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GUIDANCE FOR INVESTIGATORS
CONDUCTING RESEARCH WITH SUBJECTS WHO DO NOT READ, SPEAK
OR UNDERSTAND ENGLISH
JANUARY, 2010
Conducting research with vulnerable populations can be challenging. Because of the ethnic diversity in California’s
Central Valley, investigators conducting research could reasonably expect to encounter potential eligible subjects who are
either non-English speakers or have limited proficiency.
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.”
The purpose of this guidance is to explain methods by which researchers should obtain and document informed consent
for potential subjects who:
1. are non-English speakers or have limited English proficiency 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.
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:
• The preferred method is to provide consent forms written in a language understandable to the
subject. 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” is
allowed [21 CFR 50.27(b)(2) and 45 CFR 46.117(b)(2)]. However, routine use of this method is
strongly discouraged.
The IRB Application has a section which asks for a description of how subjects will be recruited. Investigators should
clearly address the method by which non-English speakers will be recruited and consented. Because informed consent is
ongoing throughout a study, the investigator should describe the means for providing ongoing, qualified interpretive
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services. Investigators should also describe the consent process for unanticipated subjects who do not speak English,
and for whom translated consent forms have not been prepared. By including a description of the alternative Short Form
consent method, investigators will be prepared to conduct informed consent discussions with individuals who may qualify
and potentially benefit from being in the study, but whose encounter was not originally anticipated.
Because the IRB may require changes to the English consent form during the initial review, investigators who intend to
translate the consent form into other languages should refrain from doing so until final IRB approval is granted for the
English consent document.
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 from the
IRB Office.
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 IRB supports the policy (http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm) set forth by the Office for
Human Research Protection (OHRP) and strongly encourages investigators to provide a written consent document in a
language understandable to the subject. If the investigator anticipates a substantial portion of eligible subjects to be nonEnglish speakers, then translated consent forms in the common language(s) should be prepared.
The following flow chart summarizes the consent discussion using the Preferred Method:
Translated Consent Document
(IRB Approved)



Investigator provides a written translation of the IRBapproved 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:
1. Subject or legally authorized representative
2. Witness/interpreter
Experimental Subject’s
Bill of Rights
(In the subject’s language)
+

Numerous translations are available from
the IRB Office
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.
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3. Person obtaining consent
A signed copy 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 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 (IRB-approved English version) to the
subject.
In addition to the oral presentation, a short form written consent document is required. A modified version of the
California Experimental Subject’s Bill of Rights translated into a language in which the subject is fluent should
serve as the short form.
IMPORTANT NOTES:


Institutional policy is consistent with the Office of Human Research Protection (OHRP) and the Food and Drug
Administration (FDA): routine use of the “short form” for obtaining informed consent is strongly
discouraged.
Investigators should refer to CMC policy regarding the provision of a qualified medical interpreter.
The following flow chart summarizes the consent discussion using the alternative method.
Experimental Subject’s
Bill of Rights (in the subject's language)
English-Version Informed Consent
(IRB Approved)


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:
1. Translator/Witness
2. Person obtaining consent


+

The Bill of Rights written in a language
in which the subject is fluent serves as
the “short form.”
Numerous translations are available
from the IRB Office.
Investigator writes a statement on the
Bill of Rights that the elements of
consent from the consent form were
presented orally.
Signatures required:
1. Subject or legally authorized
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A signed copy is given to the subject.
representative
2. Translator/Witness
A signed copy is given to the subject.
Translated Consent Documents:
The IRB 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 IRB reviews,
requires changes, if any, and approves the English-version consent, the investigator is responsible for having the consent
materials translated. The following information may be useful in preparing translated consent materials.
• 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.
• 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.
• Although not required by the IRB, 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 translator “back translates” the consent into English to verify equivalent meaning in the target language.
• Final IRB approval may be granted on the condition that the translated version(s) are submitted as soon as possible
and before enrolling subjects.
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 IRB Office provides reflecting the languages of the Central Valley immigrant communities.
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“SHORT FORM” CONSENT
NOTE: This form is to be translated into other languages
California law requires that any person asked to take part as a subject in research involving a medical
experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive
the following list of rights written in a language in which the person is fluent.
This list includes the right to:
1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of the procedure to be followed in the medical experiment and any drug or device to
be utilized.
3. Be given a description of any attendant discomforts and risks reasonably to be expected from the
experiment.
4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if
applicable.
5. Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be
advantageous to the subject, and their relative risks and benefits.
6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if
complications should arise.
7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the
subject may discontinue participation in the medical experiment without prejudice.
9. Be given a copy of the signed and dated written consent form.
10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the
intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s
decision.
For questions about patient rights, contact the Chairman of the Institutional Review Board at Community
Medical Centers at (559) 499-6553.
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I have carefully read the information contained above and I understand fully my rights as a potential subject in
a medical experiment involving people as subjects.
Signature (Subject or Legally Authorized Representative) Date
If signed by other than patient, indicate relationship
I have carefully explained all elements of the consent form to the subject orally.
Translator/Witness
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The Informed Consent Discussion with Legally Blind Subjects
For Investigators who enroll 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 IRB-approved consent form as well as the California Experimental Subject’s Bill of Rights should be presented
•
orally.
• 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.
• Investigators may wish to consider using a video/audio recording of the consent discussion as part of the
documentation of informed consent.
To document the consent process, IRB recommendations are consistent with guidance endorsed by the FDA and
set forth by the International Conference on Harmonisation (ICH E-6-6.4.8.9). If the subject (or subject’s legally
authorized representative) verbally agrees to participate in the study:
• If capable of doing so, the subject signs and personally dates the consent form.
• 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 the information and informed
consent was given freely.
• The person obtaining consent signs and dates the consent form.
• Signed copies are given to the subject.
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 Informed Consent Discussion with Illiterate Subjects
Investigators who enroll subjects who cannot read the consent materials due to illiteracy:
• It is recommended that an impartial witness observe the consent process.
• Consent materials should be presented orally, including the California Experimental Subject’s Bill of Rights if
enrolling for a biomedical study.
• 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, IRB recommendations are consistent with guidance endorsed by the FDA and
set forth by the International Conference on Harmonisation (ICH E-6-6.4.8.9). If the subject verbally agrees to
participate in the study:
• If capable of doing so, the subject signs, or marks an X to signify consent.
• 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 the information, and informed
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consent was given freely.
• The person obtaining consent signs and dates the consent form.
• Signed copies are given to the subject.
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 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. IRB 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 IRB-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.
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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 area, requisite
resources are being identified and made available.