Book Review

Innovation in Medical Technology: Ethical Issues and Challenges

N Engl J Med 2007; 357:1456-1457October 4, 2007

Article

Innovation in Medical Technology: Ethical Issues and Challenges
By Margaret L. Eaton and Donald Kennedy. 155 pp. Baltimore, Johns Hopkins University Press, 2007. $35. ISBN: 978-0-8018-8526-6

After publication of the Belmont Report in 1978, it became common to distinguish research, in which human subjects receive the full set of protections provided by the U.S. Common Rule (45 CFR 46), from innovative medical care, in which they do not. This distinction faces two major difficulties: it relies on a sharp differentiation between research and innovative medical care without a proper basis for drawing it, and it does not address the question of what sort of protections are appropriate for patients who receive innovative medical care. This book represents the thinking of a group that was convened by the Lasker Foundation to develop a more nuanced approach. It is a major step forward, even though it leaves important issues for further consideration.

The theme of the book is innovation. The authors recognize that innovations can sometimes be appropriately introduced in clinical practice settings, whereas on other occasions they are best introduced in formal research settings. Examples of each scenario are provided in chapters 3 through 6, in four contexts: the off-label use of drugs, surgery, assisted reproduction, and neuroimaging. These examples are also used to establish the point that “the existing binary choice between research and practice is probably too constraining” and that it is best to think of medical innovation as an in-between category that requires some oversight but not the formal institutional review board system. The authors pose several crucial questions in chapter 7: What are the thresholds and models for oversight? What information should be disclosed to patients? Is there a professional duty to learn and to educate other practitioners? Eaton and Kennedy provide guidelines in response to each question.

The crucial issue is whether these guidelines are sufficient. Consider, for example, the authors' most developed guidelines — those regarding the disclosure of information to patients. After considering and rejecting a more paternalistic approach, they suggest that the patient should receive a description of the nonstandard portion of the treatment and its risks, benefits, and alternatives, as well as all available data and information about conflicts of interest. These constitute most of the requirements in the Common Rule on research consent, but confidentiality, compensation for harms incurred, and voluntariness of participation are left out. It is hard to imagine opposition to adding those points. The authors also allude to the “reasonable patient” standard that is often used in discussions of consent in the clinical practice setting. They seem to have dealt with the in-between case of innovative therapy by combining the disclosure requirements for research and clinical practice. Only oversight of the consent process by the institutional review board is left out, and that may be one of the appropriate tasks for the oversight mechanism that the authors suggest. It is not clear what would be gained if their new guidelines were adopted.

Eaton and Kennedy are surely right that we need to explicitly recognize the in-between category of innovative research. They have also raised the right questions about that category. But more discussion is needed about how to deal with the questions they pose.

Baruch A. Brody, Ph.D.
Baylor College of Medicine, Houston, TX 77030