CIOMS cited

This open access book adopts two approaches developed in political philosophy -- "ideal" theory and "non-ideal" theory -- to develop a new approach to bioethics. It argues that both ideal theory and non-ideal theory may be preferable depending on the situation. On this basis, it proposes a new decision-making approach using five criteria to analyse different situations and to decide which one to choose. This approach is introduced theoretically and considered practically using current examples such as reproductive rights, the Covid pandemic. This book will be of interest to researchers, students, and practitioners in the fields of bioethics, medical ethics, public health, and gender studies.

Data ethics has emerged as a branch of the evolving ethical domain, particularly in addressing the ethical challenges associated with data processing, algorithms, and their applications. Ethical governance is crucial for sharing and utilizing medical scientific data. Ethical reviews serve as a practical embodiment of ethical principles, ensuring their implementation and protection within data-centric strategies and protocols. The author outlines the scope of data ethics norms, establishes a data ethics review framework based on international advancements, and analyses the applicability of basic ethical principles applied to data ethics.

Vaccination remains a cornerstone of public health, yet monitoring vaccine safety is essential to sustain confidence and guide policy. India’s large birth cohort, complex health system, and recurrent mass immunization campaigns necessitate a robust vaccine pharmacovigilance framework. This review systematically evaluates India’s vaccine safety surveillance landscape, including institutional mechanisms, surveillance models, causality assessment, and operational lessons from major immunization initiatives, to propose strategic priorities for 2025–2030.

Clinical trial (CT) safety surveillance is critical to protecting participants and ensuring reliable evidence on the safety and efficacy of new medical products. This is especially relevant in Africa, where CT activity remains limited, regulatory maturity varies, and drug safety surveillance systems are under-resourced despite considerable demographic advantages and genetic and cultural diversity. To assess the current state of CT safety surveillance in Africa, a landscape analysis of the systems for clinical trial safety data reporting, collation, and analysis was conducted. Despite challenges, opportunities exist to strengthen CT safety surveillance through digitization of reporting systems, harmonization of serious adverse event forms, regional collaboration, and capacity building for strengthening the ecosystem. The results of this landscape analysis provide a roadmap for building a coordinated model for pre-licensure safety monitoring across the continent.

This is a review of the ethical structure underlying clinical testing. It describes the chronological development of this field, with the crucial milestones—the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report—all of which recognize three basic principles: respect for persons, beneficence, and justice. The authors underline informed consent, confidentiality, and privacy as being critically important, while also mentioning historical violations of ethics as a justification for rigorous oversight in research practices. They consider different  regulatory frameworks, such as ICH GCP, guidelines by CIOMS, WHO standards, and roles of national regulatory authorities like FDA, EMA, and CDSCO. They also discuss the complexities regarding informed consent, especially in vulnerable populations, ethical dilemmas around placebo use, and randomization of trials, and also addresses new trial designs, issues related to data privacy and post-trial obligations. They conclude with a recommendation for continuous education in ethics and the elaboration of unified ethical standards internationally, and underscore that compliance with established guidelines is vital for participant protection and responsible medical knowledge acquisition.

This article analyzes the historical evolution of Brazilian ethical regulations on research involving humans. It is a qualitative, document-based study with a historical-critical approach, comparing national regulatory frameworks with key international ethical research guidelines. Although the new law represents legal progress, significant criticisms remain, particularly regarding participant protection and the independence of research ethics committees. The study concludes that the new regulation requires adjustments to address gaps related to bureaucratization of processes and the autonomy of Brazilian ethical bodies. It recommends streamlining administrative procedures, strengthening the independence of research ethics committees and the National System of Research Ethics, and aligning Brazilian legislation with best international practices to ensure effective and continuous protection of research participants.

Many high-stakes AI applications target low-prevalence events, where apparent accuracy can conceal limited real-world value. Relevant AI models range from expert-defined rules and traditional machine learning to generative LLMs constrained for classification. The authors outline key considerations for critical appraisal of AI in rare-event recognition, including problem framing and test set design, prevalence-aware statistical evaluation, robustness assessment, and integration into human workflows.