Key elements in the ethical management of health research

Abstract

Context. Research management refers to the systematic organization, coordination, and oversight of research activities within an institution, research unit, or scientific project. It involves planning, executing, and monitoring research projects to ensure their efficiency, ethical conduct, and adherence to established standards and objectives (Käser Michael, 2023). This definition emphasizes the importance of ethical governance in research, which is increasingly relevant today due to growing concerns over participant protection and data integrity. Although research ethics is essential, ethical management in research is still emerging as an established field. Identifying the key elements essential for the development of this emerging field represents a significant endeavor. Methods. In line with the context above, we aimed to conduct a narrative review of publications related to research management, and both normative and applied research ethics (including relevant regulations) to lay the theoretical foundation of ethical management in health research and identify its key elements. Using PubMed, Medline and Google Scholar search engines, we identified 1,010 relevant publications from 2024-2025. After applying selection criteria, 32 publications were analyzed. The search syntax used was: (ethics OR ethical management OR research ethics AND (health research OR biomedical research)). Results. Drawing on concepts from research management and incorporating the framework of research ethics, we developed a working definition for Ethical Management of Health Research (EMHR). EMHR refers to the application of ethical principles throughout all stages of research - from study design and data collection to the publication and use of findings - ensuring the protection of participants' rights, their well-being, and the integrity and credibility of the research process. Ethical management in research can thus be viewed as the governance of researchers' ethical conduct in health research, with a key focus on enhancing their moral competencies. However, this is only one dimension of EMHR, as the ethical management of health research requires robust institutional ethical infrastructures and effective monitoring mechanisms, all supported by clear regulations and policies. Discussion. Based on the analysis, four key concepts that could potentially shape the theoretical framework for the ethical planning, organization, implementation, and monitoring of research involving human subjects in the health sector were identified. These concepts are: ethical regulations in research, institutional ethical infrastructure, ethics committees, and the competence and social responsibility of researchers. Ethical regulations define the mandatory normative framework, establishing principles and standards to be followed. They serve as the foundation for any ethical research endeavor. Ethics committees ensure the practical application of these regulations, evaluating and monitoring projects to prevent ethical risks and support researchers in making informed decisions. Institutional ethical infrastructure provides the operational conditions for implementing applicable regulations and for the functioning of ethics committees, fostering a culture of integrity and responsibility within organizations. The researchers' competence, autonomy, and social responsibility are fundamental to applying ethical principles effectively in daily practice. Together, these elements could contribute to building a coherent and functional ethical management system for health research.