This interdisciplinary selection of essays represents the explosion of scholarly interest since the 1960s in the pioneering feminist, philosopher, novelist and political theorist, Mary Wollstonecraft. Organized by theme and genre, the collection deals with the full range of her work, reproduces the most important modern Wollstonecraft scholarship, tracks the development of the author's reputation from the nineteenth century and demonstrates Wollstonecraft's importance in contemporary social, political and sexual theory and in Romantic studies.

Volume 19, Issue 6, June 2019, Page 28-29.

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)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide (...) advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries. (shrink)

This paper examines potential ethical and legal issues arising during the research, develop- ment and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individ- ual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable (...) populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detri- mental to best personalizing treatment decisions in the clinic. (shrink)

Ted Shotter's founding of the London Medical Group 50 years ago in 1963 had several far reaching implications for medical ethics, as other papers in this issue indicate. Most significant for the joint authors of this short paper was his founding of the quarterly Journal of Medical Ethics in 1975, with Alastair Campbell as its first editor-in-chief. In 1980 Raanan Gillon began his 20-year editorship . Gillon was succeeded in 2001 by Julian Savulescu, followed by John Harris and Soren (...) Holm in 2004, with Julian Savulescu starting his second and current term in 2011. In 2000 an additional special edition of the JME, Medical Humanities , was published, under the founding joint editorship of Martyn Evans and David Greaves. In 2003 Jane Macnaughton succeeded David Greaves as joint editor. Deborah Kirklin, under whose auspices MH became an independent journal, took over in 2008, and she was succeeded in 2013 by Sue Eckstein. This short paper offers reminiscences and reflections from the two journals’ various editors.From the start the JME was committed to clearly expressed reasoned discussion of ethical issues arising from or related to medical practice and research. In particular, both Edward Shotter and Alastair Campbell, each a cleric , were at pains to make clear that the JME was not a religious journal and that it had no sort of partisan axe to grind.Campbell's appointment as founding editor was something of a surprise, as the original intention had been to appoint a medical doctor, who could be expected to know medical practice from the inside. However, in 1972 Campbell, a Joint Secretary of the Edinburgh Medical Group, had published Moral dilemmas in medicine. …. (shrink)

Clothing is central to the worlds described in early modern utopian texts: of twenty-three utopian texts written and published in England between 1516 and 1656, 91 percent mention dress, and 82 percent contain more extensive description or comment upon clothing. Written by elite authors for elite readers, these texts assign clothing a leading role in the establishment and maintenance of social order in a range of areas, including governance, social and religious control, personal expression, and ideological stance. Separated from the (...) material constraints of the physical world, dress in these worlds has meaning rather than substance; we see how the authors think about dress and fashion—not how... (shrink)

This article works in a recursive manner by using the tools of a food regime approach to reinterpret the nutrition transition that has been underway internationally for 100 years, and then describing the contributions of nutrition science to the 1st and 2nd Food Regimes and the passages between Food Regimes. The resulting history—from the ‘imperial calorie’ through the ‘protective’ vitamin to the ‘empty calorie’—illuminates a neglected dimension to food regime theorising: the role of socio-technical systems in shaping a set of (...) value relations that are central to class relations. Contestation over one such system, nutritionalisation, currently involves an ungovernable array of actors. In describing the protagonists to the system of nutritionalisation, a classic confrontation emerges between technical and lifeworld rationality. Representing the former approach are actor networks responsible for the ‘trade-in-health’ sector which produces foods and nutritional values aimed at both over-nourished and under-nourished populations. Clinging to a lifeworld rationality are ‘culture eaters’ worldwide, for whom nutrition value relations are secondary to communal and ecological relations. This dynamic appears within wealthier Asian states which are emerging as central to the trade-in-nutritional health sector while acting to protect their own customary dietary practices. (shrink)

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given (...) the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Community psychologists address social inequalities and problems by employing ecological principles, multiple methodologies, and participatory approaches to empower individuals, organizations, and communities to organize action and systems change. This article aims to contribute to mixed methods literature by presenting three models of mixed methods participatory research across a variety of geographic and sociocultural contexts. The models outline participatory processes and points of qualitative and quantitative data integration. Challenges related to the interplay between participatory approaches and mixed methods studies as well (...) as implications on social science research are discussed. (shrink)

This welcome volume offers a rich presentation of the ideas of Jane Addams, with emphases upon her contributions to the Pragmatic movement. It is divided into two parts. Chapters 1–4 “provide a historical and theoretical foundation for Addams’s social philosophy,” and chapters 5–9 “discuss how Addams applied her social theories to a variety of social issues” including pacifism, race and diversity, socialism, education broadly conceived, and religion. There is also an introduction, an afterword, and an extensive bibliography. It is (...) the author’s hope that his study will spur further work on the role of Addams, and other women, in the history of Pragmatism and American philosophy; and I anticipate.. (shrink)

In _Vibrant Matter_ the political theorist Jane Bennett, renowned for her work on nature, ethics, and affect, shifts her focus from the human experience of things to things themselves. Bennett argues that political theory needs to do a better job of recognizing the active participation of nonhuman forces in events. Toward that end, she theorizes a “vital materiality” that runs through and across bodies, both human and nonhuman. Bennett explores how political analyses of public events might change were we (...) to acknowledge that agency always emerges as the_ _effect of ad hoc configurations of human and nonhuman forces. She suggests that recognizing that agency is distributed this way, and is not solely the province of humans, might spur the cultivation of a more responsible, ecologically sound politics: a politics less devoted to blaming and condemning individuals than to discerning the web of forces affecting situations and events. Bennett examines the political and theoretical implications of vital materialism through extended discussions of commonplace things and physical phenomena including stem cells, fish oils, electricity, metal, and trash. She reflects on the vital power of material formations such as landfills, which generate lively streams of chemicals, and omega-3 fatty acids, which can transform brain chemistry and mood. Along the way, she engages with the concepts and claims of Spinoza, Nietzsche, Thoreau, Darwin, Adorno, and Deleuze, disclosing a long history of thinking about vibrant matter in Western philosophy, including attempts by Kant, Bergson, and the embryologist Hans Driesch to name the “vital force” inherent in material forms. Bennett concludes by sketching the contours of a “green materialist” ecophilosophy. (shrink)

Notes on Contributors • Preface • Christopher Peacocke, Introduction: The Issues and their Further Development I OBJECTIVE THOUGHT • John Campbell, Objects and Objectivity Commentaries • Bill Brewer, Thoughts about Objects, Places and Times • John O'Keefe, Cognitive Maps, Time and Causality II OBJECTIVITY AND THE UNITY OF CONSCIOUSNESS • Susan Hurley, Unity and Objectivity Commentaries • Anthony Marcel, What is Relevant to the Unity of Consciousness? • Michael Lockwood, Issues of Unity and Objectivity III UNDERSTANDING THE MENTAL:THEORY OR (...) SIMULATION • MARTIN DAVIES, The Mental Simulation Debate Commentaries • Jane Heal, Simulation vs. Theory Theory: What is at Issue? • Josef Perner, The Necessity and Impossibility of Simulation. (shrink)

Taking a fundamentally critical approach to the subject of business ethics, this book deals with the traditional material of ethics in business, as well as introducing and surveying some of the most interesting developments in critical ethical theory which have not yet been introduced to the mainstream. Including chapters on different philosophical approaches to ethics, this is a highly structured and clearly written textbook, the first book of its kind on this often neglected aspect of business.

Despite its place in the humanities, the career prospects and numbers of women in philosophy much more closely resemble those found in the sciences and engineering. This book collects a series of critical essays by female philosophers pursuing the question of why philosophy continues to be inhospitable to women and what can be done to change it. By examining the social and institutional conditions of contemporary academic philosophy in the Anglophone world as well as its methods, culture, and characteristic commitments, (...) the volume provides a case study in interpretation of one academic discipline in which women's progress seems to have stalled since initial gains made in the 1980s. Some contributors make use of concepts developed in other contexts to explain women's under-representation, including the effects of unconscious biases, stereotype threat, and micro-inequities. Other chapters draw on the resources of feminist philosophy to challenge everyday understandings of time, communication, authority and merit, as these shape effective but often unrecognized forms of discrimination and exclusion. Often it is assumed that women need to change to fit existing institutions. This book instead offers concrete reflections on the way in which philosophy needs to change, in order to accommodate and benefit from the important contribution women's full participation makes to the discipline. (shrink)

I argue that, according to Plato, the body is the sole cause of psychic disorders. This view is expressed at Timaeus 86b in an ambiguous sentence that has been widely misunderstood by translators and commentators. The goal of this article is to offer a new understanding of Plato’s text and view. In the first section, I argue that although the body is the result of the gods’ best efforts, their sub-optimal materials meant that the soul is constantly vulnerable to the (...) body’s influences. In the second section, I argue that every psychic disorder is a disruption of the motions of the inner psychic circles by the body; moreover, I defend my translation of 86b. In the final section, I argue that the goal of education is to restore the circles to their original orbits, and I disarm a possible objection that bad education is also a cause of psychic disorder. (shrink)

It is a commonplace that the modern world cannot be experienced as enchanted--that the very concept of enchantment belongs to past ages of superstition. Jane Bennett challenges that view. She seeks to rehabilitate enchantment, showing not only how it is still possible to experience genuine wonder, but how such experience is crucial to motivating ethical behavior. A creative blend of political theory, philosophy, and literary studies, this book is a powerful and innovative contribution to an emerging interdisciplinary conversation about (...) the deep connections between ethics, aesthetics, and politics. As Bennett describes it, enchantment is a sense of openness to the unusual, the captivating, and the disturbing in everyday life. She guides us through a wide and often surprising range of sources of enchantment, showing that we can still find enchantment in nature, for example, but also in such unexpected places as modern technology, advertising, and even bureaucracy. She then explains how everyday moments of enchantment can be cultivated to build an ethics of generosity, stimulating the emotional energy and honing the perceptual refinement necessary to follow moral codes. Throughout, Bennett draws on thinkers and writers as diverse as Kant, Schiller, Thoreau, Kafka, Marx, Weber, Adorno, and Deleuze. With its range and daring, The Enchantment of Modern Life is a provocative challenge to the centuries-old ''narrative of disenchantment,'' one that presents a new ''alter-tale'' that discloses our profound attachment to the human and nonhuman world. (shrink)

It is natural to think that there is something epistemically objectionable about avoiding evidence, at least in ideal cases. We argue that this thought is inconsistent with a kind of risk-avoidance...

In this article, I describe how gender bias can affect the design, testing, clinical trials, regulatory approval, and clinical use of implantable devices. I argue that bad outcomes experienced by women patients are a cumulative consequence of small biases and inattention at various points of the design, testing, and regulatory process. However, specific instances of inattention and bias can be difficult to identify, and risks are difficult to predict. This means that even if systematic gender bias in implant design is (...) an ethical issue, it is one with no clearly blameworthy player. From a practical perspective, there is no single obvious point at which to intervene. Philosophers working in other areas have explored structurally similar moral problems—sometimes referred to as “moral aggregation problems”—such as the type of environmental harm caused by small actions of many players. I describe key features of these type of problems and strategies to address them. I then draw on these to suggest an approach to gender bias in medical implant design and use. (shrink)

This article concerns the place of Plato’s eschatology in his philosophy. I argue that the theory of reincarnation appeals to Plato due to its power to explain how non-human animals came to be. Further, the outlines of this theory are entailed by other commitments, such as that embodiment disrupts psychic functioning, that virtue is always rewarded and vice punished, and that the soul is immortal. I conclude by arguing that Plato develops a view of reincarnation as the chief tool that (...) the gods have to ensure that virtue is victorious over vice throughout the whole cosmos. (shrink)

As one of the preeminent philosophers of the twentieth century, W. V. Quine made groundbreaking contributions to the philosophy of science, mathematical logic, and the philosophy of language. This collection of essays examines Quine's views, particularly his holism and naturalism, for their value to feminist theorizing today. Some contributors to this volume see Quine as severely challenging basic tenets of the logico-empiricist tradition in the philosophy of science—the analytic/synthetic distinction, verificationism, foundationalism—and accept various of his positions as potential resources for (...) feminist critique. Other contributors regard Quine as an unrepentant empiricist and, unlike feminists who seek to use or extend his arguments, they interpret his positions as far less radical and more problematic. In particular, critics and advocates of Quine's arguments that the philosophy of science should be "naturalized"—understood and pursued as an enterprise continuous with the sciences proper—disagree deeply about whether such a naturalized philosophy is "philosophy enough." Central issues at stake in these disagreements reflect current questions of special interest to feminists and also bridge the analytic and postmodern traditions. They include questions about whether and how the philosophy of science, as a form of practice, is or can be normative as well as questions concerning the implications of Quine's philosophy of language for the transparency and stability of meaning. In representing feminist philosophy centrally engaged with the analytic tradition, this volume is important not only for what it contributes to the understanding of Quine and naturalized epistemology but also for what it accomplishes in working against restrictive conceptions of the place of feminism within the discipline. Aside from the editors, the contributors are Kathryn Pyne Addelson, Louise M. Antony, Richmond Campbell, Lorraine Code, Jane Duran, Maureen Linker, Phyllis Rooney, and Paul A. Roth. (shrink)

Women are under-represented in surgery, especially in leadership and academic roles, and face a gender pay gap. There has been little work on the role of implicit biases in women’s under-representation in surgery. Nor has the impact of epistemic injustice, whereby stereotyping influences knowledge or credibility judgements, been explored. This article reports findings of a qualitative in-depth interview study with women surgeons that investigates gender biases in surgery, including subtle types of bias. The study was conducted with 46 women surgeons (...) and trainees of the Royal Australasian College of Surgeons. Maximum variance sampling strategies ensured a comprehensive set of perspectives. Data were analysed using iterative thematic analysis to document and classify forms of gender bias experienced by the participants, including implicit bias and epistemic injustice. It found four types of bias affecting women surgeons: (1) workplace factors such as access to parental leave and role models; (2) epistemic injustices—unfair assessments of women surgeons’ credibility by patients and colleagues; (3) stereotyped expectations that they will carry out more of surgery’s carework, such as meeting the emotional needs of patients and (4) objectification. Implicit biases arose in each category. Given that many of the biases identified in this study are small, are harmless on their own and are not necessarily under anyone’s conscious control, important questions arise regarding how they cause harm and how to address them. I draw on theoretical work on cumulative harm to answer these questions. (shrink)

Patient or public involvement in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research, and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus (...) on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients’ experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker’s idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research. (shrink)

This paper concerns Plato’s characterization of the body as the soul’s tool. I take perception as an example of the body’s usefulness. I explore the Timaeus’ view that perception provides us with models of orderliness. Then, I argue that perception of confusing sensible objects is necessary for our cognitive development too. Lastly, I consider the instrumentality relationship more generally and its place in Plato’s teleological worldview.

This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period (...) affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software—particularly software that can be remotely accessed—in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered. (shrink)

In their analysis Childress et al. (2023) suggest that withdrawal of extracorporeal membrane oxygenation (ECMO) over a patient’s dissent is not justified by existing ethical arguments. The alternat...

Medical devices with built-in bias can both result from, and contribute to, harmful systemic racial oppression—a point that Liao and Carbonell (2023) argue convincingly in the target article of thi...

This paper rejects a traditional epistemic interpretation of conditional probability. Suppose some chance process produces outcomes X, Y,..., with probabilities P(X), P(Y),... If later observation reveals that outcome Y has in fact been achieved, then the probability of outcome X cannot normally be revised to P(X|Y) ['P&Y)/P(Y)]. This can only be done in exceptional circumstances - when more than just knowledge of Y-ness has been attained. The primary reason for this is that the weight of a piece of evidence varies (...) with the means by which it is provided, so knowledge of Y-ness does not have uniform impact on the probability of X. A better updating of the probability of X is provided by P(X|Y*), where Y* is not an outcome of the chance process being observed, but the sentence 'the outcome Y has been observed', an 'outcome' of the subsequent observation process. This alternative formula is widely endorsed in practice, but not well recognized in theory, where the oversight has generated some unsatisfactory consequences. (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)