title: [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].
abstract: OBJECTIVE
  Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP.
  
  
  METHODS
  A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports.
  
  
  METHODS
  GPs, researchers and patients involved in clinical trials.
  
  
  METHODS
  Included, 504 GPs, 108 researchers, and 71 patients.
  
  
  RESULTS
  Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection.
  
  
  CONCLUSIONS
  GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.
authors.affiliation: Unidad de Investigación, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Comité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Laboratorio de Toxicología, Universitat Autònoma de Barcelona, España. Electronic address: nuria.gimenez@uab.cat.
authors.forename: Nuria
authors.initials: N
authors.lastname: Giménez
authors.affiliation: Unidad de Investigación, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España; ABS Abrera, Direcció d'Atenció Primària Costa de Ponent, Institut Català de la Salut, Barcelona, España; Departamento de Medicina, Universitat Autònoma de Barcelona, Barcelona, España.
authors.forename: David
authors.initials: D
authors.lastname: Pedrazas
authors.affiliation: Comité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Servicio de Farmacia, Hospital Universitari Mútua Terrassa, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España.
authors.forename: Susana
authors.initials: S
authors.lastname: Redondo
authors.affiliation: Comité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España.
authors.forename: Salvador
authors.initials: S
authors.lastname: Quintana
mesh_terms: D002986:Clinical Trials as Topic; D032882:Comprehension; D003430:Cross-Sectional Studies; D058005:General Practitioners; D006801:Humans; D007258:Informed Consent; D012108:Research Personnel
keywords: Atención Primaria; Bioethics; Bioética; Clinical trials; Consentimiento informado; Ensayos clínicos; Informed consent; Percepciones; Perceptions; Personal autonomy; Primary health care; Principio de autonomía