Periodic Reporting for period 1 - CHANGER (CHALLENGES AND INNOVATIVE CHANGES IN RESEARCH ETHICS REVIEWS)
Berichtszeitraum: 2024-01-01 bis 2025-06-30
Trust in science and technology as well as the utility and acceptability of their innovative outcomes is crucially dependent on the ethical qualities of the research. This is the reason why research projects are submitted to an ethical review. Although the existing ethics review infrastructure is effective in traditional (e.g. biomedical) research, this is not the case for new technologies and transformative research that pose challenges to human rights. There is a clear need for Research Ethics Committees (RECs) to evolve and be able to support innovation while embedding human rights, as well as a need that researchers are engaged in a process of reflexivity on the ethical implications of their research, embedding ethics in the research design.
The project aims to promote changes in research ethics reviews that strengthen the capacities of researchers to incorporate ethical judgements in the project design and implementation, and support ethics committees to address new research challenges. To this objective, CHANGER will provide:
1. A mapping of new challenges emerging from new technologies and new research practices, which are not sufficiently covered in the current ethics review process.
2. Innovative approaches to ethics review reform and new understandings to practice ethics-by-design, which can be used by researchers and RECs.
3. Innovative training material to address challenges in ethics reviews in four thematic areas: electronic Informed Consent (eIC), organoids, Artificial Intelligence (AI) and gene editing.
4. Informed policy choices supporting the uptake and dissemination of novel ethics review approaches in the European Research Area.
The interdisciplinary consortium of the CHANGER project is uniquely equipped to enforce the necessary adaptations in the ethics review process and translate the project outcomes into long-term impact.
The project aims to promote changes in research ethics reviews that strengthen the capacities of researchers to incorporate ethical judgements in the project design and implementation, and support ethics committees to address new research challenges. To this objective, CHANGER will provide:
1. A mapping of new challenges emerging from new technologies and new research practices, which are not sufficiently covered in the current ethics review process.
2. Innovative approaches to ethics review reform and new understandings to practice ethics-by-design, which can be used by researchers and RECs.
3. Innovative training material to address challenges in ethics reviews in four thematic areas: electronic Informed Consent (eIC), organoids, Artificial Intelligence (AI) and gene editing.
4. Informed policy choices supporting the uptake and dissemination of novel ethics review approaches in the European Research Area.
The interdisciplinary consortium of the CHANGER project is uniquely equipped to enforce the necessary adaptations in the ethics review process and translate the project outcomes into long-term impact.
In the first 18 months of the project, considerable progress has been made across various Work Packages (WPs).
WP1: The administrative and management structures and processes to be followed during the project have been established, including a Joint Controller Agreement, a Data Management Plan and the project’s Ethical Management Responsibilities. The 1st Policy Brief “Challenges and recommendations for research security: Learning from research ethics and integrity” has been published. The Dissemination and Communication Plan has been developed and implemented, while the project’s visibility within the European research community has been established through various campaigns.
WP2: Current ethics reviews were evaluated via systematic mapping of the literature, focus groups and interviews with ethics review experts. Challenges, facilitators and barriers of the current ethics review process were identified: informed consent, privacy, security, and transparency, which are tightly related to technological advancements; a range of systemic, structural, capacity-related, and cultural barriers that hinder the effectiveness of RECs; adaptability of ethics review processes across contexts and disciplines; ethical guidelines lagging behind technological advancements; complexity in research ethics in the social sciences and humanities; lack of institutional support; need for RECs to provide advice to researchers. Recommendations were formulated to improve the ethics review and the quality of research.
WP3: Five innovative methodologies for ethics reviews have been created: 1) consultative ethics review; 2) narrative ethics scenario building; 3) embedded ethics advisor, 4) iterative ethics review, and 5) two-step informed consent. The methodologies were transferred to the contexts of RECs via pilot workshops, with participation of REC members from diverse academic backgrounds. Four pilot workshops took place in Athens, Greece; Coimbra, Portugal; Bonn, Germany; Split, Croatia. The results are currently being consolidated into an overall report, which will further serve as resource to improve the methodologies. Findings so far confirm that the project’s approach and methodologies have been positively received addressing needs beyond the improvement of methods.
WP4: Innovative training material to address new challenges in ethics reviews is currently being developed in 4 thematic areas: eIC, gene editing, organoids and AI. Guidance documents for RECs as well as Massive Open Online Courses (MOOCs) for both ethics experts and researchers, have been developed for eIC and gene editing. In parallel, the guidance documents and MOOCs on organoids and AI are under preparation.
WP5 focuses on identifying and promoting policy choices supporting the uptake and dissemination of novel ethics review approaches in the European Research Area. WP2 and WP3 findings were used to develop the Dialogue Event (DE) Design Document. DEs will be organized in the second half of the project, and will engage with researchers, policymakers, funding agencies, ethics experts, activists, and representatives of the EC. An analysis of the policy frameworks relevant to the topics of the DEs has been initiated.
WP1: The administrative and management structures and processes to be followed during the project have been established, including a Joint Controller Agreement, a Data Management Plan and the project’s Ethical Management Responsibilities. The 1st Policy Brief “Challenges and recommendations for research security: Learning from research ethics and integrity” has been published. The Dissemination and Communication Plan has been developed and implemented, while the project’s visibility within the European research community has been established through various campaigns.
WP2: Current ethics reviews were evaluated via systematic mapping of the literature, focus groups and interviews with ethics review experts. Challenges, facilitators and barriers of the current ethics review process were identified: informed consent, privacy, security, and transparency, which are tightly related to technological advancements; a range of systemic, structural, capacity-related, and cultural barriers that hinder the effectiveness of RECs; adaptability of ethics review processes across contexts and disciplines; ethical guidelines lagging behind technological advancements; complexity in research ethics in the social sciences and humanities; lack of institutional support; need for RECs to provide advice to researchers. Recommendations were formulated to improve the ethics review and the quality of research.
WP3: Five innovative methodologies for ethics reviews have been created: 1) consultative ethics review; 2) narrative ethics scenario building; 3) embedded ethics advisor, 4) iterative ethics review, and 5) two-step informed consent. The methodologies were transferred to the contexts of RECs via pilot workshops, with participation of REC members from diverse academic backgrounds. Four pilot workshops took place in Athens, Greece; Coimbra, Portugal; Bonn, Germany; Split, Croatia. The results are currently being consolidated into an overall report, which will further serve as resource to improve the methodologies. Findings so far confirm that the project’s approach and methodologies have been positively received addressing needs beyond the improvement of methods.
WP4: Innovative training material to address new challenges in ethics reviews is currently being developed in 4 thematic areas: eIC, gene editing, organoids and AI. Guidance documents for RECs as well as Massive Open Online Courses (MOOCs) for both ethics experts and researchers, have been developed for eIC and gene editing. In parallel, the guidance documents and MOOCs on organoids and AI are under preparation.
WP5 focuses on identifying and promoting policy choices supporting the uptake and dissemination of novel ethics review approaches in the European Research Area. WP2 and WP3 findings were used to develop the Dialogue Event (DE) Design Document. DEs will be organized in the second half of the project, and will engage with researchers, policymakers, funding agencies, ethics experts, activists, and representatives of the EC. An analysis of the policy frameworks relevant to the topics of the DEs has been initiated.
CHANGER has identified structural and operational shortcomings in ethics review systems, especially within RECs. Overly rigid, checkbox-style reviews imported from medical ethics fail to capture the real, often evolving, ethical dilemmas researchers face, in research involving emerging and disrupting technologies or in social sciences. RECs are under-resourced, lacking expertise in digital and interdisciplinary areas, and overly shaped by legal obligations rather than ethical reasoning. A strong preference for advisory, iterative ethics support rather than purely regulatory oversight has been identified. New formats for ethical guidance are needed to address challenges posed by big data, AI, and international legal fragmentation. The need for multi-disciplinary REC composition, better networking among RECs, participatory ethics practices, researcher-led responsibility, and more flexible, reflexive, and embedded approaches to research ethics have been highlighted.
To this direction, CHANGER has developed dialogic, learning-by-doing approaches that foster reflexivity and capacity building, not only to support RECs in the changing research environment but also to support the research community in embedding ethics in research. Five innovative methodologies have been developed and proposed that go beyond the traditional “tick-box” procedure in ethics reviews, breaking the silos between researchers and RECs, adopting a culture shift of making ethics integral and strategic in the research design. After transferring these novel approaches to local contexts in RECs across countries, CHANGER will refine these methodologies and will identify the necessary policy changes to ensure the uptake of such culture shifts at different levels.
To this direction, CHANGER has developed dialogic, learning-by-doing approaches that foster reflexivity and capacity building, not only to support RECs in the changing research environment but also to support the research community in embedding ethics in research. Five innovative methodologies have been developed and proposed that go beyond the traditional “tick-box” procedure in ethics reviews, breaking the silos between researchers and RECs, adopting a culture shift of making ethics integral and strategic in the research design. After transferring these novel approaches to local contexts in RECs across countries, CHANGER will refine these methodologies and will identify the necessary policy changes to ensure the uptake of such culture shifts at different levels.