Who Guidance On The Ethical Conduct Of Controlled Human Infection Studies
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Who Guidance On The Ethical Conduct Of Controlled Human Infection Studies
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-01-13
Who Guidance On The Ethical Conduct Of Controlled Human Infection Studies written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-13 with Medical categories.
The WHO Guidance on the Ethical Conduct of Controlled Human Infection Studies has been developed in response to requests to the World Health Organization (WHO) for guidance on ethical questions associated with controlled human infection studies (CHIS), especially in the context of growing interest in conducting these studies in endemic settings. In CHIS, healthy volunteers are intentionally exposed to pathogens in a controlled environment, in order to promote understanding of the pathogenesis, transmission, prevention and treatment of infectious diseases in humans.
Human Challenge Studies In Endemic Settings
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Author : Euzebiusz Jamrozik
language : en
Publisher: Springer Nature
Release Date : 2020
Human Challenge Studies In Endemic Settings written by Euzebiusz Jamrozik and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Bioethics categories.
This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19.
International Ethical Guidelines For Health Related Research Involving Humans
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Author : Council for International Organizations of Medical Sciences (CIOMS)
language : en
Publisher: World Health Organization
Release Date : 2017-01-31
International Ethical Guidelines For Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-01-31 with Bioethics categories.
"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.
Ethical Conduct Of Clinical Research Involving Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2004-07-09
Ethical Conduct Of Clinical Research Involving Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-07-09 with Medical categories.
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Field Trials Of Health Interventions
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Author : Peter G. Smith
language : en
Publisher:
Release Date : 2015
Field Trials Of Health Interventions written by Peter G. Smith and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Health & Fitness categories.
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
Tri Council Policy Statement
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Author :
language : en
Publisher:
Release Date : 2014
Tri Council Policy Statement written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Human experimentation in medicine categories.
This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies.
The Patient As Victim And Vector
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Author : M. Pabst Battin
language : en
Publisher: Oxford University Press
Release Date : 2009
The Patient As Victim And Vector written by M. Pabst Battin and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Medical categories.
This volume is jointly written by four authors at the University of Utah with expertise in bioethics, health law, and infectious disease. In collaboration they attempt to develop a normative framework sensitive to situations of disease transmission- situations in which the patient is not only a victim but a vector; i.e. vulnerable to disease but also a threat to others.
Safe And Effective Medicines For Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-10-13
Safe And Effective Medicines For Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-13 with Medical categories.
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
The Oxford Textbook Of Clinical Research Ethics
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Author : Ezekiel J. Emanuel
language : en
Publisher: Oxford University Press
Release Date : 2008-05
The Oxford Textbook Of Clinical Research Ethics written by Ezekiel J. Emanuel and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-05 with Medical categories.
The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings.
Research Ethics In Epidemics And Pandemics
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Author : Susan Bull
language : en
Publisher: Springer Nature
Release Date : 2023
Research Ethics In Epidemics And Pandemics written by Susan Bull and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023 with Epidemics categories.
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