title: Patients' perception of the informed consent process for neurooncology clinical trials.
abstract: The informed consent process is a cornerstone of modern medical research. This study was conducted to explore the process in the context of neurooncology clinical trials. Qualitative methodology and analysis were used on open-ended, face-to-face interviews conducted with 21 patients. Six comprehensive themes emerged: (1) general understanding of the objectives and purpose of clinical trials was good, (2) recall of risks was low, (3) patients did not believe that their care would be compromised by forgoing the clinical trial, (4) patients felt participation was voluntary and free of coercion, (5) patients would not have withdrawn from the trial in the event of complications, and (6) patients were satisfied with the informed consent process. Informed consent is a dynamic process; when appropriately executed, it can be a powerful safeguard protecting patient autonomy. If sufficient time is allowed to deliberate participation and ample opportunity is provided for information sharing and disclosure, researchers can be confident that participants are knowledgeable about the trial and aware of their rights.
authors.affiliation: Division of Neurosurgery, Toronto Western Hospital, University Health Network, University of Toronto, Ontario, Canada.
authors.forename: Eva
authors.initials: E
authors.lastname: Knifed
authors.forename: Nir
authors.initials: N
authors.lastname: Lipsman
authors.forename: Warren
authors.initials: W
authors.lastname: Mason
authors.forename: Mark
authors.initials: M
authors.lastname: Bernstein
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D032882:Comprehension; D030881:Disclosure; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology* / Q000592:standards; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D010465:Perception; D035842:Research Subjects / Q000523:psychology*; D036302:Therapeutic Human Experimentation / Q000941:ethics