Institutional review boards' use and understanding of certificates of confidentiality.
Institutional review boards' use and understanding of certificates of confidentiality.
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DOI：
10.1371/journal.pone.0044050
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Wolf LE
中科院分区：
文献类型：
--
作者：
Beskow LM;Check DK;Namey EE;Dame LA;Lin L;Cooper A;Weinfurt KP;Wolf LE
由美国政府机构颁发的保密证书被视为履行道德和法律的义务以保护研究参与者隐私和保密性的重要工具。通过防止强制披露识别数据，证书旨在促进对公众健康至关重要的敏感主题的研究。虽然证书有可能适用于广泛的研究，但其全部法律的效力尚不清楚，利益相关者对其提供的保护的看法也知之甚少。为了开始应对这一挑战，我们对机构审查委员会（IRB）主席进行了一次全国性调查，随后对选定的主席进行了电话采访，以了解更多关于他们对证书的熟悉程度和意见;他们的机构使用证书;关于何时需要或推荐证书的政策和实践;以及证书在评估研究风险中的作用。总的来说，我们的研究结果表明IRB主席之间的证书的不确定性。在大多数客观知识问题上，大多数受访者选择了错误答案或“不确定”。在报告更熟悉证书的主席中，基于五个调查问题计算的综合意见得分均匀分布在积极，中立/中间和消极的观点中。此外，受访者对证书的适当使用、证书的保护目的及其对研究风险的影响表达了各种想法。尽管如此，参与我们研究的主席通常将证书视为一种潜在的有价值的工具，经常将其描述为“额外的保护层”。这些调查结果导致了一些实际的意见，需要更多的利益相关者的教育证书，考虑证书的更广泛的研究，保持警惕，并利用所有可用的工具，以保护参与者的机密性的重要性，并需要进一步的实证调查证书对研究人员和研究参与者的影响。
Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants’ privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public’s health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders’ views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions’ use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or ‘unsure’. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an ‘extra layer’ of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants’ confidentiality, and the need for further empirical investigation of Certificates’ effect on researchers and research participants.
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影响因子：
2
作者：
Hoagwood, Kimberly
通讯作者：
Hoagwood, Kimberly
DOI：
10.2307/3563582
发表时间：
2004-01-01
期刊：
IRB
影响因子：
--
作者：
Wolf, Leslie E;Zandecki, Jola;Lo, Bernard
通讯作者：
Lo, Bernard
DOI：
10.1089/gte.2004.8.214
发表时间：
2004-06-01
期刊：
GENETIC TESTING
影响因子：
--
作者：
Cooper, ZN;Nelson, RM;Ross, LF
通讯作者：
Ross, LF
影响因子：
158.5
作者：
Campbell, Eric G.;Weissman, Joel S.;Koski, Greg
通讯作者：
Koski, Greg
DOI：
10.2307/3564529
发表时间：
2005-09-01
期刊：
IRB
影响因子：
--
作者：
Currie, Peter M
通讯作者：
Currie, Peter M