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Front Matter i-xvi
ABSTRACT 1-4
THE COMMITTEE'S TASK 5-5
MAJOR FINDINGS 6-9
RECOMMENDATIONS 10-19
CONCLUDING REMARKS 20-22
ORGANIZATION OF THE REPORT 23-23
A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES 24-25
Advisory Committee on Human Radiation Experiments 26-27
The National Bioethics Advisory Commission 28-28
Shutdowns of Clinical Research at Academic and VA Medical Centers 29-30
A CALL FOR ACCOUNTABILITY 31-31
DEFINITIONS 32-32
Subject or Participant? 33-34
What Is a Human Research Participant Protection Program? 35-35
The Centrality of Informed Consent 36-37
The Rise of Clinical Trials and Privately Funded Research 38-38
Nonbiomedical Research 39-39
Independent IRBs 40-40
The Role of the Research Participant 41-41
Research Monitoring 42-42
Accreditation Versus Certification 43-44
MODELS OF ACCREDITATION 45-47
ELEMENTS OF AN ACCREDITATION PROCESS 48-48
PRIM&R and the Formation of AAHRPP 49-49
The VA and NCQA Accreditation Process 50-50
Self-Evaluation 51-51
External Evaluation 52-52
APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT 53-56
Identifying, Investigating, and Sanctioning Violations 57-58
Educating Investigators 59-59
Improving Research Monitoring 60-60
WILL ACCREDITATION ENHANCE PERFORMANCE? 61-62
3 Standards for Accreditation 63-63
STANDARDS FOR STANDARDS 64-66
DEVELOPING MEASURES TO ACCOMPANY STANDARDS 67-68
NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS 69-70
RELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTS 71-71
STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY 72-72
NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS 73-74
NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS 75-75
REVIEW OF AVAILABLE DRAFT STANDARDS 76-76
PRIM&R Standards 77-79
NCQA Standards 80-80
Extent to Which the Standards Can Be Implemented, Measured, and Enforced 81-81
What Is Missing 82-82
INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE 83-83
RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING 84-88
4 Evaluating HRPPP Pilot Accreditation Programs 89-94
References 95-102
Appendixes 103-104
PRESENTATIONS AND PUBLIC COMMENT 105-112
LITERATURE REVIEW 113-113
DRAFT STANDARDS FOR ACCREDITATION 114-114
INTRODUCTION 115-115
PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH 116-116
GLOSSARY 117-117
Section 1 - Organizational Responsibilities 118-123
Section 2 - Institutional Review Boards (IRBs) 124-130
Section 3 - Investigators and Other Research Personnel 131-132
PUBLICATIONS CITED IN ACCREDITATION STANDARDS 133-134
BACKGROUND 135-135
ORGANIZATION OF THE STANDARDS 136-140
DEFINITIONS 141-196
APPENDIX D Committee, Expert Adviser, and Staff Biographies 197-201
EXPERT ADVISERS 202-203
LIAISONS 204-205
STUDY STAFF 206-206
CONSULTANT 207-208
Index 209-216

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: Appendixes

Appendixes

My Academies

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Chapter: Appendixes

Appendixes