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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:

I. USING A WRITTEN TRANSLATION OF THE ENTIRE ENGLISH VERSION OF THE IRB-HSR APPROVED CONSENT DOCUMENT

Use of a written translation of the entire IRB-HSR approved English version is always preferred. If researchers can reasonably expect that more than an incidental number of subjects speaking the same non-English language will be enrolled (for example, if the investigator is I.targeting a non-English speaking group), translation of the entire English version is required. The IRB-HSR must approve all translated versions of the consent form.

II. USING A WRITTEN TRANSLATION OF THE "SHORT FORM" CONSENT DOCUMENT

Short Forms in several different languages are available under FORMS

Investigators cannot always anticipate the interest of a particular non-English speaking individual and provide him/her with a translation of the entire IRB-HSR approved English version of the informed consent document in a timely manner. Under these circumstances, a translation of the "short form" (which attests that the elements of consent have been presented orally) can be used to document informed consent in writing. When a "short form" is used to document informed consent, the consent process must include oral presentation of the entire English version of the consent form in language understandable to the potential subject.

Please submit to the IRB-HSR the following documents for approval:

  1. Two (2) copies of the Short Form English
  2. Two (2) copies of the Short Form-Non English

The informed consent process for enrolling subjects using the "short form" consent document is outlined below. ALL of the following requirements (1, 2, 3 and 4) must be completed:

  1. A translator must orally present the entire IRB-HSR approved English version of the consent form to the subject or the subjectís legally authorized representative in a language understandable to him/her, and the subject or the subjectís legally authorized representative must be given a written translation of the "short form" consent document to read;
  2. The entire consent process must be witnessed by an individual who is fluent in both English and the language understandable to the subject or the subjectís legally authorized representative. The translator may serve as the witness;
  3. The IRB-HSR approved English version of the consent form must be signed by a consent designee authorized by IRB-HSR (listed on the protocol) to obtain consent and the witness to the consent process. The translated "short form" must be signed by the subject or the subjectís legally authorized representative and the witness to the consent process (see 2 above); AND
  4. The subject or the subjectís legally authorized representative must be given copies of both the IRB-HSR approved English version of the consent form and the translated version of the "short form" consent document. The original signed English version with the original signed "short form" attached should be placed in the subject's research record and a copy of both placed in his/her medical record, if appropriate.

PLEASE NOTE:

An outside translator phone service, such as Cyracom, may be used. Write the interpreterís 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 significane of the number on the interpreterís signature line.

Medical Center Policy #156 addresses non-English speaking patients and translation services. A section of this policy has been re-printed below.

Medical Center employees and all health care practitioners providing services at the Medical Center shall not encourage the use of a patient's relative or family member as an interpreter of healthcare information. A patient's relative or friend shall be used as an interpreter only at the request of the patient and only if the use will not compromise the effectiveness of the medical services provided or jeopardize the patient's privacy regarding sensitive medical information. Use of minor children as interpreters is prohibited, even if such use is the patient's preference.

The Medical Center shall ensure that vital documents that are routinely provided to patients in the English language are made available in other regularly encountered languages as required by Title VI of the Civil Rights Act of 1964.

See Learning Shot: Use of Short Forms for Non-English speaking subjects

Consenting a subject who understands English but cannot read or write?

A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.

A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If:

  • the person 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

  • is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document 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. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended. From FDA IRB Information Sheets

Consenting subjects who are Legally blind or illiterate

If a Principal Investigator wishes to include a subject who happens to be illiterate 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 ďmarkĒ on the subject signature line. Signatures of the person conducting the consent interview are required in such situations.

If subjects who cannot read the consent materials due to illiteracy, blindness, or the subjectís surrogate is legally blind, the following consent process is recommended:

  • Have an impartial witness observe the consent process, such as a subject advocate or someone not affiliated with the research team. Family members are not recommended to serve as witnesses.

  • The consent forms should be presented to potential subjects orally and the potential subject. You may wish to provide the subject with an audiotape of the discussion for their reference.

  • If potential subjects have access to equipment that can read the consent document for them, provide them sufficient time to review the consent document independently of the research team.

  • As would be expected for any consent process, ensure sufficient time is allowed for questions to be asked by the potential subject, subjectís surrogate to ensure that the consent process was clear and effective.

  • Add a statement to the consent form that the subject was unable to read the consent form and that they were read to the subject by a member of the research team designated to obtain informed consent.

  • The subject signs and dates the consent form, if capable of doing so. In the case that informed consent is being obtained from the subjectís surrogate the surrogate will instead sign and date the form.

  • The witness signs and dates the consent form. A statement should precede the witnessí signature that attests that the consent information was explained and that the subject apparently understood the information, and informed consent was given freely.