This is a legal act in which a person voluntarily agrees to participate in clinical research. Informed consent involves the application of the bioethical principle of autonomy, and also constitutes a legal requirement. However, in order for the document to be valid, the patient should have received full information from the researcher, from the objectives and expected benefits of the clinical trial, to the risks and any discomfort, along with the existing alternatives and the voluntary nature of participation.
With experience of over ten years as translator of informed consent documents, Lorenzo Gallego Borghini has observed significant deficiencies in this type of legal text, both in their formal legibility and the amount and quality of information provided to the patient.Many shortcomings can be be blamed on the bad translation from English, as many scientific studies are international.
For this reason, he is presenting the Esteve Foundation Notebook La traducción inglés-español del consentimiento informado en investigación clínica. Based on over 500 documents and on a sample of 100 requests for clarification from Ethics Committees, this Notebook analyzes the main problems in the translation of informed consents from English to Spanish. Gallego also proposes a series of ideas and recommendations to improve the quality of texts presented to clinical research ethics committees, and which will be read by Spanish patients who are considering participating in clinical research.
Although there are several works that analyze the problem of translating clinical trials, this is the first that specifically tackles the translation of informed consents.Many of these documents involve literal translations of the text presented in other countries. They do not adapt to the stipulations of Royal Decree 223/2004, which regulates clinical drug trials and are often full of technical terms that are difficult for patients to understand.
The Esteve Foundation Notebook La traducción inglés-español del consentimiento informado en investigación clínica was presented on Thursday, 30 July 2015 during the course held at Universidad Menéndez Pelayo, directed by Fernando A. Navarro, entitled Problems methods and other latest issues in medical translation. Below, you can download it in PDF or ask for a free copy.
|Complete document||L. Gallego||[wpdm id=1392 type=”btn”]|
|Index and initial pages||[wpdm id=1393 type=”btn”]|
|Acknowledgements||[wpdm id=1394 type=”btn”]|
|Introduction||L. Gallego||[wpdm id=1395 type=”btn”]|
|1. The informed consent form in clinical research||L. Gallego||[wpdm id=1396 type=”btn”]|
|2.Translation: problems of style||L. Gallego||[wpdm id=1397 type=”btn”]|
|3.Translation: problems of morphosyntax||L. Gallego||[wpdm id=1398 type=”btn”]|
|4.Translation: problems of orthotypography||L. Gallego||[wpdm id=1399 type=”btn”]|
|5.Translation: problems of terminology||L. Gallego||[wpdm id=1400 type=”btn”]|
|6.Translation: problems of cultural adaptation||L. Gallego||[wpdm id=1401 type=”btn”]|
|7.Translation commentary of an informed consent||L. Gallego||[wpdm id=1402 type=”btn”]|
|Bibliography||[wpdm id=1403 type=”btn”]|
|Complementary bibliography||[wpdm id=1404 type=”btn”]|