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Biomedical Research Ethics And The Protection Of Human Research Subjects
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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 (327 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:
Author :United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : ISBN 13 : Total Pages :40 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 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : ISBN 13 : Total Pages : pages Book Rating :4.:/5 (796 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 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 :Council for International Organizations of Medical Sciences Publisher :World Health Organization ISBN 13 : Total Pages :116 pages Book Rating :4.3/5 (91 download)
Book Synopsis International Ethical Guidelines for Biomedical Research Involving Human Subjects by : Council for International Organizations of Medical Sciences
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.
Book Synopsis The Ethics of Research with Human Subjects by : David B. Resnik
Download or read book The Ethics of Research with Human Subjects written by David B. Resnik and published by Springer. This book was released on 2018-01-09 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.
Author :Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research Publisher :National Academies Press ISBN 13 :0309164605 Total Pages :284 pages Book Rating :4.3/5 (91 download)
Book Synopsis Ethical Considerations for Research Involving Prisoners by : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
Download or read book Ethical Considerations for Research Involving Prisoners written by Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research and published by National Academies Press. This book was released on 2007-01-22 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.
Book Synopsis Responsible Conduct of Research by : Adil E. Shamoo
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
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 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.
Book Synopsis The Ethics of Biomedical Research by : Baruch A. Brody
Download or read book The Ethics of Biomedical Research written by Baruch A. Brody and published by Oxford University Press, USA. This book was released on 1998 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.
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 Law and Ethics in Biomedical Research by : Duff William Ramus Waring
Download or read book Law and Ethics in Biomedical Research written by Duff William Ramus Waring and published by University of Toronto Press. This book was released on 2006-01-01 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
Book Synopsis Understanding Clinical Research by : Renato D. Lopes
Download or read book Understanding Clinical Research written by Renato D. Lopes and published by McGraw Hill Professional. This book was released on 2013-05-22 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials
Book Synopsis The Use of Human Beings in Research by : S.F. Spicker
Download or read book The Use of Human Beings in Research written by S.F. Spicker and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
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.
Book Synopsis The Ethics Police? by : Robert Klitzman
Download or read book The Ethics Police? written by Robert Klitzman and published by Oxford University Press, USA. This book was released on 2015 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies on humans have saved countless lives, but sometimes harm participants. Research ethics committees currently monitor scientists, but have been increasingly criticized for blocking important research. How these committees work, however, is largely unknown. This book uniquely illuminates this hidden world that ultimately affects us all.