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The Ethics of Research with Human Subjects by David B. Resnik Pdf
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.
United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : Unknown Page : 614 pages File Size : 41,5 Mb Release : 1978 Category : Human experimentation in medicine ISBN : UCSD:31822000897728
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.
Author : Harold Y. Vanderpool Publisher : University Publishing Group. Page : 552 pages File Size : 40,7 Mb Release : 1996 Category : Human experimentation in medicine ISBN : UOM:49015002453836
Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Publisher : National Academies Press Page : 445 pages File Size : 42,6 Mb Release : 2004-07-09 Category : Medical ISBN : 9780309133388
Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf
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.
Ethics of the Use of Human Subjects in Research by Adil Shamoo,Felix A. Khin-Maung-Gyi Pdf
Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.
James F. Childress,Eric Mark Meslin,Harold T. Shapiro
Author : James F. Childress,Eric Mark Meslin,Harold T. Shapiro Publisher : Georgetown University Press Page : 300 pages File Size : 55,8 Mb Release : 2005 Category : Human experimentation in medicine ISBN : 1589010620
Belmont Revisited by James F. Childress,Eric Mark Meslin,Harold T. Shapiro Pdf
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.
The Ethics of Research with Human Subjects by David B. Resnik Pdf
This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust.鴠 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.
Carl H. Coleman,Jerry Menikoff,Jesse Alan Goldner,Efthimios Parasidis
Author : Carl H. Coleman,Jerry Menikoff,Jesse Alan Goldner,Efthimios Parasidis Publisher : Unknown Page : 128 pages File Size : 54,6 Mb Release : 2015 Category : Human experimentation in medicine ISBN : 0327176938
Council for International Organizations of Medical Sciences
Author : Council for International Organizations of Medical Sciences Publisher : World Health Organization Page : 116 pages File Size : 51,6 Mb Release : 2002 Category : Bioethics ISBN : UOM:39015061025931
International Ethical Guidelines for Biomedical Research Involving Human Subjects by Council for International Organizations of Medical Sciences Pdf
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.
National Research Council,Institute of Medicine,Division on Earth and Life Studies,Board on Health Promotion and Disease Prevention,Board on Radiation Effects Research,Polar Research Board,Commission on Life Sciences,Commission on Geosciences, Environment, and Resources,Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131
Author : National Research Council,Institute of Medicine,Division on Earth and Life Studies,Board on Health Promotion and Disease Prevention,Board on Radiation Effects Research,Polar Research Board,Commission on Life Sciences,Commission on Geosciences, Environment, and Resources,Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131 Publisher : National Academies Press Page : 116 pages File Size : 42,8 Mb Release : 1996-01-26 Category : Medical ISBN : 9780309175920
The Arctic Aeromedical Laboratory's Thyroid Function Study by National Research Council,Institute of Medicine,Division on Earth and Life Studies,Board on Health Promotion and Disease Prevention,Board on Radiation Effects Research,Polar Research Board,Commission on Life Sciences,Commission on Geosciences, Environment, and Resources,Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131 Pdf
During the 1950s, with the Cold War looming, military planners sought to know more about how to keep fighting forces fit and capable in the harsh Alaskan environment. In 1956 and 1957, the U.S. Air Force's former Arctic Aeromedical Laboratory conducted a study of the role of the thyroid in human acclimatization to cold. To measure thyroid function under various conditions, the researchers administered a radioactive medical trace, Iodine-131, to Alaska Natives and white military personnel; based on the study results, the researchers determined that the thyroid did not play a significant role in human acclimatization to cold. When this study of thyroid function was revisited at a 1993 conference on the Cold War legacy in the Arctic, serious questions were raised about the appropriateness of the activityâ€"whether it posed risks to the people involved and whether the research had been conducted within the bounds of accepted guidelines for research using human participants. In particular, there was concern over the relatively large proportion of Alaska Natives used as subjects and whether they understood the nature of the study. This book evaluates the research in detail, looking at both the possible health effects of Iodine-131 administration in humans and the ethics of human subjects research. This book presents conclusions and recommendations and is a significant addition to the nation's current reevaluation of human radiation experiments conducted during the Cold War.
Author : Adil E. Shamoo,David B. Resnik Publisher : Oxford University Press Page : 441 pages File Size : 49,9 Mb Release : 2009-02-12 Category : Medical ISBN : 9780199709601
Responsible Conduct of Research by Adil E. Shamoo,David B. Resnik Pdf
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.
Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research,Board on Health Sciences Policy,Institute of Medicine
Author : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research,Board on Health Sciences Policy,Institute of Medicine Publisher : National Academies Press Page : 284 pages File Size : 49,7 Mb Release : 2007-01-22 Category : Political Science ISBN : 9780309164603
Ethical Considerations for Research Involving Prisoners by Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research,Board on Health Sciences Policy,Institute of Medicine Pdf
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.
Beyond Regulations by Nancy M. P. King,Gail E. Henderson,Jane Stein Pdf
Across a broad range of disciplines--in medicine, social science, and the humanities--researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm. This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful. Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak. Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them. This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.
The research ethics system was created without the help of people who know what it is like to be a research subject. This is a serious omission. Experts have overlooked ethical issues that matter to subjects. Silent Partners moves subjects to the forefront, giving them a voice in research ethics.