E-grāmata: SAGES Manual Ethics of Surgical Innovation

This text provides a comprehensive review of the ethical issues involved with the development, evaluation, and introduction of new treatments of gastrointestinal diseases. How several landmark surgical innovations were developed are described to show the challenges faced, and the ethical dilemmas these innovators dealt with. The challenges of dealing with regulatory issues, and how to work with industry partners, and investors when working on a new therapy is described. Once a new technology has been brought to the market, standards need to be developed regarding the training, credentialing and adoption of the new technology. There are insufficient standards of how to balance the desire to provide patients the latest therapy with the obligation that patients receive informed consent about the new technology, and the relationship that the physician may have had with product development. The book describes the national perspective of paying for new technology, and provides one insur

ance company"s approach to the introduction of innovative therapy.  The Sages Manual Ethics of Surgical Innovation will be a resource for surgeons, researchers and health policy personnel to understand the ethical issues related to the development, introduction and adoption of innovative therapies for gastrointestinal diseases. Although the context for discussion is the application of innovation to gastrointestinal disease, the ethical issues are applicable to any discussion of innovative medical or procedural therapies.

ForewordPreface1. HistoricalPerspective of Surgical InnovationJohn G. Hunter2. Examples ofInnovation by Surgeons: PercutaneousEndoscopic Gastrostomy and Its Ethical ImplicationsJeffrey L. Ponsky andJohn H. Rodriguez3. Examples of Innovation bySurgeons: Endoscopic Variceal LigationGregory Van Stiegmann4. Examples of Surgical Innovation bySurgeons: Natural OrificeTransluminal Endoscopic SurgeryPeter Nau and David W.Rattner5. Managing Conflict ofInterestDavid W. Easter andTazo Inui6. The FDA/CDRHPerspective on Device InnovationHerbert Lerner andMartha W. Betz7. The FDA and Surgical InnovationS. D. Schwaitzberg and C. J. Schwaitzberg8. Getting an Idea from Paper to PatientRaymond P. Onders 9. How and Why Workwith an Industry Partner?Maria S. Altieri,Caitlin Halbert, and Aurora Pryor10. Status and Impactof Evolving Medical Device Venture Capital Landscape on InnovationRichard S. Stack,William N. Starling, Mudit Jain, and James M

elton11. CorporatePerspective in Surgical Innovation Ethics: A Literature ReviewMyriamJ. Curet12. Innovations in Surgery:Responsibilities and Ethical ConsiderationsLee L. Swanström 13. Device Developmentfor the Innovative Clinician:Intellectual Property and Regulatory BasicsJeffreyUstin and Jeffrey L. Ponsky14.Training and Credentialing in New TechnologiesMeredith Duke and Timothy Farrell15. Informed Consentand Surgical InnovationLelan F. Sillin, ArthurL. Rawlings, and Phillip P. Shadduck16.Semantics and Patient Perceptions of New TechnologiesDavidR. Urbach17 TrackingOutcomes of New TechnologiesRizwan Ahmed, ChadyAtallah, and Anne O. Lidor18. Balancing the Surgeon"s Responsibility to Individuals and SocietyBruce D. Whiteand Luke C. Gelinas19. Paying for NewTechnology: Insurance Company PerspectiveDonnaStewart and Richard Dal Col20. Evolving Responsibility for SAGES-TAVACCrystal M.Krause and Dmitry Oleynikov21. Evolving Resp

onsibility for SAGES: New TechnologyGuidelineRobertD. Fanelli22. Training Physicians in InnovationDan Azagury, James Wall, Anji Wall, andThomas Krummel 23.Fundamentals of Medical EthicsArthurRawlings24. The Use ofRandomized Clinical Trials in the Evaluation of Innovative TherapyJulianeBingenerIndex