Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?
Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?
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DOI：
10.2310/6650.2006.05031
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发表时间：
2006-05-01
影响因子：
2.6
通讯作者：
Breault, Joseph
中科院分区：
文献类型：
--
作者：
Krousel-Wood, Marie;Muntner, Paul;Breault, Joseph
背景资料：要求书面知情同意的最低风险surveillance.Methods：数据从一个横断面调查的177名老年患者（87名黑人和90名白人）与高血压登记在管理式医疗保险风险产品被用来评估参与率前和放弃后的书面知情同意书和健康保险便携性和责任法案（HIPAA）授权。在获得豁免之前，我们通过邮件两次联系患者，并附上介绍信和知情同意文件。对填写并返还知情同意书的受试者进行问卷调查。6周后，从机构审查委员会获得书面知情同意书和HIPAA授权的豁免。非参与者被再次接触并要求完成问卷。结果：参与率从豁免前的21.5%增加到豁免后的57.4%（p = 75岁（28.4%）vs < 75岁（14.6%; p= 0.025））。相比之下，豁免后的参与率在种族、性别或年龄亚组之间没有显著差异。在每个人口统计学亚组中，从豁免前到豁免后，参与率显著增加（所有P
Background: Requiring written informed consent for a minimal-risk survey may result in limited participation rates.Methods: Data from a cross-sectional survey of 177 older patients (87 blacks and 90 whites) with hypertension enrolled in the managed care Medicare risk product were used to assess participation rates pre- and postwaiver of written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. Prior to the waivers being granted, patients were contacted two times via mail with an introductory letter and an informed consent document. Those who completed and returned the informed consent document were administered the questionnaire. After 6 weeks, a waiver of written informed consent and HIPAA authorization was obtained from the Institutional Review Board. Nonparticipants were reapproached and asked to complete the questionnaire. Participation rates were recorded before and after receiving the waivers.Results: Participation rates increased from 21.5% in the prewaiver period to 57.4% in the postwaiver period (p = 75 years old (28.4%) versus < 75 years old (14.6%; p=.025). In contrast, the postwaiver participation rate did not differ significantly across race, gender, or age subgroupings. Significant increases in participation rates from the pre- to the postwaiver time period were noted within each demographic subgroup (all p