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研究参与者对保密证书的保障措施及局限性的看法。

Research Participants' Perceptions of the Certificate of Confidentiality's Assurances and Limitations.

作者信息

Catania Joseph A, Wolf Leslie E, Wertleib Stacey, Lo Bernard, Henne Jeff

机构信息

Oregon State University.

出版信息

J Empir Res Hum Res Ethics. 2007 Dec;2(4):53-9. doi: 10.1525/jer.2007.2.4.53.

DOI:10.1525/jer.2007.2.4.53
PMID:19385807
Abstract

THE CERTIFICATE OF CONFIDENTIALITY (COC) provides additional protections to personal and sensitive research data. COC guarantees are not absolute and investigators are obligated to inform potential participants of COC limitations. The present study utilized qualitative and partnership methodology to examine participants' (N = 24) perceptions of COC assurances and limitations in the context of a hypothetical study on depression. Although some participants were comforted by COC assurances, a majority of participants had confidentiality/privacy concerns specifically with COC passages concerning federal audits and legal reporting requirements. As one respondent noted, "Why is it that you guys don't have to turn the records over to the court unless I say so . . . but you have to give them over to the government? . . . I don't know about what is goin' on." Our findings underscore the need for larger quantitative investigations to examine the negative and positive impact of COCs on research participation and response bias.

摘要

保密证书(COC)为个人和敏感研究数据提供了额外保护。COC的保障并非绝对,研究人员有义务告知潜在参与者COC的局限性。本研究采用定性和合作方法,在一项关于抑郁症的假设研究背景下,考察了参与者(N = 24)对COC保障措施及其局限性的看法。尽管一些参与者因COC保障措施而感到安心,但大多数参与者对COC中有关联邦审计和法律报告要求的条款存在保密/隐私担忧。正如一位受访者所说:“为什么你们在未经我同意的情况下不必将记录交给法庭……但却必须交给政府?……我不明白这是怎么回事。”我们的研究结果强调,需要进行更大规模的定量调查,以研究COC对研究参与度和回应偏差的消极和积极影响。

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