CIOMS cited

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.

This book offers a collection of expert commentaries on the latest revision of the World Medical Association's cornerstone document, exploring its profound implications for global health ethics and proposing a path for its improvement. The book consists of three main parts, each focusing on key issues of human rights, integrity and inclusivity, with each chapter enriching the discourse on ethical research practices. The first part provides contextual perspectives on the implementation of research ethics, by gathering insights from different corners of the globe. This is followed by forward-looking perspectives for international ethical principles, and the final part describes not only the transformation of the Declaration, but also pushes it forward as a dynamic framework for  ethical innovation to achieve access to health for all.  

This article maps the key legal and ethical challenges which will need to be addressed for a successful roll-out of digital twin models for children living with rare diseases, using the example of phenylketonuria (PKU) as model disease. The main legal challenges, which will arise in virtually all jurisdictions worldwide, have been analysed with a focus on European Union law: data protection, medical device regulation, AI regulation, intellectual property, and product liability. The main ethical challenges have been analyzed using research and digital ethics frameworks of the WHO, UNESCO, HLEG-AI, and CIOMS: autonomy, informed consent to research, trust, and the impact on interpersonal relations, identity and self-understanding. The shortcomings with respect to current laws, regulations, and ethics guidelines are identified. Clear legal and ethical guidance is, however, urgently needed to protect vulnerable groups of patients from harm, notably children living with rare diseases, and to help innovators navigate the complex legal and ethical issues the digital twin concept raises.

Current estimates suggest that Africa contains about 14% of the world’s population and accounts for 20% of the global burden of disease. Yet, it accounts for a mere 3% of clinical trials globally.The time is ripe—even overdue—for determining how best to direct future health research efforts. In response, a call has been heard for a continent-wide Africa-centric research ethics framework to redirect health research in Africa, as well as address the health research ethics malpractices that have violated the rights, dignity and well-being of participating African communities. Nevertheless, we should remain aware of what already exists and what continues to be of value.