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)

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)

Retraction Note to: J Value Inquiry (2003) 37:195–203 DOI 10.1023/A:1025328510953This article has been retracted by the author as it was a duplication of the article "Surgical Research and the Ethics of Being First" by Isenberg JS which was published in the “Journal of the Philosophy of Surgery and Medicine” 2002; 1: 45–54.

In parallel with the rapid rise in breast cancer incidence, there is also a noticeable rise in the number of patients who experience persistent negative body image cognition after breast cancer surgery. This study aimed to explore the differences in illness perception, social support, and body image cognition among breast cancer patients with different surgical methods, and the correlation, regression, and mediation among the three variables. The Brief Illness Perception Questionnaire, the Social Support Rating Scale and the Body Image (...) Cognition after Breast Cancer Questionnaire were used to evaluate breast cancer patients’ illness perception, social support and body image cognition. Data analyses were performed by descriptive statistics, independent samples t-test, analysis of variance, Pearson correlation, and linear regression. The mediation was explored by the PROCESS V3.3. The study found that breast cancer patients undergoing radical mastectomy and modified radical mastectomy demonstrated more negative illness perception, body image cognition, and lower social support compared with the patients receiving nipple-sparing mastectomy. The subscale cognitive representation of BIPQ was strongly positively correlated with BIBCQ. Illness perception positively predicted body image cognition, while social support negatively predicted body image cognition. Social support partially mediated illness perception and body image cognition, exhibiting a positive role in post-operative body image cognition. (shrink)

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (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)

This is the first textbook of surgical ethics. It is a practical, clinically comprehenive, well-organized guide to ethical issues in surgical practice, research, and education written by leading figures in surgery and bioethics. The authors cover the surgeon-patient relationship, the full range of surgical patients, surgical education and research, and surgery and managed care. Their chapters are not abstract discussions of ethical principles; rather, they connect directly with the everyday concerns of practicing surgeons.

Background and aim: Surgical intensive care nurses should have ethical sensitivity allowing them to identify ethical issues in order that they can recognize them and make the right decisions. This descriptive study was conducted with the aim of evaluating the ethical sensitivity of surgical intensive care nurses. Materials and methods: The research was carried out with the participation of 160 nurses in six Turkish hospitals, four state, one university, and one private. The data were collected using the (...) “Nurse Description Form” developed by the researcher and the “Ethical Sensitivity Questionnaire.” The percent, mean, standard deviation, median, minimum and maximum values, significance test for the difference between two means, variance analysis, Mann–Whitney U test, and Kruskal–Wallis Variance Analysis test were used to evaluate the data. Ethical considerations: Ethical commission permission and the corporate permission of the hospitals were received before conducting the research. Results: It was determined that the ethical sensitivities of surgical intensive care nurses were moderate based on the Ethical Sensitivity Questionnaire total score and subdimension score averages. A statistical difference was determined between the Ethical Sensitivity Questionnaire total score of surgical intensive care nurses and the institution where they worked, the period of working in the occupation, and the period of working in the intensive care unit (p < 0.05). Conclusion: Based on the results of the research, the organization of training and studies devoted to the elimination of ethical sensitivity differences between institutions and workers is suggested. (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)

Background: Informed consent involves patients being informed, in detail, of information relating to diagnosis, treatment, care and prognosis that relates to him or her. It also involves the patient explicitly demonstrating an understanding of the information and a decision to accept or decline the intervention. Nurses in particular experience problems regarding informed consent. Research question and design: This descriptive study was designed to determine nurse knowledge and practices regarding their roles and responsibilities for informed consent in Turkey. The (...) class='Hi'>research was performed using 92 nurses who work at the surgical clinics. Data collection form was prepared by the researchers with assistance from the literature, and the data were evaluated by the SPSS 12.0 data analysis program. Ethical consideration: This study was approved by the Medicine and Health Sciences Research and Ethics Committee of the university. Written consent was received from the nurses. Findings: Among the nurses who participated in this study, 39.1% indicated that they were responsible for obtaining informed consent. It was also found that 90.2% of the nurses informed patients before providing nursing interventions and 32.6% of the nurses obtained consent from patients, and 90.0% of the nurses who indicated that they obtain patient consent only obtain verbal consent. Among all of the nurses, 21.7% agreed that informed consent needs to be obtained in order to protect the medical staff legally. Discussion: It is argued that a lack of official procedures at hospitals regarding informed consent and insufficient information being provided to healthcare providers has caused problems regarding informed consent. Conclusion: The nurses in this study lacked information regarding their role in obtaining informed consent from patients and they often performed incomplete and/or incorrect practices within the framework of their required role. It is believed that an increased level of education along with the creation of official policies and procedures would contribute towards solving these problems. (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)

In preparing for a lecture on the ethics of surgical complications, it became apparent that confusion exists about the definition of a ‘‘surgical complication.’’ Is it, as one medical website states, ‘‘any undesirable result of surgery?’’ [1]. In the European Journal of Surgery, Veen et al. [2] provide a more elaborate definition: ‘‘every unwanted development in the illness of the patient or in the treatment of the patient’s illness that occurs in the clinic’’ [2]. An esteemed historian of (...) science suggests yet another definition in a recent volume on surgical complications: ‘‘a complication, in any sphere of endeavour, is something out of the norm, and the product of extraneous and unexpected factors’’ [3]. Such is the discrepancy in definitions that Rampersaud et al. [4] declared in 2006 that ‘‘presently, there is no clear or consistent definition of a complication in the surgical literature.’’ Much research in surgery aims to reduce the risk of surgical complications. However, until we have a stable and agreed definition of what counts as a surgical complication, we cannot reliably compare different studies to discover what best reduces the chance of surgical complications [5]. Therefore, the topic is more than mere pedantry; defining surgical complications will help us with the broader question of how to improve surgical practice. A basic PubMed search returned nearly 800 articles with the phrases ‘‘surgical complications’’ or ‘‘surgical complication’’ in the title. But unlike the sources above. (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. (shrink)

In my reply to Wertheimer and Miller's paper on coercive offers and payment for research participation1 I claim that ‘… it's not unreasonable to suppose that there is another normative aspect to these cases, over and above the voluntariness of consent. While the parents of children at Willowbrook and the millionaire's mistress might have given consent that was voluntary and informed, they are still wronged by taking up this offer…’2 Furthermore, nowhere in my paper on surgical castration do (...) I claim that coercive offers invalidate consent,3 and I suggest that Bomann-Larsen has come closest to cashing this out correctly with her idea that ‘the wrongness of these coercive offers has more to do with the wilful creation of choices that take advantage of others vulnerabilities…’.4 So, it is puzzling that they object to my analysis of coercion and castration because coercive offers are not readily unpacked as a problem with consent. …. (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)

Although the field of surgical ethics focuses primarily on informed consent, surgical decision‐making, and research ethics, some surgeons have started to consider ethical questions regarding justice and solidarity with poor and minoritized populations. To date, those calling for social justice in surgical care have emphasized increased diversity within the ranks of the surgical profession. This article, in contrast, foregrounds the agency of those most affected by injustice by bringing to bear an ethic of accompaniment. The (...) ethic of accompaniment is born from a theological tradition that has motivated work to improve health outcomes in those at the margins through its emphasis on listening, solidarity against systemic drivers of disease, and proximity to individuals and communities. Through a review of surgical ethics and exploration of a central patient case, we argue for applying an ethic of accompaniment to the care of surgical patients and their communities. (shrink)

Background Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research. Objective Our aim was to assess whether REC approval and ICP were documented in surgical trials. Study design Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the (...) corresponding author when ethical information was lacking. Results Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP. Conclusions The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines. (shrink)

Background: Informed consent goes beyond signing a form; it is a process of providing necessary information, helping patients make an informed decision, and actively participate in their treatment. Aim/objective: This study aimed to assess the quality of obtaining surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences. Research design/participants/context: In a cross-sectional, descriptive-analytical study, 300 patients were chosen through stratified sampling from seven hospitals affiliated with Tehran University of Medical Sciences. Data were collected using a (...) questionnaire developed by the researchers and analyzed using descriptive and analytical statistics on SPSS software. Ethical considerations: Ethical approval of this study was granted by Tehran University of Medical Sciences research ethics committee. Written informed consent for participation was obtained. The participants were reassured that their information will be used anonymously and their answers will not affect their treatment and care. Findings: The mean score of quality of acquisition of informed consent was 17.13 out of 35, indicating that the quality falls in the inappropriate category. The results indicate that 48% of the signatories do not even read the form before signing it. Among the 52% who did read the consent form, 61.3% mentioned varying degrees of incomprehensibility of the consent form and 94.2% mentioned the presence of incomprehensible technical, medical and legal vocabulary. Only 12% and 18% of respondents reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form. The quality of obtaining informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries. Discussion: This study shows a poor practice in obtaining surgical informed consent in Iran. It seems necessary to consider fundamental changes in the process of acquiring consent based on the temporal and local conditions of the patients. (shrink)

The allocation of critical care resources and triaging patients garnered a great deal of attention during the COVID-19 pandemic, but there is a paucity of guidance regarding the ethical aspects of resource allocation and patient prioritization in ‘normal’ circumstances for Canadian healthcare systems. One context where allocation and prioritization decisions are required are surgical waitlists, which have been globally exacerbated due to the COVID-19 pandemic. In this paper, we detail the process used to develop an ethics framework to support (...) prioritization for elective surgery at The Hospital for Sick Children, Toronto, a tertiary pediatric hospital. Our goal was to provide guidance for the more value-laden aspects of prioritization, particularly when clinical urgency alone is insufficient to dictate priority. With this goal in mind, we worked to capture familial, relational, and equity considerations. As part of our institution’s concerted efforts to ethically and effectively address our surgical backlog, an ethics working group was formed comprising clinicians from surgery, anesthesiology, intensive care, a hospital bioethicist, a parent advisor, and an academic bioethics researcher. A reflective equilibrium process was used to develop an ethics framework. To this end, the same methodology was used to create a support for patient prioritization that identifies clinically and morally relevant factors for prioritization among medically similar surgical cases, with a substantive goal being to identify and redress health inequities in surgical prioritization, inasmuch as this is possible. While further steps are needed to validate several aspects of the framework, our research suggests that an ethics framework grounded in the practical realities of hospital operations provides consistency, transparency, and needed support for decisions that are often left to individual clinicians, as well as an opportunity to reflect upon the presence of health inequities in all domains of healthcare delivery. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Consenting for Novel and Dangerous Surgical Procedures with Minimal Supporting EvidenceMichelle J. ClarkeFrank1 was a 19–year–old man referred to me after a workup for back pain led to the discovery of a large, aggressive tumor in his sacrum. The tumor wrapped around the nerves controlling bowel, bladder, and leg function. We performed a needle biopsy and learned that the tumor was an angiosarcoma, an extremely aggressive and usually (...) deadly form of cancer. However, the tumor was unique in that it theoretically could be cured if removed in one piece. But, to do so would necessitate sacrificing the nerves, leaving the patient irreversibly incontinent, lacking sexual function, and confined to a wheelchair.Once we knew the diagnosis, Frank came to the office with his family to discuss treatment options. He appeared terrified and was almost silent through the appointment, deferring most questions to his parents. Due to the speed of tumor growth, we discussed palliative therapy, conventional treatment, and the one–piece or “en bloc” surgery, which was new and unproven for his disease. Based on the remarkable tumor growth we noted during the work–up, with palliative treatment the patient would likely survive for less than six months. Conventional treatment, in which surgery is done to remove part of the tumor while sparing the nerves to bowel and bladder function, was known to have a high rate of recurrence and death. Further, this tumor didn’t respond well to radiation and chemotherapy, so chance of survival was limited, although his life might have been extended for a short period. Thus our conversation turned to the novel “en bloc” procedure.The en bloc procedure offered a hope of long–term survival unlike the other options. However, this came with an enormous cost. The surgery itself would be planned to occur over three days with five separate surgical teams and a very real chance of major complications or death. Nerves to bowel and bladder would be cut, irreversibly leaving the patient without sexual function, and completely incontinent with a urinary catheter and colostomy. Walking was expected to be disrupted or potentially impossible due to the nerve resection. We went to great lengths over the course of many visits to describe the impact of the surgery on the patient’s function, and the impact on his quality of life. To make matters more challenging, as this procedure was so new and the tumor so rare, research did not yet exist to quantify his likelihood of long–term survival.Personally I was very uncomfortable with the situation. From a medical standpoint, the surgery offered was the best distillation of research and professional experience. En bloc surgery offered the best—if not the only—chance for survival in [End Page 5] this young man. Additionally, having treated many spine–injured patients I was aware that many patients with similar deficits led happy and productive lives following an emotional and physical adjustment period. However the surgery was also extreme. I worried that we would not be able to accomplish the goal of a one–piece resection and would accidentally spill some of the tumor, creating all of the deficits but no survival benefit. Frankly, I thought there was a 25% chance that would happen, which was explained to the family preoperatively. Were we overreaching our abilities and making a dying patient’s life worse by proceeding?Second, I was uneasy about the social situation. The patient’s family was very supportive, traveling with him to all appointments and assisting with his care. The patient himself usually deferred all scheduling to his mother, which wasn’t entirely unusual for such a young man. However it was difficult to grasp how much the patient understood of his disease or supported the plan. We attempted to delve more deeply into his thoughts, including without his parents present, but got only short answers, which revealed little. While the family appeared to have accepted the diagnosis and wanted to get to the business of treatment, the patient seemed to me to still carry the shock of his recent cancer diagnosis. Pushed by the rapid tumor growth, we were limited in how long we could wait for... (shrink)

Background: It is stated that high ethical sensitivity positively affects the quality of nursing care. However, the relationship between nursing care quality and ethical sensitivity has not been clearly demonstrated in researches. Aim: This study was carried out to determine the relationship between surgical nurses’ care behaviors and their ethical sensitivity. Method: The sample of this cross-sectional, descriptive-correlational study consists of 308 nurses who worked at the surgical departments in four Turkish hospitals. The data were collected using the (...) “Nurse Description Form” developed by the researcher, “Caring Behaviours Inventory-24” and “Ethical Sensitivity Questionnaire.” Data were evaluated by the Mann Whitney U test, Kruskal Wallis one-way analysis of variance and Spearman correlation analysis. Ethical considerations: The study was approved by the ethics committee. Verbal and written consent was received from the nurses. Results: It was found in the study that nurses’ Caring Behaviours Inventory-24 total score median was 5.25 (4.83–5.58), nurses’ perception level of caring quality was high, median of Ethical Sensitivity Questionnaire total score was 89.00 (75.00–101.00) and nurses’ ethical sensitivity was moderate. A negative significant relation was found between nurses’ Caring Behaviours Inventory-24 total score and Ethical Sensitivity Questionnaire total score (r = -0.162; p = 0.009). A negative relation was also detected between nurses’ working period at the current clinic and providing benefit (r = -0.147; p = 0.012), holistic approach (r = -0.139; p = 0.018) and orientation (r = -0.175; p = 0.003) scores of Ethical Sensitivity Questionnaire sub-scales. Conclusion: Nurses’ perception levels of caring quality were high and their ethical sensitivity levels were moderate. It was found out that nurses’ ethical sensitivity increased together with their perception of caring quality, and as their working period at the current clinic increased, the ethical sensitivity also increased in terms of the sub-scales of providing benefit, holistic approach, and orientation. The factors that adversely affect the quality of nursing care and ethical sensitivity should be examined and attempts should be made to improve the working environment. (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)

Surgical expertise does not have a clear definition and is often culturally associated with power, authority, prestige, and case number rather than more objective proxies of excellence. Multiple models of expertise progression have been proposed including the Dreyfus model, however, they all currently require subjective evaluation of skill. Recently, efforts have been made to improve the ways in which surgical excellence is measured and expertise is defined using artificial intelligence, video recordings, and accelerometers. However, these aforementioned methods of (...) assessment are still subjective or indirect proxies of expertise, thus uncovering the neural mechanisms that differentiate expert surgeons from trainees may enhance the objectivity of surgical expertise validation. In fact, some researchers have already suggested that their neural imaging-based expertise classification methods outperform currently used methods of surgical skill certification such as the Fundamentals of Laparoscopic Surgery scores. Such imaging biomarkers would not only help better identify the highest performing surgeons, but could also improve residency programs by providing more objective, evidence-based feedback and developmental milestones for those in training and perhaps act as a marker of surgical potential in medical students. Despite the potential advantages of using neural imaging in the assessment of surgical expertise, this field of research remains in its infancy. This systematic review identifies studies that have applied neuromonitoring in assessing surgical skill across levels of expertise. The goals of this review are to identify the strongest neural indicators of surgical expertise, the limitations of the current literature on this subject, the most sensible future directions for further study. We found substantial evidence that surgical expertise can be delineated by differential activation and connectivity in the prefrontal cortex across multiple task and neuroimaging modalities. Specifically, novices tend to have greater PFC activation than experts under standard conditions in bimanual and decision-making tasks. However, under high temporal demand tasks, experts had increased PFC activation whereas novices had decreased PFC activation. Common limitations uncovered in this review were that task difficulty was often insufficient to delineate between residents and attending. Moreover, attending level involvement was also low in multiple studies which may also have contributed to this issue. Most studies did not analyze the ability of their neuromonitoring findings to accurately classify subjects by level of expertise. Finally, the predominance of fNIRS as the neuromonitoring modality limits our ability to uncover the neural correlates of surgical expertise in non-cortical brain regions. Future studies should first strive to address these limitations. In the longer term, longitudinal within-subjects design over the course of a residency or even a career will also advance the field. Although logistically arduous, such studies would likely be most beneficial in demonstrating effects of increasing surgical expertise on regional brain activation and inter-region connectivity. (shrink)

Some transgender and nonbinary people undergo phalloplasty and/or metoidioplasty as part of their medical transition process. Across surgical disciplines, a variety of resources are used to assist patients who are preparing for surgeries, including educational materials, workshops, peer support, and lifestyle changes. For gender-affirming surgeries, patients undergoing assessments to discern whether they are ready to undergo the surgery, and to assist them in achieving preparedness when needed. Little research investigates what resources are useful in helping patients to feel (...) prepared to undergo phalloplasty or metoidioplasty, and how assessments and resources can promote patient autonomy in the process. Respect for patient autonomy is one of the central tenets of ethical healthcare, yet historically, scholarship related to pre-surgical assessments for gender-affirming surgery has focused determining the ideal surgical candidate rather than respecting patient autonomy and ascertaining individual patient needs. This study sought to fill this gap by utilizing data from PROGRESS (Patient-Reported Outcomes of Genital Reconstruction and Experiences of Surgical Satisfaction), a cross-sectional, community-based survey of trans and nonbinary adults from the United States of America and Canada who had undergone one or more of these surgeries. Results revealed most participants (86%, n = 186) felt prepared to undergo surgery, though the majority of our sample (53%, n = 105) did not find referral letter assessments to be helpful. Peer support such as online resources/blogs were rated as highly useful, along with surgical consults. In a multivariable logistic regression, higher perceived preparedness was associated with identifying as queer (inclusive of gay, bi and pansexual compared to being straight), and feeling that one’s assessment process was useful (as opposed to not useful). Type of assessment was not significantly associated with preparedness; therefore, what is most useful when preparing for surgery may vary across individuals. Healthcare professionals who interact with preparing patients should develop new or utilize existing resources to assist patients in identifying their preparation needs and achieving preparedness. Our data supports assessments that center surgical care planning rather than assessing level of gender dysphoria. Future longitudinal research could further refine which assessment processes are most effective in helping patients who are preparing for these surgeries. Assessments should ensure that patients are appropriately prepared to undergo and recover from surgery through a robust process of informed consent. (shrink)

A young woman called me to ask for a referral to a physician who provided hymen reconstruction surgery. She had had premarital intercourse and came from a cultural background in which it was very important to “prove virginity” on the wedding night. This article deals with my internal struggle whether or not to provide the referral. I felt that providing it would have made me complicit in supporting gender inequality, as men are not required to “prove virginity” to get married. (...) At the same time, I was concerned about the repercussions of not being able to “prove virginity” would have on the caller. I had no explicit guidance on what to do in such a situation—it was not covered by the professional responsibilities I had as a research assistant. (shrink)

Background: Informed consent can be obtained by various methods, by various people, and with use of various types of consent forms. Persistent effort is necessary to reveal the practical realities of informed consent to improve ethical and legal standards. Objective: To determine the ethical challenges of obtaining informed consent from surgical patients. Methods: The present study was a descriptive cross-sectional study using two researcher-made questionnaires and a checklist for data collection. Data were collected from nursing personnel ( n = (...) 95) and surgical patients ( n = 203) on the surgical wards of three university hospitals in Isfahan, Iran. Data were analyzed using descriptive statistics, Spearman’s rank correlation, Pearson’s correlation coefficient, and the t-test. Ethical considerations: The study was approved by the Ethics Committee of Isfahan University of Medical Sciences (No: 396478). Results: The mean scores (maximum 100) of awareness, competency, and authority were 36.3, 67.7, and 57.6, respectively. The overall quality of the informed consent was poor (score 53.9 of 100). The higher educational level in patients was correlated with lower awareness of and less authority to give informed consent. Only 12.6% of the nurses stated that patients were given sufficient information to assure informed consent. In 89.2% of the consent forms, the risks of the treatment were mentioned. However, alternative methods and risks and advantages of rejecting the treatment were not mentioned in any of the forms. Conclusion: Ethical challenges to obtaining informed consent include patients’ poor awareness of their rights, a failure to provide adequate information to patients, absence of consideration of patients’ educational level, an unclear definition of who is responsible for obtaining informed consent from the patients, time constraints, and use of unclear language and medical jargon. Constructing an ethical framework may guide nursing staff in dealing with the ethical challenges involved in obtaining informed consent. (shrink)

BackgroundBurnout is being experienced by medical students, residents, and practicing physicians at significant rates. Higher levels of Hardiness and Emotional Intelligence may protect individuals against burnout symptoms. Previous studies have shown both Hardiness and Emotional IntelIigence protect against detrimental effects of stress and can be adapted through training; however, there is limited research on how training programs affect both simultaneously. Therefore, the objective of this study was to define the association of Hardiness and Emotional Intelligence and their potential improvement (...) through hyper realistic immersion simulation training in military medical students.MethodsParticipants in this study consisted of 68 second year medical students representing five medical schools who were concurrently enrolled in the United States military scholarship program. During a six day hyper-realistic surgical simulation training course, students rotated through different roles of a medical team and responded to several mass-casualty scenarios. Hardiness and Emotional Intelligence were assessed using the Hardiness Resilience Gauge (HRG) and the Emotional Quotient Inventory (EQ-I 2.0) respectively, at two time points: on arrival (pre-event) and after completion of the course (post-event).ResultsHardiness and Emotional Intelligence scores and sub scores consistently improved from pre-event to post-event assessments. No difference in training benefit was observed between genders but differences were observed by age where age was more often associated with Emotional Intelligence. In addition, factor analysis indicated that the HRG and EQ-I 2.0 assessment tools measured predominately different traits although they share some commonalities in some components.ConclusionThis study indicates that Hardiness and Emotional Intelligence scores can be improved through immersion training in military medical students. Results from this study support the use of training course interventions and prompt the need for long term evaluation of improvement strategies on mitigating burnout symptoms. (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)

Computational design uses artificial intelligence (AI) to optimise designs towards user-determined goals. When combined with 3D printing, it is possible to develop and construct physical products in a wide range of geometries and materials and encapsulating a range of functionality, with minimal input from human designers. One potential application is the development of bespoke surgical tools, whereby computational design optimises a tool’s morphology for a specific patient’s anatomy and the requirements of the surgical procedure to improve surgical (...) outcomes. This emerging application of AI and 3D printing provides an opportunity to examine whether new technologies affect the ethical responsibilities of those operating in high-consequence domains such as healthcare. This research draws on stakeholder interviews to identify how a range of different professions involved in the design, production, and adoption of computationally designed surgical tools, identify and attribute responsibility within the different stages of a computationally designed tool’s development and deployment. Those interviewed included surgeons and radiologists, fabricators experienced with 3D printing, computational designers, healthcare regulators, bioethicists, and patient advocates. Based on our findings, we identify additional responsibilities that surround the process of creating and using these tools. Additionally, the responsibilities of most professional stakeholders are not limited to individual stages of the tool design and deployment process, and the close collaboration between stakeholders at various stages of the process suggests that collective ethical responsibility may be appropriate in these cases. The role responsibilities of the stakeholders involved in developing the process to create computationally designed tools also change as the technology moves from research and development (R&D) to approved use. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge (...) the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

Background: Nurses and surgeons may experience intra-team conflict during decision making about the use of postoperative life-sustaining treatment in the intensive care unit due to their perceptions of professional roles and responsibilities. Nurses have a sense of advocacy—a responsibility to support the patient’s best interest; surgeons have a sense of agency—a responsibility to keep the patient alive. Objectives: The objectives were to (1) describe the discourse surrounding the responsibilities of nurses and surgeons, as “advocates” and “agents,” and (2) apply these (...) findings to determine how differences in role responsibilities could foster conflict during decision making about postoperative life-sustaining treatment in the intensive care unit. Research design: Articles, books, and professional documents were explored to obtain descriptions of nurses’ and surgeons’ responsibilities to their patients. Using discourse analysis, responsibilities were grouped into themes and then compared for potential for conflict. Ethical considerations: No data were collected from human participants and ethical review was not required. The texts were analyzed by a surgeon and a nurse to minimize profession-centric biases. Findings: Four themes in nursing discourse were identified: responsibility to support patient autonomy regarding treatment decisions, responsibility to protect the patient from the physician, responsibility to act as an intermediary between the physician and the patient, and the responsibility to support the well-being of the patient. Three themes in surgery discourse were identified personal responsibility for the patient’s outcome, commitment to patient survival, and the responsibility to prevent harm to the patient from surgery. Discussion: These responsibilities may contribute to conflict because each profession is working toward different goals and each believes they know what is best for the patient. It is not clear from the existing literature that either profession understands each other’s responsibilities. Conclusion: Interventions that improve understanding of each profession’s responsibilities may be helpful to reduce intra-team conflict in the intensive care unit. (shrink)

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring (...) of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

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)

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices to read and write shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, (...) no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to safety and security; enhancement as unnecessary, unnatural or aberrant; and fairness, equality, and distributive justice. Most researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening. However, researchers unanimously felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood. (shrink)

BackgroundDespite rapid growth of the scientific literature, no consensus guidelines have emerged to define the optimal criteria for editors to grade submitted manuscripts. The purpose of this project was to assess the peer reviewer metrics currently used in the surgical literature to evaluate original manuscript submissions.MethodsManuscript grading forms for 14 of the highest circulation general surgery-related journals were evaluated for content, including the type and number of quantitative and qualitative questions asked of peer reviewers. Reviewer grading forms for the (...) seven surgical journals with the higher impact factors were compared to the seven surgical journals with lower impact factors using Fisher’s exact tests.ResultsImpact factors of the studied journals ranged from 1.73 to 8.57, with a median impact factor of 4.26 in the higher group and 2.81 in the lower group. The content of the grading forms was found to vary considerably. Relatively few journals asked reviewers to grade specific components of a manuscript. Higher impact factor journal manuscript grading forms more frequently addressed statistical analysis, ethical considerations, and conflict of interest. In contrast, lower impact factor journals more commonly requested reviewers to make qualitative assessments of novelty/originality, scientific validity, and scientific importance.ConclusionSubstantial variation exists in the grading criteria used to evaluate original manuscripts submitted to the surgical literature for peer review, with differential emphasis placed on certain criteria correlated to journal impact factors. (shrink)

In a long and many-sided career, William Hasledine Pepys contributed significantly to the advancement of the chemical and physical sciences during the first half of the nineteenth century. As an original investigator he determined, in collaboration with William Allen, the composition of carbon dioxide, and the density of ammonia, and elucidated the chemical phenomena of respiration in man, animals, and plants. The success of these researches was largely due to the use of ingenious apparatus of his own invention and design. (...) In the field of experimental physics, he investigated several aspects of the recently discovered Voltaic electricity: his 'Voltaic coil', consisting of only two plates, but of very large dimensions, was particularly suited for investigating electromagnetic phenomena and was so used in Davy's researches. Pepys was one of the co-founders of the Mineralogical and Geological Societies, and was elected a Fellow of the Royal Society in 1808. As a prominent member of both the Royal and London Institutions, he held honorary office as Manager and Vice-President, contributing materially to the direction of the affairs of these bodies. Pepys was a friend of Humphry Davy and was acquainted with nearly all the leading scientists and medical men of the day. At the same time, he superintended a notable manufacture of surgical instruments in the City, and promoted by his active directorship the affairs of two public companies, both pioneers in their technological fields, namely the Imperial Continental Gas Association, which was active in introducing the new gas illumination to cities and towns across Europe, and the General Steam Navigation Company, which first maintained a regular passenger and cargo service to Continental ports by the exclusive use of steam-propelled vessels. Pepys' advice in scientific and technical matters was widely sought and freely given; he retained his mental powers to the end of his long life, fulfilling his professional commitments until a few days before his death. (shrink)

As the demand for explainable deep learning grows in the evaluation of language technologies, the value of a principled grounding for those explanations grows as well. Here we study the state-of-the-art in explanation for neural models for natural-language processing (NLP) tasks from the viewpoint of philosophy of science. We focus on recent evaluation work that finds brittleness in explanations obtained through attention mechanisms.We harness philosophical accounts of explanation to suggest broader conclusions from these studies. From this analysis, we assert the (...) impossibility of causal explanations from attention layers over text data. We then introduce NLP researchers to contemporary philosophy of science theories that allow robust yet non-causal reasoning in explanation, giving computer scientists a vocabulary for future research. (shrink)

Background: Patients undergoing invasive neurosurgical procedures offer researchers unique opportunities to study the brain. Deep brain stimulation patients, for example, may participate in research during the surgical implantation of the stimulator device. Although this research raises many ethical concerns, little attention has been paid to basic studies, which offer no therapeutic benefits, and the value of patient-participant perspectives.Methods: Semi-structured interviews were conducted with fourteen individuals across two studies who participated in basic intraoperative research during their deep (...) brain stimulator surgery. Interviews explored interpretations of risks and benefits, enrollment motivations, and experiences of participating in awake brain research. Reflexive thematic analysis was conducted.Results: Seven themes were identified from participant narratives, including robust attitudes of trust, high valuations of basic science research, impacts of the surgical context, and mixed experiences of participation.Conclusion: We argue that these narratives raise the potential for a translational misconception and motivate intraoperative re-consent procedures. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion and the Body in Medical ResearchCourtney S. Campbell (bio)AbstractReligious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions (...) embedded in nontherapeutic use of human tissue. It finds that the “donation paradigm” typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the “resource paradigm” implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a “contribution paradigm” that provides a religious perspective within which research on human tissue can be both justified and limited.The retrieval and use of human tissue samples for diagnostic, therapeutic, research, and educational purposes represent further developments in scientific study of the human body as a source of medical information. Following the completion of its examination of the ethical and policy issues pertaining to human cloning in the spring of 1997, the National Bioethics Advisory Commission (NBAC) returned to the set of questions for which it had been originally constituted, including ethical issues that arise in human subjects research. One issue that proved controversial for the human genetics subcommittee of NBAC was the scientific, philosophical, and legal status of tissue and other body parts (usually surgical specimens) that had been retrieved from patients (not research subjects) who had given general consent to the use of their body materials for research and educational purposes. The subcommittee addressed questions about the adequacy of general versus specific [End Page 275] consent, the scientific merits of identifiable versus anonymous samples and claims about patient confidentiality, and the justification for patient refusals and requests that the materials be returned to the patient or discarded rather than made available for scientific research. In an effort to better understand the ramifications of research on human tissue, the subcommittee commissioned several background papers that examined these questions from ethical, legal, research, and religious perspectives. What follows is a modified version of the report on religious considerations originally presented to the genetics subcommittee of NBAC.The central question examined in this article is whether tissue banking for purposes of research presents distinctive theological issues or prompts objections from religious communities or scholars. Religious discussion of human organs and tissues has focused largely on donation for therapeutic purposes (what I describe as the “donation paradigm”); hence, there is very little direct consideration of nontherapeutic uses of such tissue. It is possible, however, to describe implications and suggest inferences by considering (1) religious attitudes to the human body and to organs, tissues, and cells removed from the body, and (2) religious discussions of modes of transfer of body parts, such as donations, offerings, sales, and abandonment. By and large, this discussion will reflect themes that emerge from the central Western religious traditions, with some attention given to Eastern and Native perspectives.The Body: Religious Holism, Scientific Reductionism, Private PropertyThe human body as an organic totality has long been the subject of theological reflection and a symbol for religious communities. However, much less attention has been devoted to the religious status of organs, tissues, cells, and DNA. The reflection of religious scholars and communities on the status of body parts has been prompted by the necessity to confront practical questions in personal and public health and in communal life, such as justifications for surgery, autopsies, organ donation, or burial. Scientific and research interest in parts of the body can sometimes conflict with religious values about bodily integrity. Indeed, E. Richard Gold cites the “disparate claims of scientific investigation and religious belief on the body” as the exemplary case of incommensurate values regarding the body. According to Gold (1996, p. 149), “The body, from a scientific viewpoint, is a source of knowledge of physical development, aging, and disease. From a religious perspective, the body is understood [End Page 276] as a sacred object, being created in the image... (shrink)

The surgical treatment of breast cancer has changed in recent years. Analysis of the research that led to these changes yields apparently good arguments for all of the following: (1) The research yielded very great benefits for women. (2) There was no other way of obtaining these benefits. (3) This research violated the fundamental rights of the women who were research subjects. This sets a problem for ethics at many levels.

Background: Clinical trials involving children previously considered unethical are now considered a necessity because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.DiscussionThe Zimbabwean parental informed consent document for children (...) participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in interpreting and obtaining informed consent for orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation if the Zimbabwean courts had not legally appointed them. The situation contrasted with general clinical practice where legal papers where not required for providing consent for surgical procedures for example.SummaryExperiences gained from this clinical trial revealed that while there may be internationally established guidelines governing the process of obtaining informed consent for children participating in research, there may be need to be cognizant of the culture within which the research is taking place. This may call for the development of an ethico-legal framework that governs research-involving children in Zimbabwe that would facilitate their participation in clinical research, while ensuring that they are protected from exploitation. The Medical Research Council of Zimbabwe has since started developing that framework in a process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics (...) Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (shrink)

Historically, treatment for pain relief has varied according to the social status of the sufferer. A similar tendency to make arbitrary distinctions affecting pain relief was found in an ethnographic study of animal research laboratories. The administration of pain-relieving drugs for animals in laboratories differed from standard practice for humans and, perhaps, for companion animals. Although anesthesia was used routinely for surgical procedures, its administration was sometimes haphazard. Analgesics, however, were rarely used. Most researchers had never thought about (...) using analgesics and did not consider the subject worthy of serious attention. Scientists interviewed for this study agreed readily that animals are capable offeeling pain, but such assertions were muted by an overriding view of lab animals as creatures existing solely for the purposes of research. As a result, it was the exceptional scientist who was able to focus on anything about the animal's subjective experience that might lie outside the boundaries of the research protocol. (shrink)

Deep Brain Stimulation is currently being investigated as an experimental treatment for patients suffering from treatment-refractory AN, with an increasing number of case reports and small-scale trials published. Although still at an exploratory and experimental stage, initial results have been promising. Despite the risks associated with an invasive neurosurgical procedure and the long-term implantation of a foreign body, DBS has a number of advantageous features for patients with SE-AN. Stimulation can be fine-tuned to the specific needs of the particular patient, (...) is relatively reversible, and the technique also allows for the crucial issue of investigating and comparing the effects of different neural targets. However, at a time when DBS is emerging as a promising investigational treatment modality for AN, lesioning procedures in psychiatry are having a renaissance. Of concern it has been argued that the two kinds of interventions should instead be understood as rivaling, yet “mutually enriching paradigms” despite the fact that lesioning the brain is irreversible and there is no evidence base for an effective target in AN. We argue that lesioning procedures in AN are unethical at this stage of knowledge and seriously problematic for this patient group, for whom self-control is particularly central to wellbeing. They pose a greater risk of major harms that cannot justify ethical equipoise, despite the apparent superiority in reduced short term surgical harms and lower cost. (shrink)

Classic studies in human sensorimotor control use simplified tasks to uncover fundamental control strategies employed by the nervous system. Such simple tasks are critical for isolating specific features of motor, sensory, or cognitive processes, and for inferring causality between these features and observed behavioral changes. However, it remains unclear how these theories translate to complex sensorimotor tasks or to natural behaviors. Part of the difficulty in performing such experiments has been the lack of appropriate tools for measuring complex motor skills (...) in real-world contexts. Robot-assisted surgery (RAS) provides an opportunity to overcome these challenges by enabling unobtrusive measurements of user behavior. In addition, a continuum of tasks with varying complexity – from simple tasks such as those in classic studies to highly complex tasks such as a surgical procedure – can be studied using RAS platforms. Finally, RAS includes a diverse participant population of inexperienced users all the way to expert surgeons. In this perspective, we illustrate how the characteristics of RAS systems make them compelling platforms to extend many theories in human neuroscience, as well as, to develop new theories altogether. (shrink)

Surgery is an important part of contemporary health care, but currently much of surgery lacks a strong evidence base. Uptake of evidence-based medicine (EBM) methods within surgical research and among practitioners has been slow compared with other areas of medicine. Although this is often viewed as arising from practical and cultural barriers, it also reflects a lack of epistemic fit between EBM research methods and surgical practice. In this paper we discuss some epistemic challenges in surgery (...) relating to this lack of fit, and investigate how resources from feminist epistemology can help to characterize them. We point to ways in which these epistemic challenges may be addressed by gathering and disseminating evidence about what works in surgery using methods that are contextual, pluralistic, and sensitive to hierarchies. (shrink)

Public attention on embryo research has never been greater. Modern reproductive medicine technology and the use of embryos to generate stem cells ensure that this will continue to be a topic of debate and research across many disciplines. This multidisciplinary book explores the concept of a 'healthy' embryo, its implications on the health of children and adults, and how perceptions of what constitutes child and adult health influence the concept of embryo 'health'. The concept of human embryo health (...) is considered from preconception to pre-implantation genetic diagnosis to recent foetal surgical approaches. Burgeoning capacities in both genetic and reproductive science and their clinical implications have catalysed the necessity to explore the concept of a 'healthy' embryo. The authors are from five countries and 13 disciplines in the social sciences, humanities, biological sciences and medicine, ensuring that the book has a broad coverage and approach. (shrink)