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:
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:
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.
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.
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.
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.
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. Include the name of the interpreter in the consent note.
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 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.
Full Board Studies- a certification of translation must be submitted with the translated consent
Expedited or Exempt Studies- The IRB will accept any of the following documents:
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.
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 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:
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:
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 significane of the number on the interpreter's 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.
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:
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 "mark" 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 subject's surrogate is legally blind, the following consent process is recommended: