Clark Georgina, Lipworth Wendy, Les Bokey, Little J M, Kerridge Ian H
Centre for Values Ethics and the Law in Medicine, Blackburn Building DO6, University of Sydney, NSW 2006, Australia.
J Law Med. 2006 Aug;14(1):102-9.
Collections of tumour samples can be an invaluable resource for medical research. There are, however, numerous ethical and legal challenges associated with tumour banking. While there has been extensive discussion of these issues in the legal and ethical literature, there are few available empirical data in relation to the activities of tumour banks in Australia, their practices around ethically charged issues, and their success in implementing complex regulatory guidelines. The aim of this study was to gain more information about the activities of tumour banks in New South Wales, Australia, with a particular focus on their management of, and attitudes towards, ethical and regulatory issues. A survey of 27 tumour collection and research facilities was conducted using a 55-item questionnaire. There is significant heterogeneity of research methodologies as well as of methods for gaining consent and ensuring donor privacy, and there is general concern among the research community about ethical and regulatory issues related to tumour banking. Heterogeneity of practice and uncertainty about ethical and regulatory requirements is problematic in its potential to hinder research and its potential to generate the space for unethical practice, whether intentional or unintentional. There is a pressing need to address these issues so that tumour banks can be used in the most ethical and efficient way possible.
肿瘤样本的收集对于医学研究而言可能是一项极为宝贵的资源。然而，肿瘤样本库存在诸多伦理和法律方面的挑战。尽管法律和伦理文献中已对这些问题进行了广泛讨论，但关于澳大利亚肿瘤样本库的活动、其在涉及伦理问题方面的做法以及在实施复杂监管指南方面的成效，现有的实证数据却很少。本研究的目的是获取更多有关澳大利亚新南威尔士州肿瘤样本库活动的信息，尤其关注其对伦理和监管问题的管理及态度。我们使用一份包含55个条目的问卷对27个肿瘤样本收集和研究机构进行了调查。研究方法以及获取同意和确保捐赠者隐私的方法存在显著的异质性，而且研究界普遍关注与肿瘤样本库相关的伦理和监管问题。实践中的异质性以及伦理和监管要求的不确定性，有可能阻碍研究，也有可能为有意或无意违反伦理的行为创造空间，这是个问题。迫切需要解决这些问题，以便能以最符合伦理且高效的方式利用肿瘤样本库。
