Preserving public trust : accreditation and human research participant protection programs /

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press, ©2001.
Temas:
National Committee for Quality Assurance (U.S.)
Public Responsibility in Medicine and Research (Association)
Human experimentation in medicine > Standards > United States.
Informed consent (Medical law) > United States.
Expérimentation humaine en médecine > Normes > États-Unis.
Consentement éclairé (Droit médical) > États-Unis.
MEDICAL > Laboratory Medicine.
Patients > Civil rights
Patient advocacy
Human experimentation in medicine
Informed consent (Medical law)
United States
Andre fag (naturvidenskab og teknik) > Andre fag
Electronic book.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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
  • 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
  • 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
  • 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
  • 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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