Sample Policy on the Participation of Non-English-Speaking Individuals

I. To What Does This Policy Apply:

This policy defines the standards and parameters for the involvement of non-English speaking individuals in biomedical, behavioral and social science research.

II. Definitions:

Informed Consent: An individual's voluntary agreement, based upon adequate knowledge and understanding of relevant information including risks and benefits, to participate in research.

Non-English-Speaking Individuals: An individual unable to verbally comprehend the spoken English language or read and comprehend documents written in English. The inability to comprehend handicaps their ability to engage in the consent process and make an informed decision about participation in research. This organization will consider such individuals as vulnerable due to the difficulty of ensuring informed consent and, therefore, will apply additional safeguards to protect their rights and welfare (45 CFR 46.111(b).

III. Policy Statement:

• This organization will ensure that non-English speaking individuals enrolled in research will be treated in a manner commensurate with their special status and that their participation will be ethical and in compliance with federal regulations for the protection of human subjects, specifically 45 CFR 46.111(b). This organization recognizes that the consent process only has value if researchers can engage potential subjects in a dialogue about the nature of the research, its risks and benefits and this informed dialogue can only be ensured if the consent process takes place in a language that the subjects understand (per 45 CFR 46.116).
• Investigators must be aware that individual subjects, and sometimes, significant portions of the subject population may not speak English. Non-English speaking subjects will not be excluded from research that may have potential benefits. Investigators will plan for populations that are likely to be recruited into the research and translations will be incorporated into the study design to allow for appropriate recruitment and enrollment.
• Subjects who meet the enrollment criteria, but who can not understand or read English will not be excluded because of a lack of consent form translation. The use of oral presentation of the consent information in conjunction with a short form written consent document (as permitted by 45 CFR 46.117(b)(2)) will only be used when unexpected circumstances arise and the Investigators have not had sufficient time to prepare a full consent form translation. Extra care will be taken in the informed consent process to ensure that the subject has understood the study procedures, risks, benefits, and other key elements of the study. The short form will not be used as a convenient way to circumvent the translation of the full consent form.
• Subjects who meet the enrollment criteria and who can speak and understand English, but not read or write it, will not be excluded from participation. Similarly, subjects who can understand and comprehend spoken English, but are physically unable to talk or write, will not be excluded if they are competent and able to indicate approval or disapproval by other means. Both groups of subjects will be enrolled into research studies if they a) can understand the concepts of the study and evaluate the risks and benefits when they are explained verbally and b) are able to indicate approval or disapproval to study entry, either by marking "X" on the consent form or some other means of communication. The consent form will state the method of communication used with the prospective subject and the specific means that the subject used to communicate agreement to participate in the study. A consent monitor or an impartial third party will witness the entire consent process and sign the consent form. When appropriate, a videotape or an audiotape recording may be used to document the consent process.
• The informed consent documents will be available in English and other languages as appropriate to the subject population. Researchers will develop consent documents in the language that its most easily understood by persons they wish to enroll. A qualified individual will perform written translation of informed consent documents. When possible, the consent forms will be back translated from the second language back to English as an added measure to ensure that the information is correctly conveyed. Care will be taken to ensure that the translations are made in an appropriate dialect, if applicable.
• Researchers will be fluent in the subject's language or an interpreter will be available during the consent process and throughout the subject's participation as needed. A qualified individual who is not a friend or family member of the potential subject will perform the oral translation. The individual performing the translation will be known to the investigators, have a professional relationship with the investigators and be available for ongoing communication between subjects and investigators.

DEPARTMENT: Yale University
POLICY NUMBER:
SECTION: IRB Policies for Research Affiliate Institutions
REVIEW RESPONSIBILITY: IRB Leadership and Research Collaborators
ORIGINAL CREATION DATE: April 14, 2005
REVISION DATES: August 13, 2005

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