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：对使用电子同意的当前实践和主要建议的回顾

 背景

电子方法越来越广泛地用于获取参与研究的知情同意。电子同意（e-consent）为同意过程提供了一种易于访问且通用的方法，可以通过视听和交互功能来增强该方法，以提高参与者对研究程序的参与和理解。需要以道德原则为基础的最佳实践指南，以确保有效实施研究中使用的电子同意。

 目的

确定在招募远程研究项目参与者时成功且合乎道德地实施电子同意的关键考虑因素。

 方法

对 CINAHL、Medline、Embase、DARE、HTA、PubMed、Cochrane 图书馆、Scopus、Web of Science、NHS Evidence 的电子数据库检索以及参考文献列表的手动检索。 2010 年至 2020 年期间，使用电子同意对成人（≥ 18 岁）研究参与者进行的初步研究，以英语、同行评审期刊发表，有资格纳入。

 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。使用批判性评估技能计划 (CASP) 工具对纳入的研究进行批判性评估表明，大多数研究 (n = 15) 存在低至中等偏倚风险。针对使用电子同意的研究人员的关键实践建议围绕五个主要主题确定：1) 电子同意的可访问性和用户友好性，2) 用户参与和理解，3) 根据参与者偏好和人口统计数据进行定制，4) 数据安全和 5 ）对研究团队的影响。

 结论

电子同意方法普遍受到参与者的好评，大多数研究报告用户友好的界面和参与者对同意文件的充分理解。

对实践的影响

电子同意可以通过提供面对面同意方法的可行且强大的替代方案来促进远程进行的研究，但仍应根据参与者的偏好提供纸质选项。定制电子同意平台可以提高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参与者提供实时讨论研究信息的机会。