Informed consent in decentralised clinical trials through an ethical lens

Decentralised clinical trials raise ethical questions regarding informed consent because the consent process often takes place remotely. This article explores the challenges (such as fewer in-person interactions) and opportunities (including new possibilities for exercising autonomy and engaging a more diverse research population) that a remote informed consent process raises for research participants. In addition, the article contains several approaches for mitigating the ethical problems that obtaining informed consent remotely raises in decentralised clinical trials, including moving toward a more dynamic informed consent process and using teleconference technologies to give regular feedback to participants, which may help increase transparency and foster trust between research participants and the research team.

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Publication Details

Journal
Regulatory Affairs Watch
Published
2024-12-01
DOI
https://doi.org/10.54920/scto.2024.rawatch.9.17
Citations
1
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
0.54
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article

Informed consent in decentralised clinical trials through an ethical lens

Brenda Bogaert
1 citations
Regulatory Affairs Watch
Ethics in Clinical Research
0.54
article

Informed consent in decentralised clinical trials through an ethical lens

Brenda Bogaert
article en
1 citations

Abstract

Decentralised clinical trials raise ethical questions regarding informed consent because the consent process often takes place remotely. This article explores the challenges (such as fewer in-person interactions) and opportunities (including new possibilities for exercising autonomy and engaging a more diverse research population) that a remote informed consent process raises for research participants. In addition, the article contains several approaches for mitigating the ethical problems that obtaining informed consent remotely raises in decentralised clinical trials, including moving toward a more dynamic informed consent process and using teleconference technologies to give regular feedback to participants, which may help increase transparency and foster trust between research participants and the research team.

Regulatory Affairs WatchVol. 6(9)
University of Lausanne (CH)
Peace, Justice and strong institutions
Openalex Percentile: Top 26%
Ethics in Clinical Research
0.54
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Informed consent in decentralised clinical trials through an ethical lens — Brenda Bogaert · Regulatory Affairs Watch (2024) | TGRS Research Map | TGRS