Public perspectives on consent for the linkage of data to evaluate vaccine safety

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• 作者：Jesia G. Berry^a ; ^b ; ^{Jesia.Berry@adelaide.edu.au} ; Michael S. Gold^b ; Philip Ryan^a ; Katherine M. Duszynski^b ; Annette J. Braunack-Mayer^c ; For the Vaccine Assessment Using Linked Data (VALiD) Working Group¹
• 关键词：ACIR ; Australian Childhood Immunisation Register ; ACT ; Australian Capital Territory ; AEFI ; Adverse Events Following Immunisation ; CATI ; computer-assisted telephone interviewing ; CDC ; Centers for Disease Control and Prevention ; CI ; confidence interval ; IRS
• 刊名：Vaccine
• 出版年：2012
• 期刊代码：89_0264410x
• 类别：imm
• 出版时间：13 June, 2012
• 卷：30
• 期：28
• 页码：4167-4174
• 文件大小：251 K

摘要

Introduction

We sought community opinion on consent alternatives when linking childhood immunisation and hospital attendance records for the purpose of vaccine safety surveillance.

Methods

We conducted computer-assisted telephone interviewing (CATI) of a sample of rural and metropolitan residents of South Australia in 2011.

Results

Of 2002 households interviewed (response rate 55.6%), 96.4%supported data linkage for postmarketing surveillance of vaccines; very few were completely opposed (1.5%) or undecided (2.2%). The majority (75.3%) trusted the privacy protections used in data linkage and most wished to have minimal or no direct involvement, preferring either opt-out consent (40.4%) or no consent (30.6%). A quarter of respondents (24.6%) favoured opt-in consent, but their preferences were divergent; half requested consent be sought prior to every use (11.4%) while the remainder preferred to give broad consent just once (3.4%) or renewed at periodic intervals (9.8%). Over half of the respondents gave higher priority to rapid vaccine safety surveillance (56.5%) rather than first seeking parental consent (26.6%) and one in seven was undecided (14.5%). Although 91.6%of respondents believed childhood vaccines are safe, over half (53.1%) were very or somewhat concerned that a vaccine could cause a serious reaction. Nevertheless, 92.4%of the parents in the sample (556/601) reported every child in their care as being fully immunised according to the National Immunisation Program schedule. Only 3.7%of parents (22/601) reported one or more children as under immunised, and 3.9%(23/601) reported that none of their children were immunised.

Conclusions

This survey demonstrates that data linkage for vaccine safety surveillance has substantial community support and that a system utilising opt-out consent or no consent was preferred to one using opt-in consent. These findings should inform public health policy and practice; data linkage should be established where feasible to address limitations in passive surveillance systems.