TY - JOUR
T1 - Should DBS for Psychiatric Disorders be Considered a Form of Psychosurgery? Ethical and Legal Considerations
AU - Stahl, Devan
AU - Cabrera, Laura
AU - Gibb, Tyler
N1 - Funding Information:
Clinical trials that receive federal funding from the NIH also must register and post results to clinicatrials.gov, a federally run database. Federal law mandates publishing of results (2007), but until recently there has not been enforcement of public reporting of study results. Many of the different psychiatric DBS trials registered in the clinicatrials.gov database are listed as inactive status, and others that are listed as “complete” do not show more than the initial registration information. At present, these databases represent the bare minimum for reporting data and provide very little useful information. A lack of public reporting can potentially endanger future human subjects. As Dorenberg and Wendler explain, sharing research results “helps to justify exposing participants to the risks of clinical trials and shows respect for those who assume these risks (, pp. 1149–1150).” Moreover, as was shown in the BROADEN trial, without full transparency and heightened regulatory oversight, human subjects can be abandoned and abused. Once again, enforcing the regulations already in place for these trials would go a long way in ensuring that psychiatric DBS procedures are performed ethically and transparently.
Publisher Copyright:
© 2017, Springer Science+Business Media B.V.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS.
AB - Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS.
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U2 - 10.1007/s11948-017-9934-y
DO - 10.1007/s11948-017-9934-y
M3 - Article
C2 - 28653164
AN - SCOPUS:85021292206
VL - 24
SP - 1119
EP - 1142
JO - Science and Engineering Ethics
JF - Science and Engineering Ethics
SN - 1353-3452
IS - 4
ER -