psychology

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.
Introduction
The quality of patient care delivery, to a large degree, now depends on Evidence-Based Practice (EBP). As part of professional responsibilities, many nurses participate in clinical research within institutions to increase the sufficiency of evidence on which to improve practice.
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Clinical research studies, including nursing research studies, may occur in any healthcare setting. When participating in the research process, nurses, along with other healthcare professionals, need to understand the ethical and legal concerns and advocate for the protection of potentially vulnerable human research participants.
Informed consent in clinical research is essential.
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Informed consent is a legal and ethical prerequisite for clinical research.
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The principles of informed consent allow potential research participants to make an informed and voluntary choice whether to participate, or not. Essentially, informed consent represents permission to intervene in a person’s private sphere.
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Informed consent serves to promote public confidence in the integrity of research, critical to processes of research funding and participation, and the resultant new treatments and interventions.
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One aspect of ethical research is to clarify how consent providers conduct the informed consent procedure.
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Information concerning this process is necessary to determine