یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Includes bibliographical references (pages 95-102) and index.
یادداشتهای مربوط به مندرجات
متن يادداشت
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
متن يادداشت
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
متن يادداشت
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
متن يادداشت
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
متن يادداشت
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
بدون عنوان
0
بدون عنوان
8
بدون عنوان
8
بدون عنوان
8
بدون عنوان
8
ویراست دیگر از اثر در قالب دیگر رسانه
عنوان
Preserving public trust.
شماره استاندارد بين المللي کتاب و موسيقي
9780309073288
نام تنالگان به منزله موضوع
موضوع مستند نشده
National Committee for Quality Assurance (U.S.)
موضوع مستند نشده
Public Responsibility in Medicine and Research (Association)
موضوع (اسم عام یاعبارت اسمی عام)
موضوع مستند نشده
Human experimentation in medicine-- Standards-- United States.