In September 2022, in tandem with the Global Summit of National Ethics Committees [LINK] in Lisbon, Portugal, the Health Ethics & Governance Unit hosted a workshop to explore experiences of research ethics review during COVID-19 with representatives from over 20 countries. The objectives of the meeting were: - to identify what worked and did not work in terms of research ethics review during COVID-19; - to discuss clinical trial designs such as adaptive trials and their impact on research ethics review during COVID-19; - to draft recommendations for various stakeholders and a report on the workshop findings; and - to contribute to a possible revision of WHO’s guidance for research ethics committees for rapid review of research during public health emergencies. It was agreed that additional guidance about ethical review in emergencies was not required, other than for specific issues such as new trial methods. Rather, research ethics committees need to be better prepared, better resourced, and better connected. Attention should be paid to improving relations between research ethics committees and other parts of the research ecosystem; clarifying roles and responsibilities and improving coordination at all levels; retaining and building on flexible systems and approaches developed during the pandemic; and ensuring that research ethics committees have the necessary resources to contribute effectively to the shared aim of ethical,effective research. For more detail see the meeting report [LINK] and an article in BMC Medical Ethics, co-authored by all the speakers at the meeting.

The WHO website has an introductory description for the Guidance. It states that the WHO Guidance on Research Methods for Health Emergency and Disaster Risk Management (Health EDRM) was developed to address the need to promote high quality research methods to those who commission and conduct research on Health EDRM. The intended audience includes decision makers, practitioners, and community actors who need for evidence-based policy and practice to implement the Health EDRM Framework, Sendai Framework on Disaster Risk Reduction 2015-2030, the International Health Regulations (2005), the United Nations Sustainable Development Goals (SDGs) and other relevant global, regional and national frameworks. Chapters have been written by more than 100 international authors with practical experience and expertise in a wide range of areas including research, practice and policy making. The unique collection of chapters provides straightforward and practical guidance on how to plan, conduct and report a wide variety of studies that can answer quantitative and qualitative questions in different emergency settings. Case studies of direct relevance to Health EDRM provide real-life examples of research to illustrate the methods and their impact. The book was revised in 2022 with an additional chapter on how to use this book in the context of COVID-19 pandemic.

Zusammenfassung: This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics

Pandemics such as Covid-19, Ebola, SARS, and influenza, as well as the necessary measures for their research, prevention, and treatment, raise a number of ethical issues that confront science, the medical profession, and health policy. This overview volume, written by renowned experts from medicine, the humanities, and the social sciences, addresses the central ethical issues in pandemics. Focusing on the disciplines of philosophy, public health, bioethics, and law, the book discusses issues of resource allocation, triage, and research, as well as restrictions on freedom, rights and duties of health professionals, and ethical aspects of digital medicine in crises. The volume is intended to serve as a handbook and to provide physicians as well as nurses, politicians and interested laypersons with valuable advice on how to deal with the difficult moral problems of epidemics and pandemics. With expert contributions by Steffen Augsberg (Giessen), Klaus Bergdolt (Cologne), Nikola Biller-Andorno (Zurich), Walter Bruchhausen (Bonn), Christiane Druml (Vienna), Hans-Jörg Ehni (Tuebingen), Alice Faust (Berlin), Sophia Forster (Erlangen-Nuremberg), Andreas Frewer (Erlangen-Nuremberg), Sara Gerke (Boston/Cambridge), Patrik Hummel (Eindhoven), Elena Jirovsky-Platter (Vienna), Katharina Kieslich (Vienna), Otmar Kloiber (Ferney-Voltaire), Ulrich H. J. Körtner (Vienna), Eva Kuhn (Bonn), Georg Marckmann (Munich), Timo Minssen (Copenhagen), Tim Nguyen (Geneva), Barbara Prainsack (Vienna), Andreas Reis (Geneva), Anita Rieder (Vienna), Stephan Rixen (Bayreuth), Lana Saksone (Berlin), Martina Schmidhuber (Graz), Harald Schmidt (Philadelphia), Annabel Seebohm (Brussels), Daniel Strech (Berlin), Sebastian Wäscher (Zurich), Hans-Werner Wahl (Heidelberg), Stefanie Weigold (Berlin), and Lena Woydack (Berlin).

Modernizing Global Health Security to Prevent, Detect, and Respond explores—through thoughtful, thorough, and diverse scientific review and analyses—factors that have led to recent public health emergencies and offers a vision for a better protected global environment. The authors consider the history of global health security, governance, and legal structures with an eye toward novel approaches for the present and future. The book presents a vision for a more protected and safer global public health future (with the actions needed to achieve it) to prevent, detect, and respond to (re)emerging threats. Its aim is to chart a way forward with the understanding that future pandemics must and can be prevented. Major topics examined from a public health perspective include global health security; the growing concept of One Health; epidemic and pandemic prevention, detection, and response; reviews of past (e.g., Ebola, MERS-CoV, Zika, and COVID-19) public health emergencies of international concern; roles of information and communication technology; humanmade public health threats; and legal and ethical issues (e.g., viral sovereignty, trust, and transparency). Modernizing Global Health Security to Prevent, Detect, and Respond provides the academic substance and quality for researchers and practitioners to deeply understand the why of health emergencies, and most importantly—what we can and should do now to prepare. - Highlights (re)emerging past and future threats to public health (e.g., climate change, antibiotic resistance, failures of societal sectors to work together) - Discusses new visions for global health security in each chapter - Considers how to leverage technological innovations to advance public health - Includes practical examples through case studies from around the world

Considering important aspects of general ethical research principles, this volume establishes an inspiring vision for both present and future improvements across all levels of disability research.

This tool is intended to assist WHO Member States in evaluating their capacity to provide appropriate ethical oversight of health-related research with human subjects. It has been jointly developed by WHO’s Regulatory System Strengthening, Regulation and Safety Unit and the Health Ethics and Governance Unit and will help countries to identify strengths and limitations in their laws and in the organizational structures, policies, and practices of the bodies responsible for research ethics oversight. It is also intended to guide the development of recommendations to address the identified gaps and the assessment of countries’ progress in implementing those recommendations. In addition to assisting in capacity-building efforts, the tool is intended to promote policy convergence and best practices in research ethics oversight, to enhance public trust in health research, and to ensure that the rights and safety of humans involved in health-related research are adequately protected, both in ordinary times and during public health emergencies.