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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|
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 | ||
|