Download or read book WHO guidance on the ethical conduct of controlled human infection studies written by and published by World Health Organization. This book was released on 2021-01-13 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Human Challenge Studies in Endemic Settings written by Euzebiusz Jamrozik and published by Springer Nature. This book was released on 2020 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Caring for People who Sniff Petrol Or Other Volatile Substances written by National Health and Medical Research Council (Australia) and published by . This book was released on 2011 with total page 33 pages. Available in PDF, EPUB and Kindle. Book excerpt: These guidelines provide recommendations that outline the critical aspects of infection prevention and control. The recommendations were developed using the best available evidence and consensus methods by the Infection Control Steering Committee. They have been prioritised as key areas to prevent and control infection in a healthcare facility. It is recognised that the level of risk may differ according to the different types of facility and therefore some recommendations should be justified by risk assessment. When implementing these recommendations all healthcare facilities need to consider the risk of transmission of infection and implement according to their specific setting and circumstances.
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to 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. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Download or read book Practical Healthcare Epidemiology written by Ebbing Lautenbach and published by Cambridge University Press. This book was released on 2018-04-19 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.
Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by World Health Organization. This book was released on 2002 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.
Download or read book Research Ethics in Epidemics and Pandemics written by Susan Bull and published by Springer Nature. This book was released on 2023 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Patient as Victim and Vector written by M. Pabst Battin and published by Oxford University Press. This book was released on 2009 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Public Health Ethics Cases Spanning the Globe written by Drue H. Barrett and published by Springer. This book was released on 2016-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open Access book highlights the ethical issues and dilemmas that arise in the practice of public health. It is also a tool to support instruction, debate, and dialogue regarding public health ethics. Although the practice of public health has always included consideration of ethical issues, the field of public health ethics as a discipline is a relatively new and emerging area. There are few practical training resources for public health practitioners, especially resources which include discussion of realistic cases which are likely to arise in the practice of public health. This work discusses these issues on a case to case basis and helps create awareness and understanding of the ethics of public health care. The main audience for the casebook is public health practitioners, including front-line workers, field epidemiology trainers and trainees, managers, planners, and decision makers who have an interest in learning about how to integrate ethical analysis into their day to day public health practice. The casebook is also useful to schools of public health and public health students as well as to academic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics.
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2023-10-03 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
