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Guidance for industry [[electronic resource] ] : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
| Guidance for industry [[electronic resource] ] : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] |
| Descrizione fisica | 1 online resource (unpaged) : forms |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699066103321 |
Human subject research protections : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, second session, May 3, 2000
| Human subject research protections : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, second session, May 3, 2000 |
| Descrizione fisica | 1 online resource (iii, 171 p.) |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Clinical trials - Government policy - United States |
| Soggetto non controllato |
Human experimentation in medicine
Clinical trials Medicine Medical |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Human Subject Research Protections |
| Record Nr. | UNINA-9910689449703321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (recruiting study subjects)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (recruiting study subjects) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698918503321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (screening tests prior to study enrollment)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (screening tests prior to study enrollment) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698913003321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Intentional human dosing studies for EPA regulatory purposes [[electronic resource] ] : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies
| Intentional human dosing studies for EPA regulatory purposes [[electronic resource] ] : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2004 |
| Descrizione fisica | 1 online resource (226 p.) |
| Disciplina | 174.2/8 |
| Soggetto topico |
Human experimentation in medicine - Moral and ethical aspects
Human experimentation in medicine - Government policy - United States Medical ethics Medicine - Research - Moral and ethical aspects |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-17629-6
9786610176298 0-309-53098-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910449772003321 |
| Washington, D.C., : National Academies Press, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Intentional human dosing studies for EPA regulatory purposes [[electronic resource] ] : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies
| Intentional human dosing studies for EPA regulatory purposes [[electronic resource] ] : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2004 |
| Descrizione fisica | 1 online resource (226 p.) |
| Disciplina | 174.2/8 |
| Soggetto topico |
Human experimentation in medicine - Moral and ethical aspects
Human experimentation in medicine - Government policy - United States Medical ethics Medicine - Research - Moral and ethical aspects |
| ISBN |
0-309-16641-1
1-280-17629-6 9786610176298 0-309-53098-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910783067203321 |
| Washington, D.C., : National Academies Press, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Intentional human dosing studies for EPA regulatory purposes : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies
| Intentional human dosing studies for EPA regulatory purposes : scientific and ethical issues / / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2004 |
| Descrizione fisica | 1 online resource (226 p.) |
| Disciplina | 174.2/8 |
| Soggetto topico |
Human experimentation in medicine - Moral and ethical aspects
Human experimentation in medicine - Government policy - United States Medical ethics Medicine - Research - Moral and ethical aspects |
| ISBN |
0-309-16641-1
1-280-17629-6 9786610176298 0-309-53098-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | FrontMatter -- Acknowledgments -- Preface -- Contents -- List of Tables and Boxes -- Acronyms -- Executive Summary and Recommendations -- 1 Introduction and Background -- 2 The Regulatory Framework for Protecting Humans in Research -- 3 Scientific Justification for and Conduct of Intentional Human Dosing Studies -- 4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies -- 5 Ethical Considerations in the Review of Intentional Human Dosing Studies -- 6 Procedures for EPA Review of Intentional Human Dosing Studies -- 7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment -- APPENDIXES -- Appendix A Values and Limitations of Animal Toxicity Data -- Appendix B Pharmacokinetics and Metabolism of Pesticides -- Appendix C Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants -- Appendix D Biographical Sketches of the Members of the Science, Technology, and Law Panel -- Appendix E Meeting Agendas -- Appendix F Combined Registrants List for All Meetings. |
| Record Nr. | UNINA-9910808573603321 |
| Washington, D.C., : National Academies Press, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Protecting human subjects in research : are current safeguards adequate? : hearing before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventh Congress, second session, on examining current safeguards concerning the protection of human subjects in research, while facilitating critical medical research, April 23, 2002
| Protecting human subjects in research : are current safeguards adequate? : hearing before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventh Congress, second session, on examining current safeguards concerning the protection of human subjects in research, while facilitating critical medical research, April 23, 2002 |
| Descrizione fisica | 1 online resource (iii, 53 p.) |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Medicine - Research - Government policy - United States Clinical trials - Government policy - United States |
| Soggetto non controllato |
Human experimentation in medicine
Medicine Clinical trials Medical |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Protecting human subjects in research |
| Record Nr. | UNINA-9910689542903321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
|
Protecting human subjects training
| Protecting human subjects training |
| Pubbl/distr/stampa | [Rockville, Md. : , : Food and Drug Administration, , 2012] |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Human experimentation in medicine - Government policy - United States
Medicine - Research - Government policy - United States Clinical trials - Government policy - United States |
| Soggetto genere / forma |
Internet videos.
Video recordings for the hearing impaired. |
| Formato | Videoregistrazioni  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Module 1: Evolving concern: protection for human subjects -- Module 2: Belmont report: basic ethical principles and their application -- Module 3: Balancing society's mandates: criteria for protocol review. |
| Altri titoli varianti | Human subjects research training, protecting human subjects |
| Record Nr. | UNINA-9910704789103321 |
| [Rockville, Md. : , : Food and Drug Administration, , 2012] | ||
| Videoregistrazioni | ||
| Lo trovi qui: Univ. Federico II | ||
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