Ethics in clinical trial translations
Updated: Sep 27
In the week that marks Clinical Trials Day – celebrated on May 20 – I invite you to read about translators’ ethical obligations when dealing with clinical trial materials.
Every translator must abide by a code of ethics, firmly based on three cornerstones: high-quality work, accuracy and fidelity to the source text, and confidentiality of information.
In a highly regulated and high-risk setting such as clinical research, translators should go above and beyond to make sure that there are no errors and potential misunderstandings and should keep a close eye on every section of the text – both in source and in target languages.
1. High-quality work
Quality is of particular importance in clinical trial translations. A single mistake can compromise the approval of a study, thus delaying patients’ access to a much-needed treatment – not to mention compromising patients’ safety.
Translators should endeavor to provide a service of the highest quality. To do so, translators must:
Be proficient in the source language and native of the target language.
Work on fields or topics where they have the necessary knowledge and experience.
Actively seek training opportunities to ensure that they are up-to-date (whether it is in their specialization or in writing and translation techniques).
Make use of the necessary tools to ensure consistency and correctness (e.g. translation and terminology management software).
Deliver the translation on time.
Confidentiality is an essential consideration in any clinical trial, namely regarding patient data (i.e., personal health information) and patent information (i.e., novelty or innovative products).
Translators must respect the confidentiality and privacy of the information contained in all documentation, not only for ethical reasons but also because they are legally bound to do so.
3. Accuracy and fidelity
An accurate translation preserves the meaning, style and register of the source document. However, fidelity to the source content does not exclude the need for adaptation to make the text valid in another language and country.
When dealing with clinical trial materials, translators must ensure that the text they deliver:
Follows the source text to the T.
Complies with the industry standards.
Is adapted to the target audience, e.g., patients, healthcare professionals, regulatory authorities – both in terminology and wording.
Is free from errors, ambiguities, omissions, or additions.
In addition, translators should not only focus on the target text, but also examine the source text with a critical eye to:
Identify sections that may not apply to the target audience and adapt accordingly after conferring with the author.
Highlight errors and potential ambiguities found in the source.
Suggest changes or adaptations that may improve the overall understanding of the text, if applicable.
Translators are the closest readers of any text, and their attention to detail and expertise are valuable assets when dealing with complex materials such as clinical trial documentation.
This complexity relates to the required scientific accuracy and regulatory compliance, as well as the need to produce documents that are easily understood by those who benefit the most from clinical trials – patients and their families.
Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.