The ethical foundation of informed consent in clinical research.
OBJECTIVE
To provide a foundation for understanding the ethical concept of informed consent with particular emphasis on the characteristics and principles that make it a moral imperative.


METHODS
Government reports, published articles, and book chapters from the ethics literature.


CONCLUSIONS
Informed consent is central to the conduct of cancer clinical trials and good patient care. It is a thoughtful, collaborative process whereby an individual gives autonomous authorization and the decision of the individual is respected by the health professionals.


CONCLUSIONS
Understanding the theory and practice of informed consent is an essential aspect of the nurses role. There are many challenges to this process in the oncology setting because of the severity of the diseases and the complexity of the research, and nurses must be prepared to assure that informed decision-making takes place.
McCabe
M S
MS
Office of Clinical Research Promotion, National Cancer Institute, Bethesda, MD 20892, USA.
D002986:Clinical Trials as Topic / Q000592:standards*; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D009859:Oncology Nursing; D012106:Research / Q000592:standards*; D014481:United States