CIOMS cited

Randomized controlled trials are central to progress in medicine, but trialists commonly struggle to recruit the required number of participants. Offering financial incentives is one proposed solution, but financial incentives may be problematic when they become irresistible and, thus, undermine the autonomy of potential participants. While some have dismissed this worry about undue inducement and argued that we should be paying participants more to avoid exploitation, the authors argue that this line of argument is based on a too narrow conception of undue inducement and does not fully appreciate the distinction between reimbursement, compensation, and financial incentives.

India's changing PV regulatory framework has been influenced by the incorporation of international standards, including those from the European Medicines Agency (EMA), the World Health Organization Programme for International Drug Monitoring, the Council for International Organizations of Medical Sciences (CIOMS), and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Large-scale public health initiatives, patient populations with a variety of cultural backgrounds, and the existence of ancient medical systems like Ayurveda, Siddha, and Unani are just a few of the distinctive national adaptations that India has made in response to local healthcare circumstances. The convergence of India's PV rules with international norms is examined in this review, which also identifies characteristics specific to India's regulatory framework. Overall, the path towards harmonisation has improved India's standing internationally in the drug-safety ecosystem; but full global equivalency would require continued investment, digital growth, and regulatory modernization.

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.

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.