Facilitating research ethics review during outbreaks

Facilitating research ethics review during outbreaks
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 20
Release: 2024-02-22
Genre: Medical
ISBN: 9240082816

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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.

Research Ethics in Epidemics and Pandemics

Research Ethics in Epidemics and Pandemics
Author: Susan Bull
Publisher: Springer Nature
Total Pages: 250
Release: 2023
Genre: Epidemics
ISBN: 3031418042

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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

Addressing the Challenge for Expedient Ethical Review of Research in Disasters and Disease Outbreaks

Addressing the Challenge for Expedient Ethical Review of Research in Disasters and Disease Outbreaks
Author: Derrick Aarons
Publisher:
Total Pages: 0
Release: 2019
Genre:
ISBN:

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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.

Ethics and adaptive platform trial design in public health emergencies

Ethics and adaptive platform trial design in public health emergencies
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 24
Release: 2023-10-03
Genre: Medical
ISBN: 924007967X

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Platform trials, using adaptive methodologies, have played an important role in the research response to COVID-19, and offer prospect of being widely used in future pandemic preparedness and response. As these relatively new methodologies raise a number of ethical and governance challenges, in early 2022 the Health Ethics and Governance Unit of the World Health Organization commissioned five rapid reviews, with the aim of learning from, and building on, experiences during the pandemic. These reviews covered the role and policy impact of adaptive platform trials during COVID-19 https://www.who.int/teams/health-ethics-governance/emergencies-and-outbreaks/platform-trials. The target audiences: the research community, including researchers, research funders, ministries of health and science, research ethics committee and regulators.

Research Ethics in Epidemics and Pandemics

Research Ethics in Epidemics and Pandemics
Author: Susan Bull
Publisher: Springer
Total Pages: 0
Release: 2024-05-28
Genre: Medical
ISBN: 9783031418068

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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.

Guidance for Managing Ethical Issues in Infectious Disease Outbreaks

Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2016
Genre: Medical
ISBN: 9789241549837

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"Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.

International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
Total Pages: 0
Release: 2017-01-31
Genre: Bioethics
ISBN: 9789290360889

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"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.

Research Methods in Conflict Settings

Research Methods in Conflict Settings
Author: Dyan Mazurana
Publisher: Cambridge University Press
Total Pages: 343
Release: 2013-07-22
Genre: History
ISBN: 1107038103

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This volume compiles lessons learned by field researchers, many of whom have faced demanding situations characterized by violence, distrust and social fragmentation.

Research Ethics in Africa

Research Ethics in Africa
Author: Mariana Kruger
Publisher: AFRICAN SUN MeDIA
Total Pages: 206
Release: 2014-06-01
Genre: Science
ISBN: 1920689303

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The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .