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Who Guidance On The Ethical Conduct Of Controlled Human Infection Studies
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Book Synopsis WHO guidance on the ethical conduct of controlled human infection studies by :
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.
Book Synopsis Human Challenge Studies in Endemic Settings by : Euzebiusz Jamrozik
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.
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :World Health Organization ISBN 13 :9789290360889 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)
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.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
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.
Author :National Health and Medical Research Council (Australia) Publisher : ISBN 13 :9780648464426 Total Pages :0 pages Book Rating :4.4/5 (644 download)
Book Synopsis National Statement on Ethical Conduct in Human Research 2023 by : National Health and Medical Research Council (Australia)
Download or read book National Statement on Ethical Conduct in Human Research 2023 written by National Health and Medical Research Council (Australia) and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them"--Page 6.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030945252X Total Pages :159 pages Book Rating :4.3/5 (94 download)
Book Synopsis Controlled Human Inhalation-Exposure Studies at EPA by : National Academies of Sciences, Engineering, and Medicine
Download or read book Controlled Human Inhalation-Exposure Studies at EPA written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-10 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.
Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel
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.
Book Synopsis The Patient as Victim and Vector by : M. Pabst Battin
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: Bioethics emerged at a time when infectious diseases were not a major concern. Thus bioethics never had to develop a normative framework sensitive to situations of disease transmission. The Patient as Victim and Vector explores how traditional and new issues in clinical medicine, research, public health, and health policy might look different in infectious disease were treated as central. The authors argue that both practice and policy must recognize that a patient with a communicable infectious disease is not only a victim of that disease, but also a potential vector- someone who may transmit an illness that will sicken or kill others. Bioethics has failed to see one part of this duality, they document, and public health the other: that the patient is both victim and vector at one and the same time. The Patient as Victim and Vector is jointly written by four authors at the University of Utah with expertise in bioethics, health law, and both clinical practice and public health policy concerning infectious disease. Part I shows how the patient-centered ethic that was developed by bioethics- especially the concept of autonomy- needs to change in the context of public health, and Part II develops a normative theory for doing so. Part III examines traditional and new issues involving infectious disease: the ethics of quarantine and isolation, research, disease screening, rapid testing, antibiotic use, and immunization, in contexts like multi-drug-resistant tuberculosis, syphilis, hepatitis, HIV/AIDS, and HPV. Part IV, beginning with a controversial thought experiment, considers constraint in the control of infectious disease, include pandemics, and Part V 'thinks big' about the global scope of infectious disease and efforts to prevent, treat, or eradicate it. This volume should have a major impact in the fields of bioethics and public health ethics. It will also interest philosophers, lawyers, health law experts, physicians, and policy makers, as well as those concerned with global health.
Book Synopsis Field Trials of Health Interventions by : Peter G. Smith
Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by Oxford University Press, USA. This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: "IEA, International Epidemiological Association, Welcome Trust."
Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine
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.
Book Synopsis Global Health Ethics by : World Health Organization
Download or read book Global Health Ethics written by World Health Organization and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document assists policy-makers, health care providers and researchers to understand key concepts in health ethics and to identify basic ethical questions surrounding health and health care. It illustrates the challenges of applying ethical principles to global public health and outlines practical strategies for dealing with those challenges. The document is divided into four main parts. The first part explores key concepts in health ethics and explains common terms, theories and principles. The second part examines the main challenges in the practice of health ethics from the perspective of global public health. These issues provide the reader with a concrete understanding of the various ethical obstacles that may arise in public health, health research, and the provision of health care services. The third part describes practical strategies for dealing with these challenges and the key actors involved in developing ethical frameworks. Finally, the fourth part explains why health ethics is important to WHO, and how WHO supports Member States in building capacity in health ethics.
Book Synopsis Reviewing Clinical Trials by : Chinese University of Hong Kong
Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Author :United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : ISBN 13 : Total Pages :614 pages Book Rating :4.:/5 (318 download)
Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
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:
Book Synopsis Women and Health Research by : Institute of Medicine
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 "Ethically Impossible" written by and published by Createspace Independent Pub. This book was released on 2011 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to a request by President Barak Obama on November 24, 2010, the Presidential Commission for the Study of Bioethical Issues oversaw a thorough fact-finding investigation into the specifics of the U.S. Public Health Service-led studies in Guatemala involving the intentional exposure and infection of vulnerable populations. Following a nine-month intensive investigation, the Commission has concluded that the Guatemala experiments involved gross violations of ethics as judged against both the standards of today and the researchers' own understanding of applicable contemporaneous practices. It is the Commission's firm belief that many of the actions undertaken in Guatemala were especially egregious moral wrongs because many of the individuals involved held positions of public institutional responsibility. The best thing we can do as a country when faced with a dark chapter is to bring it to light. The Commission has worked hard to provide an unvarnished ethical analysis to both honor the victims and make sure events such as these never happen again.
Book Synopsis Practical Healthcare Epidemiology by : Ebbing Lautenbach
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.
Book Synopsis Casebook on Ethical Issues in International Health Research by : World Health Organization
Download or read book Casebook on Ethical Issues in International Health Research written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: I. Defining "research"--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.
