtaining consent to ensure the subject comprehends the consent information.
  • Consider using an audio recording of the consent discussion as part of the documentation of informed consent.

To document the consent process, the HRP recommendations are consistent with guidance endorsed by the FDA and set forth by the International Conference on Harmonisation (ICH E-6 4.8.9). If the subject (or subject's legally authorized representative) verbally agrees to participate in the study:

  • If capable of doing so, the subject signs and personally dates the consent form.
  • The witness signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.
  • The person obtaining consent signs and dates the consent form.
  • Signed copies are given to the subject.

The Informed Consent Discussion with Illiterate Subjects

If you are enrolling subjects who cannot read the consent materials due to illiteracy:

  1. It is recommended that an impartial witness observe the consent process.
  2. Consent materials should be presented orally, including the California Experimental Subject's Bill of Rights if enrolling for a biomedical study.
  3. Sufficient time should be allowed for questions to be asked and answered, both by the subject, and by the person obtaining consent to ensure the subject comprehends the consent information.
  4. Consider using a video/audio recording of the consent discussion as part of the documentation of informed consent.
  5. See How to Consent for more detailed information.

To document the consent process, the UCI HRP recommendations are consistent with guidance endorsed by the FDA and set forth by the International Conference on Harmonisation (ICH E-6 4.8.9). If the subject verbally agrees to participate in the study:

  1. If capable of doing so, the subject signs, or marks an X to signify consent.
  2. The witness signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.
  3. The person obtaining consent signs and dates the consent form.
  4. Signed copies are given to the subject.

The Informed Consent Discussion with English-Speaking Subjects Who Cannot Talk or Write

To enroll subjects who understand English but who are unable to talk or write due to physical limitations, investigators must assess the subject's ability to understand the consent materials and to indicate their wish to participate or not. Obtaining and documenting consent for these subjects should be consistent with the FDA guidance published in 1998 titled, "A Guide to Informed Consent." The subject may be entered into the study if the person:

  1. "...retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent), and
  2. is able to indicate approval or disapproval to study entry..."

Informed consent should be obtained and documented as follows:

  1. An impartial witness should be present during the entire consent discussion.
  2. The IRB-approved consent form, along with the California Experimental Subject's Bill of Rights, should be presented orally and clearly explained by the person obtaining consent
  3. Sufficient time should be allowed for questions to be asked if the subject is capable of doing so. The person obtaining consent should ask questions to ensure the subject comprehends the consent information.
  4. See How to Consent for more detailed information.
  5. If the subject indicates agreement to participate in the study, informed consent should be documented as follows:
    • The consent form should be annotated by hand to describe the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study.
    • Consider using a video tape recording to further document the consent discussion.
    • The witness signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained and that the subject apparently understood and informed consent was given freely.
    • The person obtaining consent signs and dates the consent form.

Translation Services

The following translation companies are provided for your convenience; the UCI HRPP does not endorse any translation service. Additions to this list are appreciated.

Chao Cancer Center Translations
If you will be submitting an award through the Chao Family Comprehensive Cancer Center please note that their translation service provider of choice is Executive Linguist Agency, Inc. You may contact Executive Linguist directly for a quote, but please be sure to contact the Purchasing Coordinator at the CFCCC Business Office for expense approval at (714) 456-2346.

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