Interpreter Services
Researchers may seek to enroll research participants who do not fully comprehend written and/or verbal communication about a study because of:
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- limited English proficiency (LEP)
- Illiteracy or low literacy, such as a reading level below the language used in study documents
- vision impairments, and/or
- hearing impairments
Recruitment of clinical research participants can be a complex process and many research staff have expressed interest in additional training and resources surrounding best practices and approach to utilizing language services.
Utilization of language services will allow University of Minnesota researchers to enroll more participants who do not speak English proficiently, and help to ensure that access to research studies is equitable. It is not ethical to systematically exclude participants with low English proficiency, especially when participation in a study may have direct benefits to potential participants.
To assist researchers and their teams, the Research Office (in partnership with MHealth Fairview Research Administration, CTSI and the IRB) put together a resource handbook, training seminar, and slide deck for utilizing interpreter services in research.Â
Note: The seminar and slides were prepared when the Covid-19 pandemic emergency orders were in place. The attestation model is no longer an IRB approved method for virtual consenting processes.
HELPFUL RESOURCES
MHealth Fairview Interpreter Services
- Cost: No cost to study if the research visits is taking place at a MHealth Fairview-managed facility.
- Fairview Limited English Proficiency Policy
- Fairview Communication Disabilities Policy
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If you have further questions about utilizing Fairview Interpreter Services:
- Contact Fairview directly at interpreterscheduling@fairview.org or call 612-273-3780, option #2.
- You may also contact Fairview Research Administration with and other questions research@fairview.org.Â
Contracted Vendor Interpreter Services
- Cost: Link to Service Rates.
- Service Agreement Required.
- More information on how to set up a service agreement - coming Summer 2024Â
UMN IRB Guidance and Worksheets
- Please consult the IRB website toolkit library for manuals, SOPs and worksheets
- If you have further questions about policy related to documentation or consenting processes, connect with a UMN IRB representative by scheduling a 15-minute consultation or by emailing them directly at irb@umn.edu.
Applicable Federal Regulation and Guidance
FDA Regulations:
Guidance
- A Guide to Informed Consent (relevant sections: “Non-English Speaking Participants” and “Illiterate English-Speaking Subjects”)
OHRP/Common Rule
- Regulations - 45 CFR 46.116(a)(3), 45 CFR 46.117(a)
- Guidance -Â Informed Consent of Participants Who Do Not Speak English (1995)
- Informational videos – About Research Participation (available in English and Spanish, with subtitles)
- Federal nondiscrimination provisions
- Americans with Disabilities Act (ADA)
- Affordable Care Act (ACA) – 45 CFR 92
*Recorded when Covid-19 pandemic emergency orders were in place. The attestation model is no longer an IRB approved method for virtual short-form consenting processes.