[Informed consent: a dialogic praxis for the research]

Rev Invest Clin. 2009 Jan-Feb;61(1):73-82.
[Article in Spanish]

Abstract

The informed consent is a process in which a person agrees to participate in a research, knowing the risks, benefits, problems or consequences that may arise during developing it. The aim of this study is to collect the characteristics of the informed consent process (ICP) so its understanding and compliance allow an ethical dialog, thoughtful and responsible exercise for the researcher. We present the results of an extensive review of the ICP elements from its components to their legal and ethical foundation, including the myths and realities that exist about the format of informed consent as a legal protection. The informed consent is not an established format that researchers reproduce in their research, but its praxis is a daily task in the research with human subjects as critical, deliberative, and committed communication between two moral agents: the researcher and the researched one.

El consentimiento informado es un proceso, en el que una persona acepta participar en una investigation, conociendo los riesgos, beneficios, consecuencias o problemas que se puedan presenter durante el desarrollo de la misma. El objetivo de este trabajo es reunir las caracteristicas del proceso de consentimiento informado (PCI) pare que su discernimiento y cumplimiento posibilite el ejercicio etc° dialogico, reflexivo y responsable del investigador. Se presentan los resultados de una extensa revision de les elementos del PCI, desde sus cornponentes hasta su fundamento etico y legal, incluyendo los mites y realidades que existen sobre el formato de consentimiento informado come recurso legal de protection. El consentimiento informado no es un formato establecido que los investigadores repliquen, se trata de que la praxis del PCI sea una tarea cotidiana dentro de la investigation con seres humanos, como comunicaciOn deliberative y critica, responsable y comprometida entre dos agentes morales, investigador-investigado.

Publication types

  • English Abstract
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Confidentiality
  • Ethics, Research*
  • Europe
  • Helsinki Declaration
  • Human Experimentation / ethics*
  • Human Experimentation / legislation & jurisprudence
  • Human Experimentation / standards
  • Humans
  • Informed Consent* / ethics
  • Informed Consent* / legislation & jurisprudence
  • Informed Consent* / standards
  • International Agencies
  • Personal Autonomy
  • Research Subjects / legislation & jurisprudence
  • Research Subjects / psychology
  • Spain