The challenges of translating Patient Information Leaflets and Informed Consent Forms

In a clinical study, a multitude of documents are written, recorded, and often translated by the different participants in the process, but from a translation point of view, probably the most important are the Patient Information Leaflet (PIL) and the Informed Consent Form (ICF) – which are basically two documents that always go together and are sometimes combined.

The PIL details all the possible aspects of the trial for the patient – including advantages and risks, inclusion and exclusion criteria, and the timeline – and lets them know that they can withdraw from the study at any time without any justification.

By signing the ICF, the patient expressly acknowledges that they have read and understood the entire PIL and they are participating in the clinical trial after having familiarized themselves with all the details.

If there is any problem with the text of the PIL or the ICF, the approval of the trial is at risk, but legal and other risks should be also taken into account when these documents are created – and of course, during translation too.

Understandability issues 

Patient information should always be given in a way that is fully understandable for the participant, and so the written text must not be too complicated or scientific. The main objective is for the patients to be fully and unambiguously informed so that they can decide appropriately whether to participate or not.

In the case of translation, even if this task is performed by subject matter experts, it is important to keep in mind the above principles and to align the formulation of the target text to both the source and the characteristics of the target language. The range of participants can be quite broad, and the style of the text should be appropriate for the least educated and least literate among them. Also, if the trial is recruiting young patients or children, a “child-friendly”, simpler and more informal version can be necessary, even if the consent form is signed by their guardian.

The quality of the translation can be assured and checked in a number of ways – one of them is backtranslation. This is one of the key steps in linguistic validation, and is when a third-party linguist, who is different from the original translator, translates the target text back into the original language without seeing the original. For example, in the case of a multicenter study, it is useful to translate the Hungarian translation of the original PIL back into English. Then the sponsor of the study or an assigned linguist compares the two English versions and, in case of discrepancies or suspect wording, checks the questionable parts with the translator.

Country-specific differences 

An issue related not only to translation but also to the legal environment is that each country may have their own rules regarding patient information in clinical trials. These can sometimes be stricter than the international standard. For example, in Hungary, the internationally accepted version of a PIL or an ICF might need serious rework in order to gain approval during the trial authorization process.

In this case, it is more precise to speak about adaptation and not translation. This has to be done by a person who is fully aware of all the legal requirements of the given country and is capable of revising the text appropriately. Ideally, this would be an employee of the CRO company requesting the approval who has participated several times in such authorization procedures, and who is very familiar with clinical trials and the legal language associated with them.

Once the edited or completed version is done, it is very much recommended to proceed with backtranslation. This will not only allow the sponsor to filter out the eventual translation errors, but also to check what new parts were added to the text in the target country, and to clarify any doubts with the local person in charge.

In such complex cases, the translators should not only be experienced in clinical trials and the related terminology, but they must be excellent communicators as well: smooth and seamless communication is essential due to the back-and-forth nature of the process.

To sum up, appropriate patient information is a crucial part of all clinical studies. If there is one area of the healthcare industry that cannot allow even the smallest translation error, this is it. Without a professional team experienced in clinical trials this is almost impossible to achieve. Hunnect Outcomes is happy to help you with this task in a large number of languages.