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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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Suggested Citation

Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. https://doi.org/10.17226/10085.

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Publication Info

232 pages |  6 x 9 | 

ISBNs: 
  • Paperback:  978-0-309-07328-8
  • Ebook:  978-0-309-17109-0
DOI: https://doi.org/10.17226/10085
Chapters skim
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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