Background Female genital mutilation and circumcision (FGM/C) practices present physicians in Germany with numerous challenges. One possible intervention is elective clitoral reconstruction for esthetic and physiological recovery after FGM/C. Even if the study situation regarding the results achieved by clitoral reconstruction is controversial, the range of reconstruction options is increasing. Arguments The aim of this study is to critically examine the epistemic and ethical dimensions of the interdisciplinary debate on clitoral reconstruction that has arisen over the last 20 years. It (...) is intended to provide orientation in the complex field in which cultural, gender-specific, sexual, and psychosocial factors interact with anatomical–physiological knowledge and the lack thereof. The analysis shows the ambivalent role of evidence claims and promises in relation to clitoral reconstruction. Conclusions Difficulties in testing and comparing existing surgical procedures and in the use of standardized questioning tools demonstrate how essential cultural competence and diversity awareness are in dealing with those affected. The prima facie correct argument of insufficient evidence on the efficacy, comparability, and long-term consequences of reconstruction procedures proves to be problematic for ethical and epistemic reasons. In order to generate valid and useful data on sexuality, body perception, pain, and pleasure before and after clitoral reconstruction, survey modalities that address the culturally heterogeneous target group of women with FGM/C are needed. Cultural competence and sensitivity in medicine are also urgently needed for target group-oriented education and counseling as a prerequisite for self-determined decisions for/against clitoral reconstruction. (shrink)

PurposeAdolescents develop their decision-making ability as they transition from childhood to adulthood. Participation in their medical care should be encouraged through obtaining assent, as recommended by the American Academy of Pediatrics (AAP). In this research, we aim to define the current knowledge of AAP recommendations and surgeon practices regarding assent for elective reconstructive procedures.MethodsAn anonymous electronic survey was distributed to North American paediatric surgeons and fellows through the American Pediatric Surgical Association (n=1353).ResultsIn total, 220 surgeons and trainees (...) responded (16.3%). Fifty per cent of the surgeons who are familiar with the concept of assent had received formal training; 12% of the respondents had not heard of assent before the survey. Forty-seven per cent were aware of the 2016 AAP policy statement regarding assent in paediatric patients. Eighty-nine per cent always include adolescents as part of the consent discussion. Seventy-seven per cent solicit an expression of willingness to accept the proposed care from the patient. The majority (74%) of the surgeons perceived patient cooperation/understanding as the biggest barrier to obtaining assent. Over half of the respondents would consider proceeding with elective surgery despite the adolescent patient’s refusal. Reasons cited for proceeding with elective surgery include surgeons’ perception of medical necessity, perceptions of disease urgency, and lack of patient maturity.ConclusionPaediatric surgeons largely acknowledge the importance of assent, but variably practice the principles of obtaining assent from adolescent patients undergoing elective reconstructive procedures. Fewer surgeons are explicitly aware of formal policy statements or received formal training. Additional surgeon education and institutional policies are warranted to maximise inclusion of adolescents in their medical care. (shrink)

Background The German Diagnosis-Related Groups (G-DRG) system has led to a revenue-orientated hospital financing system. This article examines the ethical implications and consequences of this system using the example of reconstructive measures (defect care) in patients with oral cavity carcinoma. At the same time, the interplay between the G‑DRG system and guideline development must also be scrutinized. This is preceded by introductory information on oral cavity carcinoma and the existing treatment options: conventional reconstruction techniques versus cost-intensive high-end surgery. Methods (...) The case scenario “treatment of medium-sized defects after tumor resection” forms the methodological basis and argumentative reference point of the study. Results and discussion The G‑DRG system and the economic incentives lead to far-reaching ethical implications concerning the demand-orientated treatment of patients and lead to multidimensional interactions. The existing tendency towards high-end surgery harbors the risk of overuse and misuse and, therefore, runs counter to the principles of beneficence and nonmaleficence. The one-sided indication in favor of high-end surgery also suggests that patient information is given in a directive manner (violation of respect for patient autonomy). Moreover, costly high-end procedures counteract the principle of economic efficiency and, thus, touch on issues of distributive justice. Finally, the clinical favoring of high-end procedures also affects logic within medicine, namely the publication landscape (publication bias), the design of the relevant guidelines, and surgical expertise. Conclusions There is a need to raise the awareness of all those working in the field of surgery (surgeons, guideline experts, reviewers). (shrink)

With the recent advent of facial transplant (FT) treatment, patients who live with facial disfigurement have a new hope of improved facial aesthetics and quality of life. However, FT has been the subject of intense ethical debate, and there are numerous important ethical considerations surrounding FT that require further in-depth exploration. In the present review, the numerous ethical issues surrounding FT are elucidated, especially the weighty psychosocial impacts of FT, issues surrounding patients’ consent, selection and donor matching, and current challenges (...) with postoperative complication management and the facial reconstruction of donors. These are discussed with a key focus on stakeholders’ perspectives including recipients, donors’ families, and the medical teams involved. This review found that a number of key ethical questions remain unanswered in the field of FT, and further consideration is needed for this novel surgical procedure to have the same evidence-based ethical backing as conventional surgical procedures. (shrink)

Seeing from somewhere in particular -- Embracing binocularity -- Creativity and gratitude -- Technology as vlaue-free and as value-laden -- Nobody's against true enhancement -- Comprehending persons as subjectss and as objects -- Respecting persons as subjects and as objects.

Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated. There are several reasons explaining this difference, and all of them point to the difficulty of conducting (...) well-designed RCTs in surgery. However, we argue that none of these arguments is decisive and that, under certain conditions, surgical RCTs can be morally justified and methodologically sound. Although ethical constraints restrict the number of testable surgical procedures, and surgical trials might not be as dependable as pharmaceutical RCTs, our analysis suggests that, in certain cases, it is possible to obtain high-quality evidence about the safety and efficacy of surgical procedures. Untested surgical treatments may prove to be ineffective and harm patients. Therefore, regulation of surgical procedures seems not only morally acceptable and able to provide reliable scientific evidence, but also desirable and justified from an ethical-political standpoint. (shrink)

Background There is increasing use of the Internet by patients as an educational tool prior to a surgical procedure. However, the quality of information is highly variable, and it is imperative that as clinicians, we are aware of the information available to ensure that consent is valid and avoid unrealistic expectations. Our aim is to assess the quality of medical information available on the Internet related to common surgical procedures. Methods Analysis of the quality of patient information (...) on 10 websites for six common surgical conditions ( n = 54 following exclusions) was assessed using the DISCERN questionnaire and, for readability, using the Flesch reading ease test. Results There was high variation in the DISCERN score from 1.34 to 4.4 (mean 2.75). Overall, poor quality of patient information is available. Consistent scoring below 55 on Flesch reading ease score suggests a reading level beyond the majority of the patient population. Conclusion The majority of patient-centred health education on the Internet is poor. Therefore, improved verbal and written information during consultation combined with local, national and international websites is important to meet patient’s expectations and avoid issues regarding consent. (shrink)

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

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed in a number (...) of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients’ access to the relevant procedural information and therefore enhance informed decision-making.In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices. (shrink)

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

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

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)

Background: Attending surgeons must maintain balance between promoting education and assuring safe, transparent patient care. This investigation aimed to define ethics that guide surgical training. We hypothesized that resident autonomy in the operating room is influenced by attending approach to patients, specifically patients considered to be vulnerable. Materials and Methods: After IRB approval, surgeons from three institutions were invited to participate in a pilot, survey, exploring how principles of patient autonomy, physician beneficence, nonmaleficence, and justice apply to participant opinions. (...) Responses were transcribed and coded for quantitative and qualitative analysis. Results: 51 attendings and 55 residents completed the survey. We identified that patient autonomy is upheld through transparent consent practices. Intraoperative supervision is a key practice that maintains the principles of physician beneficence and nonmaleficence and mitigates the risk of resident participation. Vulnerable patients were defined by respondents as those unable to participate in their own consent and those limited by social determinants of health and barriers to medical literacy. In contrast, resident participation is not limited in the care of vulnerable patients but is restricted in cases of higher complexity and those procedures deemed to have lower error margins. Conclusions: Although residents measure the success of their training based on their level of intraoperative independence, autonomy afforded to the resident does not only depend on objective skill. There are ethical considerations that the attending must navigate as they decide on effective teaching and safe surgical management, which is especially relevant in the care of complex cases. (shrink)

Young children with cancer are treated with interventions that can have a high risk of compromising their reproductive potential. ‘Fertility preservation’ for children who have not yet reached puberty involves surgically removing and cryopreserving reproductive tissue prior to treatment in the expectation that strategies for the use of this tissue will be developed in the future. Fertility preservation for prepubertal children is ethically complex because the techniques largely lack proven efficacy for this age group. There is professional difference of opinion (...) about whether it is ethical to offer such ‘experimental’ procedures. The question addressed in this paper is: when, if ever, is it ethically justifiable to offer fertility preservation surgery to prepubertal children? We present the ethical concerns about prepubertal fertility preservation, drawing both on existing literature and our experience discussing this issue with clinicians in clinical ethics case consultations. We argue that offering the procedure is ethically justifiable in certain circumstances. For many children, the balance of benefits and burdens is such that the procedure is ethically permissible but not ethically required; when the procedure is medically safe, it is the parents’ decision to make, with appropriate information and guidance from the treating clinicians. We suggest that clinical ethics support processes are necessary to assist clinicians to engage with the ethical complexity of prepubertal fertility preservation and describe the framework that has been integrated into the pathway of care for patients and families attending the Royal Children’s Hospital in Melbourne, Australia. (shrink)

The article reconstructs, in economic terms, managerial business ethics perceptions in the Japanese consumer market for fast-moving daily consumption products. An economic, three-level model of moral agency was applied that distinguishes unintentional moral agency, passive intentional moral agency and active intentional moral agency. The study took a qualitative approach and utilized as empirical research design an interview procedure. The study found that moral agency of Japanese firms mostly extended up to unintentional and intentional passive moral agency. Certain myopic managerial views (...) were found to affect active moral agency. This leaves room for business ethics program that aim at the development of active moral agency. (shrink)

ObjectivesTo identify and analyse ethical considerations raised when individuals with body dysmorphic disorder consult for non-surgical cosmetic procedures.MethodsEthical analysis was conducted addressing the issues of best interests and capacity to consent for non-surgical cosmetic procedures in individuals with BDD. Analysis was informed by the findings of semistructured interviews with non-surgical cosmetic practitioners and mental health professionals.FindingsNon-surgical cosmetic interventions were viewed not to be in the best interests of individuals with BDD, as they fail to (...) address core psychological issues, result in dissatisfaction post-procedure, and risk harm. Referral to mental health services was advocated, however numerous obstacles to this were perceived. The issue of capacity to consent to non-surgical cosmetic procedures raised questions regarding whether standard capacity assessment is sensitive to the manner in which BDD may influence decision-making processes. In addition, concerns were voiced that decisions made by individuals with BDD in this context may be judged foolish, and thus wrongly equated with lack of capacity.Discussion/conclusionsEthical analysis, informed by the available evidence base, suggests that it is generally not in the best interests of individuals with BDD to undergo non-surgical cosmetic intervention, and referral to mental health services is indicated. Analysis of capacity draws parallels between BDD and anorexia nervosa, as decision-making capacity in both conditions can be impaired by pathological values derived from the disorder. Means of differentiating clinical assessment of pathological values from inappropriate value judgements are advocated, in order to safeguard against the latter encroaching into capacity assessment. (shrink)

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by (...) proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques. (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)

Surgical Informed Consent has long been recognized as an important component of modern medicine. The ultimate goals of SIC are to improve clients’ understanding of the intended procedure, increase client satisfaction, maintain trust between clients and health providers, and ultimately minimize litigation issues related to surgical procedures. The purpose of the current study is to assess the comprehensiveness of the SIC process for women undergoing obstetric and gynecologic surgeries. A hospital-based cross-sectional study was undertaken at Hawassa University (...) Comprehensive Specialized Hospital in November and December, 2016. A total of 230 women who underwent obstetric and/or gynecologic surgeries were interviewed immediately after their hospital discharge to assess their experience of the SIC process. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeon’s standards of informed consent practices for surgical procedures. Descriptive summaries are presented in tables and figures. Forty percent of respondents were aged between 25 and 29 years. Nearly a quarter had no formal education. More than half of respondents had undergone an emergency surgical procedure. Only 18.4% of respondents reported that the surgeon performing the operation had offered SIC, while 36.6% of respondents could not recall who had offered SIC. All except one respondent provided written consent to undergo a surgical procedure. However, 8.3% of respondents received SIC service while already on the operation table for their procedure. Only 73.9% of respondents were informed about the availability of alternative treatment options. Additionally, a majority of respondents were not informed about the type of anesthesia to be used and related complications. Only 54.2% of respondents reported that they had been offered at least six of the 13 SIC components used by the investigators. There is gap in the provision of comprehensive and standardized pre-operative counseling for obstetric and gynecologic surgeries in the study hospital. This has a detrimental effect on the overall quality of care clients receive, specifically in terms of client expectations and information needs. (shrink)

The National Health Service (NHS) in the UK is currently facing a significant waiting list backlog following the disruption of the COVID-19 pandemic, with millions of patients waiting for elective surgical procedures. Effective treatment prioritisation has been identified as a key element of addressing this backlog, with NHS England's delivery plan highlighting the importance of ensuring that those with ‘the clinically most urgent conditions are diagnosed and treated most rapidly’. Indeed, we describe how the current clinical guidance on (...) prioritisation issued by The Federation of Surgical Specialty Associations serves this aim. However, whilst there are strong reasons to prioritise elective surgery in accordance with clinical need, we argue that it would be a mistake to assume that prioritisation in accordance with clinical need requires only a clinical or scientific judgement. The understanding of clinical need that we choose to employ in a prioritisation system will be grounded by some key ethical judgements. Moreover, we may also have to make trade-offs between addressing clinical need, safeguarding equality, and achieving other benefits. As the UK faces up to the backlog, it is important that surgical prioritisation guidelines enshrine a broad range of values that we believe ought to determine access to care in non-emergency circumstances. Our analysis suggests that the current approach to prioritisation is not a sufficiently nuanced way of balancing the different moral values that are operative in this context. (shrink)

Introduction: Informed consent constitutes one of the most important legal, professional, and ethical principles of a surgical operation. Consent obtained from a patient is only valid when the patient has received enough information regarding the proposed treatment option. This study aims to determine how much the patients are informed before undergoing surgery, as well as the factors influencing it in hospitals affiliated with Tehran University of Medical Sciences. Method: This is a cross-sectional, descriptive–analytic study of 300 patients undergoing surgery (...) in 7 teaching hospitals affiliated with Tehran University of Medical Sciences. The patients were recruited through clustered sampling. Data were collected using a questionnaire completed by interview. Data were analyzed on SPSS software using descriptive and inferential statistics. Result: The mean score of data provision for patients was 27.09 out of 60, indicating the level of information provided as unacceptable. Among 12 questions dealing with data provision, patients had received an intermediate level of information about nature of the disease, type of surgery, benefits and importance of the surgery, and complications of rejecting the recommended therapy. On the contrary, they had not received enough information about the surgical procedure, type of anesthesia, potential complications of surgery, potential risks of surgery, other therapy options instead of surgery, length of hospital stay for surgery, postsurgical follow-up, and expenses of the surgery. In the majority (85%) of cases, the surgeon was reported to be the information provider. Among the variables studied, level of information received was directly related to the patient’s education level. Discussion: The findings of this study indicate that during the process of obtaining an informed consent for surgery, patients do not receive sufficient information, and it is necessary to provide the essential information in an understandable manner adjusted for the patient’s level of education. (shrink)

Labioplasty is a surgical procedure performed to alter the size and shape of the labia minora. The reasons for women requesting this procedure remain largely unknown and recently girls and young women under the age of 18 years have been requesting this type of surgery. This paper examines the ethical acceptability of performing this procedure on under 18s. We will first discuss whether labioplasty can be considered to be a therapeutic technique. We will claim that, while it is difficult (...) to offer a definitive definition of what constitutes a therapeutic technique, in our view labioplasty cannot be considered as such. This conclusion has relevance for the ethical acceptability of the procedure, its legal status in regard to the Female Genital Mutilation Act and the debates over who can give consent for it. It will be concluded that in our current state of knowledge, the benefits of labioplasty are far from clear, whereas the harms are demonstrable and therefore this procedure should not be offered to those aged under 18 years. (shrink)

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

The concerns regarding patient autonomy presented in August A. Culbert et al.’s “Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees” fall just short of addressing the main issue. Patient autonomy is not something that just one member of a team should consider, and it should not be something that any protocol should have the power to subvert, particularly in an environment as tenuous as the operating room. This article will take the concerns regarding (...) the ethics of removing a patient’s hearing aid prior to entering the operating room presented in the aforementioned article and show the necessity for a new standard operating procedure. (shrink)

Allowing relatively inexperienced physicians-in-training to perform invasive medical procedures is a widely accepted practice, generally felt to be justified by the need to train future generations of physicians. The ethical justification of this practice, however, is rarely if ever explored in any depth. This essay examines the moral issues associated with this practice, in the setting of a specific clinical scenario involving the emergency intubation of a critically ill newborn. The practice is ultimately shown to be justified based not (...) only on the needs of society and future patients but also on the best interests of the patient being treated. However, several important qualifications need to be satisfied in order for this practice to be ethically permissible. The arguments and qualifications presented can be extended to clinical situations beyond the specific scenario discussed and are relevant to a wide range of medical and surgical settings. (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 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)

Background: Maximum safe resection of infiltrative brain tumors in eloquent area is the primary objective in surgical neuro-oncology. This goal can be achieved with direct electrical stimulation to perform a functional mapping of the brain in patients awake intraoperatively. When awake surgery is not possible, we propose a pipeline procedure that combines advanced techniques aiming at performing a dissection that respects the anatomo-functional connectivity of the peritumoral region. This procedure can benefit from intraoperative monitoring with computerized tomography scan and (...) brain shift correction. Associated with this intraoperative monitoring, the additional value of preoperative investigation combining brain mapping by navigated transcranial magnetic stimulation with various neuroimaging modalities has not yet been reported.Case Report: A 42-year-old left-handed man had increased intracranial pressure, left hand muscle deficit, and dysarthria, related to an infiltrative tumor of the right frontal lobe with large mass effect and circumscribed contrast enhancement in motor and premotor cortical areas. Spectroscopy profile and intratumoral calcifications on CT-scan suggested an WHO grade III glioma, later confirmed by histology. The aforementioned surgical procedure was considered, since standard awake surgery was not appropriate for this patient. In preoperative time, nTMS mapping of motor function was performed, combined with magnetic resonance imaging -based tractography reconstruction of 6 neural tracts and resting-state functional MRI connectivity of sensorimotor and language networks. In intraoperative time, DES mapping was performed with motor evoked response recording and tumor resection was optimized using non-rigid image transformation of the preoperative data to iCT data. Image guidance was updated with correction for brain shift and tissue deformation using biomechanical modeling taking into account brain elastic properties. This correction was done at crucial surgical steps, i.e., when tumor bulged through the craniotomy after dura mater opening and when approaching the presumed eloquent brain regions. This procedure allowed a total resection of the tumor region with contrast enhancement as well as a complete regression of IICP and dysarthria. Hand paresis remained stable with no additional deficit. Postoperative nTMS mapping confirmed the good functional outcome.Conclusion: This case report and technical note highlights the value of preoperative functional evaluation by nTMS updated intraoperatively with correction of brain deformation by iCT. This multimodal approach may become the optimized technique of reference for patients with brain tumors in eloquent areas that are unsuitable for awake brain surgery. (shrink)

Ethical medical decision-making for a child is generally navigated with various standards and models that have been developed to address its complexities. A case is presented of the parents’ refusal of a surgical procedure for their child considered by medical providers as essential and potentially lifesaving, along with the ethical debate of whether the parents’ decision was in the child’s best interest and whether their refusal reached a threshold to report and seek state intervention. Utilizing the best interest standard (...) and additional ethical decision-making tools, the ethicists helped the medical team accept the parents’ decision as reasonable, thus avoiding involvement with Child Protective Services. It is my goal to clarify the parents’ decision as reasonable and as honoring their child’s best interests and inherent dignity through the lens of Catholic anthropological and moral principles. These strengthen the ethical and moral arguments for the parents’ decision and the opposition to state intervention. (shrink)

Due to a history of coerced sterilization, a federal Medicaid sterilization policy mandates that a specific consent form be signed by a patient at least thirty days prior to when the patient undergoes sterilization. However, in contemporary obstetrical practice, the Medicaid sterilization policy serves as a policy‐level barrier to autonomously desired care. We review the clinical and ethical implications of the current Medicaid sterilization policy. After discussing the utility and impact of waiting periods for other surgical procedures, we (...) explore the psychology of time required for decision‐making and consider scientific understanding of regret. We argue that the current Medicaid sterilization waiting period is clinically and ethically unjustifiable and that the policy ought to be revised in light of the goals, preferences, and concerns of the people most affected by it. While the need for continued protection against coercion remains, the current mandated waiting period does little to enforce the high‐quality shared decision‐making that is desired for sterilization counseling. (shrink)

Aesthetic medicine merges art and medical sciences, focusing on the modification and enhancement of physical appearance through surgical and non-surgical procedures. While it is not globally recognized as a medical specialty, aesthetic medicine has become a cornerstone of medical tourism in several Asian countries, including India, Malaysia, Singapore, South Korea, and Thailand. Despite its popularity, there is notable gap in literature concerning its ethical and regulatory perspective. This study aims to provide a comprehensive analysis of existing regulations (...) and ethical considerations in aesthetic medicine within the context of the selected Asian countries. Given the field’s growth and its potential impact on both domestic and international health practices, this study is significant for healthcare providers, policymakers, and consumers alike. By identifying areas for improvement in current regulatory frameworks, the paper advocates for further examination to ensure that stakeholder rights and well-being are adequately protected. (shrink)

Live broadcasts of surgical procedures are most common at professional conferences, but they are not uncommon in the wider public arena, with operations having recently been transmitted in realtime on public television in the UK. This phenomenon raises ethical concerns familiar from the professional context, along with some distinct considerations which merit further attention. In this article I aim to examine the issues in terms of patient autonomy, patient welfare and the public interest. Prompted by the interest recently (...) expressed by the Royal College of Surgeons of England, under each topic I pose a series of questions, before closing with a call for enhanced ethical oversight, such as might be afforded by a clinical ethics committee. (shrink)

The question of whether Do Not Resuscitate orders should be sustained in the operating room was brought to our ethics committee by a pulmonologist and involved one of his patients for whom he serves as a primary care physician. His patient, a woman with chronic obstructive lung disease was electing, for comfort purposes, to have a hip pinning following a fracture. At the same time, she wished to have a DNR order covering her entire hospital stay. The anesthesiologist described her (...) direction as “improper” and refused to participate in surgical procedures if DNR orders extended to the operating room. The patient refused to rescind the order during surgery. As a result, the surgery was canceled to the great chagrin of the patient. (shrink)

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial (...) of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

Scheduling surgical procedures among operating rooms is mistakenly regarded as merely a tedious administrative task. However, the growing demand for surgical care and finite hours in a day qualify OR time as a limited resource. Accordingly, the objective of this manuscript is to reframe the process of OR scheduling as an ethical dilemma of allocating scarce medical resources. Recommendations for ethical allocation of OR time—based on both familiar and novel ethical values—are provided for healthcare institutions and individual (...) surgeons. (shrink)

Informed consent is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions. Adult postsurgical patients in nine general hospitals of Italy’s Campania Region were interviewed via (...) a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire. The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients and patients with higher levels of education were more likely to read the written IC form. The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures. (shrink)

People for the Ethical Treatment of Animals (PETA) called for a ban on mulesing in the Australian sheep industry in 2004. Mulesing is a surgical procedure that removes wool-bearing skin from the tail and breech area of sheep in order to prevent flystrike (cutaneous myiasis). Flystrike occurs when flies lay their eggs in soiled areas of wool on the sheep and can be fatal for the sheep host. PETA claimed that mulesing subjects sheep to unnecessary pain and suffering and (...) took action against the Australian wool industry that resulted in a number of international clothing retailers choosing not to use Australian wool. Although the Australian sheep industry agreed to phase out mulesing in 2010, there is some uncertainty as to whether this deadline will be achieved. The changing social ethic towards animal welfare suggests that the way the Australian sheep industry manages the phase out of mulesing in 2010 is vital to its future survival and success. It is likely that if mulesing does not cease in 2010 there will be a negative market reaction to Australian wool and the risk of legislation to ban mulesing. To avoid losing control of its animal welfare strategy, the Australian sheep industry should ensure that mulesing is phased out in 2010 and endorse the animal welfare ethic underpinning this change. The industry should also educate farmers and other industry stakeholders in how the changing social ethic for animal welfare can create new market opportunities for wool. (shrink)

A face transplant is as challenging a surgical procedure as any patient can undergo. In this introduction I present the medical aspects of this surgery, the profound ethical issues it raises, and optimal interventions that clinicians can pursue to help these patients and their loved ones. I then discuss how to help other kinds of patients and loved ones who confront similar stresses. I end by presenting a goal that author Sharrona Pearl puts forth after she studied many face (...) transplant patients. The efforts she urges should maximize our capacity to see face transplant patients—and anyone—as they are, as opposed to how they look. (shrink)

This article examines soldier performance optimisation, enhancement, and augmentation across the three dimensions of physical performance, cognitive performance, and socio-cultural understanding. Optimisation refers to combatants attaining their maximum biological potential. Enhancement refers to combatants achieving a level of performance beyond their biological potential through drugs, surgical procedures, or even gene editing. Augmentation refers to a blending of organic and biomechatronic body parts such as electronic or mechanical implants, prosthetics, and brain–machine interfaces. This article identifies that soldier optimisation is (...) a necessity to protect individual combatants and to give them the ability to make legal and morally justifiable decisions in battle. While enhancement and augmentation of military personnel can lead to accelerated and more destructive warfare, it can also be argued that there is an ethical and moral responsibility to provide combatants the best opportunity for survivability, and that better functioning, less fatigued, and better informed military personnel can make better decisions in battle. There is also a moral responsibility of the state for the combatants themselves, and short-term military success must be balanced against the short- and long-term health and wellbeing of the personnel. This article concludes that it is both the intent and the degree that decide the acceptability. (shrink)

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)

In recent years, progress in cancer treatment has greatly increased the chances of recovery. Yet, treatment may have irreversible effects on patients’ fertility. In order to protect future fertility, preservation of ovarian tissue may be offered today even to very young girls, involving a surgical procedure that may be performed by minimally invasive laparoscopy, under general anesthesia. However, in the tragic event of a girl’s death, questions may arise regarding the possible use of the preserved ovarian tissue by her (...) parents. Should posthumous reproductive use of ovarian tissue without the girl’s prior consent (due to her young age) be considered a violation of her rights? On the other hand, can it be argued that it is in the interest of a child who died young to leave a genetic trace through posthumous reproduction, because genetic continuity is in the interest of every human being? After presenting the relevant clinical facts, we explore the ethical dimensions of this possible practice through an analysis of the interests of the deceased, her parents, and the child that may be born posthumously. (shrink)

ArgumentIn the 1970s a public controversy erupted over the proposed use of brain operations to curtail violent behavior. Civil libertarians, civil rights and community activists, leaders of the anti-psychiatry movement, and some U.S. Congressmen charged psychosurgeons and the National Institute of Mental Health, with furthering a political project: the suppression of dissent. Several government-sponsored investigations into psychosurgery rebutted this charge and led to an official qualified endorsement of the practice while calling attention to the need for more “scientific” understanding and (...) better ethical safeguards. This paper argues that the psychosurgery debate of the 1970s was more than a power struggle between members of the public and the psychiatric establishment. The debate represented a clash between a postmodern skepticism about science and renewed focus on ultimate ends, on the one hand, and a modern faith in standards and procedures, a preoccupation with means, on the other. These diverging commitments made the dispute ultimately irresolvable. (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)

This article consists of four parts. In the first part it briefly describes the history of body‐to‐head transplantation (BHT) and the surgical plan proposed by Drs. Sergio Canavero and Ren Xiaoping on a human subject. In the second part it argues that the BHT procedure that they propose is scientifically invalid and technically infeasible so therefore would end in failure. In the third part it argues that the present conceivable procedure of BHT cannot be ethically justified because it would (...) bring great harm to the human subject, it is uncertain who would be the possible beneficiary, and valid informed consent cannot be obtained. In the fourth part it argues that the action of performing the procedure of BHT might violate China’s current criminal and civil laws. The conclusion that follows from the arguments above is that BHT should be prohibited now and also in the near future. However, this conclusion does not preclude scientists, neurosurgeons and bioethicists doing research into scientific, technical, surgical and ethical issues raised by BHT. (shrink)

COVID-19 is reducing the ability to perform surgical procedures worldwide, giving rise to a multitude of ethical, practical and medical dilemmas. Adapting to crisis conditions requires a rethink of traditional best practices in surgical management, delving into an area of unknown risk profiles. Key challenging areas include cancelling elective operations, modifying procedures to adapt local services and updating the consenting process. We aim to provide an ethical rationale to support change in practice and guide future decision-making. (...) Using the four principles approach as a structure, Medline was searched for existing ethical frameworks aimed at resolving conflicting moral duties. Where insufficient data were available, best guidance was sought from educational institutions: National Health Service England and The Royal College of Surgeons. Multiple papers presenting high-quality, reasoned, ethical theory and practice guidance were collected. Using this as a basis to assess current practice, multiple requirements were generated to ensure preservation of ethical integrity when making management decisions. Careful consideration of ethical principles must guide production of local guidance ensuring consistent patient selection thus preserving equality as well as quality of clinical services. A critical issue is balancing the benefit of surgery against the unknown risk of developing COVID-19 and its associated complications. As such, the need for surgery must be sufficiently pressing to proceed with conventional or non-conventional operative management; otherwise, delaying intervention is justified. For delayed operations, it is our duty to quantify the long-term impact on patients’ outcome within the constraints of pandemic management and its long-term outlook. (shrink)

Deep brain stimulation (DBS) is an approved treatment for neurological diseases and a promising one for psychiatric conditions, which may produce spectacular results very quickly. It is also a powerful tool for brain research and exploration. Beyond an overview of the ethical and legal literature on this topic, this paper aims at showing that DBS is a compelling example for ethical-legal reflection, as it combines a highly technical surgical procedure, a complex active medical device and neuromodulation of the human (...) brain to restore lost abilities caused by a chronic and evolving disease. Some of the ethical and legal issues raised by DBS are not specific, but shed new light on medical ethics and law. Others are more DBS-specific, as they are linked to the intricacies of research and treatment, to the need to tune the device, to the patients’ control over the device and its effects and to the involvement of family caregivers. (shrink)

The ethical conduct of research is central to the integrity of universities, where research and graduate education are inseparable.In the medical sciences, those who first describe a new feature, whether it's an anatomical structure, clinical sign or symptom, disease, physiological entity, or surgical procedure, often have their discoveries named after them. The insider knows what is meant by such eponymous, abstract designations as Padget's disease, the circle of Willis, Pavlov's dog, Asperger's syndrome, or the Papanicoulaou test. This kind of (...) acknowledgment is not just restricted to medicine, it also applies to other fields of science and technology, where terms like the Heisenberg uncertainty principle .. (shrink)

Common hospital and surgical center responses to the Covid‐19 pandemic included curtailing “elective” procedures, which are typically determined based on implications for physical health and survival. However, in the focus solely on physical health and survival, procedures whose main benefits advance components of well‐being beyond health, including self‐determination, personal security, economic stability, equal respect, and creation of meaningful social relationships, have been disproportionately deprioritized. We describe how female reproduction‐related procedures, including abortion, surgical sterilization, reversible contraception (...) devices and in vitro fertilization, have been broadly categorized as “elective,” a designation that fails to capture the value of these procedures or their impact on women's overall well‐being. We argue that corresponding restrictions and delays of these procedures are problematically reflective of underlying structural views that marginalize women's rights and interests and therefore threaten to propagate gender injustice during the pandemic and beyond. Finally, we propose a framework for triaging reproduction‐related procedures during Covid‐19 that is more individualized, accounts for their significance for comprehensive well‐being, and can be used to inform resumption of operations as well as subsequent restriction phases. (shrink)

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of (...) psychosurgery can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS. (shrink)