General clinical research center staff nurse perceptions and behaviors regarding informed consent: results of a national survey.
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Le résumé fourni par la source
Informed consent is a critical component for ethically conducted human subjects research.' Empirical research has suggested that often subjects have a poor understanding of a research study's intended purpose and of their rights as participants.2 However, the extent to which problems with informed consent are identified by study personnel are unclear, as is how these personnel act to rectify these problems. Although several stakeholders are involved in clinical research-including investigators, research nurses, study coordinators, and research assistants-little research has been performed to determine how any of these stakeholders view the effectiveness of the informed consent process. To further explore these issues, we conducted a national survey of General Clinical Research Center (GCRC) staff nurses to determine their attitudes, perceptions, and behaviors regarding the informed consent process. GCRCs are specialized facilities that promote clinical research by conducting both inpatient and outpatient studies.3 GCRC staff nurses monitor research participants at the bedside and help operationalize research protocols. Because GCRC staff nurses have frequent contact with numerous participants involved in study protocols of various types, they represent a unique and well-qualified group to survey regarding the informed consent process.
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