Abstract

CORONADO-VAZQUEZ, Valle  and  CEREZO-ESPINOSA-DE-LOS-MONTEROS, Javier. Zelen consent and patient autonomy: a narrative review. Rev. Bioética y Derecho [online]. 2017, n.39, pp.179-197.  Epub Nov 02, 2020. ISSN 1886-5887.

Obtaining informed consent (CI) prior to the inclusion of participants in a clinical trial is an ethical- legal requirement. In the Zelen design randomization of subjects is prior to the application for consent to participate.

In this review the studies with random of Zelen are described and analyzed according to the established in Spain by the Law 41/2002 Basic of Autonomy of the Patient, the RD 1090/2015 and the Law 14/2007 of Biomedical Investigation.

78 studies were found and 23 were selected. 61% was a "double assent". In 17,3% there was justifying itself the use of this consent because it was increasing the patients' recruitment.

Zelen's design has several ethical limitations. In the studies analysed are no clear arguments for his utilization.

Keywords : Zelen design; pre-randomization; randomized controlled trial.

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