Preserving public trust : accreditation and human research participant protection programs / / Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine

• Pubblicazione: Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (232 p.)
• Disciplina: 610.724
• Soggetto topico: Human experimentation in medicine - Standards - United States; Informed consent (Medical law) - United States
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Preserving 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. ; 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 -- 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.
• Sommario/riassunto: This 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.
• Titolo autorizzato: Preserving public trust
• ISBN: 9786610184842; 9780309171090; 0309171091; 9781280184840; 1280184841; 9780309569910; 0309569915
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910962759203321
• Lo trovi qui: Univ. Federico II