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Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 164
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Book Description
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 164
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Book Description
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 520
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Book Description
Author: Doris Schroeder
Publisher: Springer
ISBN: 3319647318
Category : Philosophy
Languages : en
Pages : 144
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Book Description
This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Author: Ezekiel J. Emanuel
Publisher: OUP USA
ISBN: 0199768633
Category : Medical
Languages : en
Pages : 848
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Book Description
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: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
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Book Description
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: United States. Department of Health, Education, and Welfare. Secretary's Task Force on the Compensation of Injured Research Subjects
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 68
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Book Description
Author: Graham Dukes
Publisher: IOS Press
ISBN: 9789051993875
Category : Law
Languages : en
Pages : 584
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Book Description
This edition reflects the evolution of legal standards, professional rules, industrial codes of ethics, and court experience in cases involving recompense for medical injury since the 1988 version. While deriving from legal standards of the US, British Commonwealth, European Union, and Nordic Council, a chapter is devoted to issues particular to developing countries. Following an introductory chapter on the emergence and recognition of problems relating to drug safety, 20 chapters cover such areas as: the legal framework (types of proceedings, evidence, and proof); the responsibility of everyone from the government and manufacturer to the prescriber and patient; clinical investigation of drugs; controlled drugs; self-medication; alternative and complementary medicine; and vaccines and biologicals. Includes a table of cases, and table of conventions, statutes, and regulations. Annotation copyrighted by Book News, Inc., Portland, OR
Author: Abraham Irving Melden
Publisher:
ISBN:
Category : Ethics
Languages : en
Pages : 87
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Book Description
