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 including those who cannot read, hear, or otherwise have full access to or understanding of English. 

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.   However, the language barrier may make it difficult to ensure that subjects fully understand the risks or benefits of participation.  Therefore, the VCU IRB has developed the following material to assist investigators in ensuring that persons are not unfairly excluded from participation and ensuring effective, ongoing informed consent.

A.     VCU Requirements for the Research Involving Persons with LEP:

In all clinical research, the risks of participation should be commensurate with the anticipated benefits.  In the case of persons with LEP, the communication barrier presents a significant additional risk that must be considered by the investigator and research staff.  Regardless of the level of research risk that the study involves, written evidence must be in place that the investigator considered the effect of LEP on the consent process.  This documentation should be in the original protocol (submitted to the IRB prior to the start of the study) or in a formal letter sent to the IRB, submitted with the Change in Research form (for the occasional, unanticipated person having LEP).

Elements to include within your original protocol or Change in Research letter to the IRB are:

1.       How will the initial informed consent process be handled?  Will there be a qualified interpreter or assistive devices available?

2.       How will ongoing research study visits be handled?  Will an interpreter be present?  How will impromptu questions be handled?

3.       Will the informed consent document be translated by a certified translator?  Will other documents be translated as needed during the course of the study?

4.       Do you feel that the risks of participation (including the added risks associated with having Limited English Proficiency) are balanced with the anticipated benefits?

5.      Additional VCU IRB Recommendations:

a)      Where possible, a qualified medical interpreter should participate in the informed consent process and should be included in an ongoing fashion over the course of the research) in research involving greater than minimal risk to the research subject.

b)      Certified translators should be used to produce translated versions of the written informed consent document.  If not formally certified, a translator ought to have evidence of extensive translation qualification as appropriate for the protocol. 

c)      Communication assistance devices should be employed for those who cannot hear or see.

B.     The Use of a Qualified Medical Interpreters:

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 non-English speaking-subjects through an interpreter with training and understanding in medical terminology.  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.

Please note that privacy issues, and the concern of potential biases, leads the VCU IRB to require that interpreters NOT be related to the research participant.

The VCU IRB provides the following notes as points to consider when working with medical interpreters:

1.       Will the medical interpreter serve as participant advocate as well as interpreting the consent material?

2.       How will the interpreter incorporate cultural considerations into the consent information?

3.       How transparent will the interpreted conversation be?  With three people communicating (participant, investigator, and interpreter), will everything said by each person be translated?

4.       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 (embedded hyperlink)] and asked by the interpreter to ascertain whether the LEP participant has understood the informed consent explanation.

5.       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?

VCU offers a Cyra-Phone system in the in-patient clinical setting.  Although this method of oral interpretation may satisfy the translation needs for therapeutic medical care, it may not be adequate for research purposes.  The investigator is encouraged to carefully evaluate whether a subject will be able to comprehend a very complex study if it is explained orally.  This is especially important if the subject with LEP is also illiterate in his or her own language.

C.     The Use of a Certified or Duly Qualified Translation Specialist:

 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 notes describe the most expeditious process for approval of a foreign language consent document: 

1.       The research protocol/plan or letter to the VCU IRB regarding an ongoing research study must reflect the 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.

4.       The involvement of the persons with LEP will be covered under the IRB approval 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, with strong emphasis upon the importance in seeking certified translations or obtaining back translations:

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.  A duly qualified translator may be used especially in minimal risk research or if the research is highly specialized.  The IRB will determine if the credentials of the duly qualified translator are sufficient.

2.       A second professional translator will back translate (if certified translation was not obtained or if the qualifications of the translator are in question) the consent into English in order to verify equivalent meaning in the target audience.  In this case, the back translation 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.       Securing the services of a certified, or duly qualified, translation professional and the cost of translating materials 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.

D.   Urgent Issues involving Persons with LEP:

It should be noted that 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 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 VCU IRB discourages this practice and maintains 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 ‘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 a research participant appears to have LEP. 

Through the ‘short form’ process, the principal investigator is responsible for:

1.       Identifying when a research participant is a person with LEP.

2.       Contacting the VCU IRB for a current copy of the ‘short-form’ language template.

3.       Ensuring that the ‘short-form’ language template is translated into the necessary language and is properly done so by a qualified translator (not a friend or family member).

4.       Involving a translator in the informed consent process where a qualified interpreter orally presents the informed consent information (VCU IRB-approved English version) to the subject, provides the subject with a copy of the ‘short form’ text in his/her language, and answers questions as they arise at the time of consent and on an ongoing basis throughout study participation.

5.       Providing a fully translated version of the complete informed consent form to the IRB within one week of utilizing the short form on a subject.  The subject or LAR should read the consent form in the presence of an interpreter and document continued consent.

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 the data collected is not used 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.

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.

REFERENCE:

45 CFR 46.112

45 CFR 46.117

21 CFR 50.20

21 CFR 50.27

"Recommendations for the Ethical Involvement of Limited English-Speakers in Research" By Elizabeth Jacobs, MD, Wilma Alvarado-Little, and Eric Hardt, MD , October 2001

National Council on Interpreting in Health Care

A Guide for Assessing a Healthcare Interpreter