This deliverable presents qualitative research on training needs for research ethics committees (RECs), focusing on four technologies selected in the iRECS project: AI in Health and Healthcare, Biobanking, Genome-Editing and Extended Reality. Based on desk research, expert consultations, and a leadership roundtable, iRECS identifies gaps in the current ethics review processes and needs to inform development of training materials. Following this analysis, iRECS formulates recommendations for each technology as well as cross-cutting recommendations. This Deliverable contributes to iRECS pedagogical goals and will inform ongoing and future work in iRECS WP4 and WP5.

irecs is a Horizon Europe project tackling the ethical challenges of research in new technologies. It aims to reinforce the reliability of science by advancing research ethics expertise and competencies. Its goal is to improve the understanding of research ethics in Europe (and beyond) and provide interactive and sustainable training programmes for research ethics committees.

The project focuses on 4 emerging technologies (AI in health and healthcare; Extended reality; Genome editing; Biobanking) and develops, implements and disseminates training material for research ethics reviewers and early career researchers.

This report deals with ethics review processes that take place outside of Europe. Taking into consideration that new and emerging technologies are basically stateless, have a global impact, and create strong interdependencies amongst nation states around the world, it is imperative to provide a view on ethics beyond the limited bounds of Europe. 

As part of WP2 that looks at ethical challenges of new technologies and ethics review processes in Europe, the report builds upon this work and expands the discussion to include perspectives from outside the European continent via quantitative (survey) and qualitative (interviews) methodologies. Based on previous research that identifies the main values and norms that influence the incorporation of ethics in official Science & Technology decision making around the world, we hereby offer a thorough analysis of ethical challenges that non-European ethics review processes are faced with. Particular attention is paid on non-European cultures represented in the project, namely those of Africa and China. Finally, recommendations on how to approach international collaborations on ethics is provided. 

This deliverable aims at identifying the adaptation needs of the ethics review process of research involving four technologies selected in the irecs project: AI in health and healthcare, extended reality, biobanking, and genome-editing at the EU, Member State and non-EU state level, drawing on earlier findings (T2.2, T2.3). It also presents results of the survey of members of RECs and other ethics experts, which was distributed among members of ENERI, EUREC, EUA and EARMA, to collect data on experiences, needs, and gaps in the ethics review process and preferred methods of  training, adding to the project knowledge base (WP4). The findings of the deliverable have been evaluated using SCORE analysis, focused on the EU and some non-EU countries, and will be integrated into the ENERI Classroom. The deliverable makes proposals for the adaptation of the ethics review process, focusing on the EC ethics self-assessment and existing guidance. to be trialled at pilot universities (T5.3).

A primary objective of the irecs project is to create new, sustainable materials for research ethics education, training, and awareness raising, related to the investigation of new technologies. The training will be applicable in Europe and beyond, meeting the current and forecast needs of ethics experts, students, and researchers.

Recognising that not all end users of the irecs training will be starting at the same point, our intention is to create a wide range of modules and support materials from which users can ‘pick and mix’ the steppingstones most suited to support their learning journey. While all modules will be designed for online learning, there will be options for self-directed as well as facilitated learning; online materials for both synchronous and asynchronous delivery; training guides for facilitators; and downloadable materials for people with poor internet access.

This report outlines how the technical developments in irecs will be rooted in sound pedagogical foundations to generate useful, learner-centred and user-friendly training materials.

In this deliverable, we report on the results of irecs task 6.1. The aim of this task has been to identify EU-funded projects, both past and ongoing, as well as networks, that address issues related to research ethics and research integrity and map their relationship to irecs. The report includes the publicly available relevant results deliverables, tools or other documents) of the selected projects and networks that provide input regarding guidelines, codes of conduct, recommendations, training material, competence profiles, and ethical /comparative analysis. These relevant results are considered to be useful for the next steps of irecs, and, in particular, in the mapping of existing needs raised by new technologies and their consequent impact on the research ethics processes, as well as in the development of training material for research ethics communities. This mapping will, also, provide the basis for developing synergies and establishing the irecs research ethics cluster, while aligning irecs to existing initiatives.