Section XVII: Special Requirements and Guidance for Investigators		WPP #: XVII-1
Title 1: Research Subjects with Limited English Proficiency (LEP)
Effective Date: 9-4-09	Revision History: 6-21-06

Objective

To provide guidance for VCU clinical investigators regarding obtaining and documenting informed consent and ensuring ongoing informed consent for subjects with Limited English Proficiency (LEP).

Description

For the purpose of this policy, research participants with Limited English Proficiency (LEP) include any persons who cannot read or otherwise do not have full access to or understanding of English.   A language barrier may make it difficult to ensure that subjects fully understand the risks or benefits of participation. 

The governing principles of human subject research - respect for persons, beneficence, and justice - require that researchers not exclude potential subjects based solely on a limited ability to read, hear, speak, or otherwise understand English.   The investigator is to fully consider that not only clinical criteria determine study eligibility.  If the subject's probability and magnitude of risk of participation is great because of language constraints, the prospective subject may not be considered eligible for the study.  Depending on the nature of the study, as well as available language and participant support, it may be in the best interests of a prospective subject with LEP (and other subjects on the study) to NOT be enrolled, even if he or she is eligible by clinical criteria.   However, in most cases, enrolling subjects with LEP is encouraged.

1. Involving Persons with LEP in Research:

There are three scenarios for involving participants with LEP in a research study.  Each scenario is further elaborated in subsequent sections of this WPP.

1. Planned involvement of subjects with LEP, either targeting a known LEP population(s) or anticipating that persons with LEP may be eligible and interested in participating.  Such planned involvement may be part of the initial submission or is reconsidered and submitted as a Change in Research.  (Section A below).
2. An occasional, unanticipated person with LEP may be eligible for a study and wants to participate.  In many cases this scenario will involve therapeutic research, where the research holds the prospect of providing direct benefit to the subject and there is time to submit a Change in Research to the IRB for prospective approval.  (Section B below)
3. An unanticipated person with LEP is eligible to participate in a therapeutic study for which the initiation of study interventions is urgent.  Due to the urgent need to enroll a person in the study, prior IRB review may not be possible.  (Section C below)
2. Planned Involvement of Research Participants with LEP

Elements to be considered and included within the  protocol for planned involvement of persons with LEP are:

1. Do you feel that the risks of participation during the course of the study (including the added risks associated with having Limited English Proficiency) are balanced with the anticipated benefits, if any?
2. Describe how persons with LEP will be identified and recruited for the study, how will research team interact with LEP participants?
3. Provide translations of all documents, including the informed consent form, which will be given to the subjects.  Alternatively (and recommended), first submit documents in English only.  After they have been approved, submit the translated documents with a Change in Research form to the IRB for approval.  Translated documents must have IRB approval before being used.  See Section E below for more information on translated documents.
4. How will the initial informed consent process be handled?  Will there be a qualified interpreter or assistive devices available?  Describe how to handle the consent process if the person with LEP is illiterate in his or her language.  See Section D below for information on interpreters.
5. How will ongoing research study visits be handled?  Will an interpreter be present?  How will impromptu questions be handled?

3. Unanticipated, non-urgent, enrollment of a subject with LEP where a Change in Research is submitted to the IRB prospectively (research intervention is not urgent)

Elements to consider and include within a Change in Research submission for the unanticipated enrollment of an eligible individual with LEP where there is time to submit to the IRB for prospective approval:

1. Do you feel that the risks of participation during the course of the study (including the added risks associated with having Limited English Proficiency) are balanced with the anticipated benefits, if any?
2. Describe how eligibility will be ascertained and recruitment handled.
3. IRB approved documents that are provided to subjects must be translated into the subject’s language.  More information on translation of documents is found in Section E below.
4. How will the initial informed consent process be handled?  Will there be a qualified interpreter or assistive devices available?
5. How will ongoing research study visits be handled?  Will an interpreter be present?  How will impromptu questions  or reports of adverse events be handled?

4. Unanticipated, urgent, enrollment of an eligible subject with LEP when research intervention must begin as soon as possible

45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) provide for a ‘short form’ process for the informed consent, in which there is an oral summary presentation of the informed consent in conjunction with a short form written consent document stating that the required elements of the full consent have been presented orally.  The ‘short form’, although originally intended to address the needs of subjects with English illiteracy, is used by many IRBs for unplanned enrollment of individuals with LEP whose clinical needs require an urgent initiation of the research interventions.  The VCU IRB does not encourage use of the short form process, maintaining that LEP subjects have the right to full and complete disclosure of a research protocol so that they may make a fully informed decision about whether to participate.  However, the VCU IRB will consider the use of the ‘short form’ process in cases of ‘urgent medical need,’ where the intervention is not available outside of the research context and time is of the essence.  In this case, it is highly recommended that the investigator notify the VCU IRB when an eligible research participant appears to have LEP.  The investigator’s clinical expertise is a crucial determinant of whether the research intervention is urgent, in which case, the following elements must be carried out by the investigator and research team:   Through the ‘short form’ process, the principal investigator is responsible for:

1. Identifying when an eligible research participant is a person with LEP.
2. Identifying one or more persons, such as family members or others, who are conversant in the subject’s language and English.  Although family members are ethically inappropriate primary interpreters, because of concerns about privacy and coercion, they may function as witnesses to the consent process.  In some cases, the presence of family support is necessary to help the subject understand the requirements of the study in order to facilitate compliance and safety during the course of the study.  The primary interpretor acts to translate interactions during the informed consent discussion.
3. Consulting the regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27 (b)(2) for requirements    relative to the ‘short form’ process.
4. Locating a short form template from the OHRP guidance memo at    http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm  (OBTAINING AND DOCUMENTING INFORMED CONSENT OF SUBJECTS WHO DO NOT SPEAK ENGLISH) and ensuring that it is translated into the necessary language and is properly done so by a qualified translator (not a friend or family member).  See Section E below for information about translation.
5. Providing a translated ‘short form’ and summary to the IRB for approval by the Chair or designee BEFORE they can be implemented.  A summary of the oral presentation given to the subject need not be translated.  In most cases, the IRB recommends that the English informed consent document serve as the ‘summary’ in the short form process.
6. Involving a qualified interpreter in the oral presentation of the informed consent form or summary and short form to the subject.  The interpreter answers questions as they arise at the time of consent and ideally on an ongoing basis throughout study participation.
7. Ensuring a presence of at least one bilingual witness to the oral presentation not associated with the study.  This can be a family member.  The investigator should be present to answer questions during the oral presentation.
8. Providing a fully translated version of the complete informed consent form to the IRB within no more than 2 weeks of utilizing the short form on a subject. (See Section E below). In addition, the Research Plan should be modified to reflect the enrollment of LEP subject(s) and submitted to the IRB.  Once approved by the IRB, the subject or LAR should read the consent form in the presence of an interpreter and continued consent should be documented. 

REMINDER: For cases where therapeutic research intervention is not urgent, the VCU IRB reminds investigators that research subjects may often gain access to investigational therapies “off protocol” where no data is collected for research purposes.  This is an alternative to consider if the above requirements (in sections A and B) prohibit the involvement of the subject in research that might involve access to investigational therapies.

5. The Use of a Qualified Medical Interpreter (for oral presentation): In some cases, the medical and technical information discussed during the initial consent discussion (and throughout the course of participation) can be complex and should be communicated to LEP subjects through an interpreter with training and understanding in medical terminology, as well as understanding of cultural contexts.  The use of a qualified medical interpreter is of greater importance in research where the risks to the subject are great.  If the research involves potentially sensitive matters and/or health information, the qualified medical interpreter must be an individual with a professional commitment to maintain strict confidentiality.  Ideally, the interpreter may also function as a participant advocate throughout the study, not only during the initial consent process.  The interpretor may be able to assist the subject ask questions and understand ongoing study-related communication.

VCU offers a CyraCom interpretor system in the in-patient clinical setting which may not be adequate for high risk, complex research.  VCUHS Language Services may be contacted for assistance regarding interpreter and translation needs in the clinical research setting. --

The VCU IRB provides the following questions to consider when working with medical interpreters:

1. How will the investigator and interpreter determine whether the subject truly understands the consent information?  The PI may consider using questions from the VCU Informed Consent Evaluation Instrument [at http://www.research.vcu.edu/forms/ICEval.doc ] and asked by the interpreter to ascertain whether the LEP participant has understood the informed consent explanation.
2. Informed consent is an ongoing process.  How will the investigator ensure that the subject will understand ongoing study-related communication?  If the subject has questions about continuing in the study, how will that be communicated to researchers?

6. The Use of a Certified or Duly Qualified Translation Specialist (for written documents):

The initial informed consent document and other written material must be provided to the prospective research subject in the language that is most understandable to them.  As such, a reliable method for translating documents is imperative. 

The following points describe the most expeditious process for approval of a foreign language consent document for scenarios related to planned or non-urgent involvement of persons with LEP: 

1. The initial research protocol/plan or Change in Research submission to the VCU IRB must reflect methods for assuring full understanding of the person having LEP, as required by the VCU IRB at time of initial review or following the identification of a communication need with a prospective subject.
2. The English version of the informed consent documents and any other written/audio/video materials should be submitted to, and approved, by the VCU IRB prior to the translation of the document.
3. When all documents submitted in English meet the approval of the VCU IRB, an approval letter will be issued, excluding persons with LEP from participation.
4. The involvement of the persons with LEP will be permitted only after certified, or duly qualified, translations have been submitted to the VCU IRB that are based upon the IRB-approved material.  IRB approval of certified, or duly qualified translations means that the IRB has approved the English version of the informed consent documents, determined the credentials of the translator are acceptable, and there is no conflict of interest for the translator.

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

1. A certified translation may include a notarized statement by the translator that he/she understands English and the target language and may list the translator’s credentials.  A copy of the certification should be attached to the translation.  If the investigator obtains a certified translation, he/she is not required to provide a back translation.
2. A back translation by a second individual is required by the IRB if:  a) the study is biomedical 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  (though, it is understood that the back translation may differ from the English version due to variations in the way that certain cultures structure sentences and convey concepts, however ALL the information must be included).
3. A duly qualified translator (one without official certification) may be used  in minimal risk research or if the research is highly specialized.  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.  
4. The cost related to services of a certified, or duly qualified, translation professional is the investigator’s responsibility.  These costs may be quite high, particularly for large studies where multiple language translations are needed.  These costs are generally paid by sponsors if included in the budget by the investigator. 

Responsibility

It is the responsibility of the principal investigator to anticipate non-English speaking or subjects with LEP and to make every effort to ensure legally effective consent if the subject is to be enrolled.

References

45 CFR 46.112
45 CFR 46.117
21 CFR 50.20
21 CFR 50.27
National Council on Interpreting in Health Care