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The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies' Soft Impacts into Account.

作者信息

van Rijssel Tessa I, van Thiel Ghislaine J M W, van Delden Johannes J M

机构信息

Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Health Care Anal. 2025 Jun;33(2):139-150. doi: 10.1007/s10728-024-00483-1. Epub 2024 May 19.


DOI:10.1007/s10728-024-00483-1
PMID:38764063
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12052907/
Abstract

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.

摘要

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本文引用的文献

[1]
Decentralised clinical trials: ethical opportunities and challenges.

Lancet Digit Health. 2023-6

[2]
Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.

Drug Discov Today. 2022-10

[3]
Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.

BMC Med Ethics. 2021-10-13

[4]
Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era.

Front Pediatr. 2021-9-1

[5]
Personalized and long-term electronic informed consent in clinical research: stakeholder views.

BMC Med Ethics. 2021-7-31

[6]
Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders.

Br J Clin Pharmacol. 2022-3

[7]
Navigating the ethics of remote research data collection.

Clin Trials. 2021-10

[8]
Informed Consent, Understanding, and Trust.

Am J Bioeth. 2021-5

[9]
Ethical Considerations of Wearable Technologies in Human Research.

Adv Healthc Mater. 2021-9

[10]
Digital tools in the informed consent process: a systematic review.

BMC Med Ethics. 2021-2-27

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