临床研究最小风险的伦理争论

Ethical Controversy of Minimal Risk in Clinical Research

介绍了最小风险概念的伦理作用,阐述美国学者L.M.Kopelman对澳大利亚、加拿大、南非、美国及国际医学组织会理事的《涉及人的生物医学研究国际伦理准则》法规或伦理规章对于最小风险不同解读方式之分析及建议,最后论述Kopelman对最小风险概念的分析及建议的意义。

The ethical function of minimal risk and American scholar L. M. Kopelman＇ s idea is introduced. Kopelman reviewed some policies of Australia, Canada, South Africa, the U. S. , and CIOMS, and revealed different interpretations of ＂minimal risk＂ are untenable. At last, the implication of Kopelman＇s idea is discussed.