Feature Article

The Language of Consent: Using the Short Form Process when Consenting non-English Speaking Subjects in Research
September 2008 Issue

Mary A. Banks BS, BSN
Director, BUMC IRB

Author has nothing to disclose with regards to commercial support.

Educational Objectives:

At the end of this activity, participants should be able to:

  • Discuss the ethical concerns related to consenting non-English speaking subjects.
  • State the federal regulations related to consenting non-English speaking subjects.
  • Describe the required steps in the newly revised BUMC policy for consenting non-English speaking subjects using the short form process.

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Introduction

When considering the optimal approach to obtaining legally effective informed consent from non-English speaking persons, investigators, Institutional Review Boards (IRBs), and institutions must consider the ethical concerns, the regulatory requirements and the local culture. The BUMC IRB Executive Committee has recently revisited the issue of using the short form process for consenting non-English speaking subjects. The purpose is to offer the opportunity for more non-English speaking subjects in the BUMC community to participate in research. The Committee approved some revisions to the institutional policy which will be presented in this article.


Ethical Concerns

As required by the Federal Wide Assurance (FWA), the institution suscribes to the Belmont principle of respect for persons. The Belmont Report clearly articulates that the desired outcome of informed consent-- respect for persons--requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. It goes on to say that “subjects should be given information, understand the information, and based on their comprehension of the information make a voluntary decision to participate in research”.

In order to achieve this desired outcome, informed consent involves more than merely a signature on a form. In its information sheet, the FDA states “Informed consent must be a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding. Institutional Review Boards (IRBs), clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject.”

The Informed Consent Form (ICF) document represents a record of what was supposed to be communicated to the subject and a “take away” reminder for subjects of what they have agreed to. The ICF is a tool for helping to assure that necessary information is communicated to potential subjects in a meaningful way, as well as a document that tells the IRB what the investigators plan to tell the subjects. A signature on the ICF should not be considered proof that the subject understands what has been presented.

Ensuring that legally effective, truly informed consent has been obtained is challenging for investigators even when they speak and read the same language as their subjects. If the subject or legally authorized representative (LAR) and person obtaining consent do not verbally communicate in the same language, or if the subject cannot read the consent document or cannot ask questions to the investigator, then the consent process is further complicated. The inability to understand English makes it very difficult for a prospective subject to meaningfully engage in the standard consent process and to make an informed decision about participation in research

Because of these complications, the FDA emphasizes that, “investigators must carefully consider the ethical/legal ramifications of enrolling a subject when there is a language barrier. If subjects do not clearly understand the consent document or can not freely ask and receive answers to their questions, then their consent will not be truly informed and may not be legally effective.”

The second ethical principle to be considered is the principle of distributive justice. The principle of justice as embodied in the Belmont Report calls for “… fair procedures and outcomes in the selection of research subjects”. To ensure that the burdens and benefits of research are fairly distributed, Federal regulations require that IRBs consider whether selection of subjects is equitable. The BUMC IRB follows this principle by requiring that investigators do not automatically exclude subjects who cannot understand or read English, but otherwise are eligible to participate. The IRB also requires the inclusion of non-English speaking persons in research studies that have the prospect of direct benefit to subjects unless there is a compelling justification for their exclusion.

 

The Regulations and Guidance

Both the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) have regulations and guidance that speaks to the issue of enrollment of non-English speaking subjects.

FDA regulations and guidance state

  • The informed consent document should be in language understandable to the subject/LAR.
  • When the study subject population includes non-English speaking people or the investigators/IRB anticipate that the consent interviews will be conducted in a language other than English, the IRB should require a translated ICF and assure that the translation is accurate.
  • A copy of the translated consent document must be given to each subject.
  • While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.
OHRP regulations and guidance require that
  • Informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing.
  • Where informed consent is documented, the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent.
  • Providing each subject with a consent document in his/her language is always preferable. When non-English speaking subjects are targeted for enrollment or when their enrollment is anticipated, they must be provided an IRB-approved translated ICF. Investigators should plan ahead for expected subject populations who are unable to speak or read English and should arrange for translation of the IRB-approved English informed consent/assent form prior to beginning study recruitment.
  • When obtaining consent from non-English speaking subjects, the informed consent process is the same as for English speaking subjects; however, a qualified interpreter must be present to facilitate the consent conversation between the investigator and the potential subject prior to enrollment.
  • Oral presentation of informed consent information in conjunction with a translated short form written consent document and a written summary (in English) of what has been presented orally is permitted, but a witness to the oral presentation is required and the subject must be given copies of the short form document and the summary.

BUMC Policies and Procedures

Previously, the BUMC IRB only approved the use of the short form consent process in very limited situations-- mostly for studies that were less than minimal risk. The BUMC IRB Executive Committee recently revisited this policy and decided to allow for expanded use of the short form process to encourage enrollment of non-English speaking subjects in research. The Executive Committee emphasized that use of a fully translated ICF is always preferable, and that the short form process should not be used for situations where enrollment of non-English speaking subjects is anticipated or such groups are targeted for enrollment. The Committee also restated its position that ad hoc verbal translation of the English consent for non-English speaking subjects is NOT allowed.

The Executive Committee agreed that the IRB would continue to approve the use of the short form process on a protocol-by-protocol basis but would be more willing to consider allowing incidental use of the short form process when non-English speaking subjects are not anticipated.

The IRB Executive Committee has reviewed and approved a revised version of the English short form. This short form utilizes the OHRP’s recommended language but has been simplified to 7th grade language. This BUMC English short form has been translated into 6 languages common to this institution and validated. They are posted on the IRB website along with the approved English version.

Process for obtaining IRB approval for use of the short form process

  1. Complete the short form request (on the IRB website) and attach to the protocol in Section S of INSPIR
  2. Download the IRB-approved English version of the short form and all of the translated short forms you wish to use from the IRB website and attach to the protocol in Section S of INSPIR
  3. Submit to the IRB via INSPIR with a new protocol, as an amendment or as a request with the next Progress Report. (Do NOT email these requests separately to the IRB).
  4. Approval for use of the short form (with any stipulations) will be noted in the IRB approval letter.
Process for obtaining consent from using the short form
  1. The protocol is IRB-approved to use the short form process
  2. A non-English speaking person presents requesting to enroll
  3. The investigator secures an interpreter (unless he/she speaks the subjects language).
  4. Investigator, via the interpreter, conducts the consent process with the subject. The interpreter verbally reviews the contents of the short form with the subject. Using the full English version of the consent as a script, the interpreter reviews the entire full consent with the subject.
  5. The investigator answers any of the subject’s questions (via the interpreter).
  6. A witness (who is fluent in both languages) is required. If an interpreter is used, then the interpreter can serve as the witness.
  7. The short form is signed by the subject/LAR, the witness and the person obtaining consent (investigator).
  8. The English version of the consent is signed by the person obtaining consent (investigator) and the witness.
  9. The subject is given a copy of the translated short form (in his/her language) and a copy of the full English version of the ICF (which will serve as a written summary).

Obtaining an Interpreter

In many cases, investigators will require interpreter services to help with their research subject interactions. Because of limited capacity, Boston Medical Center is unable to provide in-person interpreters for research studies. However, arrangements have been made to allow the use of a telephonic interpreter service for research. BMC has already positioned over 100 telephones throughout inpatient and outpatient sites. These phones have two handsets to allow investigators and subjects to simultaneously speak to the interpreters. A list of these locations and more detailed instructions on their use can be found on the IRB website.

In brief, the investigator and subject each dial the number for the interpreter services, identify the language they need support for and inform the interpreter that this is a research study. The investigator must provide the interpreter with the name of the principal investigator and the IRB protocol number (located on the consent form). This service is available both for the consenting process as well as for follow up visits. The cost of the service is $1.00 per minute. As the interpreter will serve as a formal witness for the consent process, the investigator must ask the interpreter for his/her interpreter number and document this on the consent form. This number can be used as a legally-acceptable signature for informed consents and follow-up visit reports.

After Consent, Then What?

Informed consent is a process that requires investigators to continuously reassess the subject’s understanding of the nature of the research, its risks and benefits. Adequate communication between the research staff and subject must occur throughout the research to ensure the safety and welfare of the subject and the integrity of the research data. As part of the short form request, the IRB will ask investigators of their plans for how they will communicate with non-English speaking subjects in emergency situations, who will interpret for all study visits, and their plans for translation of additional study materials.

 

Summary

The BUMC IRB has approved the expanded use of the short form process for consenting non-English speaking subjects to encourage enrollment of non-English speaking subjects in research at BUMC. The IRB reminds investigators that it is the responsibility of the person obtaining consent--and ultimately the responsibility of the PI--to ensure that a truly informed, legally effective consent is obtained. This requires more than just obtaining signatures on the consent document. Investigators must be committed to the consent process and recognize that obtaining consent from non-English speaking subjects using the short form will require additional time and effort.


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