General Management of Information Systems, Agency for Health Plans and Insurance (ANS), Av. Augusto Severo, 84, 10°. Andar, Glória, Rio de Janeiro, Rio de Janeiro 22021040, Brazil.
J Med Ethics. 2012 Oct;38(10):639-42. doi: 10.1136/medethics-2011-100208. Epub 2012 Mar 8.
Record linkage is a useful tool for health research. Potential benefits aside, its use raises discussions on privacy issues, such as whether a written informed consent for access to health records and linkage should be obtained. The authors aim to systematically review studies that assess consent proportions to record linkage.
8 databases were searched up to June 2011 to find articles which presented consent proportions to record linkage. The screening, eligibility and inclusion of articles were conducted by two independent reviewers. The authors carried out meta-regression, subgroup and sensitivity analyses to assess heterogeneity.
Of the 141 studies identified, only 11 presented empirical consent proportions and were included in the systematic review. The consent proportion varied widely from 39% to 97%. Seven studies presented consent proportions of 88% or higher, one of 72%, and only three presented consented proportion equal to or lower than 53%. None of the studies' characteristics evaluated explained heterogeneity.
The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data.
记录链接是健康研究的有用工具。除了潜在的好处之外，它的使用还引发了关于隐私问题的讨论，例如是否应该获得书面同意以获取健康记录和链接。作者旨在系统地回顾评估记录链接同意比例的研究。
截至 2011 年 6 月，8 个数据库被搜索以查找呈现记录链接同意比例的文章。文章的筛选、合格性和纳入由两名独立审查员进行。作者进行了荟萃回归、亚组和敏感性分析，以评估异质性。
在确定的 141 项研究中，只有 11 项提出了实证同意比例，并纳入了系统综述。同意比例差异很大，从 39%到 97%不等。有 7 项研究提出了 88%或更高的同意比例，1 项研究提出了 72%的同意比例，只有 3 项研究提出了等于或低于 53%的同意比例。没有一项研究的特征评估解释了异质性。
本综述的结果表明，一般来说，个人倾向于同意将其数据用于记录链接，但在特定人群或少数群体中存在例外。作者认为，这以及引用的文献支持了这样一种政策，即在保留相关伦理控制的同时，对于每个依赖二次数据的研究，并不需要获得个人的知情同意。
