The Ethical Dilemmas of Experimental Invasive Brain Technologies

摘要

The prospective ethical examination by Gilbert and colleagues of the first-in-human (FIH) neurology trial of optogenetics (Gilbert, Harris, and Kapsa 2014) is important, in part because the design of such a trial would involve testing the limits of what is ethically acceptable in clinical research. The technology thatGilbert and colleagues describe appears to entail extraordinarily high levels of invasiveness and potential for irreversible harm in the brain. By themselves, however, invasiveness and potential for irreversible harm in the central nervous system (CNS) are features shared by other technologies that have been or are currently tested in FIH clinical trials, such as first-time transplantation of novel stem-cell products. Given that these trials involve high levels of uncertainty regarding safety and efficacy, as well as heavy burdens for the research subjects, they are difficult to design ethically. Some of these trials may have overridden principles of research ethics, even if it was surely not the deliberate intent of the sponsors and investigators to do so. For instance, the very first human transplantation of neural stem cells involved submitting very young and sick children, who had no chance of deriving significant clinical benefits from the study, to a series of burdensome procedures, including skull trephination at multiple sites and repeated magnetic resonance imaging (MRI) (Hess, 2012; Martin and Robert, 2007). This study conflicted with the ethical principle set forth in the Declaration of Helsinki, which states that individuals who cannot consent should not participate in risky or burdensome research unless there is a prospect that they may derive some direct clinical benefits commensurate with the involved risks and burdens (World Medical Association [WMA] 2008). Neurology FIH studies of invasive technologies are scarce: nomore than a very few per year. However, their examination is crucial because in the end they pose the question of where we, as members of the general society and ultimate beneficiaries of these studies, should set the ethical boundaries that clinical research should not cross.