Parent perspectives on consent for the linkage of data to evaluate vaccine safety: A randomised trial of opt-in and opt-out consent
Parent perspectives on consent for the linkage of data to evaluate vaccine safety: A randomised trial of opt-in and opt-out consent
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DOI：
10.1177/1740774513480568
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发表时间：
2013-06-01
期刊：
影响因子：
2.7
通讯作者：
Gold, Michael S.
中科院分区：
文献类型：
--
作者：
Berry, Jesia G.;Ryan, Philip;Gold, Michael S.
背景我们研究了父母的同意偏好和对选择加入或选择退出邀请的理解，以参与儿童疫苗上市后安全性监测的数据链接。2009年在南澳大利亚一家医院出生的1129名婴儿的家庭在产后6周收到了信息，解释儿童免疫接种和疫苗安全监测医院记录的数据联系，有4周的时间通过回复表格、电话或电子邮件选择加入或退出。在产后10周，通过电话随访1026名（91%）父母。结果在选择加入（n = 564）和选择退出（n = 565）组中，五分之四的父母回忆起收到的信息（81%对83%，P = 0.35），五分之三的人报告阅读了它（63%对67%，P = 0.11），但只有五分之二的人正确识别了要链接的健康记录（43%对39%，P = 0.21）。主动同意（选择加入）的父母比被动同意（没有选择退出）的父母更有可能回忆起信息（100% vs. 83%，P < 0.001），报告阅读信息（94% vs. 67%，P < 0.001），并正确识别数据来源（60% vs. 39%，P < 0.001）。大多数家长支持疫苗安全监测的数据链接（94%），并信任其隐私保护（84%）。大多数父母希望有最小的或没有直接参与，宁愿选择退出同意（40%）或不同意（30%）。四分之一（24%）的家长表示应寻求选择性同意;其中，8%的家长在每次使用前都要求同意，5%的家长倾向于只给予一次广泛的同意，11%的家长倾向于定期更新。五分之三的父母更优先考虑快速疫苗安全性监测（61%），而不是首先征求父母同意（21%），七分之一的父母尚未决定（15%）。虽然91%的父母报告说，他们的婴儿是完全免疫（76%）或免疫不足（15%），并信任疫苗是安全的（90%），五分之三（62%）是非常或有点担心严重的反应。只有回忆和理解保留在1个月后enrollment.Conclusions本试验表明，知情同意，以人口为基础的监测计划不能现实地实现使用基于邮件的选择和选择退出的方法。虽然与被动同意（没有选择退出）的父母相比，主动同意（选择加入）的父母对研究目的的回忆和理解更好，但参与率却低得多（分别为21%和96%）。大多数家长似乎对疫苗安全性监测的数据关联了解不多;尽管如此，他们支持数据关联。他们更喜欢使用选择退出同意或不同意的系统，而不是使用选择加入同意的系统。
Background We examined parents' consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines.Methods A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance, with 4 weeks to opt in or opt out by reply form, telephone, or email. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview.Results In both the opt-in (n = 564) and opt-out arms (n = 565), four-fifths of the parents recalled receiving the information (81% vs. 83%, P = 0.35), three-fifths reported reading it (63% vs. 67%, P = 0.11), but only two-fifths correctly identified the health records to be linked (43% vs. 39%, P = 0.21). Parents who actively consented (opted in) were more likely than those who passively consented (did not opt out) to recall the information (100% vs. 83%, P < 0.001), report reading it (94% vs. 67%, P < 0.001), and correctly identify the data sources (60% vs. 39%, P < 0.001). Most parents supported data linkage for vaccine safety surveillance (94%) and trusted its privacy protections (84%). Most parents wished to have minimal or no direct involvement, preferring either opt-out consent (40%) or no consent (30%). A quarter (24%) of parents indicated opt-in consent should be sought; of these, 8% requested consent prior to every use, 5% preferred to give broad consent just once and 11% preferred periodic renewal. Three-fifths of the parents gave higher priority to rapid vaccine safety surveillance (61%) rather than first seeking parental consent (21%), and one in seven was undecided (15%). Although 91% of parents reported that their babies were fully immunised (76%) or under-immunised (15%), and trusted vaccines as safe (90%), three-fifths (62%) were very or somewhat concerned about serious reactions.Limitations The context of data linkage is limited to vaccine safety surveillance. Only recall and understanding retained at 1 month post enrolment were measured.Conclusions This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study's purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent.