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Human Subjects Protection and Federal Regulations of Clinical Trials
1Bio-Optronics Inc. Rochester NY.
Objectives:
To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant's informed consent, and the role the oncology clinical research nurse has within the clinical trial setting.
Data Sources:
Peer-reviewed journal articles, internet, book chapters, white papers.
Conclusion:
Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process.
Implications For Nursing Practice:
The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process.
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