Correction: 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.

[This corrects the article DOI: 10.1371/journal.pone.0285807.].

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.

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.

Clinical and medial temporal features in a family with mood disorders.

It is debated whether non-affected relatives of patients with affective disorders share a specific brain structure endophenotype. Aim of this work is to explore the medial temporal morphology in affected and non-affected members of a family with mood disorders. Hippocampi and amygdalae were manually traced from the 3D magnetic resonance imaging of five affected family members, 10 non-affected relatives, and 15 unrelated matched controls. Affected and non-affected relatives were characterized by larger left amygdalae (18%, p=0.030), smaller right hippocampus (up to 18%, p<0.0005), and reduced hippocampal asymmetry (p<0.001) than controls. Abnormal, albeit non significant, positive correlations of MTL volumes with age were observed, with the exception of smaller volume of the left hippocampus with advancing age (r=-0.76) in the affected relatives. These data add to the evidence that abnormal medial temporal structures may constitute an endophenotype for affective disorders.