The impact of HIPAA authorization on willingness to participate in clinical research
The impact of HIPAA authorization on willingness to participate in clinical research
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DOI：
10.1016/j.annepidem.2007.05.006
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发表时间：
2007-11-01
影响因子：
5.6
通讯作者：
Dunlop, Boadie
中科院分区：
文献类型：
--
作者：
Dunlop, Anne L.;Graham, Tracie;Dunlop, Boadie
目的：本研究系统地考察了纳入《健康保险可携带性与责任法案》（HIPAA）授权对具有不同社会人口特征的非裔美国人参与临床研究意愿的影响，并探讨了不参与的原因。方法：从2005年8月到2006年5月，对384名非裔美国门诊患者进行有目的的抽样，比较他们在两种实验条件下参与抗高血压药物的假设临床研究的意愿。受访者随机分为单独知情同意组（对照组）和HIPAA授权知情同意组（HIPAA组）。他们被问及他们是否会参加以及他们决定的原因。结果：HIPAA组中愿意参加研究的受访者比例较小（27% vs. 39%; p = 0.02），调整后的优势比为0.56（95%可信区间= 0.36-0.91）。HIPAA组的人更有可能给出与隐私相关的原因（p < 0.001），对表格的理解不足（p = 0.01），以及不信任或害怕研究（p = 0.04）。结论：在知情同意过程中纳入HIPAA授权可能会对非裔美国人参与临床研究的意愿产生不利影响，并可能引起对隐私、对表格的理解以及对研究的不信任或恐惧的担忧。
PURPOSE: This study systematically examined the impact of inclusion of Health Insurance Portability and Accountability Act (HIPAA) authorization on the willingness of African Americans of diverse sociodemographic characteristics to participate in a clinical research study and explored reasons for nonparticipation.METHODS: For a purposive sample of 384 African American outpatients at four metropolitan primary care clinics from August 2005 through May 2006, willingness to participate in a hypothetic clinical research study of an antihypertensive medication under one of two experimental conditions was compared. Interviewees were randomly assigned to undergo informed consent alone (control group) or informed consent with HIPAA authorization (HIPAA group). They were asked whether they would participate and reasons for their decisions.RESULTS: A smaller proportion of interviewees in the HIPAA group were willing to enroll in the study (27% vs. 39%; p = 0.02), with an adjusted odds ratio of 0.56 (95% confidence interval = 0.36-0.91). Those in the HIPAA group were more likely to give reasons related to privacy (p < 0.001), poor understanding of the form (p = 0.01), and mistrust or fear of research (p = 0.04) for nonparticipation.CONCLUSIONS: The inclusion of HIPAA authorization within the informed consent process may adversely affect the willingness of African Americans to participate in clinical research and may raise concerns about privacy, understanding the forms, and mistrust or fear of research.