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Vulnerable Brains: Research Ethics and Neurosurgical Patients

Published online by Cambridge University Press:  01 January 2021

Paul J. Ford
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Extract

The vulnerability of patients receiving significantly innovative neurosurgical procedures, either as research or as non-standard therapy, presents particularly potent challenges for those attempting to substantially advance clinical Neurosurgical practice in the most ethically and efficacious manner. This beginning formulation has built into it several important notions about research participation, balancing values, and clinical advancement in the context of neurological illness. For the time being, allow vulnerability to act as a placeholder for circumstances or states of being wherein the established checks and balances of power and interest are no longer sufficient in promoting the just treatment of persons. Further, the phrase to substantially advance Neurosurgical practice encompasses radical innovation as well as significant research into new procedures. Finally, few of these explorations involve true randomized placebo controlled trials, but rather they enroll patients rightfully hoping for some benefit by means of undergoing the procedure.

When a neurosurgeon asks me, as an ethicist, to meet with a patient who has medically refractory disease and no good standard therapy options remaining, he is asking for help concerning whether to offer, as a last chance, an unproven therapy as either innovation or research.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 1 , Spring 2009 , pp. 73 - 82
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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