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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Vulnerable Subject Populations - Those Who Do Not Read, Speak or Understand English (Revised October 2004, Revised December 2004)

•	Brief Overview and CHR Approval Process Flowchart
•	The Informed Consent Discussion with Non-English-Speaking Subjects
•	The Preferred Method (with Preferred Method Flowchart)
•	The Alternative “Short Form” Method (with Short Form Method Flowchart)
	•	Providing a Qualified Medical Interpreter
	•	Working Effectively with Medical Interpreters
•	Translated Consent Documents
	•	Anticipating the Need for a Written Translation
	•	Preparing Translated Consent Materials
	•	California’s Experimental Subject’s Bill of Rights
•	The Informed Consent Discussion with Legally Blind English-Speaking Subjects
•	Informed Consent Discussion with Illiterate English-Speaking Subjects
•	Informed Consent Discussion with Persons Who Cannot Talk or Write
•	Ethical and Legal Considerations
•	Resources

Brief Overview

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

1. are non-English speakers and require a medical interpreter and translated consent materials, or
2. understand English but cannot read due to blindness or illiteracy, or
3. understand English but cannot talk or write due to incapacitation.

Because the San Francisco Bay Area is a diverse region of many cultures and languages, investigators who enroll research subjects in San Francisco, Oakland and surrounding cities must consider the likelihood of encountering eligible subjects with limited English proficiency. A look at the populations served by a particular hospital 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:

(1)	study participation is voluntary, as indicated by free and truly informed consent (respect for persons); and
(2)	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
(3)	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. 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 UCSF 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:

•	The preferred method is to provide consent forms written in the subject’s language. In addition, for biomedical studies, the Experimental Subject’s Bill of Rights must be provided in a language in which the subject is fluent.
•	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)]. However, routine use of this method is strongly discouraged by the University and federal regulators.

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CHR REVIEW PROCESS FOR TRANSLATED CONSENT MATERIALS
(CONSENT MATERIALS PREPARED FOR USE WITH THE PREFERRED METHOD)

CHR APPLICATION Describes consent process for non-English speakers Identifies languages likely to be encountered Includes consent materials: English version only Written at 8th grade level or lower Submitted with the application

CHR REVIEW If needed, the CHR requests changes to the English version consent materials. Researcher revises English version and resubmits with response. CHR-APPROVAL Approval letter identifies CHR-approved English version consent form by date.

TRANSLATIONS Researcher obtains accurate written translations of the CHR-approved English version consent. Researcher submits translated consent materials to the CHR before enrolling subjects using the target language consent form as described in the “preferred method.

The Informed Consent Discussion with non-English-Speakers

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.

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 safety must not be endangered due to a language barrier.

•	Preferred Method: The Committee on Human Research (CHR) 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. Numerous translations of the Bill of Rights are available for investigators on the CHR website.

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The following flow chart summarizes the consent discussion using the preferred method:

FLOWCHART: THE PREFERRED METHOD FOR OBTAINING AND DOCUMENTING INFORMED CONSENT FOR NON-ENGLISH SPEAKERS

Translated Consent Document (CHR Approved)	+	Experimental Subject’s Bill of Rights (In the subject’s language)
Investigator provides a written translation of the CHR-approved English version consent. Investigator provides a qualified interpreter to facilitate the consent discussion. By answering and asking questions, the investigator determines whether the subject comprehends the consent information to ensure the informed consent is valid. Signatures required: Subject or legal surrogate Witness/interpreter Person obtaining consent A signed copy is given to the subject.		Many translated versions are available on the CHR Website Additional translations can be arranged by contacting the CHR at (415) 476-1814. The consent form states that the Bill of Rights has been given to the subject, and, by signing the consent, the subject acknowledges receiving the Bill of Rights. A copy of the Bill of Rights is given to the subject.

•	Alternative “Short Form” Method: 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.
	•	A qualified interpreter may orally present the informed consent information (CHR-approved English version) to the subject.
	•	In addition to the oral presentation, a short form written consent document is required. A version of the Experimental Subject’s Bill of Rights translated into a language in which the subject is fluent can serve as the short form.

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The following flow chart summarizes the consent discussion using the alternative method.

FLOWCHART: THE “SHORT-FORM” METHOD FOR OBTAINING AND DOCUMENTING INFORMED CONSENT FOR NON-ENGLISH SPEAKERS

English-Version Informed Consent (CHR Approved)	+	Experimental Subject’s Bill of Rights (in the subject's language)
The investigator provides a qualified interpreter to orally present the informed consent information and to facilitate the discussion. By answering and asking questions, the investigator determines whether the subject comprehends the consent information to ensure the informed consent is valid. Signatures required: Translator/Witness Person obtaining consent A signed copy is given to the subject.		The Bill of Rights written in a language in which the subject is fluent serves as the “short form.” Many translations are available on the CHR website. Additional translations can be arranged by contacting the CHR at (415) 476-1814 Write a statement on the Bill of Rights that the elements of consent from the consent form were presented orally. Signatures required: Subject or legal surrogate Translator/Witness A signed copy is given to the subject.

•	Providing a Qualified Medical Interpreter: 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.
	•	Contact information for in-hospital medical interpreter services is shown below:
		•	For the UCSF Medical Center:
			•	If a translator is needed during regular business hours, call the Ambulatory Care Services at (415) 353-2690
			•	If a translator is needed after hours or on the weekends, call Nursing Administration at (415) 353-1797.
		•	For San Francisco General Hospital:
			•	During business hours call (415) 206-5133
			•	After business hours call (415) 206-8000
		Information about medical interpreters is available from professional organizations including:
			•	The American Translators Association – maintains a Directory of Translation and Interpreting Services
			•	The California Healthcare Interpreter Association (CHIA) - has formulated standards and protocols for medical interpreters.
			•	The National Council on Interpreting in Health Care (NCIHC) provides a guide for assessing medical interpreters.
	•	Future services may include videoconferencing medical interpretation (VMI). A report on VMI evaluated at Highland Hospital (Alameda County) and at SFGH is available. The program was launched in Alameda County in February 2003.
	IMPORTANT NOTES: Although it may be necessary in some rare cases to have a bi-lingual family member or staff person serve as a medical interpreter, keep in mind the following issues.
	•	The routine use of ad hoc interpreters should be avoided.
	•	Children should not be asked to serve as an interpreter.
	•	Complex ideas and treatment regimens may demand that a trained professional be employed.
	•	Issues of privacy must be considered if family members are asked to translate.

•	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.
	•	Will the medical interpreter serve as patient/subject advocate as well as interpreting the consent material?
	•	If the English version is presented orally 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?

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Translated Consent Documents

The CHR Application requires researchers to describe the consent process for non-English-speaking subjects, and to submit the English-version consent materials, ideally written at the 8th grade level or lower. After the CHR reviews, requires changes, if any, and approves the English-version consent, the investigator is responsible for having the consent materials translated. The CHR review and approval process is summarized in the flowchart presented in the “Brief Overview” section. The following information may be useful in preparing translated consent materials.

•	Anticipating the Need for Written Translations: As part of the CHR 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 UCSF research community.
•	Preparing Translated Consent Materials: The English version consent and study materials submitted to the CHR should be written at the 8th grade level or lower. Translations are prepared after CHR review and approval of the English version. Links to organizations that provide translation services are available from the Recruitment and Consent section of the CHR website.
	•	Although not required by the CHR, some means of validating translations are discussed below:
		•	A “certified translation“ includes a notarized statement by the translator that he/she understands English and the target language and may list the translator’s credentials. A copy of the certification should be attached to the translation.
		•	A professional translator “back translates” the consent into English to verify equivalent meaning in the target language.
	•	Final CHR approval may be granted on the condition that the translated version(s) are submitted as soon as possible and before enrolling subjects.
	IMPORTANT NOTE: The cost of translating written consents is the investigator’s responsibility. These costs may be quite high, particularly for large studies where multiple languages 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 Experimental Subject’s Bill of Rights: California law requires the “Bill of Rights” to be part of the informed consent process for all biomedical studies.
	•	The Bill of Rights must always be provided in a language in which the subject is fluent.
	•	The CHR provides many translations reflecting the languages of the San Francisco Bay Area immigrant communities.
	•	If additional translations of the Bill of Rights are needed, contact the CHR at (415) 476-1814. The CHR will arrange for and cover the costs of these translations.

The Informed Consent Discussion with Legally Blind Subjects

If you are enrolling subjects who cannot read the consent materials due to blindness, or the subject’s legally authorized representative is legally blind:

•	It is recommended that an impartial witness observe the consent process.
•	The CHR-approved consent form should be presented orally.
•	Subjects in biomedical studies must receive the California Experimental Subject’s Bill of Rights which is available in Braille by the CHR. Call the CHR office at (415) 476-1814.
•	Sufficient time should be allowed for questions to be asked and answered, both by the subject, and by the person obtaining consent to ensure the subject comprehends the consent information.
•	Consider using a video/audio recording of the consent discussion as part of the documentation of informed consent.

To document the consent process, CHR 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 (or subject’s legally authorized representative) verbally agrees to participate in the study:

IMPORTANT NOTES: 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 Informed Consent Discussion with Illiterate Subjects

If you are enrolling subjects who cannot read the consent materials due to illiteracy:

To document the consent process, CHR 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:

IMPORTANT NOTES: 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 Informed Consent Discussion with English-Speaking Subjects Who Cannot Talk or Write

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. CHR recommendations for obtaining and documenting consent for these subjects are 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:

1. “…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
2. is able to indicate approval or disapproval to study entry…”

Informed consent should be obtained and documented as follows:

•	An impartial witness should be present during the entire consent discussion.
•	The CHR-approved consent form, along with the California Experimental Subject’s Bill of Rights, should be presented orally and clearly explained by the person obtaining consent.
•	Sufficient time should be allowed for questions to be asked if the subject is capable of doing so. The person obtaining consent should ask questions to ensure the subject comprehends the consent information.
•	If the subject indicates agreement to participate in the study, informed consent should be documented as follows:
	•	The consent form should be annotated by hand to describe 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.
	•	Consider using a video tape recording to further document the consent discussion.
	•	The witness signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained and that the subject apparently understood and informed consent was given freely.
	•	The person obtaining consent signs and dates the consent form.

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.

Ethical and Legal Considerations

As part of each consent discussion, clinical researchers 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. With more and more advocacy and outreach to immigrant populations in the SF Bay Area, requisite resources are being identified and made available.

Resources

Culture & Nursing Care: A Pocket Guide, edited by Juliene G. Lipson, Suzanne L. Dibble, and Pamela A. Minarik, UCSF Nursing Press

Handbook of Immigrant Health, edited by Sana Loue, Plenum Press, New York.

United States Census Bureau (California QuickLinks)

National Council on Interpreting in Health Care and its Working Paper Series

A Guide for Assessing a Healthcare Interpreter

California Healthcare Interpreting Association

California Standards for Healthcare Interpreters: Ethical Principles, Protocols, and Guidance on Roles & Intervention available through The California Endowment

Health Care Interpreters in California, by Catherine Dower, 2003 UCSF Center for the Health Professions

http://ethnomed.org/