SUMMARY
WP4 applies the Responsible Research and Innovation framework to assess the ethical, societal, and economic implications of gene therapy in lung transplantation. Through stakeholder engagement, legal-ethical analyses, economic modeling, and implementation science, WP4 ensures alignment with societal values and healthcare priorities. It addresses consent, equity, cost, and accessibility while identifying barriers to clinical adoption—ultimately designing a sustainable, ethically grounded roadmap for gene therapy in transplantation.
WP4 leader is Prof. Rieke van der Graaf, from Universitair Medisch Centrum Utrecht.
Donor and recipient ethics: consent, risk, and identity
DC13 focuses on lung donors, exploring the ethical and legal implications of genetic modification within opt-out systems. It investigates donor attitudes and performs a conceptual analysis of whether a genetically modified lung alters the organ's moral status. DC14 studies lung recipients’ beliefs, expectations, and concerns about genetic modification, including informed consent and perceived benefits and risks—critical for clinical trials and eventual uptake.
Health equity and economic feasibility of gene therapy
DC12 and DC14 evaluate how gene therapy can be equitably and affordably integrated into healthcare. Using modeling tools like Markov simulations, DC12 defines performance benchmarks, pricing corridors, and clinical outcomes needed for cost-effective implementation. Together with DC14, they explore questions of who should access modified lungs, how to allocate resources fairly, and how to prevent financial barriers from limiting patient access to potentially life-saving treatments.
Bridging research and clinical practice through implementation science
DC15 applies implementation science to close the gap between research and healthcare delivery. By identifying systemic barriers and involving stakeholders early, it helps ensure LifeLUNG findings are translated efficiently and ethically into practice. Using the Barkhordarian 7-step framework, DC15 creates tailored strategies for real-world adoption, contributing to a comprehensive roadmap alongside economic and ethical findings to ensure maximum societal benefit from LifeLUNG innovations.
