CIOMS cited

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.

This review synthesizes global and Indian perspectives on real world evidence (RWE) for signal detection, outlines current frameworks, evaluates available real world data sources, and examines emerging methods including artificial intelligence/machine learning. It also discusses operational, regulatory, and ethical challenges in India and proposes a roadmap for strengthening RWE-based pharmacovigilance (PV) systems. By consolidating insights from open-access scientific literature and regulatory guidance, this review aims to support PV scientists, regulators, and healthcare policymakers in harnessing RWE to enhance drug safety and public health in India

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.

Artificial intelligence (AI) is increasingly used in health-related research to generate knowledge, insights and technologies, but its application may challenge established ethical principles and human rights protections and create novel risks that existing oversight systems do not fully address. This report examines ethics review and oversight of three categories of AI-related health research: health-related data science using AI; research conducted with AI tools and technologies; and health-related research on AI tools and technologies. It analyses gaps in current ethical standards and oversight, challenges faced by research ethics committees, and measures to strengthen researchers’ adoption of ethical principles. The report also considers complementary roles for funders, data access mechanisms, scientific journals and publishers, regulatory agencies and other third parties. Particular attention is given to risks and inequities affecting low- and middle-income countries, including fairness, benefit sharing, data colonialism, ethics dumping, power imbalances and capacity-building. It further examines the benefits and risks of using AI in ethics review and provides non-exhaustive considerations for strengthening responsible research conduct and oversight.

The increasing dependence of pharmaceutical research on personal and sensitive health data has elevated the importance of effective data protection frameworks within clinical and biomedical research environments. This paper critically examines the regulatory compliance landscape governing data protection in pharmaceutical research in Nigeria, situating the discussion within both domestic legal frameworks and international best practices.

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.

The COVID-19 pandemic posed unprecedented challenges to global research ethics governance. In response to the urgent need for rapid scientific data, ethics review processes were accelerated, informed consent procedures adapted, and new research methods introduced. These changes were guided by the proliferation of research ethics guidelines issued by national, regional and international bodies. However, there has been limited systematic analysis of how these guidelines addressed key ethical challenges during the pandemic and shaped future ethical frameworks. This study aims to map the global network of pandemic related research guidelines, to analyze how they addressed the main pandemic specific ethical challenges.