Section XI:

Informed Consent

WPP #: XI-5

Title 5:

Enrolling Research Subjects with Limited English Proficiency (LEP)

Effective Date:

3-24-15

Revision History:

6-21-06; 09-04-09

Policy Statement

Research participants with Limited English Proficiency (LEP) include any person who is not fluent in English. To ensure equitable selection of research subjects, investigators should provide an opportunity for LEP individuals to participate in research when appropriate. Involving LEP individuals in research requires that all aspects of a study be conducted in a way that ensures the ability to fully and safely participate, including carrying out the informed consent process so that LEP individuals have a complete understanding of the risks and benefits to participation and are able to complete all other study activities in an understandable language.

Background

The IRB may only approve research where selection of subjects is deemed to be equitable, taking into consideration the purposes of the research and the setting in which the research will be conducted [46 CFR 111(a)(3); 21 CFR 56.111(a)(3)]. In order to meet the IRB approval criteria of equitable subject selection, if possible, LEP individuals should not be excluded from research that may have potential benefits.

Research that offers the possibility of direct benefit, such as treatment studies that target serious or life-threatening conditions, should make the greatest effort to ensure the research is available equitably, without excluding individuals unnecessarily. When research is greater than minimal risk without the prospect of direct benefit, the exclusion of LEP subjects may be justifiable. Additionally, in some situations, the instruments used in the research cannot be translated to multiple languages or are not validated in other languages, making it impossible to conduct the research in any language other than English.

When there is not adequate justification for excluding LEP individuals from research, it is essential that informed consent be obtained from prospective subjects in a manner and language that they can understand.

Guidance and Procedures

  1. Informed Consent Process for LEP Research Participants

    To ensure that LEP participants have a clear understanding of the consent document and have the opportunity to ask and receive answers to questions, the informed consent process must be conducted in a language that is understandable to them. When enrolling a LEP participant, there are two options available for obtaining written consent.

    Translated Consent Documents:
    If the targeted population is anticipated to include 5% or more of LEP subjects, investigators should include translated consent forms and documents with their protocol, as well as a plan for continued communication with the LEP subjects.

    The consent form must be submitted to the VCU IRB either with the initial submission or as an amendment submission. An English language document should also be submitted with the translated document. It is strongly recommended that documents be submitted in English first, and once the English language documents are approved by the IRB, translated documents can be submitted via an amendment.

    When planning to involve participants with LEP, researchers should ensure that the following items are considered and addressed within the protocol:

    • Risks of participation during the course of the study (including the added risks associated with having LEP) are balanced with the anticipated benefits.
    • Clearly describe how persons with LEP will be identified and recruited for the study and how the research team plans to interact with LEP participants during the consent process and throughout the conduct of the study.
    • Clearly describe how the initial informed consent process will be handled and whether there will be a qualified interpreter or assistive translational devices available. Section B below provides information on interpreters and assistive devices.

    Short Form Document:
    The short form process is intended for situations where the likelihood of encountering eligible LEP individuals is small (i.e., <5% of the patient population typically served). However, in order to provide equitable access to research, there may be the need to enroll subjects who are not fluent in English. The short form process involves the combination of a short form consent (a translated document indicating that the elements of consent have been verbally discussed with the subject) and the English language, IRB approved consent form.

    It is important to note that the use of the short form only covers the initial consent process, and not the process for continued communication with the subject.

    The IRB provides translated versions of the short form in multiple languages, which are available on the IRB Forms webpage: Consent Short Forms. These documents may be used by the study team without prior approval from the IRB. No changes to them may be made other than to add a protocol title, PI name and contact information, and emergency contact information if appropriate.

    If the researcher creates a new short form document in another language, this document must be pre-approved by the IRB. The new short form, English version of the document, and translator certification must be submitted to the IRB for approval.

    The following key points should be considered when utilizing a short form consent process:

    • The short form consent process requires the assistance of a qualified interpreter or an individual who speaks the participant’s language and English fluently. When possible, a trained interpreter should be used. For studies that are greater than minimal risk, the individual involved in the informed consent process cannot be a family member or in the social circle of the participant. However, communication during subsequent study visits or procedures may utilize the family member or friend.
    • A witness who can speak both English and the participant’s language must be present at the oral presentation of the consent form. The witness maybe the interpreter or a family member; however this person cannot also be the individual conducting the short form consent process for the study team.
    • If a study team member is fluent in the participant’s language, they may perform the short form process and serve as the interpreter; however another individual must serve as the witness.

    The process for enrolling subjects with the short form is as follows. All steps in this process must be completed.

    1. The IRB approved English version of the consent form must be orally translated to the LEP subject in a language understandable to him/her.
    2. The subject must be given a copy of the short form document translated into their language to read and review.
    3. The entire consent process must include a witness to the oral conversation and presentation of the consent form.
    4. The IRB-approved English version of the consent form must be signed by the individual authorized in the approved protocol to obtain consent (PI, research nurse etc.) and the witness.
    5. The short form document must be signed by the subject and the witness to the consent process.
    6. Copies of the signed IRB approved English version of the consent form and translated version of the short form must be given to the subject. Original copies of both documents should be maintained appropriately by the study team.
  2. LEP Participation Following Enrollment
    • A translated version of any other documents or materials essential for participation in the study, such as surveys or instructions, must be provided to subjects in their native language. These documents must be translated and submitted to the IRB in an amendment submission for review and approval prior to use. This amendment must be submitted with adequate time for the IRB to review and approve the materials prior to the procedures in which the documents will be used.
    • A plan for continued communication with the LEP subject must be submitted to the IRB with the translated versions of other documents. Please refer to sections C and D below for additional information on the use of interpreters and translators.
    • At the time of continuing review, the study team must report the use of the short form in the previous approval period.
  3. Translation and Interpreter Services at VCU/VCUHS

    Use of Qualified Medical Interpreter:
    During the informed consent process, the use of a qualified medical interpreter is encouraged. In some cases, the medical and technical information discussed during the initial consent discussion can be complex and should be communicated to a LEP participant through an interpreter with training and understanding in medical terminology as well as understanding of cultural contexts. The interpreter may be able to assist the subject with asking questions. VCUHS Language Services offers translation and interpretation services in cases where medical and technical information is discussed.

    CyraCom Interpreter System:
    The CyraCom interpreter system is located in the in-patient clinical setting at VCUHS. CyraCom is a language service that allows hospitals and physicians to utilize a three-phone system to provide interpretation. Researchers must be mindful that the CyraCom system may not be adequate for informed consent discussion and interpretation of high risk, complex studies.

  4. Translation Requirements

    The use of a certified or duly qualified translation specialist is necessary for written document translation. A reliable method for translating ensures that subjects receive accurate written material in the language that is most understandable to them.

    The Use of a Certified or Duly Qualified Translation Specialist for Written Documents:

    The VCU IRB provides the following guidance regarding working with translation professionals:

    1. Translations should be submitted only after the English-version of all documents have received IRB approval, and should be translated directly from the English versions of the IRB-approved documents.
    2. A certified translation includes a signed statement by the translator that he/she understands English and the target language, and should list the translator’s credentials. A copy of the certification should be provided in the IRB submission with the translation.
    3. A back translation by a second individual may be required by the IRB if: a) the study is research greater than minimal risk , b) the study is very complex, c) no certified translation is available, or d) the qualifications of the translator are in question. In this case, the back translation by a person unaffiliated with the research should also be provided to the VCU IRB as proof of the quality of the translation.
    4. A duly qualified translator (one without official certification) may be used in minimal risk research. Appropriate translator credentials may include: a) a native speaker of the target language, b) experience living where the language is spoken, or c) college-level preparation in the language. The IRB will determine if the credentials of the duly qualified translator are sufficient, given the nature of the research.
    5. The cost related to services of a certified, or duly qualified, translation professional is the investigator or sponsor’s responsibility.

References

21 CFR 50.27(b)(2)
FDA Guide to Informed Consent – Information Sheet
45 CFR 46.117(2)
OHRP Guidance: Obtaining and Documenting Informed Consent of Subjects Who do not Speak English
Research Subjects with Limited English Proficiency: Ethical and Legal Issues, Resnik and Jones