CIOMS cited

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.

The aim of the study was to evaluate the incidence, nature, and clinical manifestations of adverse events (AEs) and adverse drug reactions associated with Guhong Injection, and to provide evidence for the safe clinical use of this drug. The overall AE rate of Guhong Injection was classified as uncommon according to CIOMS guidelines.

This chapter describes important points of the common ground, similarities, and differences between the two authoritative documents of research ethics principles: the 2024 Declaration of Helsinki of the World Medical Association and the 2016 International Ethical Guidelines for Health-related Research involving Humans of the Council for International Organizations of Medical Sciences, considering the latest revision of the Declaration of Helsinki, adopted in October 2024. Since the 1990s, the author (currently Vice-President of CIOMS) has been contributing to revisions of these documents. While there have been plentiful discussions about both, some points deserve in-depth consideration. This chapter highlights new items and controversial points in the 2024 revision of the Declaration of Helsinki, namely, good governance practice of research teams or institutions, community engagement and vulnerability, research waste and social value, and placebo-controlled trials.

The main research question of this scoping review was: What empirical research exists on how research ethics boards (REBs) identify and train members and ensure they have adequate expertise to review research protocols? The authors found a small and diverse body of literature from around the world. They summarized findings in four themes: scientific expertise; ethical, legal and regulatory training and expertise; diversity of identity and perspectives; and engagement with research participant perspectives. Studies reviewed identified issues for all aspects of membership expertise and training. The authors of this study echo the calls of many of the authors of studies they reviewed: namely, education and support for all REB members needs to improve.

The authors had three key objectives: to identify pregnancy-related ethics recommendations from leading international guidance documents; to identify areas of divergence; to make recommendations for how research ethics committees (RECs)/institutional review boards (IRBs) could be supported in their review of clinical trials of HIV prevention for the enrolment of pregnant and lactating individuals. Their goal was promote the efficient and consistent application of ethics recommendations across these research protocols. The authors found a rich abundance of relevant ethics recommendations. They also found that most guideline recommendations are synergistic, with the most notable divergence arising in the terminology used for when it is acceptable to transition from preclinical (animal) studies to exposing pregnant/lactating humans to the study product. They developed a brief resource setting out guidance-informed queries that REC/IRB reviewers could use to focus their review.