Consenting Non-English Speakers

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 Document". The Experiemental Participants Bill of Rights (for applicable studies) is also provided in the participants preferred 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

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)

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:

Hint: The participant and person obtaining consent sign the document that they each understand – that is, the participant signs the Short Form Consent Document in their native language and the person obtaining consent signs the English consent form.

Short Form Method FAQs

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:

Step 1. A qualified interpreter helps present the revised consent information and facilitates the consent discussion

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.

Step 2. The participant signs the Short Form Consent Document in the participant's language.

In addition to the oral presentation, the participant must sign a Short Form Consent Document translated into a language in which the participant is fluent. 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.

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

Working Effectively with 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.

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. Certified translations are required for all Greater than Minimal Risk Studies and Minimal Risk Studies.

The UCSF IRB strongly supports efforts to increase research participation among diverse populations. Study teams may utilize translation companies to translate study documents. Request a certification of translation from the translation company so it can be included in the IRB submission when you submit the translated documents. 

To provide study teams with an additional option and flexibility for translating study documents, the IRB  permits study teams to translate their own documents for greater-than-minimal-risk and 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.

• 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 policy to support earlier access to studies for non-English speaking participants
• This policy provides study teams with flexibility, cost reduction and efficiency
• This policy 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

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.

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.

• FDA Guidance for Institutional Review Boards and Clinical Investigators “Non-English-Speaking Subjects”
• OHRP Guidance: “Informed Consent of Subjects Who Do Not Speak English (1995)”

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: /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:

1. Provide the Consent document.
2. Provide an opportunity for participants to ask new questions.
3. Request that the participant sign the document.
4. 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

• Re-Consenting Non-English Speakers (Preferred Method)
• Re-Consenting Non-English Speakers- Short Form Method

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: /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.