title: Informed consent in clinical research; Do patients understand what they have signed?
abstract: 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.
authors.affiliation: Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid.. evillabueno@telefonica.net.
authors.forename: Elena
authors.initials: E
authors.lastname: Villamañán
authors.affiliation: Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid.. evillabueno@telefonica.net.
authors.forename: Margarita
authors.initials: M
authors.lastname: Ruano
authors.affiliation: Technical Secretary of Clinical Research Ethic Committee. Hospital Universitario La Paz, Madrid.. evillabueno@telefonica.net.
authors.forename: Enma
authors.initials: E
authors.lastname: Fernández-de Uzquiano
authors.affiliation: Technical Secretary of Clinical Research Ethic Committee. Hospital Universitario La Paz, Madrid.. evillabueno@telefonica.net.
authors.forename: Paz
authors.initials: P
authors.lastname: Lavilla
authors.affiliation: Spanish Agency of Medicines and Medical Devices. Ministry of Health, Social Services and Equality. Spain.. evillabueno@telefonica.net.
authors.forename: Diana
authors.initials: D
authors.lastname: González
authors.affiliation: Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid.. evillabueno@telefonica.net.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Freire
authors.affiliation: Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid.. evillabueno@telefonica.net.
authors.forename: Carmen
authors.initials: C
authors.lastname: Sobrino
authors.affiliation: Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid.. evillabueno@telefonica.net.
authors.forename: Alicia
authors.initials: A
authors.lastname: Herrero
mesh_terms: D035843:Biomedical Research; D006801:Humans; D007258:Informed Consent; D011320:Primary Health Care