Resumo

GALLEGO BORGHINI, Lorenzo. 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. Rev. Bioética y Derecho [online]. 2015, n.33, pp.14-27. ISSN 1886-5887.  https://dx.doi.org/10.4321/S1886-58872015000100003.

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.

Palavras-chave : informed consent form; patient information; clinical research; translation; Spanish; Spain; legibility; clinical trial; quality.

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