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Clinical research and the law [[electronic resource] /] / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr
Clinical research and the law [[electronic resource] /] / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr
Autore Tereskerz Patricia M
Pubbl/distr/stampa Chichester, West Sussex, : John Wiley & Sons, 2012
Descrizione fisica 1 online resource (282 p.)
Disciplina 344.04/196
Altri autori (Persone) EdelmanRobert <1936->
McKinneyRoss
Soggetto topico Biology - Research - Law and legislation - United States
Medicine - Research - Law and legislation - United States
Clinical trials - Law and legislation - United States
Human experimentation in medicine - Law and legislation - United States
ISBN 1-299-31371-X
1-118-27216-1
1-118-27215-3
1-118-27218-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Research malpractice & negligence -- Duty of care : understanding the legal differences between medical treatment and medical research -- Establishing standard of care & violation of standard of care -- Informed consent in clinical research -- Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs) -- Legal aspects of financial conflicts of interest in clinical trials -- Disclosure of clinical trial information : legal ramifications of withholding study results -- Clinical trials & insider trading -- Clinical trials and criminal law -- Clinical trial contracts.
Record Nr. UNINA-9910141270803321
Tereskerz Patricia M  
Chichester, West Sussex, : John Wiley & Sons, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical research and the law [[electronic resource] /] / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr
Clinical research and the law [[electronic resource] /] / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr
Autore Tereskerz Patricia M
Edizione [1st ed.]
Pubbl/distr/stampa Chichester, West Sussex, : John Wiley & Sons, 2012
Descrizione fisica 1 online resource (282 p.)
Disciplina 344.04/196
Altri autori (Persone) EdelmanRobert <1936->
McKinneyRoss
Soggetto topico Biology - Research - Law and legislation - United States
Medicine - Research - Law and legislation - United States
Clinical trials - Law and legislation - United States
Human experimentation in medicine - Law and legislation - United States
ISBN 1-299-31371-X
1-118-27216-1
1-118-27215-3
1-118-27218-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Research malpractice & negligence -- Duty of care : understanding the legal differences between medical treatment and medical research -- Establishing standard of care & violation of standard of care -- Informed consent in clinical research -- Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs) -- Legal aspects of financial conflicts of interest in clinical trials -- Disclosure of clinical trial information : legal ramifications of withholding study results -- Clinical trials & insider trading -- Clinical trials and criminal law -- Clinical trial contracts.
Record Nr. UNINA-9910817238103321
Tereskerz Patricia M  
Chichester, West Sussex, : John Wiley & Sons, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Experimenting with the consumer [[electronic resource] ] : the mass testing of risky products on the American public / / Marshall S. Shapo
Experimenting with the consumer [[electronic resource] ] : the mass testing of risky products on the American public / / Marshall S. Shapo
Autore Shapo Marshall S. <1936->
Pubbl/distr/stampa Westport, Conn., : Praeger, 2009
Descrizione fisica 1 online resource (302 p.)
Disciplina 346.7303/8
Collana Non-Series
Soggetto topico Products liability - United States
Technological innovations - Law and legislation - United States
Human experimentation in medicine - Law and legislation - United States
Soggetto genere / forma Electronic books.
ISBN 1-282-33378-X
9786612333781
0-313-36528-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Experimentation : a survey at trench level -- HIV/AIDS drugs : speeding up science under political pressure -- Breast implants : a parable of law's response to improvements on nature -- Treating thyself with drugs - for men only : the saga of Viagra -- Estrogens : a gathering of data, a gathering storm -- Estrogens - the storm breaks : a struggle of medicine, law, and politics -- Experiments at the billionth level : nanotechnology.
Record Nr. UNINA-9910455410503321
Shapo Marshall S. <1936->  
Westport, Conn., : Praeger, 2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Experimenting with the consumer [[electronic resource] ] : the mass testing of risky products on the American public / / Marshall S. Shapo
Experimenting with the consumer [[electronic resource] ] : the mass testing of risky products on the American public / / Marshall S. Shapo
Autore Shapo Marshall S. <1936->
Pubbl/distr/stampa Westport, Conn. : , : Praeger Publishers, , 2008
Descrizione fisica 1 online resource (302 p.)
Disciplina 346.7303/8
Collana Non-Series
Soggetto topico Human experimentation in medicine - Law and legislation - United States
Products liability - United States
Technological innovations - Law and legislation - United States
ISBN 979-84-00-64901-1
1-282-33378-X
9786612333781
0-313-36528-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Experimentation : a survey at trench level -- HIV/AIDS drugs : speeding up science, under political pressure -- Breast implants : a parable of law's response to improvements on nature -- Treating thyself-for men only : viagra -- Estrogens : a gathering of data, a gathering storm -- Estrogens, the storm breaks : a struggle of medicine, law, and politics -- Experiments at the billionth level : nanotechnology.
Record Nr. UNINA-9910778489703321
Shapo Marshall S. <1936->  
Westport, Conn. : , : Praeger Publishers, , 2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Experimenting with the consumer : the mass testing of risky products on the American public / / Marshall S. Shapo
Experimenting with the consumer : the mass testing of risky products on the American public / / Marshall S. Shapo
Autore Shapo Marshall S. <1936->
Edizione [1st ed.]
Pubbl/distr/stampa Westport, Conn. : , : Praeger Publishers, , 2008
Descrizione fisica 1 online resource (302 p.)
Disciplina 346.7303/8
Collana Non-Series
Soggetto topico Human experimentation in medicine - Law and legislation - United States
Products liability - United States
Technological innovations - Law and legislation - United States
ISBN 979-84-00-64901-1
1-282-33378-X
9786612333781
0-313-36528-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Experimentation : a survey at trench level -- HIV/AIDS drugs : speeding up science, under political pressure -- Breast implants : a parable of law's response to improvements on nature -- Treating thyself-for men only : viagra -- Estrogens : a gathering of data, a gathering storm -- Estrogens, the storm breaks : a struggle of medicine, law, and politics -- Experiments at the billionth level : nanotechnology.
Record Nr. UNINA-9910812876903321
Shapo Marshall S. <1936->  
Westport, Conn. : , : Praeger Publishers, , 2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2013]
Descrizione fisica 1 online resource (111 p.)
Disciplina 344.73041
Soggetto topico Social sciences - Moral and ethical aspects
Human experimentation in medicine - Law and legislation - United States
Soggetto genere / forma Electronic books.
ISBN 0-309-28824-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Session 1: Review of the Evidence -- Session 2: Risks and Harms -- Session 3: The Consent Process and Special Populations -- Session 4: Data Use and Sharing and Technological Advancements -- Session 5: Multisite and Multidisciplinary Studies -- Session 6: Purview and Roles of Institutional Review Boards -- Appendix A: Workshop Agenda -- Appendix B: Biographical Sketches of Speakers.
Record Nr. UNINA-9910464418603321
Washington, District of Columbia : , : The National Academies Press, , [2013]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2013]
Descrizione fisica 1 online resource (111 p.)
Disciplina 344.73041
Soggetto topico Social sciences - Moral and ethical aspects
Human experimentation in medicine - Law and legislation - United States
ISBN 0-309-28826-6
0-309-28824-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Session 1: Review of the Evidence -- Session 2: Risks and Harms -- Session 3: The Consent Process and Special Populations -- Session 4: Data Use and Sharing and Technological Advancements -- Session 5: Multisite and Multidisciplinary Studies -- Session 6: Purview and Roles of Institutional Review Boards -- Appendix A: Workshop Agenda -- Appendix B: Biographical Sketches of Speakers.
Record Nr. UNINA-9910789236103321
Washington, District of Columbia : , : The National Academies Press, , [2013]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Proposed revisions to the common rule : perspectives of social and behavioral scientists / / Robert Pool, rapporteur ; Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2013]
Descrizione fisica 1 online resource (111 p.)
Disciplina 344.73041
Soggetto topico Social sciences - Moral and ethical aspects
Human experimentation in medicine - Law and legislation - United States
ISBN 0-309-28826-6
0-309-28824-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Session 1: Review of the Evidence -- Session 2: Risks and Harms -- Session 3: The Consent Process and Special Populations -- Session 4: Data Use and Sharing and Technological Advancements -- Session 5: Multisite and Multidisciplinary Studies -- Session 6: Purview and Roles of Institutional Review Boards -- Appendix A: Workshop Agenda -- Appendix B: Biographical Sketches of Speakers.
Record Nr. UNINA-9910819187603321
Washington, District of Columbia : , : The National Academies Press, , [2013]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Regulating human research : IRBs from peer review to compliance bureaucracy / / Sarah Babb
Regulating human research : IRBs from peer review to compliance bureaucracy / / Sarah Babb
Autore Babb Sarah L.
Pubbl/distr/stampa Stanford, California : , : Stanford University Press, , 2020
Descrizione fisica 1 online resource (185 pages)
Disciplina 174.28
Soggetto topico Institutional review boards (Medicine) - United States
Human experimentation in medicine - Law and legislation - United States
Medical ethics committees - United States
Bureaucracy - United States
Soggetto non controllato Institutional Review Boards (IRBs)
bureaucracy
compliance
delegated governance
organizations
professions
regulation
work
ISBN 1-5036-1123-X
Classificazione AK 24400
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Frontmatter -- Contents -- Acknowledgments -- Introduction -- 1. The federal crackdown and the twilight of approximate compliance -- 2. Leaving it to the professionals -- 3. Organizing for efficiency -- 4. Ethics review, inc. -- 5. The common rule and social research -- 6. Varieties of compliance -- Conclusion -- Appendix: research informants -- Notes -- Bibliography -- Index
Record Nr. UNINA-9910795111703321
Babb Sarah L.  
Stanford, California : , : Stanford University Press, , 2020
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Regulating human research : IRBs from peer review to compliance bureaucracy / / Sarah Babb
Regulating human research : IRBs from peer review to compliance bureaucracy / / Sarah Babb
Autore Babb Sarah L.
Pubbl/distr/stampa Stanford, California : , : Stanford University Press, , 2020
Descrizione fisica 1 online resource (185 pages)
Disciplina 174.28
Soggetto topico Institutional review boards (Medicine) - United States
Human experimentation in medicine - Law and legislation - United States
Medical ethics committees - United States
Bureaucracy - United States
Soggetto non controllato Institutional Review Boards (IRBs)
bureaucracy
compliance
delegated governance
organizations
professions
regulation
work
ISBN 1-5036-1123-X
Classificazione AK 24400
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Frontmatter -- Contents -- Acknowledgments -- Introduction -- 1. The federal crackdown and the twilight of approximate compliance -- 2. Leaving it to the professionals -- 3. Organizing for efficiency -- 4. Ethics review, inc. -- 5. The common rule and social research -- 6. Varieties of compliance -- Conclusion -- Appendix: research informants -- Notes -- Bibliography -- Index
Record Nr. UNINA-9910808712303321
Babb Sarah L.  
Stanford, California : , : Stanford University Press, , 2020
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui