Objectives
Key objective: To develop an operational ethics and integrity framework, which safeguards key ethical values, supports a rapid and effective research response to crises and improves overall pandemic preparedness.
Outputs
Create an international network of research funders (private and public), researchers, policy makers, publishers and citizens:
- To identify, analyse and validate the emergent research ethics and integrity challenges in the context of sudden, unexpected and global crisis,
- To facilitate bottom-up, solution-focused, participatory dialogue,
- To develop a values-based framework for research ethics and integrity in a global crisis which supports rapid and effective decision-making whilst maintaining scientific reliability and avoiding short-cuts in the protection of research participants,
- To propose policy options at the EU level and tailored support for relevant stakeholders in the form of operational guidelines and short complements to existing codes and
- To achieve influential strategic engagement through high-level synergy building and the provision of engaging training material to ensure uptake of the project's outputs so as to improve overall preparedness for global crises.
Key project results/activities for RECs and ethics experts
The PREPARED project has shed light on the challenges faced by RECs amid global crises such as the COVID-19 pandemic. These unforeseen circumstances necessitate significant adaptations to REC workflows, as adhering to standard operating procedures often becomes unfeasible.
According to the M2 “Stakeholder Needs” milestone report , published in December 2022, the challenges encountered by RECs during the COVID-19 pandemic were multifaceted. RECs had to grapple with an upsurge in research proposals and an intensified demand for rapid ethics review, particularly in projects related to pandemic prevention, treatment, and solutions. This surge prompted some RECs to develop fast-track review procedures, making the prioritisation of research projects a significant challenge. Additionally, the shift from traditional in-person meetings to remote workflows presented technological barriers, affecting REC members without easy access to technology or structured digital processes. Moreover, funding shortages hindered the recruitment of external experts capable of conducting comprehensive reviews of submitted research.
RECs also struggled to conduct risk-benefit analyses during crises under uncertain conditions. Key areas of concern highlighted by RECs encompassed adjustments to informed consent procedures, the identification and inclusion of vulnerable groups, the evaluation of human challenge trials, issues related to placebos when effective treatments or vaccines were available, the prevention of therapeutic misconception, the consideration of benefit sharing, and efforts to prevent ethics dumping.
Proposed solutions include the implementation of new fast-track procedures, adapting to new work formats, increasing financial support and human resources, collaborating with other stakeholders, facilitating remote research and interaction, and raising awareness about the pivotal role of RECs during crises.
PREPARED seeks to implement these findings into training materials for research stakeholders in coming years. PREPARED released a case study app which introduces the wider public to ethical dilemmas faced in research during crises, including cases on REC reviews. In addition, PREPARED will develop fast-track procedures to help RECs accelerate review processes and support ethical and high-quality research. Lastly, a values-based code of conduct will guide RECs in rapid ethical decision-making.
Duration
September 2022 - August 2025
Website
prepared-project.eu
Cordis Entry
cordis.europa.eu/project/id/101058094
