Ethics Involved in Simulation-Based Medical Planning
Tongen, Anthony L., Adam, Mary B., Ethics & Medicine
Computational biology, including simulation and modeling, is a burgeoning field with a recent influx of mathematicians, computer scientists, and engineers. With this recruitment, significant advancement has been made in numerous biological areas. However, as is the case in almost any rapidly evolving field, innovation can move beyond ethical considerations. We discuss one specific example of a simulation-based model that impacts surgical decision making on human patients. We then discuss a recent code of ethics for simulationists and its inadequacy in addressing issues relating to human subjects research. Finally, we recommend a system of validations for computational simulations involved in research applied to human subjects.
With the fairly recent influx of data in the areas of biology and genetics, there has been enormous growth in the field of computational biology and genomics. The National Institute of Health has promoted this growth by opening major avenues of funding to disciplines like mathematics, computer science, and engineering to augment the already well established field of computational biology. With the influx of researchers, much progress is being made as they collaborate to answer questions about human disease processes. However, in some cases ethical considerations become a background rather than a foreground issue.
First, we will discuss and define computational biology; this will lead to our focus on simulation-based medical planning. We will then discuss a fairly recent code of ethics for simulationists, which is intended to address general ethical questions for those involved in simulation. Finally, we will make suggestions of a verification procedure for those interested in computational simulations that apply to human subjects.
Computational Biology and Simulation
Computational biology is an emerging field of research for both biologists and non-biologists and includes areas such as anthropology, genomics, physiology, ecology, and evolutionary biology. Computational biology encompasses all areas of biology where computational modeling and simulation are used. In this arena of research, simulations are goal-driven experiments with models that vary in time;1 and simulationists are professionals who are involved in these modeling activities.2 Simulationists develop computational models and use these models to study and predict the behavior of physical systems. This focus on simulation and modeling has resulted in an influx of mathematics and mathematicians into the biological sciences. A good illustration of the influx of mathematicians into the area of computational biology is the work of James Keener and James Sneyd. They wrote a book in 1998 titled Mathematical Physiology.3 This work exemplifies the tremendous diversity in computational biology. We would like to specifically examine one application of computational biology that relates to research on clinical decision-making in human subjects.
The application of computational biology to clinical decision-making in human subjects is in need of a more reflective process. Simulationists may be familiar with modeling applications that involve human physiology; however, their experience with research that directly involves human subjects may be limited. Also, while many human physiological systems are understood as mechanistic processes, humans cannot be reduced to mechanistic processes alone. Simulationists often collaborate with experts in other fields, i.e. physicians, utilizing their mathematical and programming expertise to answer important clinical questions. In these situations, simulationists may rely on physicians to deal with the ethical considerations in the interdisciplinary research involving human subjects. However, as the research advances and the mathematical and programming aspects of the simulation move beyond most physicians' abilities to assess correct methodology, it becomes important for simulationists to consider ethical issues in human subject research. …