McNeill P M
School of Community Medicine, University of New South Wales, High Street, Kensington.
Med J Aust. 1989 Mar 6;150(5):264-8, 271. doi: 10.5694/j.1326-5377.1989.tb136461.x.
The New Zealand Cervical Cancer Inquiry established that patients with carcinoma-in-situ were left untreated in order to observe the natural history of their disease. Many patients developed invasive carcinoma unnecessarily and some died. The Inquiry found the research to have been unethical in that: the risk of progression to invasive carcinoma was known; the subjects had not consented to such study; and the study was designed and conducted poorly. The Inquiry was critical of the lack of proper review and the failure of responsible doctors and administrators to intervene in the interests of the patients. This article considers reasons for this failure and background issues of ethics and law. It is concluded that there is no cause for complacency in Australia in that provisions that are designed to protect patients may be ineffective. The NZ recommendations for changes in communication with patients, in the treatment of patients, in reviews of research, and in the training of doctors should be examined for their possible adoption in Australia.
新西兰宫颈癌调查发现,原位癌患者未得到治疗,以便观察其疾病的自然发展过程。许多患者不必要地发展成了浸润性癌,一些患者死亡。调查发现该研究不道德,原因如下:已知有发展为浸润性癌的风险;受试者未同意参与此类研究;研究设计和实施不佳。调查批评了缺乏适当审查,以及负责的医生和管理人员未能为患者利益进行干预。本文探讨了这种失败的原因以及伦理和法律的背景问题。结论是,澳大利亚没有理由自满,因为旨在保护患者的规定可能无效。应该研究新西兰在与患者沟通、患者治疗、研究审查和医生培训方面提出的变革建议,看是否有可能在澳大利亚采用。