Main description:

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.

Contents:

Foreword

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. Swanstroem <

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