Enrolling Non-English Speaking Subjects
In accordance with ethical principles that guide human subject research conduct, research must be designed to enroll a diverse population that is representative of those who will be impacted by the results of the research.
Nevertheless, the decision to enroll non-English speaking subjects into research should not be taken lightly; investigators must ensure they understand and have a process for meeting the requirements for enrolling non-English speaking subjects.
Deciding to enroll non-English speaking subjects
Investigators must give careful consideration to how they will communicate with non-English speaking subjects throughout the entire lifecycle of the research.
impact of language barriers
Enrolling subjects when a language barrier exists can impact:
- A subject’s ability to make an informed and voluntary decision about initial and continued study participation, as well as the study team’s ability to assess the subject’s comprehension of the information provided during the consent process.
- Data collection procedures, particularly when data is collected via subject-completed measures such as questionnaires, surveys, diaries or assessments.
- A subject’s ability to follow tasks, procedures and/or investigational product instructions.
- The identification, assessment, management and follow-up of adverse events and unanticipated problems.
- The ability of both the study team and subject to ask and/or answer questions.
- The study budget (e.g., costs related to translation services).
informed consent
When/if an investigator decides to enroll non-English speaking subjects, it’s important to bear in mind that applicable ethical principles and federal regulations (45 CFR 46.116; 21 CFR 50.20) concerning the informed consent process must still be met. The informed consent process must:
- Provide enough information for a reasonable person to make a decision about participating;
- Provide the information in a manner that is understandable to the potential subject (i.e., the subject’s primary/native language);
- Provide sufficient opportunity for the subject to consider participation;
- Present the information in a manner that is free from coercion and undue influence;
- Document subject consent via written signature on an Institutional Review Board (IRB) approved consent document (unless waived); and
- Provide the subject a copy of the signed consent document.
document translation
Consistent with the obligation to provide information in a manner that is understandable to the potential subject, OHSP Policy 701: Informed Consent requires investigators to translate all consent documents, subject-completed forms (i.e., questionnaires, surveys, diaries, assessment forms), and any other relevant subject materials (e.g., recruitment materials, instructional or educational forms) into the primary language of the study population.
All translated documents, and accompanying translator declarations, must be submitted to the Research Subjects Review Board (RSRB) for approval prior to use (reference additional process details below).
Short forms
In the event a non-English speaking subject presents unexpectedly and is eligible for participation in research involving treatment, the RSRB may permit the one-time use of a ‘short form’ for obtaining informed consent.
When a ‘short form’ is utilized to obtain informed consent, the elements of consent (identified in the English version of the consent document) are presented orally to the non-English speaking subject via interpreter. The subject then documents their consent to participate on a translated ‘short form’ consent that indicates that all elements of consent were presented.
After the subject is enrolled, the full consent document and all relevant subject-completed forms and materials must be translated as above.
Translation ≠ interpretation
While translating written documentation is an essential part of the enrollment process, it does not solve all communication barriers. Study teams must also consider how they will communicate orally with non-English speaking subjects throughout the study. Routinely, this is accomplished through the use of an interpreter who is fluent in English and the subject’s primary language.
- Study teams should not rely on family members or friends of the subject to interpret conversations.
- Study teams should document the use of an interpreter in the study records (on all occasions), including the name of the interpreter, method of interaction [e.g., in-person, via phone or video-conferencing], nature of the information provided via interpreter and verification that answers were provided to the subject’s questions.
- The study team should continue to use interpreters throughout the course of the research to provide continued oral communication, including, but not limited to, during study visits, study procedures, follow-up and when/if re-consent is required.
For benign, minimal risk research, a study team member fluent in the subject’s primary language may act as an interpreter and/or translator, provided their level of fluency supports meeting the ethical and regulatory requirements identified above.
However, as research becomes more complex and/or involves greater risk, professional interpreters should be utilized to interpret verbal exchanges and/or translate study documents. This is particularly important for interventional biomedical research, given the nature of the information that may need to be communicated.
Reference information on interpreter services available within the University of Rochester Medical Center and Highland Hospital.
Note:
- If the study protocol defines parameters concerning who may act as an interpreter and/or translator, these parameters must be adhered to.
- When/if a study team member acts as an interpreter and/or translator, documentation that reflects their fluency should be maintained in the study records, e.g., a resume or curriculum vitae that indicates their fluency and skill level (e.g., Spanish – Native; Spanish – Fluent; or Spanish – Conversational).
RSRB requirements ≠ Reviewing IRB requirements
In consideration of the requirements and best practices described here, bear in mind that study teams utilizing an IRB external to the RSRB may be held to different requirements/standards. Per OHSP Policy 504: IRB Reliance and Collaborative Research, investigators and research staff are required to adhere to the Reviewing (External) IRB’s policies and procedures. As such, when presented with the opportunity to enroll a non-English speaking subject, study teams are encouraged to contact the Reviewing IRB to ensure they have an adequate understanding of how to remain in compliance.
Enrolling subjects via fully translated RSRB-approved documents
Note: This process must be repeated every time re-consent and/or written notification to subjects is required when the research is modified.
Obtain RSRB approval for the English version of all documents that require translation.
Generally, it is recommended that investigators first obtain RSRB approval of the research and then, following approval, submit a modification to obtain approval for the research to include the non-English speaking population and all translated documents.
Translate all necessary documents (consent document and all relevant subject-completed forms).
A translator’s declaration should be obtained from the individual providing the translated documents, confirming the translation is true, accurate.
Submit a modification to the RSRB that includes: a) clarification of eligibility criteria (as necessary); b) submission of all translated documents; and c) submission of the completed translator’s declaration.
- On the Modification Information page, upload the translator’s declaration in the ‘Attach Files’ field.
- On the Local Site Documents page, upload all translated documents into their respective sections (e.g., translated consent forms should be uploaded in the ‘Consent Forms’ field, translated recruitment materials should be uploaded in the ‘Recruitment Materials’ field, etc.).
Following approval of the modification, non-English speaking subjects may be enrolled.
At the time of consent:
- Utilize an interpreter to relay the consent discussion, as facilitated by the study team member obtaining consent (inclusive of general consent discussion, assessment the subject’s comprehension of the information, responses and clarification to subject questions, verification of the subject’s willingness to participate in the research and any optional study activities).
- Ensure the subject has adequate opportunity to read the translated consent document and consider participation.
- Ensure all questions are answered.
- To document consent:
- The subject signs and dates the watermarked, translated consent document and completes all checkboxes/initial lines, as applicable.
- The study team member who obtained consent signs and dates the watermarked, translated consent document as the person obtaining consent. As good practice, the study team member should also provide narrative documentation of the consent process, describing the sequence of events including what information was reviewed, who was present, how the interpreter was utilized, how much time the subject was given to consider participation, whether the subject comprehended the information and confirmation of their agreement to participation. Narrative documentation can be provided directly on the consent document or as a separate note in the subject file.
- The interpreter signs and dates the watermarked, translated consent document as a witness. If a signature block has not been included for the interpreter, the interpreter should print, sign, identify themselves at the interpreter and date their name below the person obtaining consent signature.
- Provide a copy of the signed consent document to the subject.
Enrolling subjects via short form consent
Note: Utilization of the short form is only permitted at the time of initial enrollment. The process described above for full translations, must be repeated every time re-consent and/or written notification to subjects is required (e.g., due to modification).
Upon identification of a non-English speaking subject, contact your IRB Coordinator to confirm that use of the short form is permissible.
Submit a modification to request approval of the short form translated into the subject’s primary language.
- All translated short forms, including the translated short forms linked below, must be revised to include the study title, investigator, investigator contact information, Click IRB study number and version date.
- Translated short forms are available in Spanish, Russian, and Mandarin via OHSP Templates.
Following approval of the modification, the non-English speaking subject may be enrolled.
At the time of consent:
- Utilize an interpreter to:
- Read the contents of the English version of the consent document to the non-English speaking subject; and
- Relay all further consent discussion, as provided by the study team member obtaining consent (inclusive of general consent discussion, assessment of the subject’s comprehension of the information, responses and clarification to subject questions, verification of the subject’s willingness to participate in the research and any optional study activities).
- An adult witness, fluent in both English and the subject’s primary language must be present during the consent discussion.
- The witness must be independent of the study team.
- Ideally, the witness should not be a friend or family member of the subject, as the friend or family member’s role is in support of the subject’s decision-making process.
- Ideally, the interpreter should not serve as the witness, as they are part of the consent process (not just observing it). If another witness is not available, the interpreter may serve as the witness provided they are present during the consent discussion and are not a member of the study team.
- The nature of this process requires that even more focus be placed on the consent discussion, as there is no translated document for the subject to read. Ensure the subject has adequate opportunity to read the translated short form and to re-review each of the points laid out in the document when considering participation.
- Ensure all questions are answered.
- To document consent:
- The subject signs and dates the watermarked, translated short form consent document.
- The study team member who obtained consent signs and dates the watermarked, English version of the consent document as the person obtaining consent. As good practice, the study team member should also provide narrative documentation of the consent process, describing the sequence of events including what information was reviewed, who was present, how the interpreter was utilized, how much time the subject was given to consider participation, whether the subject comprehended the information and confirmation of their agreement to participation. Narrative documentation can be provided directly on the consent document or as a separate note in the subject file.
- The witness signs and dates the watermarked, translated short form consent document and the English version of the consent document.
- Provide copies of the signed translated short form and signed English version of the consent document to the subject.
- Submit a translated version of the full consent document and all relevant subject-completed forms as described above.
- Upon approval, a copy of the translated consent should be provided to the subject.