Successful innovative ‘leaps’ in surgical technique have the potential to contribute exponentially to surgical advancement, and thereby to improved health outcomes for patients. Such innovative leaps often occur relatively spontaneously, without substantial forethought, planning, or preparation. This feature of surgical innovation raises special challenges for ensuring sufficient evaluation and regulatory oversight of new interventions that have not been the subject of controlled investigatory exploration and review. It is this feature in particular that makes early-stage surgical (...) innovation especially resistant to classification as ‘research’, with all of the attendant methodological and ethical obligations—of planning, regulation, monitoring, reporting, and publication—associated with such a classification. This paper proposes conceptual and ethical grounds for a restricted definition according to which innovation in surgical technique is classified as a form of sui generis surgical ‘research’, where the explicit goal of adopting such a definition is to bring about needed improvements in knowledge transfer and thereby benefit current and future patients. (shrink)

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated (...) common conceptual areas in discussions of innovation, that we categorised alliteratively under the themes of “purpose”, “place”, “process”, “product” and “person”. These conceptual areas are used in varying—sometimes contradictory—ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term “innovation” carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term “innovation” from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery. (shrink)

Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about (...) whether to publicly fund access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long-term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations. (shrink)

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes (...) findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation, is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new". CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations. (shrink)

As innovations in the field of vascular composite allotransplantation (VCA) progress, whole-eye transplantation (WET) is poised to transition from non-human mammalian models to living human recipients. Present treatment options for vision loss are generally considered suboptimal, and attendant concerns ranging from aesthetics and prosthesis maintenance to social stigma may be mitigated by WET. Potential benefits to WET recipients may also include partial vision restoration, psychosocial benefits related to identity and social integration, improvements in physical comfort and function, and reduced (...) class='Hi'>surgical risk associated with a biologic eye compared to a prosthesis. Perioperative and postoperative risks of WET are expected to be comparable to those of facial transplantation (FT), and may be similarly mitigated by immunosuppressive protocols, adequate psychosocial support, and a thorough selection process for both the recipient and donor. To minimize the risks associated with immunosuppressive medications, the first attempts in human recipients will likely be performed in conjunction with a FT. If first-in-human attempts at combined FT-WET prove successful and the biologic eye survives, this opens the door for further advancement in the field of vision restoration by means of a viable surgical option. This analysis integrates recent innovations in WET research with the existing discourse on the ethics of surgical innovation and offers preliminary guidance to VCA programs considering undertaking WET in human recipients. (shrink)

Uterus transplantation (UTx) research has been introduced in several countries, with trials in Sweden and the United States producing successful outcomes. The growing interest in developing UTx trials in other countries, such as Spain, the Netherlands, Japan, and Australia, raises important questions regarding the ethics of surgical innovation research in the field of UTx. This paper examines the current state of UTx in the context of the surgical innovation paradigm and IDEAL framework and discusses the ethical (...) challenges faced by those considering the introduction of new trials. We argue that UTx remains an experimental procedure at a relatively early stage of the IDEAL framework, especially in the context of de novo trials, where protocols are likely to deviate from those used previously and where researchers are likely to have limited experience of UTx. We conclude that countries considering the introduction of UTx trials should build on the strengths of the reported outcomes to consolidate the evidence base and shed light on the uncertainties of the procedure. Authorities responsible for the ethical governance of UTx trials are advised to draw on the ethical framework used in the oversight of surgical innovation. (shrink)

Volume 24, Issue 10, October 2024, Page 110-112.

Volume 24, Issue 10, October 2024, Page 110-112.

Volume 19, Issue 6, June 2019, Page 25-27.

“Every surgeon carries within himself a small cemetery where from time to time he goes to pray—a place of bitterness and regret, where he must look for an explanation of his failures” René Leriche,...

Surgical advances can provide great benefits to patients but can come at a cost. The successes are often matched by failures that cause harm to patients. The risks of surgery create a strong ethical imperative for research to establish the safety and efficacy of new treatments. Surgical research is, however, challenging for a number of reasons including the lack of a clear boundary between variations in practice, innovation and research, its irreversible nature, the difficulty of performing placebo-controlled (...) randomised trials, confounding factors such as surgeon learning curves and conflicts of interest. In this chapter the ethical issues raised by surgical innovation are explored with the use of a case study based on the uptake of vaginal mesh to treat vaginal prolapse to highlight these issues (Sects. 12.1 and 12.2). In Sect. 12.3 the argument for the value of a structured approach to introducing innovations, such as that developed by the IDEAL Collaboration, which clarifies both ethical and methodological issues at each stage of research is proposed. This chapter recognises that ethical challenges extend beyond adequate ethical evaluation of the innovation in the care of individual patients to include broader issues such as justice in access to any new interventions. (shrink)

Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves value (...) judgments about the acceptability of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery. (shrink)

Volume 19, Issue 6, June 2019, Page 34-36.

The practice of surgery requires consideration of a number of specific aspects of clinical medical ethics that are different from those most influential in other areas of medical care. The nature of surgical care alters the sense of responsibility that surgeons feel for their actions and also alters the relationship between surgeons and patients. Because surgical care requires patients to place such great trust in their surgeons, surgical informed consent must emphasize the importance of that trust. Surgeons (...) must use innovative means to solve individual patient problems even if the result is a novel operation. Surgical procedures may be altered due to the unexpected findings in the operating room and therefore surgeons must have considered how to respond in such situations. The future of surgical practice will inevitably lead to increasing ethical concerns in maintaining the ethical dimension of surgery, in allowing autonomy for trainees while maintaining patients’ safety, and in balancing surgical risks of prophylactic surgery with the genetic predisposition to develop cancer. (shrink)

in Angelique M. Rietsma and Jonathan D. Moreno eds., Ethical Guidelines for Innovative Surgery. (Hagerstown, MD: University Publishing Group) 19-52. [PDF].

It is obvious that every inventor should be rewarded for the intellectual effort, and at the same time be encouraged to successively improve his or her discovery and to work on subsequent innovations. Patents also ensure that patent owners are officially protected against intellectual piracy, but protection of intellectual property may be difficult to accomplish. Nevertheless, it all comes down to this basic question: Does a contradiction exist between medical ethics and the “Medical and Surgical Procedure Patents” system? It (...) may well turn out that medical-procedure patents can have a negative influence on the standard of medical care. Medical-method patents may also interfere with the physician-patient relationship. At present, physicians do not question the usefulness of patent protection for medicines, biotechnology, equipment and devices, but they strongly oppose it for surgical procedures. (shrink)

Demands for access to experimental therapies are frequently framed in the language of rights. This article examines the justifiability of such demands in the specific context of surgical innovations, these being promising but non-validated and potentially risky departures from standard surgical practices. I argue that there is a right to access innovative surgery, drawing analogies with other generally accepted rights in medicine, such as the right not to be forcibly treated, to buy contraceptives, and to choose to have (...) an abortion, including a post-viability abortion where the mother's life or health is threatened by the pregnancy. I argue that we accept these rights because we believe that people are entitled to try to preserve their lives and health and to make choices of an important and intensely personal kind, and I suggest that a person's choice of medical treatment should be seen in the same light. However, since few rights are absolute, I also consider the circumstances in which it may be justifiable to limit the right to access innovative surgery. In discussing this question, I apply the human rights standard of proportionality, comparing the importance of the reasons for limiting the right with the severity of the invasion on liberty. (shrink)

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises (...) a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid misuse and diversion in the United States. Pain specialists may be particularly well situated to address these issues. We describe an attempt to reverse the trend at an orthopedic surgical hospital by implementing a peri-operative assessment and treatment service which minimizes preoperative opioid use, when necessary implements addiction treatment, and encourages early tapering from opioids.

In lieu of an abstract, here is a brief excerpt of the content:Laying Medicine Open: Innovative Interaction Between Medicine and the HumanitiesLaurence B. McCullough and Warren Thomas ReichThe past three decades have witnessed the emergence and remarkable success of the fields of bioethics and medical humanities. The intellectual landscape of medicine and that of the humanities have been remarkably altered in the process. Twenty-five to 30 years ago in the United States there existed but a few courses in what came (...) to be called “bioethics” in departments of philosophy, religious studies, and theology in colleges and universities, a handful of programs of teaching in medical schools such as the University of Texas Medical Branch at Galveston and Pennsylvania State University School of Medicine at Hershey, and but one independent research center (the Hastings Center) and one university-based research center (the Kennedy Institute of Ethics at Georgetown University). Articles on bioethics began to appear in the peer-reviewed medical, nursing, and humanities literature and some books were published. There was only one journal in bioethics, The Hastings Center Report (which consolidated two previously separate journals from the Hastings Center). Graduate programs in bioethics and medical humanities in colleges and universities and fellowship training in bioethics and medical humanities in medical schools did not exist. Very little existed in colleges, universities, and medical schools in other countries. Now, of course, everything is different.Teachers, scholars, and students of bioethics and medical humanities should not take these remarkable changes for granted, for they represent a sustained and innovative interaction between medicine and the humanities. We have chosen the metaphor of “laying medicine open” to characterize the history of bioethics and medical humanities of the past three decades. This surgical metaphor was used in eighteenth-century Britain by a number of writers who wanted to make medical science and practice more accessible to the sick and to the lay public more generally (Lawrence 1975). We use the metaphor to characterize the efforts of teachers and [End Page 1] scholars over the past three decades and more to make the value-laden dimensions of biomedical science and practice and of health care policy more accessible to patients and to the lay public more generally. The result of this laying open of medicine has gone a long way toward bringing closer together the two cultures of science and the humanities that had, as C. P. Snow famously described, become significantly isolated from each otherAlbert Jonsen (1998) has recently contributed the first book-length history of what he calls the “birth” of bioethics, adding to the work of other scholars such as Warren Reich (1994; 1995) and Robert Baker (1993) and, before them, Corrado Viafora (1990) and David Rothman (1991). The articles in this issue of the Kennedy Institute of Ethics Journal make additional contributions to the developing understanding of the history of the past thirty years of interaction between medicine and the humanities.Laurence McCullough provides an historical context for the three accounts of the recent laying open of medicine that follow. McCullough examines two times in the history of medicine when it has been laid open to accountability (in addition to its being laid open to and by bioethics and medical humanities). The first laying open occurred in the work of the eighteenth-century Scottish physician and philosopher John Gregory, who set out to create a profession of medicine in a true moral sense of a fiduciary profession by making medicine accountable for its scientific and moral quality. The second occurred in the late twentieth century in which the managed practice of medicine in general, and managed care in particular, have begun to lay medicine open to accountability for its scientific and moral quality, as well as its cost and, at least in the public sector, its accessibility. McCullough argues that, just as Gregory responded to the ethical challenges of medicine laid open more than two centuries ago, bioethics should respond to the ethical challenges in the current laying open of medicine.Warren Reich provides an account of André Hellegers, whose premature death left an enormous gap in the field that will never be filled. Reich claims that Hellegers was engaged substantially in much more than the laying open of medicine: he... (shrink)

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest (...) are transparency and recusal, which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. (shrink)

In this article, I am using the example of the introduction of osteosynthesis into surgical routine practice to analyze the use of the notions of art and science in medical innovation. The examination of the renegotiations of power and responsibility associated with the introduction of this new technique shows that proponents and critics actively linked their arguments to more fundamental epistemological and social issues. The proponents claimed to manage the uncertainties of innovation through making surgery more scientific, (...) drawing on the ideals of control, rationality, objectivity, and predictability. The critics mobilized another discursive pattern. They considered surgery an art and emphasized the individuality, contingency, and situatedness of medical practice. I investigate the discursive function of these argumentative patterns and how they played out in the concrete example of this surgical technique. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. 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The birth of modern gynecology in the USA is preceded by experimental exploitations of Black women’s bodies in the mid-nineteenth century, entailing a long-drawn extraction of “reproductive knowledge” from enslaved patients. Charly Evon Simpson’s Behind the Sheet (2019) stages the history of medical bondage of Black enslaved women in antebellum South, reconstructing the events that led to the surgical innovation for vesico-vaginal fistula. Scrutinizing Simpson’s dramatization of the event, this paper prompts inquiries into the interplay of power and (...) consent between the physician and the enslaved patient in plantation healthcare, highlighting the need to reexamine bioethical principles. Using the theoretical framework of medical gaze propounded by Foucault and further developed by Susan Greenhalgh, the paper analyzes the operation of white patriarchal power and the construction of physician heroism in the medical sphere. Investigating the realm of bodily autonomy in the context of medical bondage, the paper attempts to render a “herstorical” standpoint on the contributions of enslaved Black women to the field of gynecology. (shrink)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...) non-digital Informed Consent process. Methods We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia, non-interactive multimedia, and videos, and most studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures and clinical research. For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. (shrink)

Alterations in dural venous sinus hemodynamics have recently been suggested as the major contributing factors in venous pulsatile tinnitus. Nevertheless, little is known about the association between real-time alterations in hemodynamics and the subjective perception of venous PT. This study aimed to investigate the hydroacoustic correlations among diverticular vortices, mainstream sinus flow, and PT using various Doppler ultrasound techniques. Nineteen venous PT patients with protrusive diverticulum were recruited. The mainstream sinus and diverticular hemodynamics before and after ipsilateral internal jugular vein (...) compression were investigated using an innovative retroauricular color-coded Doppler method to examine the correlation between the disappearance of PT and hemodynamic alterations. To reveal the hydroacoustic characteristics of disparate segments of venous return, a computational fluid dynamics technique combined with the transcranial color-coded Doppler method was performed. When the ipsilateral IJV was compressed, PT disappeared, as the mean velocity of mainstream sinus flow and diverticular vortex decreased by 51.2 and 50.6%, respectively. The vortex inside the diverticulum persisted in 18 of 19 subjects. The CFD simulation showed that the flow amplitude generated inside the transverse–sigmoid sinus was segmental, and the largest flow amplitude difference was 20.5 dB. The difference in flow amplitude between the mainstream sinus flow and the diverticular flow was less than 1 dB. In conclusion, the sensation of PT is closely associated with the flow of kinetic energy rather than the formation of a vortex, whereby the amplitude of PT is correlated to the magnitude of the flow velocity and pressure gradient. Additionally, the range of velocity reduction revealed by the RCCD method may serve as a presurgical individual baseline curative marker that may potentially optimize the surgical outcomes. (shrink)

Little is known about health care professionals’ perceptions regarding what it means to treat patients and families with respect and dignity in the intensive care unit (ICU) setting. To address this gap, we conducted nine focus groups with different types of health care professionals (attending physicians, residents/fellows, nurses, social workers, pastoral care, etc.) working in either a medical or surgical ICU within the same academic health system. We identified three major thematic domains, namely, intrapersonal (attitudes and beliefs), interpersonal (behaviors), (...) and system (contextual) factors that influence treatment with respect and dignity. Participants suggested strategies for improving treatment of patients and families in the ICU with respect and dignity, as well as the related need for enhancing respect among the multidisciplinary team of clinicians. Implementing these strategies will require innovative educational interventions and leadership. Future research should focus on the design and evaluation of such interventions on the quality of care. (shrink)

Wolfgang Welsch examines global aestheticization phenomena, probes the relationship of aesthetics and ethics, and considers the broad relevance of aesthetics for contemporary thinking. He argues that modes of thought familiar from the aesthetic realm comprise fundamental paradigms for understanding todayÆs reality. The implications for specific and everyday issues are demonstrated in studies of architecture, advertising, the Internet, and our perception of the life world. Surgically precise, innovative, and, above all, relevant, this book is an essential resource, providing the analysis of (...) contemporary culture with philosophical bite. Aesthetics is to transcend itself, address the whole realm of aethesis, and hence enable orientation in the contemporary condition. Undoing aesthetics means releasing it from old cultural binds and giving it new ties with the future. (shrink)

The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative surgeries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. Some institutions tacitly allow the use of new surgical procedures in series of patients without informing individuals that they are participating in a scientific study, as long as no written protocol or (...) hypothesis exists. Institutions can justify this practice by viewing human research in narrow terms as an activity outlined in a formal protocol. Application of limited definitions, however, erodes patients' rights and risks losing public confidence in how biomedical research is conducted. I propose an operational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge. (shrink)

During the Second World War, through innovations in officer selection and group therapy, the army psychiatrists John Rickman and Wilfred Bion changed our understanding of leadership. They showed how soldiers under stress could develop real authority through their attentiveness to each other. From contrasting experiences 25 years earlier each had seen how people in groups are moved by elemental forces that undermine judgement and thought. This article arose from my experiences as a trainee at the Tavistock Clinic, where the method (...) of reflective work discussion, giving individuals seated in a circle the choice to speak or to remain silent, seemed similar to a Quaker meeting. Many decades later I found that this association had a basis in fact. Among other influences on Bion — a childhood in India, distinguished service in the First World War, and a surgical apprenticeship with Wilfred Trotter — there is a little-acknowledged Quaker source, in John Rickman, for Bion’s radical work in the army that led to new methods of training and organizational consultancy in the postwar Tavistock. (shrink)

Transplantation is a field of perpetual innovation. In the last 15 years, novel surgical interventions include uterine, tracheal, hand, face, and penile allotransplantation, as well as cardiac xeno...

Clinical research is a necessity if effective and safe treatments are to be developed. However, this may well include the need for research that is best described as ‘invasive’ in that it may be associated with some discomfort or inconvenience. Limitations in the undertaking of invasive research involving people with intellectual disabilities (ID) are perhaps related to anxieties within the academic community and among ethics committees; however, the consequence of this neglect is that innovative treatments specific to people with ID (...) may not be developed. Such concerns are likely to continue while there is limited published knowledge regarding the actual experiences of people with ID who have participated in invasive clinical research. As part of a pilot study trialling the novel use of a surgically inserted device to curb overeating in people with Prader–Willi syndrome (PWS) we have investigated the experience of research through semistructured qualitative interviews involving three participants and their carers. Thematic analysis revealed that the adults with PWS and their family carers rated their participation positively, seeing it as a rewarding and enriching experience. This brief report discusses findings from our interview data in order to highlight strategies which may ensure that research is acceptable to participants, meets the necessary ethical standards and is able to achieve the aims set out by the researchers. To our knowledge, this is the first study to record experiences directly from people with PWS and their carers regarding their involvement in invasive clinical research. (shrink)

This book analyzes the reasons for organ shortage and ventures innovative ideas for approaching this problem. It presents 29 contributions from a highly interdisciplinary group of world experts and upcoming professionals in the field. Every year thousands of patients die while waiting for organ transplantation. Health authorities, medical professionals and bioethicists worldwide point to the urgent and yet unsolved problem of organ shortage, which will be even intensified due to the increasing life expectancy. Even though the practical problem seems to (...) be well known, the search for suitable solutions continues and often restricts itself by being limited through disciplinary and national borders. Combining philosophical reflection with empirical results, this volume enables a unique insight in the ethics of organ transplantation and offers fresh ideas for policymakers, health care professionals, academics, and the general public. (shrink)

This study proposed a novel construct – green core competence – to explore its positive effects on green innovation and green images of firms. The results showed that green core competences of firms were positively correlated to their green innovation performance and green images. In addition, this research also verified two types of green innovation performance had partial mediation effects between green core competences and green images of firms. Therefore, investment in the development of green core competence (...) was helpful to businesses for the enhancement of their green innovation and green images. Furthermore, this study found that green core competence, two types of green innovation performance, and green images of medium & small enterprises (SMEs) were all significantly less than those of large enterprises in the information and electronics industry in Taiwan. Therefore, there was the advantage of firm size for the green core competence in this industry, and it was imperative for SMEs to develop and create their green core competences to strengthen their green innovation performance, and green images. (shrink)

This Open Access book builds on the experiences of one of the largest European projects in the domain of responsible Research and Innovation: NewHoRRIzon. It highlights the potential of and opportunity in responsible R&I to conduct innovation in a socially responsible way. Employing the methodology of Social Labs, the book analyses responsible R&I from an experience-based viewpoint and further explores the application of responsible R&I beyond scholarly and industrial interests. The contributors analyze the current European R&I landscape, provide (...) reflection and reconceptualization of its core concepts, and project future challenges in relation to responsible R&I. The book complements the readers' line of work by providing insights on how responsible R&I can be applied by the audience, for example, in their decision-making processes. (shrink)

Genome editing is revolutionising the field of genetics, which includes novel applications to food animals. Responsible research and innovation has been advocated as a way of ensuring that a wider-range of stakeholders and publics are able to engage with new and emerging technologies to inform decision making from their perspectives and values. We posit that genome editing is now proceeding at such a fast rate, and in so many different directions, such as to overwhelm attempts to achieving a more (...) reflective pace. An alternative location for reflection is during the much slower process of taking products from the lab to market. We suggest emphasising Responsible Innovation, putting the ‘I’ back into RRI, and encouraging companies to embrace an RRI approach. We review some previous attempts at developing industry-relevant frameworks for RRI. We then describe two examples of genome editing in livestock; hornless cattle and disease resistant pigs, and reflect on the sorts of questions that could be considered in these two genome editing examples. This paper seeks to take forward the discussion on RRI by extending it to bringing products to market in the context of genome edited livestock. (shrink)

Ecological innovation is an inevitable trend for firms to enhance competitiveness and sustainably operate in the context of green economy. The previous literature has rarely discussed the influence of ambidextrous learning on the eco-innovation performance of startups and ignored the moderating effect of top management’s environmental awareness from the perspective of microscopic psychology. We have conducted a questionnaire survey on 212 firms established within 4 years in the Pearl River Delta of China, using the structure mode and the (...) PROCESS by Hayes (2013) to analyze the influence of ambidextrous learning, such as exploratory learning and exploitative learning, by startups on eco-innovation performance and verify the moderating effect of top management’s environmental awareness. The results show that: exploratory learning and exploitative learning have a positive and significant influence on eco-innovation performance, indicating that the organizational learning of startups is conducive to improving eco-innovation performance; under the moderating effect of top management’s environmental awareness, the influence of exploratory learning and exploitative learning on eco-innovation performance may differ. The results also show that in the process of organizing ambidextrous learning, startups should help raise the environmental awareness of top management to improve the eco-innovation performance, thus providing guidance for startups to carry out eco-innovation activities and for local governments to make decisions on green economy. (shrink)

In some cases, the term ‘Responsible Innovation’ has been considered a type of ethical solution to the Collingridge predicament in control of technology development. In this article, I claimed that two different approaches for responsible innovation (i.e. Van den Hoven’s innovation-based approach and Owen’s social-based approach) can be considered as two different dimensions that, while being conflicting, dialectically interact and thus can be useful for solving the problem of Collingridge. For this purpose, I argue that the first (...) approach that resorts to innovations for solving moral dilemmas is successful in rearranging and removing unhelpful (i.e. amoral) obligations, but it is unable to determine useful (i.e. moral) obligations. On the other hand, the second approach believes that Responsible Innovation occurs through social processes and by virtue of concepts such as reflection, deliberation, anticipation, and responsiveness, although is effective in determining useful (i.e. moral) obligations, it cannot remove or rearrange all useless (i.e. amoral) obligations. Although these two approaches are conflicting, the result of each approach is a necessary condition for the other approach, so the problem can only be solved by a dialectical interaction. (shrink)