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|a Institute of Medicine (U.S.).
|b Committee on Assessing the System for Protecting Human Research Subjects.
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|a Preserving public trust :
|b accreditation and human research participant protection programs /
|c Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine.
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|a Washington, D.C. :
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|c ©2001.
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|a 1 online resource (xv, 216 pages)
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|a Includes bibliographical references (pages 95-102) and index.
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|a 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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| 505 |
8 |
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|a Reports from DHHS Office of the Inspector GeneralShutdowns 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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| 505 |
8 |
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|a 2 Models of AccreditationMODELS 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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| 505 |
8 |
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|a 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
|
| 505 |
8 |
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|a PRIM & R StandardsNCQA 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
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|a Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects.
|t Preserving public trust.
|d Washington, D.C. : National Academy Press, ©2001
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