Ethical Guidelines for Innovative Surgery

Edited by Angelique Reitsma, MD, and Jonathan Moreno, PhD

2006. 276 pages. ISBN 1-55572-043-9.

$34.99 plus $4.75 S&H. Please ask about instructors' discounts.

Reviews

The authors and their colleagues have brought to attention and classified the clinically relevant moral and

ethical issues that are inherent in performing innovative surgical procedures. . . . Each chapter addresses

the daily dilemmas that the practicing surgeon needs to be cognizant. . . . the factors that ultimately

confront the surgeon when deciding what is best for the patient. This is a very thoughtful and compelling

presentation that needs to be read in order to raise the awareness of just how innovative surgical practice

has become and the many ethical issues that underlie the decisions that are made every day.
— Richard M. Satava, MD, FACS
Professor, University of Washington Department of Surgery

As a spinal surgeon involved across the spectrum of surgical innovation, I found Ethical Guidelines

for Surgical Innovation fascinating. The treatise brings into sharp focus the constellation of ethical

decisions we, as surgeons, bump up against and involve ourselves with on a daily basis….

While the answers to these questions are not always clear cut, as the text demonstrates, putting

the patient’s well-being first should help guide us to appropriate ethical behavior. I thank the editors

and authors for helping me to think about these issues and for raising issues important to

every surgeon and scientist in a concise and very readable format.

— Todd J. Albert, MD
Professor and Vice Chairman, Department of Orthopaedic Surgery
Professor of Neurosurgery, Thomas Jefferson University Medical College
The Rothman Institute

Reitsma and Moreno have done medicine, science, surgery, and bioethics an enormous favor with this book.

While much of the contemporary research ethics continues to be captivated by stem cell research,

neuroethics, and nanotechnology (all important topics for debate), these topics become so politicized that the

ethical issues are lost. In contrast, surgical innovation presents an area of study every bit as challenging

but without the rhetoric. This book comprehensively lays out the landscape of ethical issues, from historical

and regulatory perspectives to ongoing gaps in education and training. But it does not stop there —

a set of proposed guidelines has been offered that will be of use to IRBs, surgical educators, investigators,

and patients alike.

 — Eric M. Meslin, PhD
Director, Indiana University Center for Bioethics

Innovative surgery is one of the more controversial political frontiers in modern American medicine:

the issues are complex. Every day, U.S. surgeons modify existing operations, attempting to improve

their technique and outcomes. Many of these procedures — perhaps most of them —

are performed under the heading of therapy, not research, and are without prior IRB approval.

How should surgeons decide if and when they should seek IRB review and patients’ consent?

What principles should guide surgeons in their efforts to improve surgery?
 

To address these questions, the authors conducted a national survey of surgeons; assembling a

multidisciplinary group of leading ethicists, physicians, philosophers,lawyers, and surgeons to

discuss these broad issues and the survey. How does surgical innovation happen, and what

difference does it make for patients, surgeons, and innovation in medicine? What practice

guidelines are necessary for a safer, more ethical, and more efficient means of introducing,

understanding, and guiding innovative surgical techniques?

 

CONTENTS

Foreword
    R. Scott Jones
Introduction
    Angelique M. Reitsma and Jonathan D. Moreno
1. The History of Ethics in Innovative Surgery: A Few Stories, Many Questions
    Paul A. Lombardo
2. Cutting Surgical Practices at the Joints: Individuating and Assessing Surgical Procedures
    Alex John London
3. Standard of Care, Innovation, and Research in Surgery: A Problem in Research Ethics or in Professional Medical Ethics?
    Laurence B. McCullough
4. The Surgeon’s Autonomy: Defining Limits in Therapeutic Decision Making
    James W. Jones
5. The Legal Treatment of Surgical Innovation
    Anna C. Mastroianni and Roger Jansson
6. Ethical Guidelines for Innovative Surgery: Obstacles for Policy Change
    Angelique M. Reitsma
7. It’s Not Easy Wearing Green: The Art of Surgical Innovation and the Science of Clinical Trials
    Charles L. Bosk and Joel E. Frader
8. The Ethics of Innovative Surgery: U.S. Surgeons’ Definitions, Knowledge, and Attitudes
    Angelique M. Reitsma and Jonathan D. Moreno
9. Ethics Guidelines for Innovative Surgery: Recommendations for National Policy
    Angelique M. Reitsma and Jonathan D. Moreno