Although the concept of Responsible Innovation (RI) has been applied to different types of innovations, three common assumptions have remained the same. First, emerging technologies require assessment because of their radical novelty and unpredictability. Second, early assessment is necessary to impact the innovation trajectory. Third, anticipation of unknowns is needed to prepare for the unpredictable. I argue that these assumptions do not hold for liminal innovation practices in clinical settings, which are defined by continuous transition on both sides of the threshold between experiment and implementation, and between research and care. First of all, technologies at the center of liminal innovation practices have different characteristics than those typically attributed to emerging technologies. Additionally, the innovation trajectory is significantly different allowing continuous assessment and shaping long after implementation. Finally, these differences demand a reorientation in RI approaches for these cases, away from anticipation of the unknown and uncertain, and returning to observation of the known and predictable.

A self-fulfilling prophecy (SFP) in neuroprognostication occurs when a patient in coma is predicted to have a poor outcome, and life-sustaining treatment is withdrawn on the basis of that prediction, thus directly bringing about a poor outcome (viz. death) for that patient. In contrast to the predominant emphasis in the bioethics literature, we look beyond the moral issues raised by the possibility that an erroneous prediction might lead to the death of a patient who otherwise would have lived. Instead, we focus on the problematic epistemic consequences of neuroprognostic SFPs in settings where research and practice intersect. When this sort of SFP occurs, the problem is that physicians and researchers are never in a position to notice whether their original prognosis was correct or incorrect, since the patient dies anyway. Thus, SFPs keep us from discerning false positives from true positives, inhibiting proper assessment of novel prognostic tests. This epistemic problem of SFPs thus impedes learning, but ethical obligations of patient care make it difficult to avoid SFPs. We then show how the impediment to catching false positive indicators of poor outcome distorts research on novel techniques for neuroprognostication, allowing biases to persist in prognostic tests. We finally highlight a particular risk that a precautionary bias towards early withdrawal of life-sustaining treatment may be amplified. We conclude with guidelines about how researchers can mitigate the epistemic problems of SFPs, to achieve more responsible innovation of neuroprognostication for patients in coma.

When information on a coma patient’s expected outcome is uncertain, a moral dilemma arises in clinical practice: if life-sustaining treatment is continued, the patient may survive with unacceptably poor neurological prospects, but if withdrawn a patient who could have recovered may die. Continuous electroencephalogram-monitoring (cEEG) is expected to substantially improve neuroprognostication for patients in coma after cardiac arrest. This raises expectations that decisions whether or not to withdraw will become easier. This paper investigates that expectation, exploring cEEG’s impacts when it becomes part of a socio-technical network in an Intensive Care Unit (ICU). Based on observations in two ICUs in the Netherlands and one in the USA that had cEEG implemented for research, we interviewed 25 family members, healthcare professionals, and surviving patients. The analysis focuses on (a) the way patient outcomes are constructed, (b) the kind of decision support these outcomes provide, and (c) how cEEG affects communication between professionals and relatives. We argue that cEEG can take away or decrease the intensity of the dilemma in some cases, while increasing uncertainty for others. It also raises new concerns. Since its actual impacts furthermore hinge on how cEEG is designed and implemented, we end with recommendations for ensuring responsible development and implementation.

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