Medical Translation Quality
It IS a Horse of a Different Color
Serving the medical industry introduces unique considerations to the translation and localization process. One notable difference is the way the quality assurance process is designed for medical industry clients. This article discusses quality considerations of the medical translation market and offers quality assurance process information tailored to the specialized needs of pharmaceutical and medical device clients.
The Basics of Quality Translation
Getting Into the Starting Gate
McElroy’s basic quality standard has always entailed a minimum of two verifications steps post translation. Each project is reviewed by a target-language native in that technical field. We maintain an editing department of subject matter specialists for translations to English and assign technical editing to a qualified second translator for translations from English.
In each case a staff proofreader conducts another project review post formatting to confirm that editorial comments were implemented, that formatting did not introduce irregularities, and that “numbers and paragraphs” match the source document. Today, this level of quality assurance is a baseline industry standard expected by clients who require custom technical translation and localization.
There is a wide range of documents for which medical clients may require translation, including research protocols, informed consent documents to be signed by patient subjects, advertisements to be used in recruiting subjects, patient questionnaires, reports of adverse events, regulatory submissions, instructions for use or package inserts, and labeling. For many materials, an additional layer of quality assurance is required by medical industry clients. Examples:
The Role of Institutional Review Boards
You Better Put Your Best Horses in the Race
Over the past 25 years, thousands of Institutional Review Boards (IRBs) have formed to help ensure human subject protections. At first, most were in large academic centers where most federally funded research occurs. As commercially sponsored research increased, IRBs emerged in the 1980s and 1990s as independent entities working outside the institutions where research is performed. Both the public and private IRB models play a vital role in protecting human research subjects.
IRBs carry out initial and continuing review functions in accordance with Federal regulations first established in the 1970s that apply to all research funded by the U.S. Department of Health and Human Services or carried out on products regulated by the Food and Drug Administration. All subjects must understand enough about the study to make an informed decision about being a research participant. This is mandated by the Office for Human Research Protections (OHRP) in the Code of Federal Regulations 45CFR46.116. An IRB’s initial review of a research plan encompasses the research protocol, the informed consent document to be signed by subjects, and any advertisements used to recruit subjects.
The IRB must approve that any risks subjects incur are warranted in relation to the anticipated benefits, and that the informed consent documents clearly convey the risks and true nature of the research.
Lynn Meyer, President, Commercial IRB IntegReview in Austin, Texas, elaborates, “IRBs are expected to provide documents to study subjects in a form that is easily read and understood. Given this responsibility, IntegReview Inc. Ethical Review Board requires sites intending to enroll non-English speaking subjects to provide study documents in a language that the potential study subjects read, speak and understand. Translations can be provided by the site or the IRB can provide this service. This requirement enhances the role of the IRB in protecting the rights and welfare of study subjects.”
The mandate for clear communication to all study participants has led some IRBs to outline very specific procedures for translation quality assurance. Wayne State University policy states that the translation process can be accomplished using a “one-way” translation into the non-English version if it is certified by the translator or company doing the translation with a guarantee of accuracy. A “two-way translation” (back translation) is also an accepted quality process. The Oregon Health & Science University Research Integrity Office does not require two-way translation but suggests an authorized translation vendor. If that vendor is not used a memo detailing the qualifications of the translator must accompany the informed consent for review. The Stanford University Research Compliance Office recommends the use of back translation and the Institutional Review Board at Duke University Medical Center not only requires it, but expands in detail on the process.
Use Great Trainers and Jockeys
What does this mean to the translation and localization community? Whether or not your company agrees that back translation is the best vehicle for quality assurance, the reality is that some clients are required to provide both forward and backward certified translations. Our job is to comply. Our responsibility is also to understand a client’s exact needs and to help them determine if and when a back translation is appropriate.
Some clients who are not required to provide back translations have heard enough about the process to inquire about the service. Others assume that bidirectional translation is standard protocol. At McElroy, we believe that our role is to inform clients of the advantages and disadvantages of bidirectional translation as a form of quality control. Providing information about the process of bidirectional translation helps clinical trial project managers charged with document compliance make informed decisions.
One advantage is that back translations can satisfy the quality assurance mandates of many IRBs. A disadvantage is the higher cost of this method of assuring quality. A basic explanation that instead of one translator and one editor they must pay for a translator and an editor in each direction will often produce what I call an “ah-ha moment” of revelation.
It is also essential to explain that while back translation adds another layer of quality assurance there is one critical caveat. A back translation will not be the mirror image of the original. Some words or concepts simply do not exist in other languages, or a translator may have rephrased an idea to address a cultural sensibility. The review of a back translation should show that the message is conveyed, if not in the exact same words originally used.
Translation Manager Ellen Boyar at Thomson Scientific emphasizes, “If you are receiving a back translation that is word for word like the original, you are not getting back a valid back translation.”
An Improved Back Translation Process
A Zebra is Not a Thoroughbred with Stripes
Ellen is a particularly savvy translation client. As McElroy started providing more and more back translations we soon realized that our customer service department was besieged with post-delivery questions about the differences in the source and back translation. Not only did we decide to focus more on client education pre-project, but in 2005 we introduced a new level of service for bidirectional requests.
Instead of simply delivering both the target and the back translation, our standard protocol for these projects now also includes an expert comparison of the original source English and the reverse translation, with research of any relevant differences. Seasoned professionals can readily distinguish between naturally occurring differences that are to be expected as a result of process, and deviations that merit attention. In the event that a question does arise our language team can then determine in which direction the discrepancy occurred and make appropriate document revisions before delivery of both translations to the client.
Some clients request one additional step beyond the process already described. As a value added service at an even more advanced level, McElroy facilitates client focus groups of international study populations to evaluate the fine nuance of cultural sensitivity of patient questionnaires that we have localized. In addition to forward and backward translation, and reconciliation of source to back translation, a final patient review of the instrument in focus group format is arranged and facilitated by a McElroy interpreter and project manager.
Your Translation Under the Microscope
Deliver a Triple Crown Level of Quality
As stated earlier, excellent quality with documented procedures is no longer a selling point for a company; it is an expectation. Whether for legal, medical, software, or marketing communications the translation/localization industry must meet the highest quality demands. Dollars and sometimes lives are at stake.
In my experience, quality assurance using back translations as a validation vehicle is currently used predominately by those segments of the medical industry with distinct responsibilities linked to fair and compliant communication with clinical trial participants.
To better serve this business unit, McElroy developed advanced processes and added related services. In medical translation, a single word or term may have critical significance. Industry-specific quality procedures and keen responsiveness is paramount when providing medical translations. The emergence of “back to English” translations is a prime example of the medical industry’s efforts to ensure safety for clinical trial participants and future patients.
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