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 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:
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 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.
Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur and published by Jones & Bartlett Publishers. This book was released on 2010-10-22 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
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:
Download or read book Optimizing the Nation s Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.
Download or read book Preserving Public Trust written by Institute of Medicine (U and published by . This book was released on 2001 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Human Subjects Research Regulation written by I. Glenn Cohen and published by MIT Press. This book was released on 2014-07-25 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects. The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts. Contributors Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf
Download or read book Intentional Human Dosing Studies for EPA Regulatory Purposes written by National Research Council and published by National Academies Press. This book was released on 2004-06-04 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.
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 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Download or read book Appendix 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 748 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Belmont Revisited written by James F. Childress and published by Georgetown University Press. This book was released on 2005 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research on human subjects has always been a highly controversial topic in the field of bioethics. The book, featuring contributions from a Who's Who of biothics scholars, analyzes the seminal document on the topic in the United States: the 1979 Belmont Report, widely regarded as the single-most influential set of guidelines in the practice of bioethics.The Belmont Report is a 20-page statement that spells out the rationale for ethical research on humans, concluding that three primary principles are at play: respect for persons, beneficence, and justice. Since the publication of Belmont these three principles, spelled out further by philosopher Tom Beauchamp and ethicist James Childress and known as the "Georgetown mantra," have dominated all discussions of research on human subjects--though, as this book will show, not everyone agrees that this is the most helpful way to think about the matter. In fact, this book is both a broad overview of the evolution of the Belmont Report and, more important, 1) an assessment of its shortcomings and 2) a strong call to rethink how hospitals and pharmaceutical companies can conduct research more humanely and more ethically. So while the book looks back to the creation of Belmont, it also looks forward to the future of research. Contributors, in addition to the editors, include Alexander Capron, Ruth Faden, Eric Cassell, Karen Lebacqz, Larry Churchill, Robert Levine, Patricia King (Georgetown), Susan Sherwin, Ezekiel Emanuel, Robert Veach (Georgetown), Henry Richardson (Georgetown), John Evans.
Download or read book Ethical Considerations for Research on Housing Related Health Hazards Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2005-11-10 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.
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.
