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Monitoring adherence to the NIH policy on the inclusion of women and minorities as subjects of clinical research, comprehensive report [[electronic resource]]
| Monitoring adherence to the NIH policy on the inclusion of women and minorities as subjects of clinical research, comprehensive report [[electronic resource]] |
| Pubbl/distr/stampa | Bethesda, Md., : National Institutes of Health, [2000]- |
| Descrizione fisica | volumes : digital, PDF file |
| Soggetto topico |
Human experimentation in medicine - Standards - United States
Clinical trials - Standards - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Monitoring adherence to the National Institutes of Health policy on the inclusion of women and minorities as subjects of clinical research |
| Record Nr. | UNINA-9910698219203321 |
| Bethesda, Md., : National Institutes of Health, [2000]- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Preserving public trust [[electronic resource] ] : 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
| Preserving public trust [[electronic resource] ] : 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 |
| Pubbl/distr/stampa | Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 |
| 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 |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-18484-1
9786610184842 0-309-56991-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456455603321 |
| Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Preserving public trust [[electronic resource] ] : 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
| Preserving public trust [[electronic resource] ] : 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 |
| Pubbl/distr/stampa | Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 |
| 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 |
| ISBN |
0-309-17109-1
1-280-18484-1 9786610184842 0-309-56991-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910780005203321 |
| Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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
| 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 |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 |
| 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 |
| ISBN |
9786610184842
9780309171090 0309171091 9781280184840 1280184841 9780309569910 0309569915 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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. |
| Record Nr. | UNINA-9910962759203321 |
| Washington, D.C. ; ; [Great Britain], : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
