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)

Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. This article considers this third pathway by examining stem cell-based innovation.Stem cell-based medical innovation is one pathway toward clinical translation. In fact, such an approach was taken in developing umbilical (...) cord blood transplantation, which is now widely viewed as a safe and effective means for treating a range of malignant and non-malignant conditions. While the Guidelines for the Clinical Translation of Stem Cells created by the International Society for Clinical Research provide an approach to clinical translation that involves “responsible innovation” as an alternative to clinical research, there are at least four sets of unanswered questions regarding the use of an innovation pathway in this context that warrant careful attention. (shrink)

Controversy swept the U.K. in January of 2000 over public disclosure of the fact that a Scottish surgeon named Robert Smith had amputated the limbs of two able-bodied individuals who reportedly suffered from a condition known as apotemnophilia. The patients, both of whom had sought and consented to the surgery, claimed they had desperately desired for years to live as amputees and had been unable, despite considerable efforts, to reconcile themselves psychologically to living with the bodies with which they were (...) born. Both surgeries were successful, and both patients, who had undergone psychiatric evaluation prior to the amputations, subsequently reported having no regrets. In the wake of a wave of sensationalistic stories in the media, the hospital at which the surgeries had been performed, the Falkirk and District Royal Infirmary, banned any future surgeries of the kind. Outraged local politicians promptly announced their intention to pass laws banning the procedure outright. One member of Scottish Parliament declared the surgery obscene and asserted that the whole thing is repugnant and legislation needs to be brought in now to outlaw this. (shrink)

Clinical emergencies necessitate immediate action to avert the danger to the patient's life or health. Emergency patients might be in greatest need of novel therapies, and even presumed willing to assume some risk, but research into emergency conditions should be conducted under commonly accepted principles that fulfil the scientific, ethical, and legal criteria. Such criteria already exist in the US, but are still under development in Europe.This article introduces criteria upon which trials in emergency settings may be ethically and legally (...) justified in Europe. Based on both legal texts and professional guidelines, the author has established seven conditions for emergency research, of which informed consent and its substitutes, as well as the conditions of direct benefit requirement and necessity, are considered most problematic and therefore analysed more closely. Other conditions include absence of alternative methods, scientific validity, and approval by an ethics committee. (shrink)

Controversy swept the U.K. in January of 2000 over public disclosure of the fact that a Scottish surgeon named Robert Smith had amputated the limbs of two able-bodied individuals who reportedly suffered from a condition known as apotemnophilia. The patients, both of whom had sought and consented to the surgery, claimed they had desperately desired for years to live as amputees and had been unable, despite considerable efforts, to reconcile themselves psychologically to living with the bodies with which they were (...) born. Both surgeries were successful, and both patients, who had undergone psychiatric evaluation prior to the amputations, subsequently reported having no regrets. In the wake of a wave of sensationalistic stories in the media, the hospital at which the surgeries had been performed, the Falkirk and District Royal Infirmary, banned any future surgeries of the kind. Outraged local politicians promptly announced their intention to pass laws banning the procedure outright. One member of Scottish Parliament declared the surgery obscene and asserted that the whole thing is repugnant and legislation needs to be brought in now to outlaw this. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients (...) and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

Stem cell-based innovation is one pathway to clinical translation that stands in contrast to clinical research and medical treatment. After reviewing recently issued guidelines for responsible innovation, this article examines the potential benefits and harms of using this pathway as well as practical barriers and conceptual concerns regarding it.