D2.4 - STRONG AYA ethics report, with interim reports following ethics workshops

1 A new, interdisciplinary, multistakeholder European network to improve healthcare services, research and outcomes for Adolescents and Young Adults with cancer. STRONG-AYA – No. 101057482 – D2.4 2 Deliverable Report WP2– Governance, Data Security and Ethics Deliverable D2.4 STRONG AYA ethics report, with interim reports following ethics workshops Due date of deliverable: 30/09/2024 Actual submission date: 15/05/2025 Project: STRONG-AYA Lead Contributor Stephane Lejeune (EORTC) Email [email protected] Other Contributors Emails Due date 30 09 2024 Delivery date 15 05 2025 Deliverable type R Dissemination level PU Description of Work Version Date Final version of report after approval of ERAB V1.0 30/04/2025 STRONG-AYA – No. 101057482 – D2.4 3 Description: STRONG-AYA Ethics report, with interim reports following Ethics workshops (year 1) Publishable summary (max ½ page) This deliverable is the report of the second meeting (4 March 2025) of the STRONG-AYA Ethics and Regulatory Advisory Board (ERAB). The ERAB aims to provide the consortium with an independent view on the ethics and legal challenges as well as the mitigation actions planned or already implemented by the consortium. The ERAB is composed of four independent experts in ethics and/or legal aspects. The ERAB meets each year together with consortium representatives. This report has been approved by the four independent experts and by the project representatives who attended the meeting. STRONG-AYA – No. 101057482 – D2.4 4 1 Table of Contents PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................... 3 1 TABLE OF CONTENTS .......................................................................................................................................... 4 2 DEFINITIONS....................................................................................................................................................... 5 3 ABBREVIATIONS ................................................................................................................................................. 6 4 INTRODUCTION .................................................................................................................................................. 7 PROJECT BACKGROUND ........................................................................................................................................... 7 DELIVERABLE INTRODUCTION .................................................................................................................................... 8 5 RESULTS ......................................................................................................... ERROR! BOOKMARK NOT DEFINED. 6 CONCLUSION .................................................................................................. ERROR! BOOKMARK NOT DEFINED. 7 REPOSITORY FOR PRIMARY DATA (ANNEX) .................................................... ERROR! BOOKMARK NOT DEFINED. STRONG-AYA – No. 101057482 – D2.4 5 2 Definitions STRONG AYA consortium members are referred to as following within this text: 1. NKI-AVL – Stichting het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NL) 2. YCE – Youth Cancer Europe (RO) 3. INT – Fondazione IRCCS Instituto Nazionale dei Tumori (IT) 4. FFUND – FFUND BV (NL) 5. CLB – Centre de Lutte Contre le Cancer Leon Berard (FR) 6. ECO – European Cancer Organisation (BE) 7. UNIMAAS – Universiteit Maastricht (NL) 8. IKNL – Stichting Integraal Kankercentrum Nederland (NL) 9. EORTC – European Organisation for Research and Treatment of Cancer AISBL (BE) 10. IGR – Institut Gustave Roussy (FR) 11. MSCNRIO – Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie – Panstwowy Instytut Badawczy (Marie Sklodowska-Curie National Research Institute of Oncology) (PL) 12. UOM – University of Manchester (UK) 13. UOL – University of Leeds (UK) 14. LTHT – Leeds Teaching Hospitals National Health Service Trust (UL) 15. SOUTHAMPTON – University of Southampton (UK) • Grant Agreement (including its annexes and amendments): the agreement signed between the beneficiaries of the HORIZON Research and Innovations Actions (hereafter referred to as Horizon) and the European Health and Digital Executive Agency (hereafter referred to as HADEA) for the undertaking of the STRONG AYA project (Grant Agreement no. 101057482). • Beneficiary: Signatories of the Grant Agreement • Associated Partner: Entities which participate in the action but without the right to charge costs or claim contributions. • Project: the sum of all activities carried out in the framework of the Grant Agreement. • Consortium: the STRONG AYA consortium, including all the aforementioned partners. • Consortium Agreement: The agreement made between STRONG AYA members for the implementation and execution of the action outlined in the Grant Agreement. The agreement shall not affect the parties’ obligations to HADEA on behalf of the European Union, and/or to one another arising from the Grant Agreement. STRONG-AYA – No. 101057482 – D2.4 6 3 Abbreviations Acronym/Abbreviation Meaning HCP Health Care Provider PRO Patient Reported Outcome PROM Patient Reported Outcome Measure COS Core Outcome Set WP Work Package WPL Work Package Lead(s) WP1 Work Package 1 (Development Core Outcome Set AYA with cancer & data collection) WP2 Work Package 2 (Governance, Data Security and Ethics) WP3 Work Package 3 (Infrastructure and Interoperability) WP4 Work Package 4 (Operation of STRONG AYA ecosystems, stakeholder and patient involvement, dissemination, exploitation, communication) WP5 Work Package 5 (Scientific coordination and project managemen t) KPI Key Performance Indicator OA Open Access PAB Patient Advisory Board EC European Commission HADEA European Health and Digital Executive Agency SC Steering Committee MT Management Team ERAB Ethics and Regulatory Advisory Committee STRONG-AYA – No. 101057482 – D2.4 7 4 Introduction Project background Cancer at adolescent and young adult (AYA) age (15-39 at primary diagnosis) is rare. However, this rarity does not reflect the significant personal and societal costs of cancer in this population, as reflected in the potential years of life lost or saved, the decreased productivity and quality-of-life due to the impact of the disease during formative years, and the long-term complications or disabilities1. AYAs with cancer form a unique group; they face age-specific issues (e.g. Infertility, unemployment, financial problems) and decreased quality of life due to cancer and its treatment. Unlike dedicated healthcare and trials for paediatric cancer patients, AYA-specific healthcare services are scarce and vary across Europe. AYAs who are at the core of society and the economy need access to age-appropriate and high-quality healthcare. The STRONG-AYA project aims to tackle the underrepresentation of AYA’s experiences and outcomes when navigating the healthcare system and in clinical care by developing national infrastructures for outcome data management and clinical decision-making within a pan-European ecosystem and establishing communication feedback for AYAs with cancer and the healthcare systems. This will be key to improving healthcare services, research, outcomes and policies for AYAs and to ultimately better cancer care for this patient group. The project brings together an international multi-disciplinary consortium (academic/research, clinical, stakeholder and patient organisations) across seven European countries. Building on previous initiatives, a STRONG-AYA data ecosystem will be set up for value-based care, research and policy for AYA with cancer by: 1. Developing a Core Outcome Set (COS) specifically for AYAs with cancer, via a participative consensus process defining most important aspects for those directly affected by AYA cancer, including patients and healthcare professionals. 2. Implementing the COS across several national European healthcare systems. Data will be collected at local level and will then be included in a data integration platform. An overall ecosystem framework for data analytics and output will be created supporting federated analyses and the creation of reports across clinical and patient-reported data and making national repositories of (patient-reported) health data, available to individual patients, patient organisations, regulatory authorities, as well as the patients’ health care providers to inform clinical decision-making. The five resulting national ecosystems will be connected to each other into the pan-European ecosystem using a federated approach also utilizing the overall ecosystem framework. 3. Disseminating the COS to a wide range of local as well as pan-European stakeholders, in particular by developing analytical tools to process and present patient outcome data and establish feedback loops that inform patients and clinicians. Implementing these project objectives are five work packages within the STRONG-AYA project: • WP1: Development Core Outcome Set AYA with cancer and Data Collection (Lead: SOUTHAMPTON) • WP2: Governance, Data Security and Ethics (Lead: EORTC) • WP3: Infrastructure and Interoperability (Lead: UNIMAAS) • WP4: Operation of STRONG-AYA ecosystems, Stakeholder and Patient involvement, Dissemination, Exploitation, Communication (Lead: E.C.O.) • WP5: Scientific Coordination and Project Management (Lead: NKI) 1 Stoneham SJ. AYA survivorship: The next challenge. Cancer 2020; 126: 2116-2119. STRONG-AYA – No. 101057482 – D2.4 8 STRONG-AYA will enable AYA care and research to benefit from collection and pooling of patientcentered data and collaboration among all stakeholders: patients, healthcare professionals, scientists, and policymakers. More widely, the project will leverage the network of interested organisations and networks established under STRONG-AYA for long-term strengthened promotion of the necessary implementation of specialist AYA cancer services across Europe. This will ultimately bring novel insights into AYA cancer care, research and policy, contributing to the long-term improvement of outcomes for people with AYA cancer. Deliverable introduction This deliverable is the report of the first meeting (3rd Nov 2023) of the STRONG-AYA Ethics and Regulatory Advisory Board (ERAB). The ERAB aims to provide the consortium with an independent view on the ethics and legal challenges as well as the mitigation actions planned or already implemented by the consortium. The ERAB is composed of four independent experts in ethics and/or legal aspects. The ERAB meets each year together with consortium representatives. This report has been approved by the four independent experts and by the project representatives who attended the meeting. 5 STRONG AYA Ethics and Regulatory Advisory Board (ERAB) – Report of the second meeting (virtual), 4 March 2025 Participants • ERAB members o Francesco Tava, UK o Francis P. Crawley, BE o Matthias Braun, DE o Santa Slokenberg, SE • Consortium members o Darian Meacham, UNIMAAS o Flora Lysen, UNIMASS o Leonard Wee, UNIMAAS o Marine Jacquemin, UNIMAAS o Simone Hanebaum, NKI o Stephane Lejeune, EORTC Agenda - Discussion on the follow-up of ERAB’ recommendations. - The use of dynamic patient consent in STRONG-AYA. - The use of the Public VaLUe Assessment TOol (PLUTO) tool in STRONG-AYA. Key points of discussion - Comments and questions on the follow-up document reporting feedback from partners on the ERAB recommendations (meeting Nov 2023). o To make sure that AYA participants are well informed about the project and their rights protected. STRONG-AYA – No. 101057482 – D2.4 9  Partners contributing with data have to ratify agreement that includes the obligation to inform participants and to protect their rights. Information about the use of the data is available from the project website. Communication campaign and stakeholder involvement activities will take place.  Was consent used as legal base and child right considered? Legal base depends on the country. Legitimate interest was used in most of the country.  The website was developed in co-creation with patients. There will be a FAQ section on the use of the data and alignment with child rights convention. o What are the acceptable purposes for using the data contributed to the project?  Acceptable purposes are limited to research and education. Project results including clinical prediction model are not validated for other use. It is not currently planned to do such validation. There will be a disclaimer on the project website.  It was clarified that the circulated document with feedback to ERAB is for project internal use only.  Any public project statement e.g. on the project website should be worded carefully to avoid confusion or contradiction regarding the acceptable purposes of use.  The consortium will not have the authority to prevent unauthorized use of project results e.g. for clinical decision. However, the use of the project data will be controlled I.e. analysis will have to be approved before being run in the system.  We need to differentiate how we conceive the scope of the project and how to communicate it to patients which should be carefully done.  Partners need to check what is written on the website to make sure we are not raising unrealistic expectation from patients or in contradiction with project rules on the use of project results. We must be clear, intelligible for lay people and avoid any mismatch. o How partners define the different types of research questions, and which types of users can access to the results of such questions?  A consortium process will define who can ask which type of research question (simple descriptive analysis versus sophisticated analysis), who can code the question and who can access to the results. The federated model will involve different levels of control and rights granularity. o How to discuss acceptable trade-off with patients?  How trade-offs are approached in the project was explained. Partners asked to patients what they find important and what are their preferences on how to be informed. Partners are reviewing the literature which is complemented with consultations with patients in a co-design approach.  Do we implement collaboration between the different project boards: scientific, ethical and patients? Good point even if the information is circulated already amongst the whole consortium but we could make it deeper.  Which topics could benefit from such cross-fertilization? Any practical/operational topic could benefit. - Dynamic patient consent. o How such concept could be implemented in STRONG-AYA? This is a way to use of more participatory and granular approach as compared to broad consent for secondary use of the data. o Dynamic consent allows patient to decide which project time span their consent is covering and for which research question. o Dynamic consent will not preplace the classical “static” consent but add a layer allowing patient to decide which data could be used for which usage and by who. o The project could provide the right situation in which dynamic consent could be implemented.