Background

Electronic approaches are becoming more widely used to obtain informed consent for research participation. Electronic consent (e-consent) provides an accessible and versatile approach to the consenting process, which can be enhanced with audio-visual and interactive features to improve participant engagement and comprehension of study procedures. Best practice guidance underpinned by ethical principles is required to ensure effective implementation of e-consent for use in research.

Aim

To identify the key considerations for successful and ethical implementation of e-consent in the recruitment of participants to research projects which are conducted remotely.

Methods

Electronic database searches of CINAHL, Medline, Embase, DARE, HTA, PubMed, the Cochrane Library, Scopus, Web of Science, NHS Evidence, and hand-searches of reference lists were performed. Primary research studies of adult (≥ 18 years old) research participants using e-consent, published in English language, peer-reviewed journals between 2010−2020 were eligible for inclusion.

Results

Of the initial 665 identified studies, 18 met the inclusion criteria: 6 cohort studies, 5 qualitative studies, 4 randomised control trials, 2 mixed-methods studies and one case-control study. Critical appraisal of included studies using Critical Appraisal Skills Program (CASP) tools suggested a low to moderate risk of bias in most studies (n = 15). Key practice recommendations for researchers using e-consent were identified around five primary themes: 1) accessibility and user-friendliness of e-consent, 2) user engagement and comprehension, 3) customisability to participant preferences and demographics, 4) data security and 5) impact on research teams.

Conclusion

E-consenting approaches are generally well received by participants, with most studies reporting user-friendly interfaces and sufficient participant comprehension of consenting documentation.

Implications for practice

E-consent may facilitate remotely-conducted research by offering a feasible and robust alternative to face-to-face consenting approaches, however paper-based options should still be offered, based on participant preference. Customising e-consenting platforms may improve accessibility for individuals with specific needs, and increase engagement with study information. Research teams must offer prospective participants opportunities to discuss study information in real-time.

中文翻译：

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远程进行研究的电子同意书：对当前实践的回顾以及使用电子同意书的主要建议

背景

电子方法越来越广泛地用于获得研究参与的知情同意。电子同意书（电子同意书）为同意过程提供了一种可访问且通用的方法，可以通过视听和交互功能来增强电子同意书，以提高参与者的参与度和对学习程序的理解。需要以道德原则为基础的最佳实践指南，以确保有效实施用于研究的电子同意书。

目标

在远程参与的研究项目的招募中，要确定成功和合乎道德的电子同意实施的关键考虑因素。

方法

电子数据库搜索CINAHL，Medline，Embase，DARE，HTA，PubMed，Cochrane图书馆，Scopus，Web of Science，NHS证据以及对参考文献清单进行手工搜索。在2010-2020年之间，使用电子同意书（以英语发表），经过同行评审的成人（≥18岁）研究参与者的基础研究符合条件。

结果

在最初确定的665项研究中，有18项符合纳入标准：6项队列研究，5项定性研究，4项随机对照试验，2项混合方法研究和一项病例对照研究。使用关键评估技能计划（CASP）工具对纳入研究的关键评估表明，在大多数研究中，偏倚风险低至中度（n = 15）。针对研究人员使用电子同意书的主要实践建议围绕以下五个主要主题确定：1）电子同意书的可访问性和用户友好性； 2）用户参与和理解； 3）参与者偏好和人口统计的可定制性； 4）数据安全性； 5 ）对研究团队的影响。

结论

参加者普遍接受电子同意的方法，大多数研究报告用户友好的界面和足够的参与者对同意文件的理解。

对实践的启示

电子同意可以通过提供可行且健壮的替代方式来面对面同意的方式来促进远程研究，但是仍应根据参与者的喜好提供纸质选项。定制电子同意平台可以改善有特定需求的个人的可访问性，并增加对研究信息的参与。研究团队必须为潜在的参与者提供实时讨论研究信息的机会。