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.


Table of Contents


Front Matter
ABSTRACT
THE COMMITTEE'S TASK
MAJOR FINDINGS
RECOMMENDATIONS
CONCLUDING REMARKS
ORGANIZATION OF THE REPORT
A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES
Advisory Committee on Human Radiation Experiments
The National Bioethics Advisory Commission
Shutdowns of Clinical Research at Academic and VA Medical Centers
A CALL FOR ACCOUNTABILITY
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
The Role of the Research Participant
Research Monitoring
Accreditation Versus Certification
MODELS OF ACCREDITATION
ELEMENTS OF AN ACCREDITATION PROCESS
PRIM&R and the Formation of AAHRPP
The VA and NCQA Accreditation Process
Self-Evaluation
External Evaluation
APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT
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
PRIM&R Standards
NCQA Standards
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
PRESENTATIONS AND PUBLIC COMMENT
LITERATURE REVIEW
DRAFT STANDARDS FOR ACCREDITATION
INTRODUCTION
PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH
GLOSSARY
Section 1 - Organizational Responsibilities
Section 2 - Institutional Review Boards (IRBs)
Section 3 - Investigators and Other Research Personnel
PUBLICATIONS CITED IN ACCREDITATION STANDARDS
BACKGROUND
ORGANIZATION OF THE STANDARDS
DEFINITIONS
APPENDIX D Committee, Expert Adviser, and Staff Biographies
EXPERT ADVISERS
LIAISONS
STUDY STAFF
CONSULTANT
Index