title: Protecting boundaries of consent in clinical research: implications for improvement.
abstract: Successful clinical research outcomes are essential for improving patient care. Achieving this goal, however, implies an effective informed consent process for potential research participants. This article traces the development of ethical and legal requirements of informed consent and examines the effectiveness of past and current practice. The authors propose the use of innovative monitoring methodologies to improve outcomes while safeguarding consent relationships and activities. Additional rigorous research will help direct policy efforts at standardizing quality improvement processes.
authors.affiliation: Loma Linda University, USA.
authors.forename: Shirley T
authors.initials: ST
authors.lastname: Bristol
authors.forename: Rodney W
authors.initials: RW
authors.lastname: Hicks
mesh_terms: D000068456:Clinical Studies as Topic / Q000941:ethics*; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: Clinical research; informed consent; quality improvement