Kennedy B J
J Bioeth. 1984 Spring-Summer;5(1):27-32. doi: 10.1007/BF01103644.
The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board (IRB) are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of the clinical investigator.
旨在保护人类受试者的知情同意和人体研究监督概念值得称赞。机构审查委员会（IRB）的规定正在对临床癌症研究产生重大影响。研究者需要更多的行政时间，患者护理机制变得繁琐，一些患者拒绝可能挽救生命的选择性医疗管理。IRB规定必须灵活，以满足人类受试者以及临床研究者的需求。
