Human Research

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The Ethics Of Research With Human Subjects

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Author : David B. Resnik
language : en
Publisher: Springer
Release Date : 2018-01-09

The Ethics Of Research With Human Subjects written by David B. Resnik and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-09 with Philosophy categories.

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.

Twentieth Century Ethics Of Human Subjects Research

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Author : Volker Roelcke
language : de
Publisher: Franz Steiner Verlag
Release Date : 2004

Twentieth Century Ethics Of Human Subjects Research written by Volker Roelcke and has been published by Franz Steiner Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with History categories.

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.

Regulating Human Research

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Author : Sarah Babb
language : en
Publisher:
Release Date : 2020

Regulating Human Research written by Sarah Babb and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Business & Economics categories.

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

The Use Of Human Beings In Research

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Author : S.F. Spicker
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

The Use Of Human Beings In Research written by S.F. Spicker and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.

This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.

The Ethics And Regulation Of Research With Human Subjects

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Author : Carl H. Coleman
language : en
Publisher:
Release Date : 2015

The Ethics And Regulation Of Research With Human Subjects written by Carl H. Coleman and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Human experimentation in medicine categories.

Protecting Participants And Facilitating Social And Behavioral Sciences Research

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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2003-07-26

Protecting Participants And Facilitating Social And Behavioral Sciences Research written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-07-26 with Computers categories.

Institutional review boards (IRBs) are the linchpins of the protection systems that govern human participation in research. In recent years, high-profile cases have focused attention on the weaknesses of the procedures for protecting participants in medical research. The issues surrounding participants protection in the social, behavioral, and economic sciences may be less visible to the public eye, but they are no less important in ensuring ethical and responsible research. This report examines three key issues related to human participation in social, behavioral, and economic sciences research: (1) obtaining informed, voluntary consent from prospective participants: (2) guaranteeing the confidentiality of information collected from participants, which is a particularly challenging problem in social sciences research; and (3) using appropriate review procedures for "minimal-risk" research. Protecting Participants and Facilitating Social and Behavioral Sciences Research will be important to policy makers, research administrators, research sponsors, IRB members, and investigators. More generally, it contains important information for all who want to ensure the best protectionâ€"for participants and researchers alikeâ€"in the social, behavioral, and economic sciences.

Clinical And Translational Science

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Author : David Robertson
language : en
Publisher: Academic Press
Release Date : 2016-11-25

Clinical And Translational Science written by David Robertson and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-25 with Science categories.

Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

Responsible Research

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2003-02-06

Responsible Research written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-02-06 with Medical categories.

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.

Conducting Research With Human Participants

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Author : Nathan Durdella
language : en
Publisher: SAGE Publications
Release Date : 2022-02-15

Conducting Research With Human Participants written by Nathan Durdella and has been published by SAGE Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Psychology categories.

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.

Research On Human Subjects

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Author : Bernard Barber
language : en
Publisher: Routledge
Release Date : 2018-04-24

Research On Human Subjects written by Bernard Barber and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-24 with Medical categories.

The use of human subjects in biomedical research has increased rapidly with scientific discoveries. However, the failure to achieve the highest - or even adequate - standards of professional moral concern and behavior is a serious side effect. Research on Human Subjects is based on four years of intensive research in which two studies were completed - one on a nationally representative sample of biomedical research institutions, the second on a sample of 350 researchers who actually used human subjects. The authors explore prevalent ethical norms, the actual ethical behavior of scientists, and the dilemma between the values of humane therapy and scientific discovery. They document the inadequate training that biomedical researchers receive in the ethics of research on human subjects, not only in medical schools but in post-graduate training as well. This landmark work makes very specific suggestions for policy change and reform for the biomedical research profession and its employment of human subjects.