5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

Last Revised: 11/12/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent for non-English speaking persons, or persons with additional needs or vulnerabilities participating in human subject research. For general considerations of informed consent see HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).


2.0 Policy

It is the policy of the Organization that:


3.0. Specific Protections and Requirements for Non-English Speaking Subjects


4.0. Specific Protections and Requirements for Visually Impaired or Blind Subjects


5.0. Specific Protections and Requirements for Hearing Impaired or Deaf Subjects


6.0. Specific Protections and Requirements for Illiterate or Low Literacy Subjects


Addendum A: Minimal Requirements for Translation of Informed Consent Documents

Translation of Consent forms into a language other than English must be performed by qualified persons, with adequate competence in English and the language of the translation, and preferably with knowledge of research methodology.

A. For research conducted solely within the Organization acceptable translation by a “qualified” translator includes, in order of preference:

  1. Translation provider by a translator certified by The American Translators Association (https://www.atanet.org/)
  2. Translation provided by a translator certified by any other non-profit organization, or Federal, State or Municipal government agency
  3. Translation provided by a professional translation service that will certify the accuracy of the translation
  4. Translation by a person deemed “competent to translate” and accompanied by a certification statement that the document translation is complete and accurate (see https://www.atanet.org/client-assistance/what-is-a-certified-translation/). A person deemed “competent to translate” includes (a) foreign language instructors employed by an accredited university or college; or (b) graduate students in foreign language currently in training at an accredited university or college; or (c) a bilingual person able to write in two languages with equal fluency (including members of the research team). For research involving greater than minimal risk (per 45 CFR 46.102(j)), translation by someone other than a certified translator (categories 1 and 2) or a professional service (category 3) must be accompanied by a back-translation by a different person or group, preferably of categories 1, 2 or 3. B. For Multi-institution research where the Organization is a participating site, translation must be accompanied by documentation that the translation was performed by a “qualified” individual, as defined above.

Addendum B: Minimal Requirements for Interpretation

Interpretation must be performed by qualified persons, who are fluent in both English and the language of the subject, and preferably with knowledge of research methodology.

Qualified interpreters include, in order of preference:

  1. A person holding certification by the National Board of Certification for Medical Interpreters, the Certification Commission for Healthcare Interpreters, or any similar credentialling body, or certified by any other non-profit organization, or Federal, State or Municipal government agency.
  2. A person employed by, or contracted by, the Organization to provide interpretation services in a clinical context. This includes commercial interpretation services (such as CyraCom).
  3. UNMC, Nebraska Medicine, CH&MC, BMC, UNO or study site staff who are fluent in both English and the language of the subject.
  4. Study personnel who are fluent in both English and the language of the subject.
  5. Other persons, including (a) foreign language instructors employed by an accredited university or college; or (b) graduate students in foreign language currently in training at an accredited university or college; or (c) a bilingual person; specifically, a person using or able to speak in two languages with equal fluency.

If a prospective subject wishes to designate his/her own interpreter, a Qualified Interpreter must also be present to ensure the quality and accuracy of the interpretation. A minor cannot be used as an interpreter.


DOCUMENT HISTORY:

 Written: 11/2/2022

 Revised: 1/27/2023 - updated hyperlinks for HRPP references 5.1, 5.3, and 5.5.

 Revised: 3/7/2023 – deleted requirement for signature of interpreter when obtaining informed consent using a translated ICF (section 3.1.1.4); revised Addendum A to explicitly state use of a profession translation service is acceptable.

 Revised: 2/7/2024 – add use of Short form to section 4.4.1.

 Revised: 11/12/2024 – allowed for recording or employee number of interpreter (rather than name) (section 3.1.6); revised numbering.


Revision #15
Created 9 November 2022 18:39:42 by Robert A Lewis
Updated 17 April 2025 16:06:26 by Robert A Lewis