JMIR Publications

ABSTRACT

Background:

The increasing reuse of personal health data raises ethical questions about who may access such data and who should participate in these decisions. European policy initiatives increasingly emphasize stronger citizen involvement in health data governance, yet in practice citizen participation often remains limited to being informed or consulted. Deliberative approaches, in which citizens actively weigh values and contribute to collective judgments on public benefit data use, offer an alternative, but their application to the ethical assessment of health data access requests remains underexplored, and it is unclear how such arrangements function in practice. To address this gap, a citizen-based ethics committee was piloted within the We Are initiative in Flanders, Belgium, in which citizens themselves collectively undertook the ethical assessment of health data access requests.

Objective:

This study aimed to explain how, why, and under which conditions a citizen-based ethics committee functions as a governance model for public-benefit-based decision-making regarding health data access requests.

Methods:

A qualitative realist evaluation of this pilot was conducted. Seven citizens completed preparatory materials and assessed three real-world health data access requests using an ethical scoring matrix, first individually and then through deliberation across two live committee sessions, with the possibility to revise their assessments. Data included session transcripts, observation notes, and pre- and post-deliberation scores. Analysis followed a retroductive approach, identifying and refining context-mechanism-outcome (CMO) configurations to explain how the committee functioned under different conditions.

Results:

The evaluation resulted in five CMO configurations explaining how the committee functioned under different contextual conditions. Citizens were able to assess the requests substantively and reach a collective decision on each case when they were supported by preparatory materials and a structured framework, and when the information provided was complete, credible, and verifiable. Deliberation triggered deliberative learning: participants engaged with one another’s arguments and reconsidered, refined, or recalibrated their judgments. Inclusion-related perspectives emerged not only through a link worker but through the diversity of viewpoints within the group. Participants valued forming independent judgments before deliberation and engaging without pressure to conform and experienced their participation as most meaningful when they believed their concerns and recommendations would influence decisions and be acted upon.

Conclusions:

A citizen-based ethics committee can operationalize meaningful citizen participation in health data governance, enabling citizens to take up a substantive rather than tokenistic role in ethical decision-making about health data access requests. Meaningful participation depended not only on preparing participants but also on complete, credible, and verifiable case information, a broad diversity of viewpoints, and a deliberative process experienced as fair and impactful. As a small-scale pilot without formal consequences for data access decisions, the study is an exploratory first step whose findings require further testing with other participants and data access requests.