irecs D5.1: Implementation Guide

D5.1: Implementation Guide [WP5 – Training programme implementation and sustainability of good practice] Lead contributor UBO Other contributors UM, MEFST, VUMC, EUA, EUREC, EARMA Due date 31 March 2025 Delivery date 02 June 2025 (extension) Type R — Document, Report Dissemination level PU – Public Keywords Implementation guide, Pilot-Universities, Training Material, Ethics Governance Funded by the European Union. UK participants in Horizon Europe Project irecs are supported by UK Research and Innovation grant numbers 10055935 (University of Central Lancashire) and 10037820 (De Montfort University). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Research Executive Agency or UKRI. Neither the European Union nor the granting authority nor UKRI can be held responsible for them. irecs, 2025 This work is licensed under a Creative Commons Attribution 4.0 International License 101058587 –– D5.1 Implementation guide 2 Abstract This report documents on the implementation of irecs training modules in a real-world setting. Based on testing by pilot universities, experiences in using the irecs materials and evaluation of it, an implementation guide is designed for higher education institutions and RFO’s. This will be disseminated through networks of EUA, ENERI, EUREC, EARMA, the Embassy of Good Science, ENRIO and ALLEA to facilitate embedding of results at institutional levels. Document history Version Date Description Reason for change Distribution V0.1 21 March 2025 First Draft Template suggested by WP 5 lead 21 March 2025 V0.2 27 May 2025 Draft finalized version With input from pilot universities V0.3 30 May 2025 Final draft Check by the coordinator of irecs 30 May 2025 V1.0 2 June 2025 Final version for upload Minor edits in layout 2 June 2025 101058587 –– D5.1 Implementation guide 3 Table of contents Abstract .................................................................................................................................................... 2 Table of contents ..................................................................................................................................... 3 Executive summary ................................................................................................................................. 4 List of acronyms/abbreviations ................................................................................................................ 5 1. Introduction .......................................................................................................................................... 6 1.1 Objectives ...................................................................................................................................... 6 2. Pilot universities: activities, opportunities and barriers ........................................................................ 6 2.1 UBO: University of Bonn ............................................................................................................... 7 2.2 UM: Maastricht University ............................................................................................................. 8 2.3 MEFST: University of Split School of Medicine ............................................................................. 9 3. Implementation guide ........................................................................................................................ 11 3.1 Four pillars of the Universities’ RE Governance: Ethics by Training, Ethics by Design, Ethics by Scientific Discourse, Ethics by Exchange ......................................................................................... 11 3.2 How the pilot universities (can) use the implementation guide ................................................... 15 3.2.1 UBO ....................................................................................................................................... 15 3.2.2 UM ......................................................................................................................................... 17 3.2.3 MEFST .................................................................................................................................. 17 4. Summary and outlook ........................................................................................................................ 20 Appendix ................................................................................................................................................ 21 101058587 –– D5.1 Implementation guide 4 Executive summary irecs (https://www.irecs.eu/) is a Horizon Europe project that focuses on extended professionalisation of research ethics expertise, for research ethics bodies, students, PhD's and other professionals. irecs takes four science and technology cases as exemplars to tackle ethical challenges of new and emerging science and technology. The project aims to reinforce the reliability of science by advancing research ethics expertise and competencies. Effective dissemination, exploitation and communication (DEC) are key to maximising the project’s impact: to improve the understanding of research ethics in Europe and to provide interactive, sustainable training programmes. This report focuses on the implementation of irecs training modules in a real-world setting. Based on testing by pilot universities, experiences in using the irecs materials and evaluation of it, an implementation guide is designed for higher education institutions and RFO’s. This deliverable results from activities in task 5.3 specifically which concerns the piloting and testing of materials by pilot universities. 101058587 –– D5.1 Implementation guide 5 List of acronyms/abbreviations Abbreviation Explanation DEC Dissemination, Exploitation and Communication WP Work package REC Research Ethics Committee ECR Early Career Researcher SAB Stakeholder Advisory Board Table 1: List of acronyms/ abbreviations 101058587 –– D5.1 Implementation guide 6 1. Introduction 1.1 Objectives irecs (https://www.irecs.eu/) is a Horizon Europe project that focuses on extended professionalisation of research ethics expertise, for research ethics bodies, students, PhD's and other professionals. irecs takes four science and technology cases as exemplars to tackle ethical challenges of new and emerging science and technology. The project aims to reinforce the reliability of science by advancing research ethics expertise and competencies. Effective dissemination, exploitation and communication (DEC) are key to maximising the project’s impact: to improve the understanding of research ethics in Europe and to provide interactive, sustainable training programmes. This report focuses on the implementation of irecs training modules in a real-world setting. Based on testing by pilot universities, experiences in using the irecs materials and evaluation of it, an implementation guide is designed for higher education institutions and RFO’s. This deliverable results from activities in task 5.3 specifically which concerns the piloting and testing of materials by pilot universities: Task 5.3: Task Lead: UBO Contributors: EUA, EUREC, EARMA, UM, MEFST Involve three pilot universities (UBO, UM, MEFST) to test all outputs, including the training programme and the proposed adaptations of ethics review processes, in a real-world setting. These universities will implement all outputs, and experiences will be evaluated (T1.5) to develop an implementation guide for higher education institutions, RPOs and RFOs. This will be disseminated through the networks of EUA, ENERI, EUREC, EARMA, the Embassy, ENRIO and ALLEA to facilitate embedding of results at institutional level. 2. Pilot universities: activities, opportunities and barriers In this section, we report on progress and performance per dedicated dissemination and communication channel. While dissemination and communication have their distinct aims and target audiences, some overlap in the channels used was unavoidable. The following three pilot universities are implementing concrete training programs at their facilities: • University of Bonn (UBO) • Maastricht University (UM) • University of Split School of Medicine (MEFST) 101058587 –– D5.1 Implementation guide 7 2.1 UBO: University of Bonn Bonn University employs 699 professors and 5 399 scientific staff, teaching more than 38 000 students, including more than 6 500 doctoral students. UBO’s third-party fundraising efforts resulted in e.g. 69 ERC-grants hosted at UBO, and providing research ethics consultancy plays a strong role in this acquisition strategy. Ethics votes are currently provided by three different RECs: one at the Psychological Institute, another at the Center for Development Research (ZEF) and thirdly the Committee at the Medical Faculty. This latter REC was established to fulfil the requirements defined by German medical and pharmaceutical law. For years, it also provided ethics votes for projects unrelated to the medical or pharmaceutical field. Although this was a practical solution, it meant that the ethics reviews on these non-medical projects were conducted by REC members who, although being highly qualified in the fields that the medical REC was designed to cover, possibly have less expertise in non-medical research work and methods. Hence, in some cases external experts from the fields in question had to be recruited on a case-by-case basis. To offer a better and more specialized research ethics support, the relevant infrastructure currently undergoes a process of fundamental improvement and restructuring. Based on the implementation guide described in more detail below, research ethics are to become an integral part of the research culture in Bonn. In this process, UBO is benefitting from the irecs-materials in a multitude of ways: • UBO developed the concept of a Research Ethics Curriculum to incorporate ethics teaching as a fixture into the education of UBO’s scientists at all levels. Approximately, 100-200 undergraduate and postgraduate students from the life sciences and agriculture were trained in two semester-long courses using the irecs materials. Another training program is currently underway with around 100 participants. • In cases where workshops or other training events are not immediate part of this Curriculum, parts of the irecs-materials are integrated into the material used. This allows for a flexible pick and match approach, ensuring that the course material actually meets the participants’ needs, even if the course consists of small, very specialized groups. • To ensure greater recognizability of irecs’ outputs, a certificate was developed that can be obtained upon successful course completion. • Furthermore, in order to ameliorate the abovementioned lack of specialized ethics review support, UBO is currently establishing a cross-faculty ethics committee additional to already exiting RECs in Medicine, Psychology, Development Research and Dual Use issues. Despite the process being complex, first milestones have been achieved, such as developing rules of procedure and naming potential members. The irecs-material will in the future be used to train said members. 101058587 –– D5.1 Implementation guide 8 2.2 UM: Maastricht University Research ethics is at the centre of the research agenda at Maastricht University (UM). The University has placed a comprehensive system of RECs to support its diverse research culture. UM has approximately 23,000 students and employs nearly 2,500 academic staff, including 411 doctoral researchers. It consists of six faculties that host 71 research institutes. A mandatory course on research ethics and integrity is provided to all PhD researchers during UM-wide training as well as at some graduate schools and research institutes within each faculty. The ethical review of scientific research involving human participants or personal data is conducted by four ethical review committees. The accredited Medical Ethics Committee (Medisch Ethische Toetsingscommissie, METC) at the academic hospital - the Maastricht University Medical Centre+ (MUMC+), reviews and approves medical studies that fall under the Dutch law - Medical Research Involving Human Subjects Act (WMO), while the REC at the Faculty of Health, Medicine and Life Sciences (FHML-REC) reviews studies that are outside of the scope of the WMO. FHML-REC also issues “ethics licences” to specific Masters courses that enable them to appoint their own ethics assessors for low-risk thesis projects, with highrisk applications being sent to FHML-REC for review. Other types of scientific studies are reviewed by the Ethics Review Committee Inner City faculties and the Ethics Review Committee Psychology and Neuroscience. These two RECs often review studies in social and behavioural sciences that involve human subjects. Additionally, the UM-REC has been established to address overarching issues in research ethics across the three faculty RECs that review non-WMO studies. irecs training materials are being integrated into MU's academic ecosystem as follows: • Training courses on research ethics tailored to different audiences, taking into account the irecs training materials: o A webinar is scheduled for May 2025 for PhD candidates (up to 400) and other junior researchers (e.g., master’s students) within the Care and Public Health Research Institute at the Faculty of Health, Medicine, and Life Sciences o We are planning webinars for REC members and supervisors of PhD and Masters students at the Faculty of Health, Medicine, and Life Sciences. • Integration of irecs training materials in undergraduate and postgraduate education: o We are working to incorporate irecs online training materials in several courses within various Masters programmes in health and life sciences. Additionally, we are exploring the possibility of issuing certificates to students who complete the online modules as a part of their course assessment. o We are considering offering training courses on research ethics and integrity to undergraduate students within two bachelor’s programmes in health sciences and social sciences. 101058587 –– D5.1 Implementation guide 9 • Dissemination of irecs materials at Maastricht University o Information about irecs online training materials has been widely disseminated within the University. This includes meetings and email list outreach to REC members and over 200 junior and senior researchers across disciplines such as law, sustainability, business, and data sciences. • Cross-sectoral and interdisciplinary forum on research ethics o We are working on an initiative to establish Research Ethics Forum to facilitate interdisciplinary exchange and discussion of research ethics issues within the University. • Research in the field of research ethics o We are planning two studies on research ethics. One study will critically examine the use of AI tools in research, while the other will investigate the relationship between legal and ethical issues concerning privacy and security in developing AI models. These topics align with the implementation guide initiatives created by all the pilot universities to promote best practices for research ethics through research activities. Lessons learned at UM: • The benefits of issuing iRECs-certificates (e.g., certificates of completion) at the end of each module. As we work to incorporate iRECs’ online training materials in several courses across multiple Master‘s programmes in health and life sciences, these certificates would greatly motivate both teachers and students to use the materials, as they can be used in course assessment. • Establish an online forum where UM researchers can discuss and exchange ideas on questions and issues related to research ethics. • Tailor the iRECs materials and provide research ethics training according to the needs of different audiences. For instance, feedback indicates that REC members and early career researchers have varying interests in different sections of the training materials. Their needs also differ based on the disciplines in which the researchers are working. 2.3 MEFST: University of Split School of Medicine University of Split School of Medicine is a part of the University of Split, functioning as a separate legal entity but collaborating with other University constituents. This enabled us to reach out to the whole university to conduct a webinar with members of the RECs and researchers from other university constituents. Our main aim was to use the irecs training materials on AI in Health to train students in the topic that they are interested in and which will be a part of their future professional work. After successfully piloting irecs training with students of medical studies (MD degree study), dental medicine studies (DMD degree study) and pharmacy studies (Master of Pharmacy study) (all programmes taught at the School of Medicine), we will incorporate irecs modules 101058587 –– D5.1 Implementation guide 16 1. The Training: With regards to training, we expanded the ethics courses since the beginning of the irecs-project, integrating the irecs-materials into UBO’s academic ecosystem. More precisely, this includes: • We provide regular training courses on various aspects of research ethics and research integrity, held at least once a semester for students and doctoral candidates in the life sciences, natural sciences and neurosciences, using the irecs training materials • Furthermore, we are in the last steps of integrating the irecs-materials into a certificate that can be obtained upon successful participation in the various selflearning modules. For this, we cooperate with the Bonn Graduate Center (BGZ), the university’s in-house provider for cross-faculty graduate trainings. On the technical side, we are using the platform “e-campus” (https://ecampus.unibonn.de/ilias.php?baseClass=ilrepositorygui&reloadpublic=1&cmd=frameset&ref _id=1&lang=en). Employing this common platform allows for easy scaling and transfer to other systems as well. Participants will receive the certificate after passing the respective module’s set of exam questions. Once certification has been successfully established in Bonn, the aim is to implement it at the other pilot universities. 2. A new cross-faculty Ethics Committee: In order to provide UBO’s researchers with easily accessible, quick and research field specific ethics reviews, we are implementing a cross-faculty ethics committee. This REC will integrate the relevant university actors in one body working together, offering ethics reviews of projects of Bonn researchers. It is important to point out that – unlike the legally required ethics reviews for medical studies – due to the high value of freedom of research, these reviews are an offer that researchers can take advantage of on a voluntary basis. • Given also the strong bottom-up structure of German universities, implementing a new acting body is a complex procedure. While this requires longer time until the committee can actually come into force, it also ensures that the committee has the support of the university as a whole. At UBO, the concept of a universitywide REC is strongly welcomed by the different parties, its necessity and addedbenefit to the research life at UBO unquestioned. • With the detailed concept as well as the Rules of Procedure ready in place, the REC currently awaits approval by the University’s senate. Furthermore, pillars 3 and 4 are strong in Bonn as well: 3. Scientific discourse: With several groups and institutions working on ethics research – DRZE, IWE, Center for Life Ethics, as well as research groups in the faculties of theology and law, to name a selection – this research field is deeply rooted in UBO’s culture, providing a constant influx of new ideas and concepts. 101058587 –– D5.1 Implementation guide 17 4. Exchange and Networking: Being in the process of implementing the cross-faculty ethics Committee, many new paths of exchange are currently forming. Furthermore, throughout the irecs-project a continuous exchange between researchers at DRZE and research administration staff was established, and we worked together closely to develop UBO’s contribution to implementation guide presented here, reflecting insights from both scientific and practical implementation perspective. 3.2.2 UM As indicated in section 2.2., training and research activities at UM have covered all four pillars identified in the template: 1. Ethics training: Training based on irecs materials will be provided to PhD researchers and junior REC members. Irecs materials will also be integrated into some undergraduate and postgraduate courses. 2. Ethics by design: Training information and irecs materials have been widely disseminated among various research institutes and REC members across all faculties. A list of grant officers and data managers at FHML has been compiled to identify potential stakeholders for future research ethics training or dissemination activities. 3. Scientific discourse: Studies on research ethics are being developed. UM has experienced researchers working at several research institutes focusing on research ethics and integrity. 4. Ethics by exchange: A UM initiative for cross-sectoral and interdisciplinary forum on research ethics. 3.2.3 MEFST MEFST is working on all four pillars: Training (Ethics by Training), Ethical Guidance and Support of Research (Ethics by Design), Research in the field of Research Ethics (Ethics by Scientific Discourse) and Platforms to Communicate between all Actors (Ethics by Exchange). 1. Training (Ethics by Training) We introduced training on research ethics and challenges to research ethics review into mandatory coursed on research methodology (Department of Research in Biomedicine and Health) and medical humanities (Department of Medical Humanities). irecs training materials are now included in courses for 1st to 3rd year of the curricula for medical, dental medicine and pharmacy students (Department of Research in Biomedicine and Health) and 4th to 6th year of the curricula for medical and dental medicine students (Department of Medical Humanities). The irecs material we used focused on the ethics of AI in health, and we plan to include the topics on gene editing from the next academic year. This training will remain as a part of the mandatory courses for students. 101058587 –– D5.1 Implementation guide 18 We have also introduced irecs training into the courses on ethics at the Doctoral School at MEFST, ensuring that doctoral students also learn about challenges to research ethics. 2. Ethical Guidance and Support of Research (Ethics by Design) We closely collaborate with the Science office at MEFST and the Science Department of the University Hospital of Split, the main teaching hospital for the University of Split. In collaboration with them, we established the collaboration around ethics issues regarding emerging technologies and ethics challenges to health research. We have also engaged with the Doctoral School at MEFST, where we have created the position of Research Integrity Advisor, which provided support for researcher about research ethics and research integrity. 3. Research in the field of Research Ethics (Ethics by Scientific Discourse) We actively engage in research regarding emerging challenges to research ethics and integrity. Here are some articles published by our group, which were influenced by irecs topics: Vasconcelos S, Marušić A. Gen AI and research integrity: Where to now? : The integration of Generative AI in the research process challenges well-established definitions of research integrity. EMBO Rep. 2025 Apr;26(8):1923-1928. doi: 10.1038/s44319025-00424-6. Roguljić M, Šimunović D, Buljan I, Žuljević MF, Turić A, Marušić A. Publishing Identifiable Patient Photographs in the Digital Age: Focus Group Study of Patients, Doctors, and Medical Students. J Med Internet Res. 2025 Mar 5;27:e59970. doi: 10.2196/59970. Grosek Š, Štivić S, Borovečki A, Ćurković M, Lajovic J, Marušić A, Mijatović A, Miksić M, Mimica S, Škrlep E, Lah Tomulić K, Erčulj V. Ethical attitudes and perspectives of AI use in medicine between Croatian and Slovenian faculty members of school of medicine: Cross-sectional study. PLoS One. 2024 Dec 5;19(12):e0310599. doi: 10.1371/journal.pone.0310599. PMID: 39637041; PMCID: PMC11620630. Kaliterna M, Žuljević MF, Ursić L, Krka J, Duplančić D. Testing the capacity of Bard and ChatGPT for writing essays on ethical dilemmas: A cross-sectional study. Sci Rep. 2024 Oct 30;14(1):26046. doi: 10.1038/s41598-024-77576-3. PMID: 39472544; PMCID: PMC11522523. We also have very good collaboration with the University’s Office for Research – in collaboration with them we organized training for RECs at all University Schools and 101058587 –– D5.1 Implementation guide 19 Departments, and offer them support in addressing the ethical issues related to emerging technologies. 4. Platforms to Communicate between all Actors (Ethics by Exchange). We closely collaborate with the Croatian Network for Reproducibility and Integrity Network (CroRIN, https://crorin.hr/en-homepage/), where we have established contact with the Croatian Science Foundation, the main public research funding body in Croatia, and the Agency for Mobility and EU Programmes. We are currently planning irecs training events for July 2025. 101058587 –– D5.1 Implementation guide 20 4. Summary and outlook This implementation guide represents a major milestone in the irecs project, showcasing how research ethics training and governance structures can be effectively embedded within diverse higher education and research environments. Drawing on insights from three pilot universities – UBO, UM, and MEFST – the guide demonstrates how tailored approaches, rooted in the irecs framework, support the development of robust, sustainable ethics infrastructures. The four pillars – Ethics by Training, Ethics by Design, Ethics by Scientific Discourse, and Ethics by Exchange – have proven to be adaptable and scalable across institutions of varying size, culture, and regulatory context. Each university has implemented the pillars in ways that reflect their institutional strengths and needs, while jointly contributing to a shared vision for advancing research ethics across Europe. Looking ahead, the implementation guide and associated training materials will continue to be disseminated via key networks including EUA, EUREC, EARMA, ENRIO, and ALLEA. The pilot universities will remain active as role models, offering tested strategies and fostering exchange with other institutions. The implementation guide will serve as a practical resource for universities and research-performing or funding organisations aiming to enhance their ethics ecosystems. A short, systematised version of the Implementation Guide is already available. It is to be distributed via our networks (see appendix). 101058587 –– D5.1 Implementation guide 21 Appendix 101058587 –– D5.1 Implementation guide 22 101058587 –– D5.1 Implementation guide 23 101058587 –– D5.1 Implementation guide 24 101058587 –– D5.1 Implementation guide 25