ArticleLearning health systems2020
Informed consent within a learning health system: A scoping review.
Article in Learning health systems, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- Available guidance for ethical challenges in learning health systems: an integrative literature review.Health research policy and systems · 2026Review
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Disentangling informing participants from obtaining their consent.Learning health systems · 2025Article
- Unresolved ethical questions of mHealth apps for Alzheimer's disease prevention.Medicine, health care, and philosophy · 2025Article
- The problem of missing data for learning health systems focused on first-episode psychosis.Schizophrenia research · 2025Article
- Verbal consent in biomedical research: moving toward a future standard practice?Frontiers in genetics · 2025Review
- The role of patients, caregivers, and communities in Learning Health Systems: a narrative review.Frontiers in health services · 2025Review
- A trust based framework for the envelopment of medical AI.NPJ digital medicine · 2024Article
- Health data social licence: An inclusive process to learn more about the perspectives of experienced public and patient advisors.International journal of population data science · 2024Article
- Asking informed consent may lead to significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems.BMC medical research methodology · 2023Article
- Optimizing cardiovascular risk assessment and registration in a developing cardiovascular learning health care system: Women benefit most.PLOS digital health · 2023Article
- Article
- Attitudes of Patients With Chronic Heart Failure Toward Digital Device Data for Self-documentation and Research in Germany: Cross-sectional Survey Study.JMIR cardio · 2022Article
- Routinely collected data and patient-centred research in anaesthesia and peri-operative care: a narrative review.Anaesthesia · 2021Review
- Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.Journal of empirical research on human research ethics : JERHRE · 2021Article
- Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public's perspective.BMC medical ethics · 2021Article
- Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium.BMC medical ethics · 2021Review
- The SPOR-Canadian Data Platform: a national initiative to facilitate data rich multi-jurisdictional research.International journal of population data science · 2020Article
- Informed consent within a learning health system: A scoping review.Learning health systems · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA 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.
methodsUsing 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.
resultsA 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.
conclusionsOur 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.