Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Institute of Medicine

doi:10.17226/10085

Consensus Study Report

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Preserving Public Trust

Accreditation and Human Research Participant Protection Programs

(2001)

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.

Contributor(s): Institute of Medicine; Board on Health Sciences Policy; Committee on Assessing the System for Protecting Human Research Subjects

RESOURCES AT A GLANCE

Press Release

Topics

Health and Medicine —Policy, Reviews and Evaluations

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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Press Release

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