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Could citizens grant access to their health data for several research projects at the same time?

Consenting to health data access for research

Can we imagine a learning health system where a person’s health data allows multiple research projects to progress simultaneously?

Instead of consenting to one project at a time, patients and citizens could agree that several projects with similar characteristics could access their health data.

The CLARET project deals expressly with this type of consent—called “meta-consent.” In CLARET individuals can choose how and how often they will receive requests for consent to the use of their health data for research purposes.

The CLARET project is studying the various ways that meta-consent might be implemented within learning health systems.

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Dr. Annabelle Cumyn explains meta-consent: citizens will have the opportunity to select the health data they would like to share with a set of research projects that have similar characteristics—for example, based on the type of health data that the projects require.

Research question

Since 2013, the Canadian Institutes of Health Research (CIHR) has invested an average of one billion dollars annually in health research.

This research is based on scientific methods whose main goal is to improve the quality of health care across the country.

Researchers depend on the quality and quantity of health data that is available and that can be accessed.

To improve health care and the health system, researchers need to collect and analyze health data, taking into account the citizens’ consent. CLARET’s research topic focuses on how citizens would wish to consent to the use of their health data for research purposes.

What is informed consent?

If a person is to accept that research teams will use his or her health data, that person must have received and understood the clear and accurate information presented about a research project’s nature, goals and methods. She must also understand exactly how her data will be used.

Informed consent is an agreement or authorization that a person gives to research teams within the framework of a research project. Strict ethical rules apply to this consent: they bind the research teams to the citizens and to the research institutions. These rules primarily aim to protect patients and citizens’ privacy and autonomy.

Researchers need to be able to conduct effective research using data dispersed throughout the health system. It is therefore unrealistic to seek informed consent from every citizen, project-by-project. This would cause delays that could render the data unusable by the project. Also, most people do not want to receive repeated requests for similar research topics.

The CLARET project focuses on the ethical and legal aspects of alternative approaches to consent that lead to informed and open decision-making in a health system in which health data is distributed over multiple organisations.

Why is it important that citizens give consent to permit access and use of their health data for research?

Scientific results have the power to change the ways in which health care is delivered and the ways in which the health system operates. This is only possible if the data for analysis represents the full spectrum of the target population.

The CLARET team uses qualitative and quantitative research methods. It proposes reflections and results that will, firstly, facilitate the mechanisms by which citizens can consent to the use of their health data for research and, secondly, improve the ways in which research teams inform citizens about how their health data is being used for research.

As more people, with variable characteristics, accept that scientists use their health data for research, there will be an increase in the knowledge gained to improve people’s health at the individual level.

The major challenge facing any research project is to access the right data, at the right place and in a timely manner—with people’s consent.

 

Conducting research in a complex health care system: what are the challenges?

Health care systems are increasingly based on science, information, management and social choices. This approach ensures that research results are rapidly integrated into health care, that quality of care continually improves and that citizens are actively involved in all relevant aspects of the system.

Such systems are called “learning health systems” because they use information to constantly improve themselves and to innovate.

Citizens’ health data is stored in multiple institutions, such as clinics, government agencies and hospitals. Researchers find it difficult to access this data, and without this data, research projects will not be able to deliver robust results.

More than ten thousand researchers are currently conducting health research in Canada, as part of several thousand different projects. Each project requires participants to give consent for participating researchers to analyze their health data.

Benefits of meta-consent

Citizens play active roles

Strengthening the bond of trust between clinicians, researchers and citizens.

Knowing how health data is used.

Knowing what research results are obtained from the data.

Get the right information

Being able to receive information about how one’s data is being used.

Choosing how often a patient must make a decision regarding the use of her or his health data.

Minimizing risks

Ensuring transparent operating procedures.

Avoiding overwhelming citizens with information.

Preventing citizens from making decisions that do not match their preferences.

Giving consent or refusal in a fully informed manner.

A societal choice

All members of civil society must agree on what the default access permissions are in a learning health system.

CLARET examines the challenges posed by meta-consent, which is based on a social contract and a societal choice.

CLARET also proposes to set up a platform that will allow citizens to indicate their preferences for meta-consent. The CLARET team is conceptualizing and experimenting with interfaces that users will find easy to use, and be intuitive and enjoyable.

Ongoing and upcoming work

Review (2017–2018)

Exploring the various approaches used to obtain citizens’ consent within learning health systems.

Developing a conceptual framework that distinguishes the steps and characteristics of the meta-consent process.

Survey and focus groups (2018–2019)

Conducting a mixed-methods, sequential design study by means of a survey followed by focus groups with Quebec citizens, researchers and members of research ethics boards.

Obtaining stakeholders’ views on the meta-consent conceptual framework.

Assessing the influence of participants’ literacy levels on their views.

Application frameworks (2018–2019)

Exploring the legislative, normative, regulatory and political conditions surrounding consent and access to health data in Quebec.

Recommending changes to existing consent frameworks to facilitate the development of learning health systems.

Partners

Principal partners

The Quebec Support Unit of the Strategy for Patient-Oriented Research is made possible under the Canadian Strategy for Patient-Oriented Research (SPOR) funded by the Canadian Institutes of Health Research (CIHR) and supported by the Ministère de la Santé et des Services sociaux du Québec and the Fonds de recherche du Québec—Santé (FRQS).

With the support of

CLARET directors

Jean-François Ethier - GRIIS - Groupe de recherche interdisciplinaire en informatique de la santé

Jean-François Ethier

Co-founder and scientific co-director of the GRIIS
Associate professor of medicine at Université de Sherbrooke
Licensed physician at the CHUS
Director of the Access to Data component at the Quebec Support Unit of the Strategy for Patient-Oriented Research

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Facilitating meta-consent for the use of health data in research