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Informed consent within a learning health system: A scoping review.

ABSTRACT: Introduction: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.

SUBMITTER: Cumyn A

PROVIDER: S-EPMC7156861 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Informed consent within a learning health system: A scoping review.

Cumyn Annabelle A Barton Adrien A Dault Roxanne R Cloutier Anne-Marie AM Jalbert Rosalie R Ethier Jean-François JF

Learning health systems 20191204 2

<h4>Introduction</h4>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 ...[more]

PMID: 32313834

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Project description:BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Project description:BackgroundThe lens of complexity theory is widely advocated to improve health care delivery. However, empirical evidence that this lens has been useful in designing health care remains elusive. This review assesses whether it is possible to reliably capture evidence for efficacy in results or process within interventions that were informed by complexity science and closely related conceptual frameworks.MethodsSystematic searches of scientific and grey literature were undertaken in late 2015/early 2016. Titles and abstracts were screened for interventions (A) delivered by the health services, (B) that explicitly stated that complexity science provided theoretical underpinning, and (C) also reported specific outcomes. Outcomes had to relate to changes in actual practice, service delivery or patient clinical indicators. Data extraction and detailed analysis was undertaken for studies in three developed countries: Canada, UK and USA. Data were extracted for intervention format, barriers encountered and quality aspects (thoroughness or possible biases) of evaluation and reporting.ResultsFrom 5067 initial finds in scientific literature and 171 items in grey literature, 22 interventions described in 29 articles were selected. Most interventions relied on facilitating collaboration to find solutions to specific or general problems. Many outcomes were very positive. However, some outcomes were measured only subjectively, one intervention was designed with complexity theory in mind but did not reiterate this in subsequent evaluation and other interventions were credited as compatible with complexity science but reported no relevant theoretical underpinning. Articles often omitted discussion on implementation barriers or unintended consequences, which suggests that complexity theory was not widely used in evaluation.ConclusionsIt is hard to establish cause and effect when attempting to leverage complex adaptive systems and perhaps even harder to reliably find evidence that confirms whether complexity-informed interventions are usually effective. While it is possible to show that interventions that are compatible with complexity science seem efficacious, it remains difficult to show that explicit planning with complexity in mind was particularly valuable. Recommendations are made to improve future evaluation reports, to establish a better evidence base about whether this conceptual framework is useful in intervention design and implementation.

Project description:BackgroundThe advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public's attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec.MethodsEight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software.ResultsOur findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.ConclusionsThis qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

Project description:BackgroundCommunities represent a highly relevant source of knowledge with regard to not only healthcare performance but also sociocultural context, yet their role in learning health systems has not been studied. Situating the learning health system as an organization, this paper explores the phenomenon of organizational learning from or with communities (defined as one of 'the people,' such as a town, a specific patient group or another group directly receiving a healthcare service).MethodsWe conducted a scoping review to determine what is known about organizational learning from or with communities that the organization serves, and to contribute to a more comprehensive evidence base for building and operating learning health systems. In March 2019, we systematically searched six academic databases and grey literature, applying no date limits, for English language materials that described organizational learning in relation to knowledge transfer between an organization and a community. Numerous variables were charted in Excel and synthesized using frequencies and thematic analysis. We updated this search in August 2020.ResultsIn total, 42 documents were included in our analysis. We found a disproportionate emphasis on learning explicit knowledge from community rather than on tacit knowledge or learning in equal partnership with community. Our review also revealed inconsistently defined concepts, tenuously linked with their theoretical and empirical foundations. Our findings provide insight to understand the organization-community learning relationship, including motives and power differentials; types of knowledge to be learned; structures and processes for learning; and transformative learning outcomes.ConclusionsOur review makes a singular contribution to organizational learning literatures by drawing from diverse research disciplines such as health services, business and education to map what is known about learning from or with community. Broadly speaking, learning health systems literature would benefit from additional research and theory-building within a sociological paradigm so as to establish key concepts and associations to understand the nature of learning with community, as well as the practices that make it happen.

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Informed consent within a learning health system: A scoping review.

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Informed consent within a learning health system: A scoping review.

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