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识别数字健康生态系统中采用动态同意的促进因素和障碍:范围综述。

Identifying facilitators of and barriers to the adoption of dynamic consent in digital health ecosystems: a scoping review.

机构信息

Office of eHealth Research and Business, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Interdisciplinary Program in Bioengineering, Seoul National University, Seoul, Republic of Korea.

出版信息

BMC Med Ethics. 2023 Dec 1;24(1):107. doi: 10.1186/s12910-023-00988-9.


DOI:10.1186/s12910-023-00988-9
PMID:38041034
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10693132/
Abstract

BACKGROUND: Conventional consent practices face ethical challenges in continuously evolving digital health environments due to their static, one-time nature. Dynamic consent offers a promising solution, providing adaptability and flexibility to address these ethical concerns. However, due to the immaturity of the concept and accompanying technology, dynamic consent has not yet been widely used in practice. This study aims to identify the facilitators of and barriers to adopting dynamic consent in real-world scenarios. METHODS: This scoping review, conducted in December 2022, adhered to the PRISMA Extension for Scoping Reviews guidelines, focusing on dynamic consent within the health domain. A comprehensive search across Web of Science, PubMed, and Scopus yielded 22 selected articles based on predefined inclusion and exclusion criteria. RESULTS: The facilitators for the adoption of dynamic consent in digital health ecosystems were the provision of multiple consent modalities, personalized alternatives, continuous communication, and the dissemination of up-to-date information. Nevertheless, several barriers, such as consent fatigue, the digital divide, complexities in system implementation, and privacy and security concerns, needed to be addressed. This study also investigated current technological advancements and suggested considerations for further research aimed at resolving the remaining challenges surrounding dynamic consent. CONCLUSIONS: Dynamic consent emerges as an ethically advantageous method for digital health ecosystems, driven by its adaptability and support for continuous, two-way communication between data subjects and consumers. Ethical implementation in real-world settings requires the development of a robust technical framework capable of accommodating the diverse needs of stakeholders, thereby ensuring ethical integrity and data privacy in the evolving digital health landscape.

摘要

背景:由于传统的同意实践具有静态、一次性的特点,在不断发展的数字健康环境中面临着伦理挑战。动态同意提供了一种有前途的解决方案,具有适应性和灵活性,可以解决这些伦理问题。然而,由于概念和相关技术尚不成熟,动态同意尚未在实践中得到广泛应用。本研究旨在确定在真实场景中采用动态同意的促进因素和障碍。

方法:本范围综述于 2022 年 12 月进行,遵循 PRISMA 扩展用于范围综述的指南,重点关注健康领域的动态同意。通过在 Web of Science、PubMed 和 Scopus 上进行全面搜索,根据预先确定的纳入和排除标准,共选择了 22 篇文章。

结果:在数字健康生态系统中采用动态同意的促进因素包括提供多种同意方式、个性化替代方案、持续沟通和及时信息的传播。然而,仍需要解决一些障碍,如同意疲劳、数字鸿沟、系统实施的复杂性以及隐私和安全问题。本研究还调查了当前的技术进步,并提出了进一步研究的考虑因素,旨在解决动态同意方面的剩余挑战。

结论:动态同意作为数字健康生态系统的一种有利伦理方法出现,其适应性强,支持数据主体和消费者之间的持续双向沟通。在真实环境中进行伦理实施需要开发一个强大的技术框架,能够满足利益相关者的多样化需求,从而在不断发展的数字健康环境中确保伦理完整性和数据隐私。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/74bf9b4236d1/12910_2023_988_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/148392030782/12910_2023_988_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/33aa78639e90/12910_2023_988_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/74bf9b4236d1/12910_2023_988_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/148392030782/12910_2023_988_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/33aa78639e90/12910_2023_988_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/10693132/74bf9b4236d1/12910_2023_988_Fig3_HTML.jpg

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Enabling secure and self determined health data sharing and consent management.

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本文引用的文献

[1]
Electronic informed consent criteria for research ethics review: a scoping review.

BMC Med Ethics. 2022-11-21

[2]
Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process.

Eur J Hum Genet. 2022-12

[3]
METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials.

Front Med (Lausanne). 2022-5-13

[4]
A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study.

JMIR Med Inform. 2021-11-3

[5]
Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?

Asian Bioeth Rev. 2019-5-25

[6]
Health data poverty: an assailable barrier to equitable digital health care.

Lancet Digit Health. 2021-4

[7]
Adding dynamic consent to a longitudinal cohort study: A qualitative study of EXCEED participant perspectives.

BMC Med Ethics. 2021-2-9

[8]
'CTRL': an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research.

Eur J Hum Genet. 2021-4

[9]
Reflections on dynamic consent in biomedical research: the story so far.

Eur J Hum Genet. 2021-4

[10]
Evaluation of patient perception towards dynamic health data sharing using blockchain based digital consent with the Dovetail digital consent application: A cross sectional exploratory study.

Digit Health. 2020-5-12

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