title: Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices.
abstract: Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent.
  
  
  
  This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity.
  
  
  
  Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols.
  
  
  
  Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.
authors.affiliation: Department of Neurology, Oregon Health and Science University, Portland, OR, USA. Department of Philosophy, University of Washington, Seattle, WA, USA. Center for Sensorimotor Neural Engineering, Seattle, WA, USA.
authors.forename: Eran
authors.initials: E
authors.lastname: Klein
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Ojemann
mesh_terms: D000818:Animals; D062207:Brain-Computer Interfaces / Q000009:adverse effects / Q000941:ethics / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D012106:Research; D012306:Risk