Analysis of the objections raised by ethics committees in Spain to the translations of clinical research patient information sheets and informed consent forms: Implications for translators
DOI:
https://doi.org/10.1344/rbd2015.33.11561Keywords:
informed consent form, patient information, clinical research, translation, Spanish, Spain, legibility, clinical trial, qualityAbstract
In many international clinical trials submitted for approval in Spain, the Spanish versions of the patient information sheets and informed consent forms (PIS/ICFs) have problems that may be attributed to the translation. A sample of 100 clarification letters from Spanish ethics committees has been analyzed to assess the objections posed by these ethics committees to the translation of PIS/ICFs, as a previous step for the preparation of a handbook on PIS/ICF translation.
As many as 67.63% of all clarification requests relate to the PIS/ICF. Of these, 31.80% is somehow relevant to the translation. Most of these objections concern general style and writing (43.62%), whereas the other two points of attention are terminological issues (34.31%) and cultural issues (22.05%). Following the analysis of these objections, the implications for the work of translators are discussed.
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