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. 2023 Jul 7;18(7):e0285807.
doi: 10.1371/journal.pone.0285807. eCollection 2023.

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Marijn Muurling  1   2 , Anna M G Pasmooij  3 , Ivan Koychev  4 , Dora Roik  5 , Lutz Froelich  5 , Emilia Schwertner  6   7 , Dorota Religa  6   8 , Carla Abdelnour  9 , Mercè Boada  10   11 , Monica Almici  12 , Samantha Galluzzi  12 , Sandra Cardoso  13 , Alexandre de Mendonça  13 , Andrew P Owens  14 , Sajini Kuruppu  14 , Martha Therese Gjestsen  15 , Ioulietta Lazarou  16 , Mara Gkioka  17 , Magda Tsolaki  17 , Ana Diaz  18 , Dianne Gove  18 , Pieter Jelle Visser  1   2   6   19 , Dag Aarsland  14   15 , Federica Lucivero  20 , Casper de Boer  1   2 ; RADAR-AD Consortium
Affiliations

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Marijn Muurling et al. PLoS One. .

Erratum in

Abstract

Introduction: Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain.

Methods: Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach.

Results: Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites.

Discussion: The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

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Conflict of interest statement

The authors have read the journal’s policy and have the following competing interests: IK is a paid medical advisor for digital healthcare technology companies Five Lives SAS and Cognetivity Ltd., outside the submitted work. CA has received honoraria as speaker from F. Hoffmann-La Roche Ltd, Zambon, Nutricia, Schwabe Farma Ibérica S.A.U, outside of the submitted work. CA is a member of the Board of Directors of the Lewy Body Dementia Association, outside the submitted work. DA has received research support and/or honoraria from Astra-Zeneca, H. Lundbeck, Novartis Pharmaceuticals, Biogen, and GE Health, and served as paid consultant for H. Lundbeck, Eisai, Heptares, Mentis Cura, and Roche Diagnostics, outside the submitted work. MB is an employee of the Ace Alzheimer Center and an advisory board member for Grifols, Roche, Eli Lilly, Araclon Biotech, Merck, Zambon, Biogen, Novo Nordisk, Bioiberica, Eisai, Servier, and Schwabe Pharma, outside the submitted work. This does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors have declared that no competing interests exist. There are no patents, products in development or marketed products associated with this research to declare.

Figures

Fig 1
Fig 1. Duration in days of the REC process per site.
Blue blocks indicate the REC review, while orange blocks indicate the preparation of the response. The long preparation of response time in Amsterdam (second orange block) was because the REC requested approval from the IT department after the second REC review round, which resulted in several months waiting time. More detailed information can be found in the S1 Table.
See this image and copyright information in PMC

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