Preserving Public Trust

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 ContentsFront MatterABSTRACTTHE COMMITTEE'S TASKMAJOR FINDINGSRECOMMENDATIONSCONCLUDING REMARKSORGANIZATION OF THE REPORTA SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATESAdvisory Committee on Human Radiation ExperimentsThe National Bioethics Advisory CommissionShutdowns of Clinical Research at Academic and VA Medical CentersA CALL FOR ACCOUNTABILITYDEFINITIONSSubject or Participant?What Is a Human Research Participant Protection Program?The Centrality of Informed ConsentThe Rise of Clinical Trials and Privately Funded ResearchNonbiomedical ResearchIndependent IRBsThe Role of the Research ParticipantResearch MonitoringAccreditation Versus CertificationMODELS OF ACCREDITATIONELEMENTS OF AN ACCREDITATION PROCESSPRIM&R and the Formation of AAHRPPThe VA and NCQA Accreditation ProcessSelf-EvaluationExternal EvaluationAPPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHTIdentifying, Investigating, and Sanctioning ViolationsEducating InvestigatorsImproving Research MonitoringWILL ACCREDITATION ENHANCE PERFORMANCE?3 Standards for AccreditationSTANDARDS FOR STANDARDSDEVELOPING MEASURES TO ACCOMPANY STANDARDSNEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODSRELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTSSTANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDYNEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTSNEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORSREVIEW OF AVAILABLE DRAFT STANDARDSPRIM&R StandardsNCQA StandardsExtent to Which the Standards Can Be Implemented, Measured, and EnforcedWhat Is MissingINTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICERECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING4 Evaluating HRPPP Pilot Accreditation ProgramsReferencesAppendixesPRESENTATIONS AND PUBLIC COMMENTLITERATURE REVIEWDRAFT STANDARDS FOR ACCREDITATIONINTRODUCTIONPRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCHGLOSSARYSection 1 - Organizational ResponsibilitiesSection 2 - Institutional Review Boards (IRBs)Section 3 - Investigators and Other Research PersonnelPUBLICATIONS CITED IN ACCREDITATION STANDARDSBACKGROUNDORGANIZATION OF THE STANDARDSDEFINITIONSAPPENDIX D Committee, Expert Adviser, and Staff BiographiesEXPERT ADVISERSLIAISONSSTUDY STAFFCONSULTANTIndex