Ethical regulation of human research in educational institutions for health professions: A cross-national study

Abstract

Introduction: International research collaboration is increasingly valued. However, the diversity of ethical regulations for human research across health professions education institutions (HPEI) presents growing challenges. While international frameworks provide an ethical foundation for human research, their interpretation and implementation vary across global, national and institutional levels, as well as during the ethical approval process, which poses obstacles to international collaboration. Aim: To explore the regulations and process for obtaining ethical approval governing human research in European HPEIs. Methods: A descriptive cross-sectional design was used, with a web-based survey administered to Erasmus+ Programme HPEIs ( n = 15) from different European countries ( n = 11). The survey was distributed to institutional representatives, including administrators, representatives responsible for Erasmus+ activities and research group leaders, who provided information on their institutions’ research ethics regulations and practices. Descriptive statistics were used for data analysis. Results: Participating HPEIs follow international ethics frameworks and national legislation for human research, but their internal regulations vary. While following similar core ethical principles, differences emerged in national legislation, institutional procedures, the ethical review process and timelines. Additionally, as necessary background knowledge, the requirements and expectations for academic staff qualifications and tasks vary, which, in turn, influences international collaboration. Conclusions: Human research in participating HPEIs is framed by a combination of international, national and institutional regulations, ethical requirements and review procedures that may vary in how ethical requirements and review processes are organised across countries and institutions. Differences in the regulation of human research and the ethical review process may pose challenges for researchers, particularly in global partnerships, as they must navigate different legal standards, unclear expectations for ethical review and administrative burdens. Improving transparency, communication and coordination between institutions, while sharing good practices and supporting researchers and research ethics committees (RECs), may facilitate more predictable and ethically robust research collaboration.