Evaluating The Science And Ethics Of Research On Humans

Author : Dennis J. Mazur
Publisher : Johns Hopkins University Press
Page : 0 pages
File Size : 55,5 Mb
Release : 2007-02-05
Category : Medical
ISBN : 0801885027

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Evaluating the Science and Ethics of Research on Humans by Dennis J. Mazur Pdf

Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research—institutional review boards, or IRBs—is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas—drugs, medical devices, and genetic information—Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.

Author : Kenneth D. Pimple
Publisher : Routledge
Page : 689 pages
File Size : 46,8 Mb
Release : 2017-05-15
Category : Philosophy
ISBN : 9781351904001

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Research Ethics by Kenneth D. Pimple Pdf

This volume includes more than 40 important articles on integrity and misconduct, biomedical research, the social and disciplinary contexts of science, research in the social sciences, the social responsibility of science and scientists, and other core issues in research ethics. A new introduction by the editor places these articles in their historical and conceptual context. The volume provides a rich library of resources, ideas and challenges in the ethics of research for any scholar concerned with such issues.

Author : Rebecca Dresser
Publisher : Oxford University Press
Page : 208 pages
File Size : 50,7 Mb
Release : 2016-10-03
Category : Medical
ISBN : 9780190459291

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Silent Partners by Rebecca Dresser Pdf

When is a human study ethical? For years, science and society have struggled with this question. Experts have put great effort into developing ethical principles and rules that adequately protect and respect volunteers in studies aimed at improving human health. But experts have missed something important. They have created a research ethics system without the help of people who know what it is like to be a research subject. This is a serious omission. Experienced research subjects can make valuable contributions to research ethics. People who have been in studies have information about the experience that other people can overlook. Their experience as subjects gives them special insights into ethics, too. Experienced subjects also know about problems that can lead people to refuse to join studies, or drop out before studies are complete. Scientists and ethicists often speak of subjects as partners in research, but the reality is quite different. Experienced subjects are rarely appointed to the advisory groups that create guidelines for ethical research, or to the committees that review individual studies to determine whether they meet ethical and regulatory standards. A large body of work describes the perceptions and viewpoints of people who have participated in research. But experts rarely use this material to guide improvements in human subject protection. Although subjects have the power to decide whether to participate in a study, they have little control over anything else that goes on in research. Silent Partners moves research subjects to the forefront. It examines what research participation is like for healthy volunteers and patients. It explains why subjects' voices should influence research ethics. Silent Partners shows how experienced research subjects can become real-not just symbolic-partners in research.

Author : Robin Levin Penslar
Publisher : Indiana University Press
Page : 346 pages
File Size : 51,6 Mb
Release : 1995-01-22
Category : Business & Economics
ISBN : 0253209064

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Research Ethics by Robin Levin Penslar Pdf

"The book provides opportunities for unusually good discussions of ethical problems that can confront researchers in any field." —Religious Studies Review ". . . this book provides a ready-made package for the teaching of ethics in research." —Journal of Third World Studies ". . . Research Ethics is an extremely useful and stimulating book . . . recommended for wide classroom use on both the undergraduate and graduate level as well as for all academic library collections." —Journal of Information Ethics " . . . an excellent introduction into research ethics." —Journal of College Science Teaching "A useful supplement to faculty teaching courses on scientific ethics and a resource for instructors who give lectures on the topic in more general courses." —Robert L. Sprague, Director, Institute for Research on Human Development "This book is important because it defines and clarifies subtle ethical issues present but not necessarily easily recognizable as such in the everyday conduct of research." —Doody's Health Sciences Book Review Journal "A very useful text for courses dealing with ethics in the research setting." —Science, Technology & Society " . . . a welcome collection of materials that can be used in a variety of ways by those who are genuinely concerned that scientific research remain faithful to its ideals." —American Journal of Human Genetics "This clearly written, reader-friendly book addresses the need for systematic education in research ethics and suggests that researchers themselves are the best teachers for their students. . . . The scenarios are realistic . . . , well presented, and organized around a series of topics that are both diverse and relevant to the practicing investigator." —American Journal of Psychiatry " . . . a landmark teaching tool . . . " —Science Books & Films [an "Editor's Choice" book] "I think this book is an excellent introduction into research ethics. The material is presented in an exceptionally thought-provoking manner, and it serves as a reference guide and as a source for seminar topics" —Robert H. Tamarin, Journal of College Science Teaching This comprehensive casebook for teaching research ethics in the sciences and the humanities covers such topics as plagiarism, confidentiality, conflict of interest, fraud and misconduct, the reporting of data, and the participation of human and animal subjects in research. An annotated bibliography will help instructors identify resources to use as supplements to cases, assist readers who are developing courses in research ethics, and aid further research on the subject.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 46,6 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : UCSD:31822000897728

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The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf

Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publisher : National Academies Press
Page : 312 pages
File Size : 51,8 Mb
Release : 2003-01-06
Category : Medical
ISBN : 9780309169035

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Responsible Research by Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants Pdf

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 : James F. Childress,Eric Mark Meslin,Harold T. Shapiro
Publisher : Georgetown University Press
Page : 300 pages
File Size : 44,9 Mb
Release : 2005
Category : Human experimentation in medicine
ISBN : 1589010620

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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.

Author : Sandu, Antonio,Frunza, Ana,Unguru, Elena
Publisher : IGI Global
Page : 373 pages
File Size : 48,7 Mb
Release : 2018-11-16
Category : Reference
ISBN : 9781522563112

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Ethics in Research Practice and Innovation by Sandu, Antonio,Frunza, Ana,Unguru, Elena Pdf

A particularly important component of any research project is its ethical dimensions which can refer to varied categories of practice – from the protection of human subjects involved in medical and social research to the publication of results research. More recently, with the estimation of the possible consequences of the implementation of technology, it is important for today’s researchers to address the standards of scientific practice and avoid unethical behavior. Ethics in Research Practice and Innovation is an essential reference source that discusses current and historical aspects of ethical values in scientific research and technologies, as well as emerging perspectives of conducting ethical research in a variety of fields. Featuring research on topics such as clinical trials, human subjects, and informed consent, this book is ideally designed for practitioners, medical professionals, nurses, researchers, scientists, scholars, academicians, policy makers, and students seeking coverage on the ethical risks and limitations of research practice.

Author : Donna M. Mertens,Pauline E. Ginsberg
Publisher : SAGE
Page : 689 pages
File Size : 54,6 Mb
Release : 2009
Category : Business & Economics
ISBN : 9781412949187

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The Handbook of Social Research Ethics by Donna M. Mertens,Pauline E. Ginsberg Pdf

Brings together international scholars across the social and behavioural sciences and education to address those ethical issues that arise in the theory and practice of research within the technologically advancing and culturally complex world in which we live.

Author : National Research Council,Institute of Medicine,Division on Earth and Life Studies,Board on Health Sciences Policy,Committee on Assessing Integrity in Research Environments
Publisher : National Academies Press
Page : 217 pages
File Size : 49,8 Mb
Release : 2002-11-02
Category : Science
ISBN : 9780309084796

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Integrity in Scientific Research by National Research Council,Institute of Medicine,Division on Earth and Life Studies,Board on Health Sciences Policy,Committee on Assessing Integrity in Research Environments Pdf

"Many people say that it is the intellect which makes a great scientist. They are wrong: it is character."-Albert Einstein Integrity in Scientific Research attempts to define and describe those elements that encourage individuals involved with scientific research to act with integrity. Recognizing the inconsistency of human behavior, it stresses the important role that research institutions play in providing an integrity-rich environment, citing the need for institutions to provide staff with training and education, policies and procedures, and tools and support systems. It identifies practices that characterize integrity in such areas as peer review and research on human subjects and weighs the strengths and limitations of self-evaluation efforts by these institutions. In addition, it details an approach to promoting integrity during the education of researchers, including how to develop an effective curriculum. Providing a framework for research and educational institutions, this important book will be essential for anyone concerned about ethics in the scientific community.

Author : Judy E. Stern,Deni Elliott
Publisher : Unknown
Page : 132 pages
File Size : 55,7 Mb
Release : 1997
Category : Research
ISBN : UOM:39015039888105

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The Ethics of Scientific Research by Judy E. Stern,Deni Elliott Pdf

Author : David B. Resnik
Publisher : Springer
Page : 316 pages
File Size : 47,7 Mb
Release : 2018-01-09
Category : Philosophy
ISBN : 9783319687568

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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.

Author : Ana Smith Iltis
Publisher : Routledge
Page : 232 pages
File Size : 46,5 Mb
Release : 2006-01-16
Category : Philosophy
ISBN : 9781135991494

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Research Ethics by Ana Smith Iltis Pdf

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.

Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller,David D. Wendler
Publisher : Oxford University Press
Page : 848 pages
File Size : 51,8 Mb
Release : 2008-04-18
Category : Medical
ISBN : 9780199883394

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The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller,David D. Wendler 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.

Author : Franklin G. Miller
Publisher : Oxford University Press
Page : 336 pages
File Size : 41,5 Mb
Release : 2012-06-01
Category : Medical
ISBN : 9780199896219

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The Ethical Challenges of Human Research by Franklin G. Miller Pdf

The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medical journals. The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." An abiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.