Preserving public trust accreditation and human research participant protection programs
| Autor principal: | |
|---|---|
| Autor Corporativo: | |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. ; [Great Britain] :
National Academy Press
c2001.
|
| Edición: | 1st ed |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622290306719 |
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 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
- 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
- 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 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
- APPENDIX B PRIM&
- R Accreditation Standards
- INTRODUCTION
- GOALS
- PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH
- GLOSSARY
- PROPOSED STANDARDS
- Section 1-Organizational Responsibilities
- Section 2-Institutional Review Boards (IRBs)
- Section 3-Investigators and Other Research Personnel
- PUBLICATIONS CITED IN ACCREDITATION STANDARDS
- APPENDIX C VA Human Research Protection Accreditation Program Draft Accreditation Standards
- BACKGROUND
- SOURCE OF STANDARDS
- ORGANIZATION OF THE STANDARDS
- OPERATION OF ACCREDITATION PROGRAM
- PROGRAM COMPONENTS UNDER DEVELOPMENT
- DEFINITIONS
- APPENDIX D Committee, Expert Adviser, and Staff Biographies
- EXPERT ADVISERS
- LIAISONS
- STUDY STAFF
- IOM BOARD ON HEALTH SCIENCES POLICY STAFF
- CONSULTANT
- Index.
