Protecting boundaries of consent in clinical research: Implications for improvement

Shirley T. Bristol, Rodney W. Hicks

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)16-27
Number of pages12
JournalNursing Ethics
Volume21
Issue number1
DOIs
StatePublished - Feb 2014

ASJC Scopus Subject Areas

  • Issues, ethics and legal aspects

Keywords

  • Clinical research
  • informed consent
  • quality improvement

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