Research ethics: From principles to practical aspects

Gonzalo Solis Sánchez; Guillermo Alcalde Bezhold; Iciar Alfonso Farnós

doi:10.1016/j.anpede.2023.06.016

Research ethics: From principles to practical aspects

An Pediatr (Engl Ed). 2023 Sep;99(3):195-202. doi: 10.1016/j.anpede.2023.06.016. Epub 2023 Aug 17.

Authors

Gonzalo Solis Sánchez¹, Guillermo Alcalde Bezhold², Iciar Alfonso Farnós³

Affiliations

¹ Hospital Universitario Central de Asturias, Universidad de Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain. Electronic address: gsolis@telefonica.net.
² CEI OSI Araba, Universidad del País Vasco, Servicio de Nefrología, Hospital Universitario Araba, Vitoria, Vizcaya, Spain.
³ Comité de Ética de la Investigación de Euskadi, Asociación Nacional de Comités de Ética en Investigación, Vitoria, Vizcaya, Spain.

PMID: 37598083
DOI: 10.1016/j.anpede.2023.06.016

Abstract

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity.

Keywords: Data protection; Ethics; Investigación; Legislación; Legislation; Protección de datos; Research; Ética.