Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.
Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.
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DOI：
10.1186/1472-6939-9-17
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发表时间：
2008-11-14
影响因子：
2.7
通讯作者：
Willison DJ
中科院分区：
文献类型：
--
作者：
Gibson E;Brazil K;Coughlin MD;Emerson C;Fournier F;Schwartz L;Szala-Meneok KV;Weisbaum KM;Willison DJ
在过去的十年里，利用健康信息的研究数量急剧增加。许多机构多年来为临床和教学目的收集了大量的生物库，但不确定在什么情况下允许研究使用这些样本。加拿大和世界其他地方的研究伦理委员会(REB)正在努力解决这些问题，但对于它们在创建和访问登记册和生物库方面的作用缺乏明确的指导。采访了加拿大大学附属于医学院的34个REB主席和/或REB管理人员。访谈包括涉及糖尿病相关情景的结构化问题，以及开放式回答和探索理由。这两个方案涉及使用几个医生诊所的临床遭遇数据建立糖尿病登记处，以及向登记处添加生物样本以创建生物库。对情景中提出的问题作出了广泛的答复，这表明对登记处和生物库的作用不够清楚。关于设立登记处，少数网站认为，将信息输入登记处不需要征得同意。是否需要患者同意才能将信息输入登记处，以及同意将在多长时间内生效，各地点有所不同。关于建立与登记处有关的生物库的问题，大多数网站认为生物库信息与其他类型的个人健康信息有质的区别。所有受访者都同意，将血液样本放入生物库需要征得患者的同意，但同意的持续时间也各不相同。与登记处相比，与会者对围绕生物库的问题更加熟悉，并对生物库表现出更高程度的关切。随着登记册和生物库的扩大，需要对REB的适当作用进行批判性分析，并就这些主题提供后续指导。最后，作者建议REB参与建立登记册和生物库，并最终起草全面的立法。
The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.