Open AccessInformed consent within a learning health system: A scoping review
Author(s) -
Cumyn Annabelle,
Barton Adrien,
Dault Roxanne,
Cloutier AnneMarie,
Jalbert Rosalie,
Ethier JeanFrançois
Publication year - 2020
Publication title -
learning health systems
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.501
H-Index - 9
ISSN - 2379-6146
DOI - 10.1002/lrh2.10206
Subject(s) - informed consent , conflation , observational study , scope (computer science) , context (archaeology) , psychology , conceptual framework , medical education , computer science , management science , medicine , alternative medicine , epistemology , sociology , engineering , social science , paleontology , philosophy , pathology , biology , programming language
A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec‐based LHS. Methods Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full‐text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent. Results A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt‐in/opt‐out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent. Conclusions Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.