Non-English Speaking Participants

Overview:

This guidance provides information on methods to be used to obtain the informed consent of human subjects who are unable to comprehend the English language.

When enrolling non-English speaking research subjects, investigators must have a plan to manage communications with the participant during all phases of study participation.  This extends beyond recruitment, the consent process and initial enrollment, to include study visits as well as possible unexpected phone calls or follow-up questions. It is not necessary for the details of this comprehensive communication plan to be summarized in the OSIRIS application. However, it is the investigator’s responsibility to be fully prepared to communicate with all participants during any phase of the study.

Definitions:

  • Back translation: process of translating written materials from one language to another and then, in a separate process, translates the document back into the original language.  This process is performed to evaluate the quality and integrity of the information being translated.
     
  • Certified Translator: a professional translator who has successfully completed a certification program or exam providing them with certified translator credentials
     
  • Interpreter: person who accompanies researchers, in real time, to convey verbal information to another person in their native language
     
  • Medical Interpreter: an interpreter who is familiar with medical terminology
     
  • Non-English speaking: unable to comprehend English language
     
  • Translator: person who converts written materials from English to another language
     
  • Witness: an individual who is fluent in both English and the necessary foreign language who will be physically present during the consent process to observe the process and sign consent forms

Exempt Studies Utilizing an Introductory Script

By definition, “exempt” research is exempt from the requirement for a signed consent form. Nevertheless, the ethical principles listed in the Belmont Report, particularly the discussion of the first principle, respect for persons, emphasizes the importance of ensuring that subjects are fully informed about the nature of the research project so that they can make an informed decision to participate or not. An Introductory Script provides this type of information.

Chronological steps when submitting an Exempt protocol:

  1. Submit the English version of the Introductory Script and any other documents participants will interact with during the course of their participation in the study.
  2. When the IRB initially approves your protocol, the approval letter will state that foreign language documents cannot be used until submitted to and approved by the IRB.  
  3. Submit the IRB approved English-language documents to a translator for translation and have them sign a translator certification form. Exempt studies do not require back translations. To determine who can act as Translator, see Table 2 below.
  4. Submit the translated documents and signed translator certification form to the IRB using the ‘Send Comments to IRB Staff’ function within OSIRIS.
  5. Wait for the IRB to respond indicating the documents have been accepted and can now be used.

Additional Considerations:

Some study designs may benefit from the addition of an Interpreter as well (i.e. focus groups, interviews). If you plan to use an Interpreter during the course of the study this should be described in the OSIRIS application. To determine who can act as Interpreter, see Table 3 below.

Expedited and Full Board Studies Obtaining Written Informed Consent

Federal regulations (45 CFR46.116 and 21 CFR50.20) require that researchers obtain the legally effective informed consent of the research subjects or their legally authorized representative (if they are not able to consent for themselves). As a consequence, all information provided to potential subjects should be in a language that is understandable to those individuals.

The Belmont Report identifies "justice" and "respect for persons" as two fundamental ethical principles that must underlie the conduct of all human subjects research.

  • The principle of justice requires tht the burdens and benefits of research arer equitable distributed and calls for "...fair procedures and outcomes in the selection of research subjects."
     
  • The principle of respect for persons requires that "adequate standards for informed consent are satisfied" so that potential subjects are provided with sufficient meaningful information to decide whether they want to enroll in a research study.

Federal regulations (45 CFR46.117 and 21 CFR50.27) identify two means by which this requirement can be met:

  • Method 1 - Written Translation of IRB-Approved Documents
    • Use of a consent document that is translated into a language that is understandable to the potential subject (or their legally authorized representative) -OR-
       
  • Method 2 - Use of Short Form & Exception Request
    • Use of an IRB-approved "short form" consent document, written in a language that the person understands and that is combined with an oral presentation of the English version of the consent document using an interpreter.
    • Submission of Execption Request

Method 1: Written Translation of IRB-Approved Documents

This method should be used when the study specifically plans to target the enrollment of non-English speaking participants.

If the study design explicitly targets the enrollment of non-English speaking subjects, investigators are required to provide a written translation of relevant study documents (see list below) in a language understandable to those participants. Documents should first be submitted to the IRB in English, and once approved, be sent to the translator. Refer to Table 1 below to determine whether your study requires a certified translator and/or back translations. A Modification should then be submitted to provide the translated documents. It can be very costly if documents are initially submitted to the IRB with the foreign translations and then changes are requested during IRB review, thus requiring an additional translation.  

Chronological steps when submitting Method 1:
  1. Submit the English version of the consent form and other relevant study documents in your IRB application
  2. Once IRB approval is obtained, submit the approved documents to the translator (see Table 1 below to determine whether your study requires a certified translator and/or back translations)
    • Back Translation (see definition above) is required for Expedited submissions involving clinical procedures and all Greater Than Minimal Risk designated studies
    • It is the investigator’s responsibility to ensure that the back translation is an accurate representation of the IRB approved English documents.
  3. Submit a Modification to the IRB for approval of the following:
    • Translated foreign language documents with the foreign language identified in the document title. (See instructions below to upload into the IRB application)
    • Signed Translator Certification form
    • Back Translations, if required

Consent Process, Signatures and Documentation for Method 1
  • The consent process must consider how researchers will effectively communicate with potential participants to obtain informed consent. Item 4.12 of OSIRIS must address how communication during the consent process will be handled (e.g. investigator or staff is fluent in foreign language, use of an interpreter, use of visual aids or demonstrations to enhance communication and understanding)
  • A study team member approved to obtain consent and participant sign the consent form after all participant questions and concerns have been satisfactory addressed. Refer to Chapter 13, Obtaining Consent, in the IRB Policies and Procedures.
  • Interpreter may interact in person, by phone or video-conferencing and does not need to sign the consent form
Documents that must be translated and where to upload in the IRB application for Method 1:
  1. All documents that will be used to interact with participants
    • Verbal consent scripts (4.6.3)
    • Written informed consent documents (4.9)
    • Assent forms (4.9)
    • Information sheets (Supporting Documentation)
    • Recruitment materials (4.1)
    • Surveys/questionnaires/interview guides (2.8)
    • Instructional materials (Supporting documentation)
    • Other documents as requested at the discretion of the IRB
       
  2. Any correspondence relating to documentation of regulatory and/or policy requirements
    • Foreign Ethics approval letter (2.19.1)
    • Site Permission letter (CS15.0 and 2.19.1 if applicable)
    • Communication from a foreign entity or regulatory body (2.19.1)
    • Other documents as requested at the discretion of the IRB
       
  3. All translator certifications and back translations
    • Signed Translator Certification form (3.4.1 and/or 2.19.2.1 if applicable)
    • Back Translations (3.4.1 and/or 2.19.2.1 if applicable)
       

Method 2: Use of a Short Form & Exception

This method is used when the approved study does not specifically plan to target the enrollment of non-English speaking subjects. However, unexpectedly, a non-English speaking subject meets enrollment criteria and wishes to participate. Given the unexpected nature of this situation and the steps that must be taken to prepare for this type of alternative consent process, it is not always possible to obtain consent on the same day a potential non-English speaking participant is identified.

Short Form consent forms are “generic” research consent forms that have been translated into multiple common languages and are limited to the basic elements of consent. When no IRB-approved study consent form is currently available in a participant’s language, the use of a written Short Form consent, along with an oral presentation of study-specific details, is permitted. Additional steps that must be taken by an Investigator using this method, includes submitting an Exception Request in OSIRIS to prospectively deviate from your approved IRB protocol, to now enroll a non-English speaking participant. The investigator must await the IRB’s approval of this Exception Request prior to obtaining consent.

Note: If at any point the study transitions to planning the enrollment of subjects that speak a particular non-English language, the IRB application must be modified and translated documents must be submitted (see Method 1 above) before enrollment of these individuals can begin.

Selected “Short Forms” are available in several languages on the IRB website. As mentioned above, short form consents are only available in some common languages, not all languages are available. (Note, the short forms have been temporarily removed from the IRB website to re-organize them. If you need a short form while they are temporarily unavailable please contact askirb@pitt.edu for assistance).

The IRB will go to additional lengths to assist investigators in trying to locate a short form consent in the language needed. However, if a short form consent in the necessary language cannot ultimately be located, the participant cannot be enrolled in the study using Method 2. If the study team still desires to enroll the non-English speaking participant for which no short form is available, they must then transition to using Method 1 outlined above.

Chronological steps when submitting Method 2:
  1. Locate the Short Form in the language needed
     
  2. Find an interpreter who:
    • Is not a family member of the participant
    • Is not a member of the study team
    • Reads, speaks, and writes the native language of the participant and English
    • Can be physically present for the consent process
      Note: Bilingual clinical staff who are not a member of the research team are permitted to act as an interpreter
       
  3. Find a Witness to the oral presentation who:
    • Reads, speaks, and writes the native language of the participant and English
    • Is not a member of the research team
    • Can be physically present for the oral presentation of the study-specific details
    • Willing to sign and date the "Short Form" consent
    • Willing to sign and date the IRB-approved English version of the consent form
      Note: The Interpreter is permitted to act as the Witness
       
  4. Prepare a written summary of the study-specific details that will be orally communicated to the subject by the Interpreter
    Note: The IRB-approved English language consent form may serve as this summary and the IRB encourages the use of the approved consent to serve this function.
     
  5. Submit an Exception request for IRB approval
    • Go to the study workspace
    • Click on the "New Exception" button located on the bottom left side of the page
    • Address the questions
    • After reviewing the Exception request, the Principal Investigator (PI) click on the "Submit" button displayed under My Activities
      Note: Only the PI is permitted to submit the request
    • Await notification that the IRB has approved the Exception request
Consent Process, Signatures, and Documentation for Method 2
  • Participant reads the "Short Form" consent in their native language
  • Interpreter presents the oral version of the IRB-approved English consent form (or written summary of study-specific details if the Investigator has decided not to use the IRB-approved English consent form to meet the oral presentation requirement)
    • A study team member, who is approved to obtain consent, must be present for this presentation.  Refer to Chapter 13, Obtaining Consent, in the IRB Policies and Procedures.
    • If the Interpreter is not also acting as the Witness, the Witness must be present during this presentation as well
    • The Interpreter facilitates participants asking questions and study team members providing answers, to ensure participant understanding
  • When all of the Participant's questions and concerns have been addressed, the Participant signs and dates the "Short Form" consent document
  • The Witness signs and dates the"Short Form" consent and the IRB-approved English consent form
  • The Study team member approved to obtain consent signs and dates the IRB-approved English consent form
  • The Participant receives copies of both consent forms.  If the study is FDA regulated, the participant must receive signed copies of both consent forms.
  • The Study team member retains the signed/dated copies of both consent forms for study records
  • The Study team member documents in the research record the names of all individuals who were present for the consent process
     

Information at a Glance

   Table 4: Is the Interpreter required to be physically present during the Consent Process?

Frequently Asked Questions

Where can I find a Translator or Interpreter to hire?

  • The IRB does not endorse or recommend any specific translator or interpreter services.
  • For research studies that do not require a certified language professional, many researchers have had success directly contacting the corresponding foreign language department at the University of Pittsburgh to identify an individual who has the language skills needed. For a list of foreign language departments  at Pitt and their contact information please see: https://www.ucis.pitt.edu/main/foreign_language
  • If your study requires a certified language professional, please first contact your Department Administrator to determine if your department has a preferred service provider. If your Department Administrator is unable to assist you, please contact Panther Express for assistance at 412-624-3578.

Once I have submitted an Exception request under Method 2, how long should I expect to wait before receiving approval of the exception?

  • In order to insure Exception Requests are reviewed in a timely manner, please call the IRB at 412-383-1480 as soon as you submit your Exception request in the OSIRIS system.
  • IRB approval of exception requests are generally granted within 1 business day of the IRB receiving them. If approval is needed sooner, please indicate this in the Exception Request itself.

What if my study does plan to target the enrollment of non-English speaking participants but, the languages participants will comprehend cannot be identified in advance?

  • The Federal regulations (45 CFR 46.117 and 21 CFR 50.27) identify two means by which legally effective informed consent of a research subject or their legally authorized representative can be obtained when participants cannot comprehend English. Those methods are identified above as Method 1 and Method 2 respectively. You must use one of the above Methods to meet this Federal requirement. The study team must decide which method they will use and follow all corresponding steps related to that method. If you have additional questions about which Method to use, please contact askirb@pitt.edu.
     

Additional Information:

 

version 4.26.2016