SciELO - Scientific Electronic Library Online

 
vol.20 issue2NEXT GENERATION SEQUENCING AND ITS EUGENICS CONTEXT IN THE HUMAN EMBRYOINFORMED CONSENT AS AN INCLUSION CRITERION. CONCEPTUAL CONFUSION, MANIPULATION, DISCRIMINATION OR COERCION? author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Article

Indicators

Related links

  • On index processCited by Google
  • Have no similar articlesSimilars in SciELO
  • On index processSimilars in Google

Share


Persona y Bioética

Print version ISSN 0123-3122

Abstract

CARRENO-DUENAS, José Alexander. INFORMED CONSENT IN CLINICAL RESEARCH: A DYNAMIC PROCESS. pers.bioét. [online]. 2016, vol.20, n.2, pp.232-243. ISSN 0123-3122.  http://dx.doi.org/10.5294/PEBI.2016.20.2.8.

In clinical research, informed consent is both a legal document and mechanism for respecting the dignity of participating subjects and protecting their rights and wellbeing. It should include information on the purpose of the research, its justification, and the risks and the benefits involved, so as to enable a subject to decide to participate voluntarily. Because it is the researcher's duty to ensure protection of the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of the subjects who take part in a study, the researcher must establish a permanent dialogue with them to assess the risks and safety inherent in their participation. This condition becomes a dynamic process that neither begins nor ends when informed consent is signed. It goes beyond legality and becomes a question of ethics and legitimacy.

Keywords : Informed consent; research subjects; human experimentation; controlled clinical trials; biomedical.

        · abstract in Spanish | Portuguese     · text in Spanish     · Spanish ( pdf )