LEADER 06462nam 2200673Ia 450 001 9910962759203321 005 20251017110138.0 010 $a9786610184842 010 $a9780309171090 010 $a0309171091 010 $a9781280184840 010 $a1280184841 010 $a9780309569910 010 $a0309569915 035 $a(CKB)111069351122092 035 $a(OCoLC)51820950 035 $a(CaPaEBR)ebrary10071388 035 $a(SSID)ssj0000226643 035 $a(PQKBManifestationID)11234635 035 $a(PQKBTitleCode)TC0000226643 035 $a(PQKBWorkID)10263401 035 $a(PQKB)10014756 035 $a(MiAaPQ)EBC3377361 035 $a(Au-PeEL)EBL3377361 035 $a(CaPaEBR)ebr10071388 035 $a(OCoLC)923270014 035 $a(Perlego)4736790 035 $a(DNLM)1126968 035 $a(BIP)7298076 035 $a(EXLCZ)99111069351122092 100 $a20021011d2001 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aPreserving public trust $eaccreditation and human research participant protection programs /$fCommittee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine 205 $a1st ed. 210 $aWashington, D.C. ;$a[Great Britain] $cNational Academy Press$dc2001 215 $a1 online resource (232 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a9780309073288 311 08$a0309073286 320 $aIncludes bibliographical references and index. 327 $aPreserving Public Trust: Accreditation and Human Research Participant Protection Programs -- Copyright -- Preface -- REVIEWERS -- Acronyms -- Contents -- Executive Summary -- ABSTRACT -- THE COMMITTEE'S TASK -- MAJOR FINDINGS -- RECOMMENDATIONS -- CONCLUDING REMARKS -- 1 Introduction, Background, and Definitions -- ORGANIZATION OF THE REPORT -- A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES -- MORE RECENT EVENTS -- Advisory Committee on Human Radiation Experiments -- The National Bioethics Advisory Commission -- Reports from DHHS Office of the Inspector General -- Shutdowns of Clinical Research at Academic and VA Medical Centers -- The Death of Jesse Gelsinger -- A CALL FOR ACCOUNTABILITY -- STATEMENT OF TASK -- 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 -- Sponsors -- The Role of the Research Participant -- Research Monitoring -- Accreditation Versus Certification -- 2 Models of Accreditation -- MODELS OF ACCREDITATION -- ELEMENTS OF AN ACCREDITATION PROCESS -- Accreditation Bodies -- PRIM& -- R and the Formation of AAHRPP -- The VA and NCQA Accreditation Process -- Eligibility Criteria and an Application Process -- Self-Evaluation -- External Evaluation -- Appeals Process -- Repeat Accreditation -- APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT -- SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS -- 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. 327 $aNEED 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 -- Scope and Focus of the Standards -- PRIM& -- R Standards -- NCQA Standards -- Relation to Existing Regulatory Requirements -- 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 -- APPENDIX A Data Sources and Methods -- PRESENTATIONS AND PUBLIC COMMENT -- LITERATURE REVIEW -- DRAFT STANDARDS FOR ACCREDITATION -- APPENDIX B PRIM& -- R Accreditation Standards -- INTRODUCTION -- GOALS -- PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH -- GLOSSARY -- PROPOSED STANDARDS -- Section 1-Organizational Responsibilities -- Section 2-Institutional Review Boards (IRBs) -- Section 3-Investigators and Other Research Personnel -- PUBLICATIONS CITED IN ACCREDITATION STANDARDS -- APPENDIX C VA Human Research Protection Accreditation Program Draft Accreditation Standards -- BACKGROUND -- SOURCE OF STANDARDS -- ORGANIZATION OF THE STANDARDS -- OPERATION OF ACCREDITATION PROGRAM -- PROGRAM COMPONENTS UNDER DEVELOPMENT -- DEFINITIONS -- APPENDIX D Committee, Expert Adviser, and Staff Biographies -- EXPERT ADVISERS -- LIAISONS -- STUDY STAFF -- IOM BOARD ON HEALTH SCIENCES POLICY STAFF -- CONSULTANT -- Index. 330 $aThis report was produced by the Institute of Medicine's Committee on Assessing the System for Protecting Human Research Subjects. The report explores a variety of issues related to the safety and rights of the participants in clinical research, including informed consent, the right of subjects to say no and the choice to change one's mind, the ability of institutional review boards to handle the complex responsibilities given to them, and the ability to organize and monitor this "nonsystem of evolutionarily unprecedented human behavior" in order to "maximize its glorious potential and control its dark risks." The report suggests ways in which accreditation might contribute to a new level of excellence. Annotation copyrighted by Book News Inc., Portland, OR. 606 $aHuman experimentation in medicine$xStandards$zUnited States 606 $aInformed consent (Medical law)$zUnited States 615 0$aHuman experimentation in medicine$xStandards 615 0$aInformed consent (Medical law) 676 $a610.724 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910962759203321 996 $aPreserving public trust$94354798 997 $aUNINA