[Ethics and laws related to human subject research].
Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.
Department of Nursing, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan, ROC. joychiu@ntunhs.edu.tw
Hui-Ju
HJ
Chiu
Ya-Ling
YL
Lee
Su-Fen
SF
Chang
D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006801:Humans