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.
Зміст
Historical Perspective of Surgical Innovation.- Examples of Innovation by Surgeons: Percutaneous Endoscopic Gastrostomy and Its Ethical Implications.- Examples of Innovation by Surgeons: Endoscopic Variceal Ligation.- Examples of Surgical Innovation by Surgeons: Natural Orifice Transluminal Endoscopic Surgery.- Managing Conflict of Interest.- The FDA/CDRH Perspective on Device Innovation.- The FDA and Surgical Innovation.- Getting an Idea from Paper to Patient.- How and Why Work with an Industry Partner.- Status and Impact of Evolving Medical Device Venture Capital Landscape on Innovation.- Corporate Perspective in Surgical Innovation Ethics: A Literature Review.- Innovations in Surgery: Responsibilities and Ethical Considerations.- Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics.- Training and Credentialing in New Technologies.- Informed Consent and Surgical Innovation.- Semantics and Patient Perceptions of New Technologies.- Tracking Outcomes of New Technologies.- Balancing the Surgeon’s Responsibility to Individuals and Society.- Paying for New Technology: Insurance Company Perspective.- Evolving Responsibility for SAGES-TAVAC.- Evolving Responsibility for SAGES: New Technology Guideline.- Training Physicians in Innovation.- Fundamentals of Medical Ethics.- The Use of Randomized Clinical Trials in the Evaluation of Innovative Therapy
Про автора
Steven Stain, MD, Department of Surgery
Albany Medical Center,
Albany, NY, USA
Aurora Pryor, MD
Division of Bariatric, Foregut and Advanced Gastrointestinal Surgery. Department of Surgery. Stony Brook University Medical Center.
Stony Brook, NY, USA
Phillip P. Shadduck, MD, FACS
Department of Surgery, Triangle Orthopaedic Associates
Plaza, Durham, NC, USA
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