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远程开展研究的电子知情同意:当前实践的回顾及使用电子知情同意的关键建议

Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting.

机构信息

Division of Radiography and Midwifery, City, University of London, UK; Department of Perinatal Imaging and Health, King's College London, UK.

Division of Nursing, City, University of London, UK.

出版信息

Int J Med Inform. 2020 Nov;143:104271. doi: 10.1016/j.ijmedinf.2020.104271. Epub 2020 Sep 13.

Abstract

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.

摘要

背景

电子方法在获取研究参与者的知情同意方面的应用越来越广泛。电子同意(e-consent)为同意过程提供了一种易于访问和通用的方法,可以通过视听和交互功能进行增强,以提高参与者的参与度和对研究程序的理解。需要有基于伦理原则的最佳实践指南,以确保电子同意在研究中的有效实施。

目的

确定在远程进行的研究项目中成功和符合伦理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 等电子数据库进行了搜索,并对 2010 年至 2020 年间发表在英文同行评审期刊上的使用电子同意的成年(≥18 岁)研究参与者的原始研究进行了手工检索。

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 1 项病例对照研究。使用批判性评估技能计划(CASP)工具对纳入研究进行批判性评估表明,大多数研究(n=15)的偏倚风险较低或中等。使用电子同意的研究人员确定了五项主要主题的关键实践建议:1)电子同意的可访问性和用户友好性,2)用户参与度和理解度,3)根据参与者的偏好和人口统计学特征定制,4)数据安全性和 5)对研究团队的影响。

结论

电子同意方法通常受到参与者的欢迎,大多数研究报告称界面友好,并且参与者对同意文件的理解程度足够。

对实践的影响

电子同意可能通过提供一种可行且强大的替代面对面同意方法来促进远程进行的研究,但是应该根据参与者的偏好提供纸质选项。定制电子同意平台可以改善特定需求人群的可访问性,并增加对研究信息的参与度。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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7668/7487205/99e73a0d46a3/gr1_lrg.jpg

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