Resumo

VILLAMANAN, Elena et al. Informed consent in clinical research: do patients understand what they have signed?. Farm Hosp. [online]. 2016, vol.40, n.3, pp.209-218. ISSN 2171-8695.  https://dx.doi.org/10.7399/fh.2016.40.3.10411.

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

Palavras-chave : Informed consent; Clinical research; Readability.

        · resumo em Espanhol     · texto em Inglês | Espanhol     · Inglês ( pdf ) | Espanhol ( pdf )