Abstract

PARDO-CABALLOS, Antonio  and  ECHARTE-ALONSO, Luis Enrique. FORMALIZATION OF INFORMED CONSENT IN RESEARCH AND THE PATIENT'S EMOTIONAL LOSS. pers.bioét. [online]. 2015, vol.19, n.2, pp.198-226. ISSN 2027-5382.  https://doi.org/10.5294/PEBI.2015.19.2.3.

Informed consent for research is part of the doctor-patient relationship, which has suffered and continues to suffer important changes. These range from the classic approach, such as friendship, to the contemporary approach, namely, a relationship between strangers (potential enemies, according to illustrated notions of society) regulated by ethical and legal standards. The primary objective of these standards is to ensure, through formal requirements, that the relationship does not harm the patient. With this perspective in mind, the study examines and compares informed consent in light of the most important international standards and under Spanish law. There is a particular focus on the patient information sheet, understanding, willingness, certification and communication of research results. The study concludes there are serious inherent constraints in these regulations that prevent rather than promote treating the patient properly.

Keywords : Doctor-patient relationship; medical illustration; clinical research; informed consent; formalization of consent.

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