This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasseslegal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for InstitutionalReview Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfallsencountered in medical research. INDICE: PrefaceChapter One: Research Malpractice & NegligenceChapter Two: Duty of Care: Understanding the LegalDifferences Between Medical Treatmentand Medical ResearchChapter Three: Establishing Standard of Care & Violation of Standard of CareChapter Four: Informed Consent in Clinical ResearchChapter Five: Liability Issues for Institutional ReviewBoards (IRB’s) and Data Safety Monitoring Boards (DSMB’s)Chapter Six: Legal Aspects of Financial Conflicts of Interest in Clinical TrialsChapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study ResultsChapter Eight: Clinical Trials & Insider TradingChapter Nine: Clinical Trials and Criminal LawChapter Ten: Clinical Trial ContractsAppendix A GlossaryAppendix B NIH Policy on Inclusion of Children as Participants in Research Involving Human SubjectsAppendix C Best Pharmaceuticals for Children Actp>Appendix D Pediatric Research Equity Act 2003Appendix E Code of Federal Regulations Title 21Appendix F NCI model contractAppendix G Conflicts of InterestIndex
- ISBN: 978-1-4051-9567-6
- Editorial: Wiley-Blackwell
- Encuadernacion: Rústica
- Páginas: 280
- Fecha Publicación: 20/04/2012
- Nº Volúmenes: 1
- Idioma: Inglés