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Author : Carl H. Coleman
Publisher :
ISBN 13 : 9780327176930
Total Pages : pages
Book Rating : 4.1/5 (769 download)
Download or read book The Ethics and Regulation of Research with Human Subjects written by Carl H. Coleman and published by . This book was released on 2015 with total page 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 : 614 pages
Book Rating : 4.:/5 (318 download)
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 : David B. Resnik
Publisher : Springer
ISBN 13 : 3319687565
Total Pages : 316 pages
Book Rating : 4.3/5 (196 download)
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 316 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 : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309071879
Total Pages : 208 pages
Book Rating : 4.3/5 (9 download)
Download or read book Protecting Data Privacy in Health Services Research written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-13 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.
Author : Nancy M. P. King
Publisher : UNC Press Books
ISBN 13 : 0807876062
Total Pages : 294 pages
Book Rating : 4.8/5 (78 download)
Download or read book Beyond Regulations written by Nancy M. P. King and published by UNC Press Books. This book was released on 2005-10-12 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Rebecca Dresser
Publisher : Oxford University Press
ISBN 13 : 0190459271
Total Pages : 321 pages
Book Rating : 4.1/5 (94 download)
Download or read book Silent Partners written by Rebecca Dresser and published by Oxford University Press. This book was released on 2017 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309379512
Total Pages : 283 pages
Book Rating : 4.3/5 (93 download)
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.
Author : Carl E. Schneider
Publisher : MIT Press
ISBN 13 : 0262028913
Total Pages : 293 pages
Book Rating : 4.2/5 (62 download)
Download or read book The Censor's Hand written by Carl E. Schneider and published by MIT Press. This book was released on 2015-04-10 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good. Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called “institutional review boards” (IRBs). Do—can—these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience—the law's learning about regulation—and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging—universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.
Author : James F. Childress
Publisher : Georgetown University Press
ISBN 13 : 9781589010628
Total Pages : 300 pages
Book Rating : 4.0/5 (16 download)
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.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)
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 Research Council
Publisher : National Academies Press
ISBN 13 : 0309175925
Total Pages : 116 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Arctic Aeromedical Laboratory's Thyroid Function Study written by National Research Council and published by National Academies Press. This book was released on 1996-01-26 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : 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)
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.
Author : Mohammadali M. Shoja
Publisher : John Wiley & Sons
ISBN 13 : 1118907426
Total Pages : 786 pages
Book Rating : 4.1/5 (189 download)
Download or read book A Guide to the Scientific Career written by Mohammadali M. Shoja and published by John Wiley & Sons. This book was released on 2020-01-09 with total page 786 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise, easy-to-read source of essential tips and skills for writing research papers and career management In order to be truly successful in the biomedical professions, one must have excellent communication skills and networking abilities. Of equal importance is the possession of sufficient clinical knowledge, as well as a proficiency in conducting research and writing scientific papers. This unique and important book provides medical students and residents with the most commonly encountered topics in the academic and professional lifestyle, teaching them all of the practical nuances that are often only learned through experience. Written by a team of experienced professionals to help guide younger researchers, A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing features ten sections composed of seventy-four chapters that cover: qualities of research scientists; career satisfaction and its determinants; publishing in academic medicine; assessing a researcher’s scientific productivity and scholarly impact; manners in academics; communication skills; essence of collaborative research; dealing with manipulative people; writing and scientific misconduct: ethical and legal aspects; plagiarism; research regulations, proposals, grants, and practice; publication and resources; tips on writing every type of paper and report; and much more. An easy-to-read source of essential tips and skills for scientific research Emphasizes good communication skills, sound clinical judgment, knowledge of research methodology, and good writing skills Offers comprehensive guidelines that address every aspect of the medical student/resident academic and professional lifestyle Combines elements of a career-management guide and publication guide in one comprehensive reference source Includes selected personal stories by great researchers, fascinating writers, inspiring mentors, and extraordinary clinicians/scientists A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing is an excellent interdisciplinary text that will appeal to all medical students and scientists who seek to improve their writing and communication skills in order to make the most of their chosen career.
Author : I. Glenn Cohen
Publisher : MIT Press
ISBN 13 : 0262320835
Total Pages : 393 pages
Book Rating : 4.2/5 (623 download)
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
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171091
Total Pages : 232 pages
Book Rating : 4.3/5 (91 download)
Download or read book Preserving Public Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-02 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements. In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309084881
Total Pages : 313 pages
Book Rating : 4.3/5 (9 download)
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.
Author : J. C. Barnes
Publisher : John Wiley & Sons
ISBN 13 : 1119110726
Total Pages : 967 pages
Book Rating : 4.1/5 (191 download)
Download or read book The Encyclopedia of Research Methods in Criminology and Criminal Justice, 2 Volume Set written by J. C. Barnes and published by John Wiley & Sons. This book was released on 2021-09-08 with total page 967 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Encyclopedia of RESEARCH METHODS IN CRIMINOLOGY & CRIMINAL JUSTICE The most comprehensive reference work on research designs and methods in criminology and criminal justice This Encyclopedia of Research Methods in Criminology and Criminal Justice offers a comprehensive survey of research methodologies and statistical techniques that are popular in criminology and criminal justice systems across the globe. With contributions from leading scholars and practitioners in the field, it offers a clear insight into the techniques that are currently in use to answer the pressing questions in criminology and criminal justice. The Encyclopedia contains essential information from a diverse pool of authors about research designs grounded in both qualitative and quantitative approaches. It includes information on popular datasets and leading resources of government statistics. In addition, the contributors cover a wide range of topics such as: the most current research on the link between guns and crime, rational choice theory, and the use of technology like geospatial mapping as a crime reduction tool. This invaluable reference work: Offers a comprehensive survey of international research designs, methods, and statistical techniques Includes contributions from leading figures in the field Contains data on criminology and criminal justice from Cambridge to Chicago Presents information on capital punishment, domestic violence, crime science, and much more Helps us to better understand, explain, and prevent crime Written for undergraduate students, graduate students, and researchers, The Encyclopedia of Research Methods in Criminology and Criminal Justice is the first reference work of its kind to offer a comprehensive review of this important topic.
