| Description |
1 online resource (xix, 290 pages) : illustrations |
| Contents |
1. Introduction -- 2. A Systematic approach to human research participant protection programs -- 3. Back to basics: scientific, conflict of interest, and ethical review of research protocols -- 4. The Participant-investigator interface -- 5. Improving protection through oversight and data and safety monitoring -- 6. Improving human research participant protection program performance and clarifying roles -- 7. Improving an evolving national human research participant protection system |
| Summary |
Issues addressed in the book include the need to distinguish the 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 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 sponsors--but also including volunteers who may agree to serve as research participants |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL |
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English |
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Print version record |
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digitized 2010 HathiTrust Digital Library committed to preserve pda MiAaHDL |
| Subject |
Human experimentation in medicine -- Moral and ethical aspects
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Medical ethics.
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Medical protocols.
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Patients -- Legal status, laws, etc.
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Human experimentation in medicine.
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Institutional review boards (Medicine)
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Informed consent (Medical law)
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Safety
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Clinical Protocols
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Human Experimentation
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Patient Rights
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Safety
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Ethics, Medical
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Truth Disclosure
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Clinical Trials Data Monitoring Committees
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Conflict of Interest
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Ethical Review
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Ethics Committees, Research
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Government Regulation
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Human Experimentation -- standards
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Informed Consent
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Public Policy
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Research Subjects
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Researcher-Subject Relations
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MEDICAL -- Ethics.
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Human experimentation in medicine -- Moral and ethical aspects
|
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Medical ethics
|
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Medical protocols
|
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Patients -- Legal status, laws, etc.
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Onderzoek.
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Medische ethiek.
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Patiëntenrecht.
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| SUBJECT |
United States |
| Genre/Form |
Juvenile works
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| Form |
Electronic book
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| Author |
Federman, Daniel D., 1928-2017
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Hanna, Kathi E.
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Rodriguez, Laura Lyman.
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Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Participants.
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| ISBN |
030950046X |
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9780309500463 |
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9786610209392 |
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6610209391 |
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1280209399 |
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9781280209390 |
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