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
