See the Quick Guide on Consenting Non-English Speakers for a summary of this info.
- Background
- Two Methods of Consent: Preferred and Short Form
- Preferred Method
- Re-Consenting Non-English Speakers (Preferred Method)
- Short Form Method
- Re-Consenting Non-English Speakers (Short Form Method)
- Obtaining HIPAA Authorization
- Providing a Qualified Medical Interpreter
- Translating Study Documents
- Translated ICFs FAQs
Background
The San Francisco Bay Area is a diverse region, and you likely will encounter eligible participants with limited English proficiency when recruiting locally. The governing principles of human participant research require that investigators a) not exclude participants based solely on their inability to read, speak or understand English and b) find a way to communicate with participants to ensure that consent is voluntary and informed.
Federal regulations from OHRP and FDA state that informed consent “shall be in language understandable to the participant or the representative” and describe how consent is to be documented. California state law also requires the Experimental Participants Bill of Rights be provided “in a language in which the participant is fluent” to individuals participating in a biomedical study.
Two Methods of Consent: Preferred and Short Form
If you anticipate that your study may enroll non-English speaking participants, explain in the IRB Application which method(s) of consent you will utilize.
Preferred Method: The preferred method is to provide consent forms written in the participant’s language. The researcher obtains and submits written translations of the IRB-approved consent form(s) after the study is approved.
Short Form Method: This method only should be used for the occasional and unexpected enrollment of a non-English-speaking participant in a study for which there is no translated consent form in the participant’s language. Instead of signing the English-language consent form (which the participant does not understand), the participant signs a "short form consent" — the Experimental Participants Bill of Rights in his/her language.
Routine use of this method is not permitted. After enrolling 2 non-English speakers who speak the same language, the IRB requires translation of the full informed consent in the language of the two non-English speaking enrollees. Unless, the study has completed enrollment.
A translated consent addendum may be used to document ongoing consent in response to study changes.
Reminders for Both Methods
You must indicate in the IRB Application that non-English speakers will be enrolled, and the IRB must approve this request before you can enroll non-English speakers.
Clarify who will be conducting the consent process and how this person will communicate with non-English speakers.
The medical and technical information discussed during the consent process and throughout the study can be very complex and should be communicated through an interpreter with training and understanding in medical terminology.
As such, medical interpreters or investigators (or perhaps knowledgeable Key Study Personnel) who are fluent in English and the language in question should conduct the consent discussion. In the latter case, the investigators and Key Study Personnel should ensure that they are truly capable interpreters and can translate the complex medical terminology adequately.
By answering and asking questions through the interpreter, the investigator determines whether the participant comprehends the consent information to ensure the informed consent is valid.
Informed consent is an ongoing process throughout the study, so describe how you will provide continued, qualified interpretive services throughout the study and how you plan to document this ongoing communication.
It is the investigator’s responsibility to evaluate the participant’s comprehension of the consent information, including the understanding that participation is voluntary and that the participants has the right to withdraw at any time during the study. If the investigator doubts the participants’s consent comprehension, do not enroll the participant in the study. The participants’s safety must not be endangered due to a language barrier.
Allow sufficient time for explaining each section of the consent and for the participants 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.
Federal regulations also require that participants are given the opportunity to read through the information before documenting their decision via the signing of the short form or full informed consent.
The IRB will obtain a translation of the document for you at no cost to you. Please contact us in advance of the consent visit to allow time for us to obtain the translation.
The IRB strongly encourages you to use the preferred method and provide participants with a written consent document in language they can understand. In particular, use the preferred method if you anticipate a substantial portion of eligible participants will be non-English-speakers and your study involves and FDA regulated drug, device and/or biologic.
A qualified interpreter should facilitate the consent process. If you are conducting a biomedical study, provide the participant with a copy of the Experimental Participants Bill of Rights in a language in which the participant is fluent. If HIPAA applies to your study, review information on obtaining HIPAA authorization.
IRB Review Process for Translated Consent Materials (Preferred Method)
- In the "Subjects" section of the IRB Application, indicate that you wish to enroll non-English speakers. Then describe in the IRB Application the consent process for non-English speakers and identify languages likely to be encountered in the subsequent section.
- Attach the English-language consent documents only. Also submit English-language versions of recruitment materials or other study materials that will need to be translated.
- If needed, the IRB requests changes to the English-language consent materials and PI submits the revised versions.
- IRB approves the consent plan and consent documents.
- Researcher obtains accurate written translations of the IRB-approved English consent documents.
- Researcher submits translated consent documents and other study materials that required translation to the IRB before enrolling participants using the translated language consent form. Submit these materials in iRIS as an administrative modification.
Preferred Method Documentation
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Translated Informed Consent (IRB Approved) |
Experimental Participants Bill of Rights (Download in the participants language – contact the IRB for add’l translations) |
HIPAA Authorization |
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Signatures required: 1. Participant 2. Person obtaining consent Document in the research file that an interpreter was used. Give a signed copy to the participant. |
Signatures required: None Give a copy to the participant. Only required for biomedical studies when using the preferred method. |
If you need to obtain HIPAA authorization from the participant, follow the instructions below. |
Re-Consenting Non-English Speakers (Preferred Method)
It is likely that Non-English speakers may need to be occasionally re-consented. If the preferred method is identified as the approved method for obtaining consent from non-English speaking participants an addendum (or summary of changes) should be used to facilitate ongoing consent. To submit an addendum for the purpose of re-consenting a non-English Speaker, complete the following steps:
Step 1. PI submits English-language addendum
- Attach the English-language addendum documents only. Also submit English-language versions of recruitment materials or other study materials that will need to be modified and used during the re-consent process.
Step 2. The IRB reviews and approves this request
- If needed, the IRB requests changes to the English-language addendum materials and PI submits the revised versions.
- IRB approves the re-consent plan and addendum documents.
Step 3. PI obtains translations and submits them as an administrative modification
- Researcher obtains accurate written translations of the IRB-approved English addendum documents.
- Researcher submits translated addendum documents and other study materials that required translation to the IRB before re-consenting participants using the translated language consent form. Submit these materials in iRIS as an administrative modification.
Short Form Method
The “short form” method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking participant in a study for which there is no translated consent form in the participant’s language. The University and federal regulators strongly discourage routine use of the short form method.
Short Form Consent Method Steps:
In the "Subjects" section of the IRB Application, indicate that you may wish to enroll the occasional and unexpected non-English speaker. Then describe how you will conduct the short form consent process for non-English speakers. The IRB must approve the use of the short form in your study before you utilize this method.
A qualified interpreter assists in orally presenting the IRB-approved informed consent information to the participant. By answering and asking questions, the investigator determines whether the participant comprehends the consent information to ensure the informed consent is valid.
In addition to the oral presentation, the participant must sign a short form written consent document. The Experimental Participants Bill of Rights translated into a language in which the participant is fluent will serve as the short form. A witness also must sign.
Short Form Method Documentation
Short Form Method Documentation
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English-Language Informed Consent (IRB Approved) |
Experimental Participants Bill of Rights (Download in the participants language – contact the IRB for add’l translations) |
HIPAA Authorization |
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Signatures required: 1. Person obtaining consent 2. Witness Document in the research file that an interpreter was used. Give a signed copy to the participant. |
The Bill of Rights written in a language in which the participant is fluent serves as the “short form.” Signatures required: 1. Participant 2. Witness Give a signed copy to the participant. |
If you need to obtain HIPAA authorization from the participant, follow the instructions below. |
Hint: The participant and person obtaining consent sign the document that they each understand – that is, the participant signs the Bill of Rights in his/her native language and the person obtaining consent signs the English consent form.
Short Form Method FAQs
The witness is signing to document that an oral presentation in a language the participant can understand took place. The witness can be the interpreter or another adult (other than the person obtaining consent) who witnessed the involvement of an interpreter. Preferably, this adult would not be a family member of the participant, unless the person is a health professional or otherwise knowledgeable about research.
If necessary, add the required signature and date lines by hand to the form. Each signature line should have its own date.
The interpreter does not need to “read” an entire consent document to the potential participant. As in a normal consent process, the person obtaining consent should ask the interpreter to provide the participant with key information about the study (e.g. the elements of informed consent described on the Bill of Rights).
Re-Consenting Non-English Speakers- Short Form Method
If the IRB approves the Short Form Method as the primary way of consenting participants the process may be applied for the purpose of re-consenting active participants. Study teams must follow the steps below:
A qualified interpreter assists in orally presenting the IRB-approved revised informed consent information to the participant. By answering and asking questions, via the interpreter the investigator determines whether the participant comprehends the updated consent information to ensure the re-consent is valid.
In addition to the oral presentation, the participant must sign a short form written consent document. The Experimental Participant’s Bill of Rights translated into a language in which the participant is fluent will serve as the short form. A witness also must sign.
The study team must maintain a note to file for each consent and re-consent of a Non-English speaker.
Obtaining HIPAA Authorization
If you need to obtain HIPAA authorization from a non-English-speaking participant, follow the instructions based on whether a translated UCSF HIPAA Authorization form is available in the participant’s language.
The participant should sign the translated form. An interpreter does not need to sign the translated form. However, an interpreter should be available to speak with the participant about this form, and document in the research file that an interpreter was available.
If a translated version of the HIPAA Authorization form is unavailable, translation of the form into a language the participant is fluent in must be facilitated by the study team before the consent process occurs.
The SFVAHCS Authorization for Release of PHI for Research is only available in English. It must be signed by the participant, interpreter and the person obtaining the authorization. Check with other institutions about their HIPAA requirements.
Providing a Qualified Medical Interpreter
The medical and technical information discussed during the initial consent discussion and throughout the study can be very complex. It should be communicated to non-English speaking-participants through an interpreter with training and understanding in medical terminology, as well as a professional commitment to maintain strict confidentiality.
Although it may be necessary in some rare cases to have a bilingual 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.
Contacting In-Hospital Medical Interpreter Services
During regular business hours, call the Ambulatory Care Services at 415-353-2690. After hours or on the weekends, call Nursing Administration at 415-353-1797.
During business hours, call 415-206-5133. After business hours, call 415-206-8000.
Working Effectively with Medical Interpreters
The field of medical interpretation is evolving, so here are some topics you may want to discuss with the interpreter before participating in an interpreter-assisted consent discussion.
- How transparent will the interpreted conversation be? With three people communicating (participant, investigator and interpreter), will everything said by each person be translated?
- Informed consent is an ongoing process. How will the investigator ensure that the participant will understand ongoing study-related communication? If the participant has questions about continuing in the study, how will that be communicated to the researchers?
- If the English version is presented orally for the alternative “short form” method, how will the interpreter incorporate cultural considerations into the consent information?
- The American Translators Association, including a Directory of Translation and Interpreting Services
- The California Healthcare Interpreter Association (CHIA)
- The National Council on Interpreting in Health Care (NCIHC) provides a guide for assessing medical interpreters.
After the IRB reviews and approves the consent documents and other study materials (such as advertisements or questionnaires), the investigator is responsible for having these documents translated.
The investigator is responsible for the cost of translating study materials. These costs may be quite high. Include the costs of written translations, as well as medical interpreter services, on grants and contracts. Industry sponsors often are willing to pay these costs.
If assistance is needed with translation requirements, investigators should request a consultation from the CTSI’s Research Action Group for Equity (RAGE) program, which has been formed to assist study teams with diversifying participant populations.
For additional details on the RAGE program, please fill out the consultation request form: https://ctsi.ucsf.edu/about-us/programs/rage.
Translating Study Documents — Greater Than Minimal Risk Studies
Certified translations are required for all Greater than Minimal Risk Studies.
Please include the associated certificate(s) of translation upon submission of the translated document(s). Please do so when the documents are added for the first time and when they are revised. Please find an example of a certificate of translation here. To learn more about what qualifies as a certified translation please review the ATA website (Certification – American Translators Association (ATA) (atanet.org)).
NEW OPTION MAY 2024
The UCSF IRB strongly supports efforts to increase research participation among diverse populations. To provide study teams with an additional option and flexibility for translating study documents, the IRB now permits study teams to translate their own documents for greater-than-minimal-risk studies by utilizing a qualified translator. A qualified translator is a person who is proficient in both the source and target languages, including grammar, vocabulary, cultural contexts and nuances.
Why is the IRB making this change?
- This policy supports the IRB’s commitment to inclusivity and equitable access, ensuring that language barriers do not impede diverse populations from participating in research
- The IRB expects this new policy to support earlier access to studies for non-English speaking participants
- To provide study teams with flexibility, cost reduction and efficiency
- May enhance the quality and relevance of the translations
An example
A co-investigator on the study is proficient in the source language and the target language, and grew up in a community that speaks the target language. The co-investigator has an in-depth understanding of both the target language and cultural context. With proficiency in the nuances, grammar, and vocabulary of both the source and the target language, the co-investigator is well-positioned to translate the study documents.
Notes
- Study teams can continue to utilize translation companies
- This does not replace utilizing a medical interpreter
- The IRB strongly recommends that a bilingual cultural expert (e.g., a native speaker of the translated language) performs a quality check on the translations
Steps
- A qualified translator translates the IRB-approved English version of a document
- Qualified Translator and Principal Investigator complete the UCSF IRB Certification of Translation Form
- Submit for IRB review a Modification Form that includes only the translated document(s) and the completed UCSF IRB Certification of Translation Form
- Note in the Modification Form that the modification is for the translated material only
Translating Study Documents — Minimal Risk Studies
Certified translations are encouraged for minimal risk studies, but not required by the IRB. Investigators may also request a consultation from the CTSI’s Research Action Group for Equity (RAGE) program if assistance is needed with translation.
- The Language Bank
- TransPerfect — email [email protected] for assistance
- Northwest Translations Inc
- All Language Alliance, Inc. Certified Medical Translation Services for Clinical Trials in All Foreign Languages
Translated ICF FAQs
Consistent with the expectation that the “short form” method for obtaining informed consent only be used for the occasional and unexpected enrollment of a non-English-speaking participant, effective December 15, 2021, the IRB implemented policy requiring that the Non-English Consenting Short Form method be limited to only two uses for any given language. Once the study team encounters a third participant speaking the same language, the Informed Consent Document must be fully translated to the language of the 3 non-English speaking participants.
What studies does the change apply to?
All active studies. FDA and OHRP guidelines are specifically applicable to studies with Federal oversight and/or Federal funding.
What is the effective date for requiring translated consents?
December 15, 2021.
This guidance applies for continuing participant visits. Once a fully translated consent document becomes available, participants who were initially consented using the short form method should be provided with the translated document at the next scheduled visit. Note: remote consenting methods of consent are acceptable for this process.
How should I complete the iRIS application for non-English speaking participants?
If more than 2 participants able to read the same foreign language are anticipated, check both the ‘Preferred Method’ and ‘Short-Form’ boxes under section 11.12 (NON-ENGLISH CONSENT METHOD). Update the text to say that participants speaking XX foreign language are anticipated and will be consented via the preferred method. All other non-English speaking participants will be enrolled via the short form method
If you do not anticipate enrolling more than 2 participants speaking the same foreign language, check the ‘Short-form’ box under section 11.12 and use the standard explanation: “If non-English speaking participants are enrolled, a qualified interpreter will be present (or the clinical team will use a telecommunication device (e.g., VMI, Video Visit, or speaker phone) at the time of consenting and at visits when toxicity assessments are done. Translated documents will be provided when available.”
What if I do not anticipate enrolling more than 2 participants speaking the same foreign language, but then a third participant is identified, and I want to approach them for consent?
If the screening window is short and consent is required immediately, you may consent using the short form method and then obtain a translated copy of the informed consent form. Once the translated copy has been received and approved by the IRB, then the translated ICF should be presented to all participants that speak the Non-English language once available. The participant must be asked to sign the consent and be given a copy. Documentation of the initial consent and presentation of the translated consent should be made in the participant’s study chart.
If there is flexibility in the timing of enrollment, a translated copy of the consent must be obtained prior to consenting the participant.
Workflows for IRB approval of non-English speaking participants, short-form and preferred methods are available on the IRB website: https://irb.ucsf.edu/consenting-non-english-speakers
Do I need to provide the translated copy of the ICF to participants 1 and 2 once participant 3 is consented with the fully translated consent?
Yes, all Non-English-speaking participants (that speak the same language) should have access to the translated version of the Consent form that they can read and refer to as the Research continues.
For active participants, once the consent document is translated:
- Provide the Consent document.
- Provide an opportunity for participants to ask new questions.
- Request that the participant sign the document.
- Study team files a copy of the signed document and sends copy to participant.
For multi-center studies, is each center allowed to consent 2 participants of the same foreign language before a translated consent is obtained?
Each center should follow their own institutional guidelines for consenting non-English speaking participants.
Do I need to get a consent amendment fully translated to reconsent the participant?
This depends on the non-English consent process indicated on your application form and whether there are 3 participants enrolled in the research that do not speak English but speak the same language. The short-form method may be used when there are only 1-2 Non-English-speaking participants. Alternatively, a Consent addendum should be translated to facilitate the re-consent discussion and documentation of the participant’s decision to continue in the research.
Additional guidance is available at the following links
Do I need to update the translated ICF if a consent amendment is required?
Yes, if you intend to enroll more non-English speaking participants in a specific foreign language. However, if you do not have the consent amendment translated yet and a participant needs to be enrolled expeditiously, you may use the translated consent and the short form method for the amendment. Be sure to document in detail what versions were used for the consent and how the participant was made aware of the amendment. Please provide a copy of the revised translated consent to the participant once it is obtained.
How do I know how many participants of each language have been enrolled at UCSF?
Study teams must maintain an accurate accounting of the participants enrolled in the research so that they may track the number of participants consented and the languages in which participants consent.
Where can the approved translated ICFs be found in iRIS?
In the ICF section (same location as the English consent). The consents will be labeled appropriately with the correct language.
How can I get the ICF translated?
Details on the translation and validation process, along with possible vendors are available on the IRB website: https://irb.ucsf.edu/consenting-non-english-speakers#translating . Study teams are not required to use the suggested vendors and may use any vendor as long as the requirements are met, including provision of a certificate.