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Informed consent within a learning health system: A scoping review.
Annabelle Cumyn1,2, Adrien Barton2,3, Roxanne Dault2
1Département de médecine, Faculté de médecine et des sciences de la santé Université de Sherbrooke Quebec Canada.
Learning Health Systems
|April 22, 2020
Summary
For learning health systems (LHS), distinguishing consent features is key. Metaconsent, emphasizing communication, is a feasible and acceptable model for participant data use in research.
Area of Science:
- Health Systems Research
- Informed Consent in Research
- Data Governance
Background:
- Implementing learning health systems (LHS) requires addressing participant consent for research data utilization.
- Identifying proposed consent types for observational research within LHS is crucial for ethical data handling.
Purpose of the Study:
- To identify and evaluate consent approaches for research participation in learning health systems (LHS).
- To determine the most feasible and acceptable consent strategies for a Quebec-based LHS.
Main Methods:
- A scoping review methodology was employed, searching scientific, legal, and gray literature.
- Full-text articles were independently reviewed by two authors based on LHS and consent approach concepts.
- Data analysis utilized NVivo software within a conceptual framework distinguishing consent dimensions.
Main Results:
- Analysis of 93 publications revealed conflicting conclusions on optimal consent within LHS.
- Distinguishing consent characteristics highlighted the primacy of the communication process over scope or opt-in/opt-out mechanisms.
- Metaconsent and dynamic consent models emerged as particularly relevant.
Conclusions:
- Careful differentiation of consent process features is essential for LHS implementation.
- The metaconsent model offers a valuable framework for LHS, addressing feasibility and acceptability concerns.
- Integrating information process modalities into the metaconsent model is proposed.
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