| Abstract [eng] |
Background the COVID-19 pandemic posed unprecedented challenges to global research ethics governance. In response to the urgent need for rapid scientific data, ethics review processes were accelerated, informed consent procedures adapted, and new research methods introduced. These changes were guided by the proliferation of research ethics guidelines issued by national, regional and international bodies. However, there has been limited systematic analysis of how these guidelines addressed key ethical challenges during the pandemic and shaped future ethical frameworks. This study aims to map the global network of pandemic related research guidelines, to analyze how they addressed the main pandemic specific ethical challenges. Methods We conducted a systematic search of published research ethics and regulatory guidelines developed in response to the COVID-19 pandemic between 2020 and 2022. We applied a mixed methods approach: citation network analysis was used to visualize interconnections between guidelines and identify influential sources, and a thematic analysis was used to examine how guidelines addressed specific ethical issues. Results the citation network analysis revealed a globally interconnected ethical framework with the WHO outbreak guidelines (2016) and CIOMS guidelines (2016) emerging as central references. Thematic analysis identified eight recurring ethical themes: research prioritization, research ethics oversight, inclusion of vulnerable populations, balancing risks and benefits, modifications of informed consent, data sharing and transparency, collaboration and preparedness, and public engagement. Guidelines encouraged procedural flexibilities (e.g., expedited reviews, e-consent) but also emphasized the need to maintain ethical rigor and scientific integrity. Tensions between speed and scrutiny, centralization and local context, public health goals and individual protection were recurring concerns. Integration of public health ethics, research integrity, and human rights frameworks emerged as a defining feature of most guidelines. Conclusions COVID-19 catalyzed a shift toward more integrated and adaptive research ethics frameworks that combine individual protection and collective public health goals. These shifts are being reflected in recent updates of major ethics instruments such as the Declaration of Helsinki and new policy initiatives such as the European Health Data Space Regulation. However, gaps remain in harmonization, implementation, and preparedness planning. Continuous efforts are needed to harmonize ethics guidance, support research ethics committees in crisis contexts, and integrate preparedness planning into global research ethics governance. |
