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.