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IRB-HSR > Managing Protocol After Initial Approval > Informed Consent > Consenting Subjects Who Do Not Read, Speak or Understand English

 

 

 

 

 

 

Consenting Subjects Who Do Not Read, Speak or Understand English

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

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

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:

  • Study participation is voluntary , as indicated by free and truly informed consent (respect for persons); and
  • 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
  • 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. T

There are 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.
  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)].

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.

  • 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?
  • How transparent will the interpreted conversation be? With three people communicating (subject, investigator and interpreter), will everything said by each person be translated?
  • How will the investigator and interpreter determine whether the subject truly understands the consent information?
  • 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?

NOTE:  An outside translator phone service, such as Cyracom, may be used.  Write the interpreter’s ID# in place of the signature for the interpreter.  In addition, write a detailed note regarding the consenting process which includes the use of the Cyracom system and the significance of the number on the interpreter’s signature line. 

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.

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 IRB must receive and approve all foreign language versions of the short form document and any other translated documents presented to the subjects. Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

If a Principal Investigator wishes to include a subject who happens to be illiterate or if no translated consent document in the subject's language is reasonably available, then appropriate arrangements must be made to obtain verbal consent. Illiterate persons who understand English may have the consent read to them and make a "mark" on the subject signature line. Signatures of the person conducting the consent interview are required in such situations.

Translation Requirements:

The IRB will accept documents translated by an individual fluent (i.e., can speak, read and write) in a given language. 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.

Short Forms:

Short Forms in several different languages are available under FORMS