Protecting Human Research Subjects

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Protecting Human Research Subjects At The Department Of Energy

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Author : United States. Department of Energy. Office of Health and Environmental Research
language : en
Publisher:
Release Date : 1992

Protecting Human Research Subjects At The Department Of Energy written by United States. Department of Energy. Office of Health and Environmental Research and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Body, Human categories.

Protecting Human Research Subjects

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Author : Robin Levin Penslar
language : en
Publisher: U.S. Government Printing Office
Release Date : 1993

Protecting Human Research Subjects written by Robin Levin Penslar and has been published by U.S. Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Education categories.

2d edition. Issued in looseleaf form with index dividers and a spinelabel. Prepared under contract by Robin Levin Penslar, at IndianaUniversity, Poynter Center for the Study of Ethics and AmericanInstitutions. Includes sections on: institutional administration (ofthe Institutional Review Board, the IRB); regulations and policies;biomedical and behavioral research, an overview; special classes ofsubjects (such as fetuses, women, children, prisoners, comatosepatients, and volunteers); bibliography; glossary; texts ofinternational human rights documents (Nuremburg, Helsinki, andBelmont); lists of contacts; Federal regulations; and otherinformation.

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.

Protecting Human Research Subjects

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Author : United States. Department of Energy. Office of Health and Environmental Research
language : en
Publisher:
Release Date : 1995

Protecting Human Research Subjects written by United States. Department of Energy. Office of Health and Environmental Research and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Human body categories.

Protecting Human Research Subjects

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Author : United States. Department of Health and Human Services. Office of Inspector General
language : en
Publisher:
Release Date : 2000

Protecting Human Research Subjects written by United States. Department of Health and Human Services. Office of Inspector General and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Human experimentation in medicine categories.

Human Subjects Research Handbook

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Author :
language : en
Publisher:
Release Date : 1996

Human Subjects Research Handbook written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Human body categories.

Preserving Public Trust

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-08-02

Preserving Public Trust 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 2001-08-02 with Medical categories.

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.

Protection Of Human Research Subjects

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Author : D.M. Maloney
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Protection Of Human Research Subjects written by D.M. Maloney 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.

Regulations on human subjects research have evolved over a 20-year period and now provide a formal set of requirements for the conduct of federally sponsored studies. Over time, government regulations, like taboos in primitive societies, develop a life of their own, seemingly dissociated from their origins and justifica tions. When the investigator suffers the burdens of trying to comply with com plex rules, it is easy for him or her to lapse into a frustration that can be eased by being informed or reminded of why the rules were created in the first place and what they were designed to accomplish. Dennis Maloney's work provides a handy historical record of the processes by which the regulations were created and modified. He also recounts his own experience with research at Boys Town and provides instructions on how to cope with the system. It is difficult to find in one place the current status and appropriate citations for regulations as well as the contacts and know-how to obtain more information on the subject. In this respect, by providing a history and guide to interpretation and compliance, "Protection of Human Subjects" is a reference of importance and utility to the investigator entering into or working in the field of biomedical or behavioral research involving human subjects.

Protecting Human Subjects Of Research

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Author :
language : en
Publisher:
Release Date : 1994

Protecting Human Subjects Of Research written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Clinical trails categories.

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.