Simplifying informed consent for biorepositories: Stakeholder perspectives
Simplifying informed consent for biorepositories: Stakeholder perspectives
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DOI：
10.1097/gim.0b013e3181ead64d
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发表时间：
2010-09-01
影响因子：
8.8
通讯作者：
Weinfurt, Kevin P.
中科院分区：
文献类型：
--
作者：
Beskow, Laura M.;Friedman, Joelle Y.;Weinfurt, Kevin P.
目的：在参与生物样本库的同意过程中必须传达复杂且有时有争议的信息，研究表明同意文件的长度和复杂性总体上正在增加。作为创建简化的生物样本库同意书的第一步，我们从多个利益相关者那里收集了数据，了解哪些信息对于潜在参与者在做出参与生物样本库的决定时最重要。方法：我们招募了来自北卡罗来纳州达勒姆和坎纳波利斯的 52 名研究参与者、12 名研究人员和 20 名机构审查委员会代表。这些受试者被要求阅读生物样本库同意书范本并突出显示他们认为最重要的句子。结果：平均而言，机构审查委员会代表认为 72.3% 的句子重要；研究人员选择了 53.0%，参与者选择了 40.4% (P = 0.0004)。参与者最常选择关于可能提供的个人研究结果类型、隐私风险和大规模数据共享的句子。研究人员强调了有关生物样本库的目的、隐私保护、成本以及参与者对个人结果的访问的句子。机构审查委员会代表强调了有关基本个人信息的收集、医疗记录访问和存储期限的句子。结论：这三个群体的不同任务可能会转化为关于哪些信息重要且适合纳入同意书的意见分歧很大。这些差异可能会阻碍将生物样本库和其他类型的研究的简化表格转化为实际使用的努力，尽管人们不断呼吁使用此类表格。基因医学 2010:12(9):567-572。
Purpose: Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. Methods: We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. Results: On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. Conclusion: The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms-for biobanking as well as for other kinds of research-into actual use, despite continued calls for such forms. Genet Med 2010:12(9):567-572.