Contemporary issues for protecting patients in cancer research workshop summary
"In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archiv...
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| Autores Corporativos: | , |
| Otros Autores: | , , |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Washington, District of Columbia :
National Academies Press
2014.
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| Edición: | 1st ed |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820311706719 |
Tabla de Contenidos:
- Introduction
- Current regulatory arena
- Common rule and HIPAA
- Shortcomings of current regulations and guidances
- Context
- Data deindentification
- Impediment to quality improvement and learning
- Varied interpretation
- Misaligned incentives
- Lack of harmonization with international standards
- Informed consent forms
- Informed consent process
- Consent tools
- Beyond consent
- HITECH
- Advanced notice of proposed rulemaking
- Patient perspectives on research protections
- Ethical challenges of genetic advances
- Patient consent for use of archived biospecimens
- Return of research results
- Clinically actionable findings
- Context matters
- Who pays
- Biospecimens from deceased participants
- The changing context of research and care
- Oversight in a learning health care system
- Oversight of pragmatic trials
- Multisite studies and IRB review
- Central IRBs
- New England Reliance Agreement
- Value of local IRBs
- Educational needs
- Research needs
- Wrap-up.
