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.
Authors
- Brenda Bogaert (ORCID: https://orcid.org/0000-0001-7557-3709)
Institutions
- University of Lausanne (CH)
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