A recent issue of IEEE Pulse (March/April 2015) featured an article by Shannon Fischer entitled “Inside Tract: Can Deep Brain Stimulation Survive Its Reputation for Success?” Deep brain stimulation (DBS) has been a well-accepted therapeutic intervention for Parkinson’s disease for many years. Recently, it has found acceptable considerations in many other applications including mental health disorders, weight control, and more.
What sort of ethical considerations do these and other applications imply and what are the implications for biomedical applications and for the biomedical engineering community in general? What are our responsibilities, and for that matter, what level of involvement should we have in the implications of how such devices impact society? Are there times in history when devices of this sort had an impact on other societies? Let’s take a look from a historical prospective.
Dating back to the 18th century, physicians, scientists and researchers were basically their own subjects. In the 19th and early 20th century, research subjects often were patients on a ward or prisoners. The benefits of research were mostly for private patients and not the subjects. But by the mid-20th century the Nazi war crimes changed the entire fabric of research investigations.
There was a Nazi doctor named Mengele who was obsessed with twins and wanted to study their blood, their body, their iris coloration, their hair color, etc. In a scene from a Frankenstein movie, he rounded up 14 pairs of Romani child twins, killed them, and went about dissecting them to investigate their nature.
During the Nuremberg war crimes trials, 23 German doctors were charged with crimes against humanity for performing medical experiments on concentration camp inmates and other living subjects without their consent. During those experiments, the doctors committed murders, brutalities, cruelties, torture, atrocities, and other inhuman acts. From those gruesome days, we developed the Nuremberg code in 1947, which provided very specific rules for medical experiments including voluntary consent, understanding the benefits with respect to the risks, and the ability of the subject to terminate their participation.
Such behavior was not exclusive to men of the Nazi regime. From 1932 through 1972, the United States Public Health Service together with the Tuskegee Institute, studied the natural course of untreated syphilis in black American men. These impoverished share croppers from Alabama were basically unknowing participants in a study. The men were not told they had syphilis, nor were they offered any effective treatment. When the study was finally published, there was a public outcry that made the front page of The New York Times and resulted in a class action suit by the NAACP. It wasn’t until 1997 that President Clinton finally apologized to the living subjects and families on behalf of this nation.
These two seminal events ultimately gave rise to the National Research Act of 1974, culminating in the Belmont Report of 1979, which has given us the standards and the ethical background for today’s modern research. These documents define our ethical responsibilities and behavior if we are to advance science with human clinical research.
Clearly, an ethical researcher’s first priority is to evaluate how our participants are treated. Such treatment must be reviewed by approved boards, such as Institutional Review Boards (IRB), and also have external peer reviews. Even if the study involves animals, there are extensive controls and guidelines to be followed. Most importantly, the risk/benefit ratio must be evaluated with no lasting harm as the hallmark before even considering bypassing that analysis.
So when we look at deep brain stimulation and everything that could come of it, we are forced to look at it in the context of ethical behavior and how it impacts our role as educators, scientists, and researchers. Just because a procedure may have been approved for a particular pathology (e.g., DBS for Parkinson’s), does not necessarily mean that it is automatically approved for every other consideration and application. We as biomedical engineers and most importantly, as compassionate human beings, need to be aware of the ethical oversight that must be applied to everyone in our efforts.
I cordially invite readers to submit for consideration ethical issues or dilemmas that they have been faced with. All specific names and identifying details will be neutralized before publication. We are eager to hear your thoughts on these matters in general. Please send your thoughts and comments to Ethics@pulse.embs.org.