In the 2024 revision of the Declaration of Helsinki (DoH) by the World Medical Association (WMA), paragraph 33 on placebo-controlled trials was one of the focuses, but no meaningful amendments were made. Particularly, the discrepancy between the Council of International Organizations of Medical Sciences (CIOMS) guidelines and the DoH in terms of the acceptable risk for research participants in a placebo arm when there is a proven intervention was a key issue: the CIOMS defines “minor increase above minimal risk” while (...) the DoH defines “no increase of serious or irreversible harm.” Although the Uruguayan Medical Union made a motion to amend it for consistency with the CIOMS, it was voted down.The concern is that vulnerable study participants may be disproportionately exposed to the risk defined to be “acceptable” by the 2024 DoH. This is against the principle of justice. Furthermore, the WMA states the fundamental (core) principle that the rights and interests of research participants take precedence over the goal of the research. The contradiction between this fundamental principle and the placebo clause must be resolved. The continuing debates over the placebo clause in the DoH are a testament to the commitment and aspiration of the global research ethics community seeking the highest ethical standards that simultaneously meet the demands of ethics and science. (shrink)

The changes in the 2024 Declaration of Helsinki (DoH) to promote the engagement of vulnerable people and communities will certainly contribute to innovative research and development (R&D) of interventions for neglected tropical diseases (NTDs).Firstly, this presupposes the establishment of robust community participation in all stages of the research to overcome structural inequalities in healthcare around the world. Secondly, counteracting previous cautionary measures that systematically excluded vulnerable populations from research will avoid perpetuating the vicious cycle of health disparities. Thirdly, with these (...) changes in the 2024 DoH, research with vulnerable participants could be facilitated for their benefit. Above all, to protect against exploitation, post-trial benefit-sharing must be guaranteed.This chapter reviews the improvement of the renewed DoH from the viewpoint of technological innovation from R&D for NTDs in neglected populations (twice neglected) to achieve equitable and sustainable goals of global health. (shrink)

Post-trial access as the norm of ethics in health research was established by the World Medical Association (WMA) in the 2000 version of the Declaration of Helsinki (DoH), as the right of study participants to continued access to the best-proven interventions if needed after the completion of trial participation. However, due to pressure from regulators, industries, and researchers who argued difficulties with implementation, this principle in the DoH has been downgraded and it became the merely item in the protocol and (...) informed consent form. In its 2024 revision, small improvements were made, reflecting discussions at WMA’s meetings as the voices of resource-limited regions were heard but there was a failure to reinstate the past achievement of 2000.This chapter carefully examines the small improvements made in the post-trial provisions and other relevant paragraphs of the 2024 DoH, to implement post-trial access as health is one of the fundamental human rights. In conclusion, post-trial access must be guaranteed to (1) study participants, (2) study host community, and (3) all those in need in the global community. (shrink)

The experiences in Brazil in responding to the AIDS and COVID-19 pandemics underscore the critical importance of bioethics as guiding principles in confronting public health crises. While Brazil’s response to the AIDS pandemic, marked by a strong ethical framework promoting and protecting human rights, serves as a notable example of successful intervention, the COVID-19 pandemic revealed significant shortcomings in the application of these principles, particularly concerning social equity, international solidarity and the role of scientific evidence.This chapter emphasizes the importance of (...) a universal public health system and a national research ethics framework for the protection of human research participants. It also examines how the highest research ethics principles, promulgated by the Declaration of Helsinki (DoH) by the World Medical Association in 2000, have been incorporated into and have contributed to the Brazilian research ethics framework, which has been maintained until now. The analysis compares not only Brazil’s responses to the AIDS and COVID-19 pandemics, but also the DoH 2000 and the 2024 versions, to be shared with the global community of research ethics for deliberations. (shrink)

This chapter provides an overview of the book in which the 2024 Declaration of Helsinki (DoH), adopted by the World Medical Association (WMA) on 19 October 2024, is discussed. This book is planned and conducted as a voluntary initiative, independent of the WMA, with the goal of promoting the Highest Ethical Standards to protect research participants and ensure the social value of research.It is highly commendable that the WMA leaders involved in the 2024 revision of the DoH have provided two (...) Forewords for this book. Chapter authors participated in the review process for the 2024 DoH in a variety of ways. Editors and some authors presented alternative views that were critical of the DoH, while recognising the unique value of the DoH as a driving force of global deliberations.This chapter also presents challenges for future revisions of the DoH as well as perspectives for a strengthened global research ethics framework established based on the Human Rights Covenant. (shrink)

This book takes you on a journey into the future of ethical research, offering 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, particularly in the Global South and Asia, by gathering revealing 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. The 2024 Declaration of Helsinki could be marked by global discussions to be consolidated towards the highest ethical standards based on the experience of the COVID-19 pandemic, trends to promote the involvement of patients, participants and public in research projects, and the growing attention to data-driven research. Each chapter demonstrates the pathway to Ethical Innovation for Global Health. The 2024 Declaration of Helsinki: Global Efforts Towards Highest Ethical Standards is essential reading for scientists, practitioners, and policymakers committed to the highest standards of ethical conduct in research. Members of research ethics committees, pharmaceutical company employees, medical students, patients and members of the public involved in human research will also find this volume useful. (shrink)