In order to support an effective adaptation of the ethics reviews to the evolution of scientific research, notably due to the emergence of new areas of research and new forms of research collaborations, projects are expected to contribute to the following outcomes:

• Evaluate the effectiveness of current approaches to the ethics reviews in ensuring the embeddedness of human rights in the development of digital technologies and promoting adherence to ‘digital rights’ and ‘digital principles’ in the context of research and related international cooperation and partnership^[1];
• Develop new approaches to ethics reviews and assessments. This should focus on developing systems and procedures that promote an ethics by design culture fostering innovation, while supporting the research community to operationalise and embed new and upcoming EU human rights driven legal frameworks in research proposals, in line with the ethics by design approach;
• Enable the ethics processes to better inform policy choices about the uses of new and emerging technologies and support the researchers in incorporating ethical considerations into their research, thereby contributing to the protection of human rights and the promotion of EU values. For example, the GDPR, since its adoption has inspired the adoption and reform of privacy and data protection frameworks globally, resulting in a so-called ‘Brussels effect’^[2].

The emergence of new areas of research and development, including in the areas of gene editing and artificial intelligence, and the shift of research activities and collaborations to the online digital space, challenge the future of research ethics reviews.

At the same time, ethics should focus on the adherence to values and principles and not be a legal compliance mechanism. It is also necessary to prevent ethics reviews and assessments from becoming a red-tape mechanism, especially as the ex-ante-model of traditional ethics oversight might not be apt to deal with new challenges for example stemming from various forms of data re-use and the often unpredictable and tentative nature of big data research and unforeseeable risks.^[3]

Among the key concerns are research activities that do not involve traditional ‘research participants’ or where there are no established practices or legal obligations to undergo ethics review. A pertinent example is research assembling and analysing large volumes of existing (anonymised) research data, data produced as a by-product of people’s use of technological devices and services, and other categories of non-personal data. The absence of the traditional individual research participant or data subjects, however, does not mean the research activities do not pose ethical challenges or risks.

In addition, a broader variety of players, often in an international setting, is frequently involved in such research activities. These may include universities, corporations, public and private foundations, civil society organisations, online service providers, open exchange and collaboration initiatives and platforms, and other formal and informal associations.

Another important element to be taken into account when investigating how the ethics committee should evolve is the development of a new legal framework related to the protection of human rights. In particular, to prepare for ‘Europe’s Digital Decade’, there are several important initiatives in the pipeline that aim to facilitate the access to and use of digital data, such as the Data Governance Act^[4] and the proposals for a Data Act^[5] and the European Health Data Space^[6] .Meanwhile, the EU has been a frontrunner in the formulation of normative frameworks that aim at safeguarding human rights and freedoms in the context of digital innovation, and has committed to incorporate those values into international research collaboration^[7]. What is more, the GDPR, since its adoption, has inspired the implementation and reform of privacy and data protection frameworks globally, resulting in a so-called ‘Brussels effect’,^[2] and the Commission has indicated a clear willingness to move further ahead with the proposal for an Artificial Intelligence Act^[9] and the Declaration on Digital Rights and Principles for the Digital Decade.

In this context, the proposed actions should:

1. Analyse the strengths and weaknesses of the current approaches to ethics review in their capacity to address the challenges above (new technologies, new players, new forms of collaboration and partnerships, new human rights related framework, etc.), and, on this basis, propose concrete ways of adapting ethics committees (working methodologies, composition, etc.) in view of matching the new challenges. The overall objective is to identify gaps in practice and formulate proposals to enhance the capabilities of the existing ‘ethics infrastructure’ in Europe. As regards the role of the bodies, it is important not to limit the scope to the ex-ante ethics review, prior to the start of the research concerned, but to also cover the monitoring during the implementation of the research and innovation activities. Practical ways to support the work of relevant stakeholders, notably research funders should also be identified, including the development of quality criteria or benchmarking tools to assist in the evaluation of existing research ethics oversight mechanisms^[10]. The applicability of the proposed approaches should also be tested via the use of specific case-studies (involving non-EU partners where appropriate);
2. Organise stakeholder consultations and interdisciplinary mutual learning initiatives to enable the identification of best practices for the ethics oversight of new modes of research. As cutting-edge research is of cross-border character, this action should involve institutions that engage in research ethics review and relevant related activities, including at the international level;
3. Develop guidelines and corresponding training and education materials to enable ethics experts involved in ethics reviews to assess compliance with the new ethics standards resulting from the new challenges addressed under point 1 and above;
4. Train Framework Programme ethics appraisal scheme experts (250-300). Close attention should be paid to gender balance, as well as to gender equality- and diversity-related ethical aspects. Feedback of the trainees should be used to improve the trainings.

In addition, this action should produce traditional and innovative training material (reflecting the developed approaches and guidelines) for students, early career and experienced researchers, as well as for research administrators and managers (to support the professionalisation of research management in the area of research ethics). The priorities of the EU Digital Education Action Plan (2021-2027)^[11] should be taken into account.

Proposals should ensure that the publicly available results from relevant EU-funded research projects (e.g., SOPs4RI, SHERPA, SIENNA, TechEthos, RoSie) ^[12] are incorporated, in particular the guidelines that they have produced.

Proposals should foresee budget for cooperation with Embassy of Good Science (including the necessary technical aspects) and ENERI^[13], as well as cooperation with other existing European Networks with clear attribution of research ethics responsibilities, including (associations of) European networks of (early) career researchers or educators in the field of research ethics and integrity. The material must be made available on the e-platform Embassy of Good Science^[14].

In order to improve the impact of the expected output (such as effectiveness of training courses, guidelines, toolboxes, etc.), cooperation with research management offices and ethics officers in Research Performing Organisations is highly recommended. In addition, National Contact Points should be provided with all the materials relevant to support their advisory activities.

To achieve the expected outcomes, international cooperation is strongly recommended.

Consortia with EU partners or Associated Countries partners that have not previously collaborated are encouraged to participate.

For all published articles and deliverables produced in the context of the activities, an authorship contribution statement must be added, in accordance with a recognised standardised taxonomy developed for this purpose (e.g., CRediT).

[1] Communication From the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: 2030 Digital Compass: the European way for the Digital Decade, COM(2021) 118 final, Brussels, 9.3.2021, https://eur-lex.europa.eu/resource.html?uri=cellar:12e835e2-81af-11eb-9ac9-01aa75ed71a1.0001.02/DOC_1&format=PDF

[2] Floridi, L. The European Legislation on AI: a Brief Analysis of its Philosophical Approach. Philos. Technol. 34, 215–222 (2021). https://doi.org/10.1007/s13347-021-00460-9.

[3] Ferretti, A., Ienca, M., Sheehan, M. et al. Ethics review of big data research: What should stay and what should be reformed?. BMC Med Ethics 22, 51 (2021). https://doi.org/10.1186/s12910-021-00616-4.

[4] https://data.consilium.europa.eu/doc/document/PE-85-2021-INIT/en/pdf

[5] https://digital-strategy.ec.europa.eu/en/library/data-act-proposal-regulation-harmonised-rules-fair-access-and-use-data

[6] https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en

[7] As confirmed by the Marseille Declaration on International Cooperation in Research and Innovation of 8 March 2022, and reflected as priority of the European Research Area Policy Agenda for 2022-2024.

[8] Floridi, L. The European Legislation on AI: a Brief Analysis of its Philosophical Approach. Philos. Technol. 34, 215–222 (2021). https://doi.org/10.1007/s13347-021-00460-9.

[9] EUR-Lex - 52021PC0206 - EN - EUR-Lex (europa.eu)

[10] For health research, a notable example of a Benchmarking Tool for ethics oversight has been developed by the WHO. See https://cdn.who.int/media/docs/default-source/ethics/who-benchmarking-tool_research-ethics-oversight_draft-for-consultation-26-nov-2021.pdf?sfvrsn=ed34a0ec_5

[11] https://ec.europa.eu/education/education-in-the-eu/digital-education-action-plan_en

[12] Detailed information of the mentioned EU-funded projects can be found on CORDIS website: https://cordis.europa.eu/

[13] http://eneri.eu/

[14] https://embassy.science/