Work Packages
WP1 - Coordination, management and evaluation
ONT is an agency of the Spanish Ministry of Health responsible for coordinating, organizing and overseeing the donation and clinical use of organs, tissues and cells at national level, in coordinationwith regional authorities. ONT coordinates all activities regarding the donation, allocation and transplantation of organs, and the management of national waiting lists. It manages national IT systems necessary for its coordinating role, defines guidelines,protocols and procedures to maximize the availability of organs, tissues and cells, and ensure its quality, safety and effectiveness. It fixes parameters for transplant quality assessment, promotes information campaigns for the public and develops trainingcourses for professionals of the donation and transplantation Spanish network. ONT has a vast experience in the coordination of national and international initiatives in the field of transplantation (ONT is Collaborating Center of the World Health Organizationand President of the Iberoamerican Network-Council of Donation and Transplantation). ONT has developed one of the most robust KEPs in Europe. Moreover, ONT is member of the SAT and participates in the international KEP developed under the framework of thistransnational alliance (KEP-SAT), where ONT is responsible for managing the IT platform, performing the international matching runs and organizing the logistics to perform LDKTs. ONT is or has been participating as coordinator or partner of several EU-fundedprojects and Joint Actions in transplantation, among others, ALLIANCE-O, DOPKI, FOEDUS, ACCORD, EQSTB, EUSTITE, EUROCET, SOHOV&S, EURO-GTP II, EFRETOS, TRANSPOSE, EGALITE and EUROTRACTOR.
The scope of this WP is the overall management of the activities to be performed in the project, including quality assurance and risk management, monitoring of the projectprogress and achievements, financial management and relations with the European Commission.
WP1 objectives include:
The overall management of the project and consortium according to the governance structure and procedures explained in section 3.2.
To set the practical direction for the Project and to orchestrate the technical activities (WPs) in a coordinated and seamless manner.
The assurance of the fulfilment of the Project objectives, according to the timing and financial commitments stated in the work plan and establish effective framework and proceduresfor efficient communication, collaboration and fast and accurate decision-making.
The management of legal, financial and administrative duties of the Project.
The anticipation and management of change and the resolution of disputes during the project (i.e. involving all stakeholders to reach consensus, problem solving and establishing andmaintaining a high level of team spirit and esprit de corps).
To review and analyse risks and coordinate the design of appropriate quality and contingency plans.
WP2 - IT Infrastructure and Computational Efficacy Studies
Work package 2 (WP2) is responsible for the development of the KEPsoft software in order to provide an enhanced tool that can meet the demands of international kidney exchange programmes (KEPs), and support a pan-European KEP in particular. Furthermore it is responsible for the parallel development of the KEPsoft simulator (formerly known as the ENCKEP simulator) in order to allow further policy studies and analyses to be conducted. The specific activities of WP2 include, among others, the following:
development of both software tools to meet a larger scope of demand;
thorough testing of the software solutions to ensure they provide robust, reliable, scalable and secure platforms;
provision of clear documentation for both software products for their ease of use;
conducting studies to estimate the benefits of collaboration and to analyse different collaboration policies.
The tasks involved in WP2 are being carried out through a collaborative effort, mainly involving colleagues from HUN-REN KRTK, Óbuda University, University of Glasgow, INESC TEC, and ISEP.
WP3 - Guidelines for Implementation of EURO-KEP
WP3 is a joint venture between Agence de la Biomédecine (ABM) and Scandiatransplant (SCTP).
ABM is the Competent Authority for organ, tissue and cell transplantation, medically assisted reproduction, human genetics and embryo and stem cell research. Among its missions are the management of waiting lists, rules of allocation, procurements and allocation in France/abroad and evaluation of transplantation activities. It advises on inspection and licensing and is responsible for vigilance in its fields. ABM has a long history of supporting transplantation systems in Maghreb and in Eastern Europe, and was the coordinator of “Alliance-O”, the first EU funded transplantation project. Since, ABM participated in numerous European projects, contributing to the harmonisation of European practices.
SCTP is the organ exchange organization for Denmark, Finland, Iceland, Norway, Sweden, and Estonia.
In 2019, SCTP launched the Scandiatransplant Exchange Program (STEP), one of the three international KEPs that been established in Europe. STEP allows kidneys from living donors to be exchanged between participating transplant hospitals in Denmark, Finland, Norway and Sweden. STEP is the only European transnational KEP that performs all matching runs with a merged donor-recipient pool including all participating countries, where no national program exists in parallel. The expertise of SCTP in running this complex international KEP is seen as pivotal for the development of EURO-KEP.
As the leader of WP3, ABM will provide its expertise in the technical and legal implementation of the project. ABM will focus on addressing the legal (including GDPR) and ethical challenges of international Kidney Exchange Programs (KEPs). It will conduct a study on the legal frameworks in all participating countries to identify obstacles that may limit full participation in EURO-KEP.
SCTP will be responsible for analyzing the operational procedures used in existing national and transnational KEPs in Europe. This includes identifying how and what information is collected, utilized, and shared across country borders in these programs, with a focus on the organizational structure and the required information and assessments for donors and recipients before and after matching runs. Additionally, SCTP will assess the compatibility, prioritization, and optimization criteria used in matching runs, as well as current practices for donor and recipient follow-up. Based on these findings, SCTP will define a common operational procedure for pan-European matching runs.
WP4 - Implementation of EURO-KEP, Governance and Sustainability Plan
WP4 involves SCTP, ABM, ONT, IPST, HTO, OVSZ, NHSBT as beneficiaries and is led by the Italian National Transplant Centre (ISS-CNT). Its aim is to validate the EURO-KEP program by conducting a pilot of a pan-European kidney exchanges programme and establishing a governance plan for its sustainability.
Activities include:
the setting up of a Network of Competent Authorities (EURO-KEP network), responsible for the development and approval of both governance and sustainability plans;
the organization of pilots of EURO-KEP program, supporting national/regional efforts and testing pan-European kidney exchanges program.
the preparation and issuing of recommendation for improvement of the EURO-KEP guidelines (developed in the framework of WP3), on the basis of evaluation of pilot program results in order to highlight strengths and weaknesses in the light of efficacy and feasibility of implementing the pan-European KEP;
the proposition of a governance scheme, to be discussed and approved by the whole consortium and to be considered for adoption by the EURO-KEP network;
the design of a long-term sustainability plan addressing key relevant aspects such as the maintenance of the IT platform beyond project duration and EU funds availability, management of intellectual properties, financial coverage and business continuity plan.
WP5 - Dissemination
The role of WP5 is to ensure that the Project, its outcomes and deliverables are made known to all relevant target groups and stakeholders. The specific objectives of WP5 are to develop a unique visual appearance of the Project, to identify all relevant target groups, to develop a concise dissemination plan and to inform all target groups about the Project, its overall objectives, goals, development, outcomes and results.
The WP will communicate the EURO-KEP approach and its interim and final results to a wide range of target groups making use of a set of target-group adapted and tailor-made communication tools and through targeted networking activities. The main target groups are professional/scientific communities as well as policy makers from national- and international levels. The WP will also organise the long-term exploitation of the EURO-KEP network. The ultimate goal of this WP is community building to involve as many researchers as possible.