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.

Guideline 20 of the updated International Ethics Guidelines for Health-related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre-screen study protocols to expedite ethical reviews in a situation of crisis, that pre-arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low- and middle-income countries.

"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

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