The Cosnautas Blog

Five terms in informed consent forms

en Cinco términos / / 3 comments

Emma Goldsmith, traductora médica y autora de la excelente bitácora Signs and Symptoms of Translation, nos ha obsequiado con esta revisión de cinco términos del Libro rojo. Le agradecemos calurosamente su aportación.

For this article I will be stepping into the shoes of an English into Spanish translator, despite the fact that I don’t normally translate in this direction. And I will also take the liberty of referring to the Libro Rojo as the Red Book in order to avoid the pitfalls of using foreign loanwords, an example of which can be found in the recent relaxing cup of café con leche fiasco.

I’m going to look at five terms in an informed consent form, an apparently straightforward translation task because there shouldn’t be any medical jargon to unravel. After all, the source text should be worded clearly and concisely so that it can be understood by people from all walks of life, including those who have a very limited understanding of their medical condition.

But even the simplest of terms can entail translation difficulties, so it is useful to have the Red Book, which provides succinct explanations and translation solutions in just a couple of mouse clicks. Here are five such terms:

subject

A detailed entry for subject in the Red Book explains that in the context of clinical trials it has become fashionable to use subject or individual instead of patient in English, but it advises against doing the same in Spanish. In English, subject already sounds quite aseptic so I can appreciate the negative connotations of sujeto. The solution of using participante is not ideal, because participants also include clinical trial investigators and study sites. Fernando Navarro suggests simply using personas (as an umbrella term for enfermos and voluntarios sanos), wisely swimming against the tide of sujeto that is found in the pharma industry.

assent

In the case of minors, informed consent forms have to be signed by a legal representative. However, the clinical trial details may also be adapted in a separate document so that children can provide their assent, understood as their will to participate in the trial.  Under the entry age of consent, the Red Book explains the difference between the two concepts and confirms that asentimiento is the correct translation. Although assent does not have its own entry in the Red Book, the cross reference age of assent takes you to the above entry. It is one of the many new additions in the online format of the Red Book.

privacy

The section on privacy may be worded in many different ways, such as, “How will my privacy be protected?” or “Will my health information be kept private?” The entry on privacy in the Red Book provides the key to translating this term. The Anglicisms privacidad and privacía should be avoided, despite their existence in the RAE dictionary for the last thirteen years, because there are better alternatives such as intimidad, vida privada or confidencialidad. In the context of data privacy, confidencialidad is the best solution, because intimidad and vida privada refer more to personal privacy (or lack of intrusion in one’s person), which is skilfully explained by means of examples in the Red Book.

clinic

Patients may be told that they will have to return to the clinic for x follow-up visits. The Red Book entry starts with a warning about the use of clínica in this context, explaining that the word clinic is usually best translated as consultorio (consultorio de alergología, cardiología, oftalmología, etc.) but if the type of clinical trial site is known, then clínica or hospital may be more appropriate. Fernando Navarro also acknowledges that consulta is widely used in Spain. 

randomise

Randomisation is often discussed in an informed consent form: “You will be randomised to receive the active treatment or placebo.” Fernando Navarro advises against using the Anglicism randomizar and suggests different alternatives, such as aleatorizar, distribuir al azar or asignar al azar. Since the aim is to write in plain English – or plain Spanish in this case – I think that the latter, asignar al azar, is a good option, especially since the sentence will probably be backed up by a patient-friendly explanation of what randomisation means: es como lanzar una moneda al aire.

I hope this brief analysis of five terms has offered a taster of what the Red Book offers medical translators. If you’d like to add any other challenging terms that come up in informed consent forms, please add them in the comments section below and we can discuss them over a cup of café con leche.

Emma Goldsmith

British freelance translator, specialising in medicine

Web page: http://www.goldsmithtranslations.com/

Blog: http://signsandsymptomsoftranslation.com/ 

This is interesting and gives me a few more words to add to my glossary. Thank you.
by Donald Rutherford / Nov 4, 2013
Regarding "subject" versus "patient": I believe that, in the context of a clinical trial, it is important to use the word "subject" or "volunteer" or "participant", rather than "patient". The reason is that not all subjects in a clinical trial are receiving the investigative medicine or treatment; some are receiving a placebo, or are simply being observed. The term "subject" makes sense from the research point of view: clinical trials are types of research or experimentation using human subjects. From the point of view of the doctors and nurses conducting the clinical trial, it seems dehumanizing to refer to people as "subjects", but if they are not receiving the standard of care, "subjects" is exactly what they are. In some "subject-facing" documents, it may be acceptable to refer to volunteers as "patients", but in regulatory submissions they should always be called "subjects". I translate Russian to English, and the Russian term for a clinical trial volunteer is "???????", which is a cognate of the English word "patient". However, the more common word with a Slavic root is "???????/???????" (literally, "one who is hurting/in pain/suffering"). Seeing "???????" translated into English as "patient" is one of my pet peeves!
by Amy Lesiewicz / Nov 14, 2013
I wish there were something similar in Italian. It would be so useful! Thank you, anyway :-)
by Giovanna Maria Parisi / Apr 29, 2017