Show
The purpose of this guidance is to explain how researchers should obtain and document informed consent for subjects who:
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:
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:
Important Notes:
Ethical and Legal ConsiderationsAs 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.
Anticipating the Need for Written TranslationsAs 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:
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. English-Speaking Subjects Unable to Read and WriteA person who can understand and comprehend spoken English, but is physically unable to talk or write, can be enrolled in a study using an English consent form if they are competent and are able to indicate approval or disapproval by other means. The subject must:
The consent form (or research record) should document the method used for communication with the potential subject and the specific means by which the potential subject communicated agreement to participate in the study.
Note: English-speaking subjects who are unable to read and write must not be confused with non-English speaking subjects who are able to read and write in another language. A certified translation of the English consent form must be used to consent non-English speaking subjects. The Experimental Subject's Bill of RightsCalifornia 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.
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. Please review the HRP Informed Consent Process 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 Applications and Forms Page. 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 the Application.
Procedures for the Alternative Short Form Consent Method:
If you are enrolling subjects who cannot read the consent materials due to blindness, or the subject's legally authorized representative is legally blind:
To document the consent process, the HRP recommendations are consistent with guidance endorsed by the FDA and set forth by the International Council on Harmonisation (ICH E-6 4.8.9). If the subject (or subject's legally authorized representative) verbally agrees to participate in the study:
The Informed Consent Discussion with Illiterate SubjectsIf you are enrolling subjects who cannot read the consent materials due to illiteracy:
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:
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:
Informed consent should be obtained and documented as follows:
|