Zelen consent and patient autonomy: a narrative review

Authors

  • Valle Coronado Vázquez Servicio Aragonés de Salud
  • Javier Cerezo Espinosa de los Monteros Agencia de Calidad Sanitaria de Andalucía

DOI:

https://doi.org/10.1344/rbd2017.39.17721

Keywords:

Zelen design, pre-randomization, randomized controlled trial

Abstract

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.

Author Biographies

Valle Coronado Vázquez, Servicio Aragonés de Salud

Médico de familia en el Servicio Aragonés de Salud. Coordinadora del Centro de Salud de Andorra (Teruel, España).

Javier Cerezo Espinosa de los Monteros, Agencia de Calidad Sanitaria de Andalucía

Médico especialista en Medicina Preventiva y Salud Pública. Agencia de Calidad Sanitaria de Andalucía (Sevilla, España).

How to Cite

Coronado Vázquez, V., & Cerezo Espinosa de los Monteros, J. (2017). Zelen consent and patient autonomy: a narrative review. Revista De Bioética Y Derecho, (39), 179–197. https://doi.org/10.1344/rbd2017.39.17721

Issue

Section

From the master