加拿大多中心临床研究的伦理申请方案：儿科风湿病学经验
Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience.
作者信息
Matheson Loren A, Huber Adam M, Warner Aleasha, Rosenberg Alan M
机构信息
Department of Pediatrics, University of Saskatchewan; Saskatoon, Saskatchewan;
出版信息
Paediatr Child Health. 2012 Jun;17(6):313-6.
INTRODUCTION
Individual institutions govern research ethics applications and each must administer and regulate their own protocols. Variations in ethics review procedures and expectations among centres impose impediments to efficiently conducting multicentre studies.
METHODS
Observations relating to preparing multisite ethics documents for a study conducted by Canadian paediatric rheumatology investigators are described. Research ethics applications from the 12 participating centres were compared.
RESULTS
Although the applications were similar in their content, they differed in their formatting. All applications shared a commitment to ensuring that the study conformed to exemplary ethical standards.
CONCLUSIONS
There is wide variation in the multicentre clinical study ethics application process at the institutional level. Considering the common fundamental elements required by all ethics review boards, the present study conceptualized introducing a discipline-specific uniform ethics application process acceptable to all Canadian research ethics boards. This may be a more efficient strategy that could help lessen the burden of collaborative research.
引言
各个机构负责管理研究伦理申请，每个机构都必须管理和规范自己的方案。各中心之间伦理审查程序和期望的差异给高效开展多中心研究带来了阻碍。
方法
描述了与为加拿大儿科风湿病研究人员开展的一项研究准备多中心伦理文件相关的观察结果。对12个参与中心的研究伦理申请进行了比较。
结果
虽然申请内容相似，但格式不同。所有申请都承诺确保研究符合模范伦理标准。
结论
机构层面的多中心临床研究伦理申请流程差异很大。考虑到所有伦理审查委员会都需要的共同基本要素，本研究设想引入一个所有加拿大研究伦理委员会都能接受的特定学科统一伦理申请流程。这可能是一个更有效的策略，有助于减轻合作研究的负担。
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