Centre for Research Ethics & Bioethics, Department of Public Health and Caring Sciences, Uppsala University, Sweden.
Cancer Epidemiol. 2012 Dec;36(6):575-8. doi: 10.1016/j.canep.2012.06.009. Epub 2012 Jul 15.
Medical registries serve patients as beneficiaries of quality standards and new treatment opportunities. However, it has been argued that registries threaten patient privacy interests and should therefore be more strictly regulated.
With the European Treatment and Outcome Study for Chronic Myeloid Leukemia as a concrete example we identify and describe how four of the major arguments put forward for stricter regulation fail.
We conclude that medical registries should be promoted both for research and quality control, and that the regulatory bureaucratic burden should be reduced.
医学注册机构为患者提供质量标准和新治疗机会的受益方。然而,有人认为这些注册机构威胁到患者的隐私利益,因此应该受到更严格的监管。
以欧洲慢性髓系白血病治疗和结果研究为例,我们确定并描述了为加强监管而提出的四个主要论点中的四个论点是站不住脚的。
我们的结论是,应该促进医学登记处的发展,以进行研究和质量控制,同时减少监管官僚主义的负担。