|
- Covers ethical issues that are applicable to any discussion of innovative medical or procedural therapies
- Written by experts in the field
- Provides a perspective of SAGES role in 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 insurance 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. Table of ContentsForeword Preface - 1. Historical Perspective of Surgical Innovation
John G. Hunter - 2. Examples of Innovation by Surgeons: Percutaneous
Endoscopic Gastrostomy and Its Ethical Implications
Jeffrey L. Ponsky and John H. Rodriguez - 3. Examples of Innovation by Surgeons: Endoscopic Variceal Ligation
Gregory Van Stiegmann - 4. Examples of Surgical Innovation by Surgeons: Natural Orifice Transluminal Endoscopic Surgery
Peter Nau and David W. Rattner - 5. Managing Conflict of Interest
David W. Easter and Tazo Inui - 6. The FDA/CDRH Perspective on Device Innovation
Herbert Lerner and Martha W. Betz - 7. The FDA and Surgical Innovation
S. D. Schwaitzberg and C. J. Schwaitzberg - 8. Getting an Idea from Paper to Patient
Raymond P. Onders - 9. How and Why Work with an Industry Partner?
Maria S. Altieri,Caitlin Halbert, and Aurora Pryor - 10. Status and Impact
of Evolving Medical Device Venture Capital Landscape on Innovation
Richard S. Stack,William N. Starling, Mudit Jain, and James Melton - 11. Corporate Perspective in Surgical Innovation Ethics: A Literature Review
Myriam J. Curet - 12. Innovations in Surgery: Responsibilities and Ethical Considerations
- Lee L. Swanström
- 13. Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics
Jeffrey Ustin and Jeffrey L. Ponsky - 14. Training and Credentialing in New Technologies
Meredith Duke and Timothy Farrell - 15. Informed Consent and Surgical Innovation
Lelan F. Sillin, Arthur L. Rawlings, and Phillip P. Shadduck - 16.Semantics and Patient Perceptions of New Technologies
David R. Urbach - 17 Tracking Outcomes of New Technologies
Rizwan Ahmed, Chady Atallah, and Anne O. Lidor - 18. Balancing the Surgeon's Responsibility to Individuals and Society
Bruce D. White and Luke C. Gelinas - 19. Paying for New Technology: Insurance Company Perspective
Donna Stewart and Richard Dal Col - 20. Evolving Responsibility for SAGES-TAVAC
Crystal M. Krause and Dmitry Oleynikov - 21. Evolving Responsibility for SAGES: New Technology Guideline
Robert D. Fanelli - 22. Training Physicians in Innovation
Dan Azagury, James Wall, Anji Wall, and Thomas Krummel - 23.Fundamentals of Medical Ethics
Arthur Rawlings - 24. The Use of Randomized Clinical Trials in the Evaluation of Innovative Therapy
Juliane Bingener
Index
|
