Informed consent process in clinical trials: Insights of researchers, patients and general practitioners

Nuria Giménez, David Pedrazas, Susana Redondo, Salvador Quintana

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)

Abstract

© 2015 Elsevier España, S.L.U. 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. Design A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. Setting GPs, researchers and patients involved in clinical trials. Participants 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.
Original languageEnglish
Pages (from-to)518-526
JournalAtencion Primaria
Volume48
DOIs
Publication statusPublished - 1 Oct 2016

Keywords

  • Bioethics
  • Clinical trials
  • Informed consent
  • Perceptions
  • Personal autonomy
  • Primary health care

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