Vulnerable Brains: Research Ethics and Neurosurgical Patients

For the sake of transparency, my perspective is deeply influenced by my regular collaboration with neurosurgeons in my job as a clinical bioethicist. Further, although I am a philosopher by training, I also belong to three neurosurgical societies and am a full member of the ethics committee for one of those societies.

The term “treatment” has a potentially dual meaning in this context. First, it means the behavior toward a person. Second, it means attempting to medically cure for a person. This is not intended to be a claim about the efficacy of attempt to cure or ameliorate the medical condition through the research or innovation. Simply it is meant as the appropriate relation to a person.

I fully appreciate the distinctions often drawn between innovation and research. However, the territory of interest in neurosurgery involves that vague intersection and adjoining territory in these concepts. This will be discussed several times throughout the article. New procedures can be procedures that are new techniques, new devices, or new application of procedures or devices.

The term patient is purposely used instead of subject since both the surgeon and person being operated on are hoping, or expecting, a clinical improvement. This use of “patient” is chosen with the full appreciation of the complex discussions that occur regarding “participant” or “subject” in research.

See Baumeister A. A. , “The Tulane Electrical Brain Simulation Program: A Historical Case Study in Medical Ethics,” Journal of the History of the Neurosciences 9, no. 3 (2000): 262–278; Pressman J. D. , Last Resort: Psychosurgery and the Limits of Medicine (New York: Cambridge University Press, 1998).

We will set aside for now the interesting challenge of pharmaceuticals and biologics that use molecular tagging to be attracted to specific cells. That type of technology is an exception to the generalization about pharmaceuticals.

Of course electrical neurostimulators are a hybrid of these two, where there is a minimal damage while affecting only a limited area within the brain.

I draw explicitly on the language of Ken Kipnis used in his seminal article on pediatric research. Given that I draw on the Kipnis article, it might seem a little odd for the paper to explicitly avoid the special considerations of pediatric neurosurgery. However, pediatrics creates another layer of complexity deserving a fuller exploration in itself. See Kipnis K. , “Seven Vulnerabilities in the Pediatric Research Subject,” Theoretical Medicine and Bioethics 24, no. 2 (2003): 107–120.

For instance see Mastroianni A. C. , “Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy,” Health Matrix Cleveland, Ohio 15, no. 2 (2006): 351–442.

See Wiebe S. Jette N. , “Randomized Trials and Collaborative Research in Epilepsy Surgery: Future Directions,” Canadian Journal of Neurological Sciences 33, no. 4 (2006): 365–371.

See Fins J. J. , “From Psychosurgery to Neuromodulation and Palliation: History's Lessons for the Ethical Conduct and Regulation of Neuropsychiatric Research,” Neurosurgery Clinics of North America 14 (2003): 303–319; Ford P. J. Henderson J. M. , “The Clinical and Research Ethics of Neuromodulation,” Neuromodulation 9, no. 4 (2006): 249–252.

For an interesting discussion between surgical and pharmaceutical research see Paradis C. , “Bias in Surgical Research,” Annals of Surgery 248, no. 2 (2008): 180–188.

The two major professional societies, Congress of Neurological Surgeons (CNS) and the American Association of Neurological Surgeons (AANS) both break the subspecialties into the following areas: Spine and peripheral nerves; stereotactic and functional neurosurgery; tumors; pediatric; neurotrauma and critical care; pain; and cerebrovascular. However, for the purposes of this paper, this way of distinguishing things is less helpful.

See Bernstein M. Bampoe J. , “Surgical Innovation or Surgical Evolution: An Ethical and Practical Guide to Handling Novel Neurosurgical Procedures,” Journal of Neurosurgery 100 (2004): 2–7.

See Ford P. J. Kubu C. S. , “Stimulating Debate: Ethics in a Multidisciplinary Functional Neurosurgery Committee,” Journal of Medical Ethics 32, no. 2 (2006):106–109.

See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Use of Psychosurgery in Practice and Research: Report and Recommendations , 42 Fed. Reg. 26318 (1977); Fins J. J. Rezai A. R. Greenberg B. D. , “Psychosurgery: Avoiding an Ethical Redux While Advancing a Therapeutic Future,” Neurosurgery 59, no. 4 (2006): 713–716.

This point is well made in C. M. Simon's observations of an early Gamma Knife clinical care committee. See Simon C. M. , “Images and Image: Technology and the Social Politics of Revealing Disorder in a North American Hospital,” Medical Anthropology Quarterly 13 (1999):141–162.

One may argue further that a review from an outside neurosurgeon might provide a benefit in terms of risk management. This could be a secondary benefit and perhaps an extra incentive to implement this practice.

See Leentjens A. F. , “Manipulation of Mental Competence: An Ethical Problem in Case of Electrical Stimulation of the Subthalamic Nucleus for Severe Parkinson's disease,” Ned Tijdschr Geneeskd 148, no. 28 (2004): 1394–1398.

See Farris S. Giroux M. DeMarco J. P. Ford P. J. , “Deep Brain Stimulation for Risky Patients: Ethical Considerations,” Movement Disorders 23, no. 14 (2008): 1973–1976.

This argument may be found in Ford P. J. , “Neurosurgical Implants: Clinical Protocol Considerations,” Cambridge Quarterly of Healthcare Ethics 16, no. 3 (2007): 310–313.

See Ford P. J. Boulis N. Montgomery E. Rezai A. , “Ethical Dilemmas When a Patient Intraoperatively Revokes Consent,” Neuromodulation 10, no. 4 (2007): 259–262.

See Racine E. Waldman S. Palmour N. Risse D. Illes J. , “Currents of Hope: Neurostimulation Techniques in U.S. and U.K. Print Media,” Cambridge Quarterly of Healthcare Ethics 16, no. 3 (2007): 312–316.

Thanks to Leah Schaffer for her structured search during a summer internship. These results are yet unpublished.

A great deal of literature exists on therapeutic misconception. Of particular interest is Jonathan Kimmelman's analysis of the ways in which the therapeutic misconception has been improperly expanded to include concerns such as the one I raise. However, the concern of poor decision making because of over optimistic views has been interwoven within the therapeutic misconception debate. See Kimmelman J. , “The Therapeutic Misconception at 25: Treatment, Research, and Confusion,” Hastings Center Report 37, no. 6 (2007): 36–42.

Frank S. Kieburtz K. Holloway R. , “What Is the Risk of Sham Surgery in Parkinson Disease Clinical Trials? A Review of Published Reports,” Neurology 65, no. 7 (2005): 1101–1103; Frank S. A. Wilson R. Holloway R. G. Zimmerman C. Peterson D. R. Kieburtz K. Kim S. Y. , “Ethics of Sham Surgery: Perspective of Patients,” Movement Disorders 1 (2008): 63–68; Horng S. H. Miller F. G. , “Placebocontrolled Procedural Trials for Neurological Conditions,” Neurotherapeutics 4, no. 3 (2007): 531–536.

Benabid A. L. , “What the Future Holds for Deep Brain Stimulation,” Expert Review of Medical Devices 4, no. 5 (2007): 895–903.

Bernstein and Bampoe refer to the inclination to have an increasingly large number of activities fall under IRB purview as “IRB Creep” that should be avoided since they begin to take on more responsibility than they are charged with or qualified for. See Bernstein Bampoe , supra note 14.