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Federal regulation of REB review of clinical trials: a modest but easy step towards an accountable REB review structure in Canada. 临床试验REB审查的联邦法规:加拿大向负责任的REB审查结构迈出的温和但容易的一步。
Pub Date : 2005-01-01
Trudo Lemmens
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引用次数: 0
The long arm of administrative law: applying administrative law principles to research ethics boards. 行政法的长臂:行政法原则在研究伦理委员会中的应用。
Pub Date : 2005-01-01
Michael Hadskis, Peter Carver
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引用次数: 0
A cultural understanding of research ethics governance. 研究伦理治理的文化理解。
Pub Date : 2005-01-01
Fern Brunger, Michael Burgess
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引用次数: 0
Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions. 横跨49度纬线的研究伦理:加拿大研究机构试行“同等保护”的潜在价值。
Pub Date : 2005-01-01
James V Lavery, Michael McDonald, Eric M Meslin

Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.

加拿大和美国拥有世界上最大的贸易伙伴关系,两国对共同行业不同的监管方式日益感到担忧。加拿大的研究机构从美国国立卫生研究院获得的研究经费比其他任何国家都多,其中大部分用于资助两国之间的多中心和合作研究。由于这些密切的经济和研究联系,以及两国在审查和监督人类受试者研究伦理方面的广泛相似之处,我们建议加拿大将是一个理想的国家,可以对“等效保护”的可行性进行试点测试,这是一项美国法规,允许比较两国机构对人类受试者的保护。美国的许多机构都提倡“同等保护”,认为这是一种潜在的有益机制,可以改善对外国审判的监督。同样,我们认为,“同等保护”可以在五个具体方面证明对加拿大有价值:(1)通过潜在地减轻管理美国联邦研究经费的加拿大研究机构的行政负担;(2)通过创造美国明确承认的象征价值,即加拿大研究机构通常遵循的保护人类受试者的程序至少相当于美国法规所规定的程序;(3)降低在加拿大投资研究的机会成本;(4)为加拿大提供一个机会,以加强其在国际研究中的领导作用,为保护人类受试者提供美国监管模式的替代方案;(5)为由加拿大机构资助但在其他国家进行的研究如何解决同等保护的问题提供一个模型。
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引用次数: 0
Electronic health records as a threat to privacy. 电子健康记录对隐私的威胁。
Pub Date : 2005-01-01
Glenn Griener
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引用次数: 0
Evidence-based practice of research ethics review? 研究伦理审查的循证实践?
Pub Date : 2005-01-01
Brenda Beagan, Michael McDonald
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引用次数: 0
A practitioner's response to the Final Report of the Select Special Health Information Act Review Committee. 从业者对特别健康信息法案审查委员会最终报告的回应。
Pub Date : 2005-01-01
Mat Rose
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引用次数: 0
Research governance, bio-politics and political will: recent lessons from Newfoundland and Labrador. 研究管理、生物政治和政治意愿:来自纽芬兰和拉布拉多的最新经验。
Pub Date : 2005-01-01
Daryl Pullman
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引用次数: 0
Commentary: an independent voice?: conflicts of interest and research on ethical, legal and social issues. 评论:一个独立的声音?:利益冲突和伦理、法律和社会问题的研究。
Pub Date : 2005-01-01
Timothy Caulfield
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引用次数: 0
The constitutionality of mandatory reporting of gunshot wounds legislation. 枪伤强制报告立法的合宪性。
Pub Date : 2005-01-01
Wayne Renke
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引用次数: 0
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Health law review
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