Presentation of CLARET
The CLARET initiative aims to review the current methods of information and consent, as well as to propose alternatives that would be better adapted to the various activities of a Learning Health System (LHS).
During the last year, we performed a thorough review of the literature to identify approaches proposed to obtain participants’ consent according to the type of activity realized within a LHS. This review of the literature allowed us to develop a conceptual framework, which distinguishes relevant characteristics of the consent processes.
During the year 2018-2019, we will conduct a sequential mixed-methods study consisting of a survey followed by focus groups with Quebec citizens, researchers and Research Ethics Committee members. Precisely, this study aims to ascertain these key stakeholders’ opinion on the conceptual framework developed previously. The evaluation of the impact of literacy on the participants’ point of view will be a central component of the study.
At the same time, during the summer of 2018, we will explore the legal, normative, statutory and political framework which applies to consent for research, as well as for health data access in Quebec. Afterward, we will analyze the information gathered and express it according to our conceptual framework. Finally, we will issue propositions of changes to the current frameworks, in order to adapt them to LHS.
- Conceptual framework on the approaches to consent according to the type of activity conducted in a LHS
- Recommendations on how to integrate consent into a LHS
- Legal framework and recommendations surrounding consent
Relevance of the CLARET initiative and the link with patient oriented research
The development of the Learning Health and Social Services Research Platform (PARS3) in Quebec raises many issues . One of the major issue concerns the way to inform and obtain consent from participants for various types of research activities carried out in PARS3. Indeed, within a LHS, a variety of research activities (e.g.: pragmatic studies, comparative effectiveness research, quality improvement studies, etc.) with specific characteristics (e.g.: study funded by a private organization compared to a public organization, an observational study compared to an interventional study, etc.) can take place. This complexity implies that the current model of direct informed consent cannot be applied directly in PARS3. The thorough examination of the literature also allowed us to note that there is no consensus as for the alternative models of consent recommended in this new context of research.
 Malboeuf M-C. Des Dossiers Médiaux Exploités à des fins commerciales. La Presse [En ligne]. 2018 2 mars. Section ACTUALITÉS. Disponible : http://mi.lapresse.ca/screens/835b3057-d3e8-4cea-a202-47789f917442__7C___0.html
|Adrien Barton||Principle investigator, Expert in ethics and philosophy of science|
|Anne-Marie Cloutier||Scientific assistant to the director of the Quebec SPOR Support Data Platform|
|Annabelle Cumyn||Principle investigator, President of the Ethics Committee of the research in health at the human being of the CIUSSS of Estrie-CHUS|
|Roxanne Dault||Research officer – CLARET’s initiative coordinator|
|Jean-François Ethier||Co-investigator, Director of the Quebec SPOR Support Data Platform|
|Nissrine Safa||Research officer|