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IRB Application Instructions International, Non-English, Foreign Culture [F1.0500]
International Research
Human subjects outside of the United States who participate in research projects should receive an equal level of protection as research participants inside the United States. If you will conduct research at an international location, identify and describe:
- relevant local regulations
- data privacy regulations
- applicable laws
- ethics review requirements for human subject protection
To identify applicable ethical or regulatory requirements, consult the country listing from the OHRP International Compendium or NIH ClinRegs.
OHRP: International Compendium
If the project has been or will be reviewed by a local ethics review board, attach a copy in the “Additional Information/Materials” section of E-IRB.
UK International Travel Policy
All UK students (including graduate and professional) and employees traveling internationally for a UK purpose are required to register their travel with the UK International Center. UK students are prohibited from traveling to higher-risk destinations without review and approval from the University’s International Health, Safety & Security Committee. For more information, contact the Director of Global Risk and Strategic Operations, Jason Hope.
Recruiting Non-English Participants or Subjects from a Foreign Culture Cultural and Language Consultants
Translated Documents
If you are recruiting non-English speaking subjects, the consent document needs to be in the subject’s native language. Use the applicable model consent template provided on the website and in the "All Templates" option on the left-hand menu of your E-IRB application as a guide for developing the consent document. Spanish versions of informed consents and HIPAA authorization documents are available.
If you are recruiting subjects from a foreign culture, or subjects for whom English is a second language, you may be required to develop a plan for evaluating the level of English comprehension and the threshold for providing a translation, or explain why an evaluation would not be necessary.
Attach both the English and translated consent documents in the “Informed Consent" section.
Consent Process
Describe the process for obtaining informed consent, including plans for interpreters as needed. While the IRB considers interpreter fit on a case-by-case basis, facilities may have specific interpreter policies.
- UK Healthcare Policies: For information on document translation and use of interpreters for UK HealthCare patients, please contact the Language Service Coordinator, Sarah Hesler, or call (859) 218-0455.
Cultural/Language Consultant
If you are recruiting non-English speaking subjects, and/or subjects from a foreign culture, include contact information for someone who can act as a cultural consultant for your study. The person should be familiar with the culture of the subject population and/or be able to verify that translated documents (if applicable) are the equivalent of the English version of documents submitted. The consultant should be able to provide comments/suggestions for the IRB regarding consent procedures and the appropriateness of the research for the culture. The consultant should not have any direct involvement with the study.
Note: The Office of Research Integrity does not have resources to compensate consultants; consultants are asked to provide such services on a voluntary basis by donating their time. Any consultant identified by an investigator should be made aware of this when agreeing to provide services. Please contact staff in the Office of Research Integrity for additional guidance, if needed.
If you do not know someone who would be willing to act as your cultural consultant, the Office of Research Integrity will try to find someone to fill this role (this may delay the approval process for your protocol). Please include the name, address, telephone number, and email of the person who will act as the cultural consultant for your study.
Application
If you are proposing research that involves non-English speaking subjects or subjects from a foreign culture, mark "yes" to the question "Does your research involve Non-English Speaking Subjects or Subjects from a Foreign Culture?" at the end of the Research Description section in your E-IRB application.
[D158.0000] Incidentally Encountering a Non-English Participant or Subject from a Foreign Culture (Short Form Process)
Fair selection is a regulatory criterion for IRB approval. While non-English speaking participants should not be routinely excluded from research offering potential benefit, their enrollment requires time, effort, and financial cost, typically borne by the researcher.
The short form process is a regulatory option when not targeting or anticipating non-English speaking individuals, but one is incidentally encountered. It may be especially useful when the research offers a potential benefit to the participant. The process allows the IRB to approve enrollment of individuals with limited or no English proficiency, provided resources are available to communicate effectively with the participants during the recruitment process, while obtaining consent, and for the duration of the study.
Short Form Consent Process
A short form consent process may be used when a potential participant does not speak English, and there is not enough time or resources available to translate the English version of the approved consent document into a language the potential participant understands. The short form is provided in the language the participant understands as a summary of what will be discussed verbally with an interpreter. It also documents that the elements of informed consent, as required by the Department of Health and Human Services (HHS) and the Federal Food and Drug Administration (FDA), have been presented orally to the participant and/or the participant's legally authorized representative (LAR).
Short forms and stand-alone HIPAA Authorizations, translated in several languages, are available on the UK Office of Research Integrity (ORI) website. In the IRB application, check the non-English speaking on the subject demographic section and describe your proposed consent process in the Research Description. Include the applicable translated short form(s) with your IRB submission. Attach as a “consent document type” form to receive the IRB approval stamp. If you need a form in a language that is not currently available as a template, you must have the English short form and HIPAA Authorization translated into the applicable language and then approved by the IRB prior to use.
Short Form Consent Parties
Enrolling a non-English speaking participant with a short form generally involves the following:
- The participant (and/or the participant’s LAR, if applicable),
- The study personnel obtaining consent,
- An interpreter (might not be needed if the person obtaining consent is fluent in the respective language),
- A witness to the oral presentation.
An interpreter
After the interpreter presents the short form to the potential participant, the study personnel obtaining informed consent presents the IRB-approved English version of the consent form while the interpreter orally translates the information to the participant or participant’s LAR.
The investigator may propose, and the IRB may consider who would be qualified to serve as an interpreter, given the context of the research and applicable facility requirements. In some cases, study personnel fluent in both English and the non-English language would be available to conduct the oral process. Family members may be adequate for non-technical or minimal risk research. However, they may not be best suited if potentially biased, or if not familiar with complex research or medical terminology. Also, physical facilities in which the research will take place may have specific policies on who may serve as an interpreter (e.g., UK Healthcare). Ensure you are aware of and compliant with all applicable facility-based requirements.
A study personnel obtaining consent
Study personnel authorized to obtain informed consent verbally present the English informed consent with the assistance of the interpreter. The process should incorporate standard efforts such as dialogue to determine participants’ key concerns and teach back to ensure understanding. If the participant does not clearly understand the information presented, consent will not be truly informed.
A witness
The role of the witness in this situation is to verify that the oral consent process took place in the participant’s (or LAR’s) language. The witness must be impartial and independent of the study team, such as a family member of the participant or a hospital staff member who is not part of the study team. The witness should have enough proficiency in the language to be able to attest to the adequacy of the verbal process and voluntariness of the participant. Also, if the interpreter is present for the process in person or by video conference, the interpreter may also serve as the witness. If the interpreter takes part by phone, use a separate witness.
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Signatures
If the participant agrees to be in the study:
- The English version of the full IRB-approved consent form is signed and dated by both the person obtaining informed consent and the witness.
- The short form is signed and dated by the participant (and his/her/their legal authorized representative (LAR), if applicable), and the witness. The interpreter does not have to sign unless they are also acting as the witness. However, the investigator should document who served as the interpreter for reference.
- The translated stand-alone HIPAA Authorization (if applicable) is signed and dated by the participant. The person obtaining consent then prints his/her/their name and dates the stand-alone HIPAA Authorization.
- The study personnel obtaining informed consent provides the participant with a copy of the fully executed short form consent and the full IRB-approved consent document (and HIPAA Authorization, if applicable).
Short Form Use Limitation
A short form may be used up to five times in the same language. Generally, if a sixth participant is to be enrolled, the entire IRB-approved English consent form must be translated. The fully translated consent form must then be submitted as a Modification Request and approved for use by the UK IRB before being used to consent a participant. After the translated consent form is approved, any previous participants still active in the study may need to be re-consented with the approved translated consent form, as deemed appropriate by the IRB.
Additional Actions Post-Enrollment
For FDA clinical investigations with complex or long-term interventions, the investigator should obtain a translated version of the standard IRB-approved consent for the subject’s ongoing reference. All studies should provide interpreter services throughout as needed.
Short Form Templates
Stand-Alone HIPAA Authorization Templates
Short Form Consent Process Overview
2023 FDA Guidance
FDA "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors"