| Description |
1 online resource (xv, 216 pages) |
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text file |
| Bibliography |
Includes bibliographical references (pages 95-102) and index. |
| Contents |
""Preserving Public Trust: Accreditation and Human Research Participant Protection Programs""; ""Copyright""; ""Preface""; ""REVIEWERS""; ""Acronyms""; ""Contents""; ""Executive Summary""; ""ABSTRACT""; ""THE COMMITTEE'S TASK""; ""MAJOR FINDINGS""; ""RECOMMENDATIONS""; ""CONCLUDING REMARKS""; ""1 Introduction, Background, and Definitions""; ""ORGANIZATION OF THE REPORT""; ""A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES""; ""MORE RECENT EVENTS""; ""Advisory Committee on Human Radiation Experiments""; ""The National Bioethics Advisory Commission"" |
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""Reports from DHHS Office of the Inspector General""""Shutdowns of Clinical Research at Academic and VA Medical Centers""; ""The Death of Jesse Gelsinger""; ""A CALL FOR ACCOUNTABILITY""; ""STATEMENT OF TASK""; ""DEFINITIONS""; ""Subject or Participant?""; ""What Is a Human Research Participant Protection Program?""; ""The Centrality of Informed Consent""; ""The Rise of Clinical Trials and Privately Funded Research""; ""Nonbiomedical Research""; ""Independent IRBs""; ""Sponsors""; ""The Role of the Research Participant""; ""Research Monitoring""; ""Accreditation Versus Certification"" |
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""2 Models of Accreditation""""MODELS OF ACCREDITATION""; ""ELEMENTS OF AN ACCREDITATION PROCESS""; ""Accreditation Bodies""; ""PRIM & R and the Formation of AAHRPP""; ""The VA and NCQA Accreditation Process""; ""Eligibility Criteria and an Application Process""; ""Self-Evaluation""; ""External Evaluation""; ""Appeals Process""; ""Repeat Accreditation""; ""APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT""; ""SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS""; ""Identifying, Investigating, and Sanctioning Violations""; ""Educating Investigators""; ""Improving Research Monitoring"" |
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""WILL ACCREDITATION ENHANCE PERFORMANCE?""""3 Standards for Accreditation""; ""STANDARDS FOR STANDARDS""; ""DEVELOPING MEASURES TO ACCOMPANY STANDARDS""; ""NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS""; ""RELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTS""; ""STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY""; ""NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS""; ""NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS""; ""REVIEW OF AVAILABLE DRAFT STANDARDS""; ""Scope and Focus of the Standards"" |
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""PRIM & R Standards""""NCQA Standards""; ""Relation to Existing Regulatory Requirements""; ""Extent to Which the Standards Can Be Implemented, Measured, and Enforced""; ""What Is Missing""; ""INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE""; ""RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING""; ""4 Evaluating HRPPP Pilot Accreditation Programs""; ""References""; ""Appendixes""; ""APPENDIX A Data Sources and Methods""; ""PRESENTATIONS AND PUBLIC COMMENT""; ""LITERATURE REVIEW""; ""DRAFT STANDARDS FOR ACCREDITATION"" |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
National Committee for Quality Assurance (U.S.) |
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Public Responsibility in Medicine and Research (Association) |
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Human experimentation in medicine -- Standards -- United States.
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Human experimentation in medicine. |
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United States. |
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Informed consent (Medical law) -- United States.
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Informed consent (Medical law) |
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Human Experimentation. |
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National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division. |
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Accreditation -- standards. |
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Informed Consent. |
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Patient Advocacy. |
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Public Policy. |
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United States. |
| Indexed Term |
Andre fag (naturvidenskab og teknik) Andre fag |
| Genre/Form |
Electronic books.
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| Other Form: |
Print version: Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects. Preserving public trust. Washington, D.C. : National Academy Press, ©2001 9780309073288 (DLC) 2001273385 (OCoLC)47721949 |
| ISBN |
0309569915 (electronic book) |
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9780309569910 (electronic book) |
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0309073286 (print) |
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9780309073288 (print) |
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