Why is translating patient consent forms in a simple language so important?
Sometimes as the nature of a procedure is often very technical, it is important that the patient fully understands simply what the procedure involves so as they are fully aware of how the procedure will work, what is expected of them doing it, what the potential consequences might be – if it is a new drug they are trialling or a vaccine, is there potential that the patient might fall ill? Should sensitivity be placed around a certain cultural population? Could religious beliefs play a part in the patient population taking part? Have all these factors been considered when carrying out the study?
For research involving human subjects, informed consent is required (with limited exceptions), both ethically and legally. As part of this requirement, study information must be presented “in language understandable to the subject.” The Office of Human Research Protections strongly encourages that non-English-speaking subjects be provided with written consent materials in their own language. Creating consent materials in languages other than English, and ensuring that they are understandable to participants, can be a significant challenge.
In general, consent documents are often written using complex and technical language and empirical analyses continue to reveal major limitations in subject comprehension. As one way to confront comprehension issues, some researchers have invested significant effort to empirically develop and test simpler consent materials. While these efforts cannot solve all comprehension problems, they are an important step in improving the informed consent process.
Unfortunately, such efforts are often limited to development of English materials. The challenges to providing non-English-speaking subjects with informative and understandable consent materials are compounded when information must be translated and adapted from English.
With so much to consider when writing Patient Consent Forms in English, you can understand why not only it is so important to write these documents in Laypersons’ English, but that, when translating in a new target language, it’s even more important that a native medical translator is chosen to complete the translations.
According to the BBC consensus published in 2011, 138,000 people within the UK could not speak English and a further 736,000 could speak English but not well. Fast forward to 2020 where we have now seen this increase substantially and couple this with the ongoing current COVID pandemic, we’re seeing larger populations of non English speaking patients asked to take part in the clinical trials; sensitively accurate translations have therefore never been more so in demand.
According to a recent NCBI publication addressing the issue of misinterpretation of Patient Consent Forms and how to resolve this issue is looking at the process of sense checking:
The above process is something that we have worked on here for several of our life sciences clients and we would highly recommend that when having a non-native speaking English population take part in your trials that you look at and we can certainly help you with this.
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Sense checking, translation, HLPR & back translation importance: