Research Ethics: When Innovation Is Clearly Research

Abstract

With recent major advancements in scientific discovery and clinical research, the technical capabilities of the physician have vastly grown. However, in this predominant culture to advance knowledge and with this increase in technical possibility, the line between patient care and pure research becomes less clear. A fundamental and easily applicable set of ethical principles should therefore be utilized by physicians whenever they are faced with the question of whether an act is truly in their patient’s best interest. Years ago, Emanuel et al. laid out a framework of seven principles to use when evaluating whether clinical research is ethical. These include (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk-benefit ratio, (5) independent review, (6) informed consent, and (7) respect for potential and enrolled subjects. In this chapter, we aim to apply these principles to a neurosurgical problem that has recently gained widespread media attention. Recently, head transplant has gained attention as neurosurgeons have proposed performing this procedure on a human in the near future. By critically evaluating this proposed procedure via each of the seven aforementioned principles, we conclude that it does not meet the ethical requirements to be performed on a human. While the surgery has the potential to provide new information and guide future treatments, it fails to respect the patient as a person and does not offer a favorable risk-benefit ratio. Ultimately, it is the responsibility of the physician, and neurosurgeon in this case, to understand the limits of research and to appreciate when the research is truly experimental and not yet ready to be performed on a patient. Ultimately, physicians must remember, first and foremost, to do no harm.