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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.
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 : 52,5 Mb Release : 2015 Category : Human experimentation in medicine ISBN : 0327176938
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.
Twentieth century ethics of human subjects research by Volker Roelcke,Giovanni Maio Pdf
Debates on the ethics of human subjects research meet with an increasing interest both within the medical profession and the broader public. Frequently, historical arguments are used to propagate or attack certain positions within these debates. However, there is a tendency to oversimplify the complexities of the past for present day purposes, and at the same time a lack of awareness of the historical dimension implicit in today's value preferences. Twentieth Century Ethics of Human Subjects Research brings together leading historians of medicine to reconstruct and analyse the history of actual experimental practices, the debates on human subjects research, and the attempts to regulate such research during the twentieth century. The volume addresses cases of medical research in France, Britain, Israel, the United States, and Germany, including the Nazi period; the major developments of ethical debates in these and further national contexts, such as the Soviet Union, the Czech Republic, and Japan. It also explores religious views (Catholic, Jewish) on human experimentation, and the origins and contexts of international codes and declarations. "Volker Roelckes Uberblick uber die Geschichte der Menschenversuche im Dritten Reich sei jedem empfohlen, der sich kurz und pragnant uber dieses dustere Kapitel deutscher Geschichte informieren mochte." FAZ.
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.
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.
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 : 128 pages File Size : 46,9 Mb Release : 1978 Category : Human experimentation in medicine ISBN : LCCN:79601661
Author : Harold Y. Vanderpool Publisher : University Publishing Group. Page : 552 pages File Size : 51,7 Mb Release : 1996 Category : Human experimentation in medicine ISBN : UOM:49015002453836
Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131,Commission on Geosciences, Environment, and Resources,Commission on Life Sciences,Polar Research Board,Board on Radiation Effects Research,Board on Health Promotion and Disease Prevention,Division on Earth and Life Studies,Institute of Medicine,National Research Council
Author : Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131,Commission on Geosciences, Environment, and Resources,Commission on Life Sciences,Polar Research Board,Board on Radiation Effects Research,Board on Health Promotion and Disease Prevention,Division on Earth and Life Studies,Institute of Medicine,National Research Council Publisher : National Academies Press Page : 98 pages File Size : 45,9 Mb Release : 1996-02-09 Category : Science ISBN : 9780309588843
The Arctic Aeromedical Laboratory's Thyroid Function Study by Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine-131,Commission on Geosciences, Environment, and Resources,Commission on Life Sciences,Polar Research Board,Board on Radiation Effects Research,Board on Health Promotion and Disease Prevention,Division on Earth and Life Studies,Institute of Medicine,National Research Council 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 activity--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.
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 : 51,8 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.
Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data.
Ethics in Research with Human Participants by Bruce Dennis Sales,Susan Folkman Pdf
The American Psychological Association offers this book to help researchers understand ethical conflicts. The examples and analyses help researchers in identifying conflicts of interest and solving ethical dilemmas, planning research, recruiting participants, training researchers, managing matters of informed consent and confidentiality, dealing with intellectual property issues, working with special populations, and updating protocols for institutional review boards.
Conducting Research with Human Participants by Nathan Durdella Pdf
Conducting Research with Human Participants: An IRB Guide for Students and Faculty by Nathan Durdella is the only guidebook students and faculty will need to navigate the IRB process and secure swift approval of research protocols. This book serves as an advisor to walk researchers through all the details of drafting, submission, and revision of materials for Institutional Review Boards so they can complete their research projects or dissertations faster. This text walks readers through the history of Institutional Review Boards, the contemporary context of ethical research, strategies to effectively draft, submit, and revise an IRB protocol, and guidance on working with an approved protocol in the field. The latest updates to the Common Rule and other regulatory frameworks, including special protections for working with vulnerable groups, are covered throughout the text. Not every research project goes according to plan, so adverse events and reporting receive special coverage. A final chapter on ethical research practices beyond IRB compliance encourages researchers to think through how to exit the field of research and ensure their research benefits the individuals, families, and communities in which they work. Take the guesswork out of the IRB process from start to finish with this handy guide.
Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller
Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Publisher : OUP USA Page : 848 pages File Size : 50,6 Mb Release : 2011-02 Category : Medical ISBN : 9780199768639
The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Pdf
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.
