Mary A. Banks BS, BSN
At the end of this activity, participants should be able to:
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.
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
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.
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.
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
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.
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.
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.
This Quiz applies to the recertification period from July 1, 2007 to June 30, 2009. CME credits are no longer offered or available as of 9/15/2010.