Ethical Issues in Surgical Innovation
By Peter Angelos, MD, PhD, FACS
Introduction
Anyone who pays attention to slogans cannot have missed the way in which innovation is marketed in contemporary society. Most medical institutions refer to themselves as being “innovative” and possessing the latest in “modern technology.” If one turns specifically to surgical practices or departments, the benefits of surgical innovation are widely touted. Most new things are thought to be better. Frequently a new surgical technique is described as a “surgical advance” before there is any data to suggest that it is better for patients. This blind acceptance of the benefits of surgical innovation by the public has prompted self-examination about whether new is always better in surgery.
If one explores the historical record, one sees many examples of changes in surgical practice that all would agree are beneficial to patients. Forty years ago a patient with a diverticular abscess might have been given a three-stage procedure: first, diverting colostomy; second, resection of the affected segment of colon; and third, colostomy take down. Today, many such patients would be treated with percutaneous drainage and eventually a single stage procedure to resect the affected colon. Most would argue that this change and many others have clearly been beneficial to patients.
However, there are other examples of changes in surgical practice that have not proven beneficial to patients. For example, internal mammary artery ligation was advocated by many authorities for years as a treatment of angina. After many patients had been treated this way, it eventually became clear that this was not an effective treatment. In the 1950s and 1960s, many surgeons advocated gastric freezing as a means to treat ulcer disease. Again, eventually evidence showed that this treatment modality was not effective and, in fact, created a number of problems.
What these good and bad results of purported surgical “innovations” suggests is that just because a procedure is new, does not mean it is better. In contrast to new drugs that require approval from the Food and Drug Administration (FDA) based on studies to prove effectiveness, surgeons are allowed significant latitude in the operating room in an attempt to benefit their patient. In fact, there has traditionally been little or no oversight of innovation by surgeons in the operating room. Whether this is a good thing or not depends on how one looks at the current situation. If one sees freedom by surgeons to innovate as a good thing, any restrictions on surgical innovation would be seen as impediments to allowing patients access to the maximal creativity of their surgeons to solve their patients’ problems. In contrast, if one sees such freedom as a bad thing, then the lack of oversight of surgical innovation means that vulnerable patients have little protection from overzealous surgeons. In other words, should we be encouraging more new technology and innovation to help more patients or should we be protecting patients from the unbridled enthusiasm of surgical innovators?
The Regulatory Paradigm and the Innovation Paradigm
For some commentators, the freedom of surgical innovation can best be tempered by the strict oversight that is the hallmark of human subjects’ research. According to this view, ensuring that all surgical innovation is considered to be surgical research that requires review and approval by an Institutional Review Board (IRB) would best protect patients. This position has been described by MacKneally and Daar as the regulatory ethics paradigm.1 This paradigm involves formal rigorous review and oversight by the IRB. Alternatively, an innovation ethics paradigm would be an informal process with little oversight.1
The biggest problem with the regulatory ethics paradigm is that it depends on formal IRB review based on Federal regulations for human subjects’ research. This approach, although potentially valuable as a means of protecting vulnerable human subjects, is too cumbersome to be helpful in the context of surgical innovation where creative and innovative ideas may need to be rapidly considered and acted upon in order to benefit a specific patient. As a result, if all surgical innovation required IRB review and approval before being made available to a patient, the pace of surgical innovation would likely draw to a virtual halt.
The SUS Position Paper
In an attempt to be sensitive to the need for speed and flexibility when reviewing surgical innovation, another potential solution has been suggested by the Society for University Surgeons (SUS). In an attempt to provide meaningful oversight, but not significantly slow the pace of surgical innovation, a taskforce on surgical innovation was empanelled by the SUS. This group recently published their findings in the journal of the American College of Surgeons.2
Three distinctions were made about potentially new and different procedures. Minor modifications of previously accepted procedures are thought to be completely within the purview of the surgeon. There is no need for disclosure of such minor modifications, nor is there need to obtain informed consent from the patient. An example of such a minor modification would be a surgeon’s decisions about whether to perform a stapled or hand-sewn anastomosis. An innovative procedure is a new or modified procedure that differs from currently accepted local practice. Innovative procedures should be discussed ahead of time with patients if they are planned or immediately afterwards if they are unplanned. Finally, research is a systematic investigation that is designed to contribute to generalizable knowledge. When research is undertaken, the specific regulations for IRB performance hold sway.
Surgical Innovation Committees
In an attempt to avoid the potential problems with utilizing IRBs for the oversight of all surgical innovation, the SUS Taskforce suggested that surgical departments put together Surgical Innovation Committees to review applications for innovative surgery. One could imagine that these surgical innovation committees would be within departments of surgery, but various potential options for the positioning of the committee are possible. Such a surgical innovation committees could be freestanding committees or function as credentialing committees within an institution.
Yet another option that has been adopted by the University of Chicago has been to locate the Surgical Innovation Committee within the structure of the Surgical Quality Committee. This option allows the deliberations of the committee to be protected and gives the committee the opportunity to undertake retrospective review of prior cases of surgical innovation. In this fashion, a rational approach to prospective surgical innovations can be developed.
1. McKneally MF, Daar AS. Introducing new technologies: protecting subjects of surgical innovation and research. World Journal of Surgery 2003; 27(8):930-4; discussion 934-5.
2. Biffl WL, Spain DA, Reitsma AM, et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. Journal of the American College of Surgeons 2008; 206(3):1204-9.
Peter Angelos, MD, PhD, FACS, is professor and chief of endocrine surgery and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.