Center for Genome Ethics, Law & Policy, Duke Institute for Genome Sciences & Policy, Duke University, Durham, North Carolina 27708, USA.
Genet Med. 2010 Sep;12(9):567-72. doi: 10.1097/GIM.0b013e3181ead64d.
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.
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.
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.
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.
在参与生物库的过程中，必须传达复杂且有时存在争议的信息，并且研究表明，一般来说，同意书的篇幅和复杂性都在增加。作为创建简化生物库同意书的第一步，我们从多个利益相关者那里收集了数据，了解当参与者决定参与生物库时，哪些信息对他们最重要。
我们从北卡罗来纳州达勒姆和卡诺普斯招募了 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一份模型生物库同意书，并突出他们认为最重要的句子。
平均而言，机构审查委员会代表确定了 72.3%的重要句子；研究人员选择了 53.0%，参与者选择了 40.4%（P = 0.0004）。参与者最常选择的句子是关于可能提供的个人研究结果的种类、隐私风险和大规模数据共享。研究人员强调了关于生物库目的、隐私保护、成本以及参与者获取个人结果的句子。机构审查委员会代表强调了关于收集基本个人信息、访问医疗记录和存储期限的句子。
这三个群体的不同任务可能会导致对哪些信息重要和适合包含在同意书中产生广泛的分歧。尽管人们不断呼吁使用这种表格，但这些差异可能会阻碍简化表格——无论是用于生物库还是其他类型的研究——的实际使用。
