On 9 June, Prof. Johanna Blom, FACILITATE Coordinator, and Daniela Quaggia from Cittadinanzattiva – Active Citizenship Network (ACN) presented the work and progress of the FACILITATE project to the Industry Pharmacogenomics Working Group (I-PWG), following an invitation from the group’s co-chair.
The meeting offered the opportunity to provide an overview of FACILITATE’s achievements to date, with a particular focus on the project’s approach to the Return of Individual Participant Data (RoIPD) “by design”, where RoIPD is a component of research rather than an optional add-on. Professor Blom highlighted how this approach advocates for a shift from ad hoc goodwill to structured governance and standardized protocols across European research ecosystems.
“A central tenet of this framework is proportionality, which adapts data return based on scientific validity, clinical utility, and participant vulnerability” stated Blom “FACILITATE categorizes data into two distinct layers: a core layer of medically actionable information and a participant choice layer for personal relevance findings”.
Professor Blom continued her presentation by stating that to implement this, the project utilizes a “logic of enablement,” employing a sequential decision tree to assess a study’s plausibility, feasibility, and organizational capacity.
This approach is intended to build trust and reciprocity by treating data as shared, participant-controlled assets rather than mere byproducts. By increasing transparency, the project seeks to improve participant recruitment and long-term retention. Current efforts include piloting ROIPD in clinical trials and developing a comprehensive toolkit to help research infrastructures adopt these practices.
As part of the presentation, Daniela Quaggia introduced the FACILITATE Principles: a short, plain-language summary of the project’s work designed to ensure the process is meaningful and ethical . This set of guiding principles for RoIPD were drawn from the FACILITATE White Paper and designed to make RoIPD easier to understand, communicate and implement across different stakeholder communities. said Daniela Quaggia.The framework is built upon six core principles (Figure below).
“This approach operationalizes RoIPD through three pillars making the process people-centered, planned by design, and flexible enough to adapt to various clinical contexts” she concluded. These efforts are underpinned by ethical values such as autonomy, empowerment, and justice, transforming participants from passive subjects into active partners in the research process.
I-PWG is an association of pharmaceutical and biotech companies actively engaged in the field of pharmacogenomics (PGx) research, a key area for advancing more participant-centred, transparent and trustworthy data practices.
The participation in the I-PWG meeting represents another important step in the dissemination of FACILITATE’s work across the clinical research ecosystem, helping to foster discussion with industry stakeholders and support the practical implementation of RoIPD in future research.
The full presentation slidedeck is available HERE
