In pediatric oncology, genetic and genomic tests are proposed throughout the care pathway for many reasons (e.g., cancer characterization, identification of the most appropriate treatment, patient selection for clinical trials, identification of tissue/organ donors, or risk of relapse prediction). Despite the many different approaches (somatic or germline testing, targeted gene or genome sequencing), the implicated individuals are confronted with situations that may intersect and that are interesting to compare. No study has identified and analyzed the available works on these new practices in pediatric oncology. The aim of this narrative literature review was to describe the ethical and psychological perspectives of children with cancer, parents, and healthcare professionals when genetic or genomic testing is proposed as part of the cancer management. Eighteen articles met the inclusion criteria and were comprehensively coded using MAXQDA. Their analysis showed that concerning the subjective implications of genetic and genomic testing, the areas of ambivalence (desire of treatment, desire for knowledge, uncertainty, and guilt) reported by patients and their parents seem to mirror the healthcare professionals\' concerns. The ethical and psychological issues about predisposition testing, long discussed in the context of hereditary retinoblastoma and Li-Fraumeni syndrome, represent a useful starting point for a wider discussion of a genetic and genomic testing pathway in pediatric oncology more broadly.

In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.

Medical ethics is relevant to the clinical practice of allergy and immunology regardless of the type of patient, disease state, or practice setting. When engaging in clinical care, performing research, or enacting policies on the accessibility and distribution of healthcare resources, physicians regularly make and justify decisions using the fundamental principles of medical ethics. Thus, knowledge of these principles is paramount for allergists/immunologists. To date, there has been a shortage of medical ethics research in allergy and immunology. This review describes this scarcity, highlights publication trends over time, and advocates for additional support for research and training in medical ethics with a focus on topics germane to the practice of allergy and immunology.

The involvement of animals in research procedures that can harm them and to which they are deemed unable to consent raises fundamental ethical dilemmas. While current ethical review processes emphasize the application of the 3Rs (Replacement, Reduction, and Refinement), grounded in a human-centered utilitarian ethical approach, a comprehensive ethical review also involves a harm-benefit analysis and the consideration of wider ethical issues. Nevertheless, to our knowledge, approaches are still needed to facilitate the integrative assessment and iterative revision of research designs to improve their ethical value or to identify cases in which using animals is irremediably unethical. Additionally, frameworks are lacking that explicitly include an animal-centered perspective into the ethical review process beyond welfare concerns, failing to cover broader ethical considerations (such as consent). In previous work we proposed an Animal-Centered Research framework (ACRf) comprising four animal-centered research principles (relevance, impartiality, welfare and consent) which could help researchers and ethical review bodies apprise research designs from an animal-centered perspective. This paper builds on and further develops our previous work by contextualizing the ACRf within the bigger picture of animal research ethical review and by illustrating how the ACRf could be operationalized within current ethical review processes. We contribute an extended framework that integrates the application of the ACRf principles within the ethical review process. To this end, we present findings from a theoretical case study focusing on the ethical review of a research protocol on the study of stress response in pigs. We discuss how our extended framework could be easily applied to facilitate a holistic approach to the ethical review process, and inform an iterative process of refinement, to support the development of research designs that are both more ethical and scientifically valid.

Introduction: Aesthetic liposuction represents one of the most commonly performed cosmetic procedures worldwide. The purpose of this article is to examine and synthesize reported complication rates and explore the analytical prospect of possible patient or procedure-related predictive factors associated with specific complications. Methods: A systematic review was performed using the Pubmed, Cochrane, and Embase databases in line with specific criteria set to ensure an accurate assessment of complication rates; extracted data was synthesized through a random-effects model and meta-analysis of proportions. Results: A total of 60 studies were included in the meta-analysis, representing 21,776 patients undergoing aesthetic liposuction. Most studies followed an observational design. The overall complication rate was 12% (95% confidence interval [CI] 8%, 16%). When stratifying according to specific complications, the incidence of contour irregularities was determined to be 2% (95% CI 1%, 2%), seroma 2% (95% CI 1%; 2%), hematoma 1% (95% CI 0%, 1%), surgical site infection 1% (95% CI 1%, 2%), fibrosis or induration 1% (95% CI 1%, 2%), and pigmentary changes 1% (95% CI 1%, 1%), among others. A meta-regression to identify patient- or procedure-related factors associated with greater complication rates proved infeasible given the nature of the available data. Conclusion: Overall, liposuction demonstrated a relatively low complication rate profile, however, a considerable degree of heterogeneity exists within the examined literature preventing the recognition of predictive risk factors. While this calls for efforts to establish consensus on unified methods of outcomes reporting, the present meta-analysis can serve to provide practitioners with an evidence-based reference to improve informed consent and inform clinical guidelines, specifically pertaining to the incidence of commonly encountered complications in aesthetic liposuction, of which presently available survey studies and database queries remain devoid.
Introduction : La liposuccion esthétique est l’une des procédures esthétiques le plus souvent réalisées dans le monde. L’objectif de cet article est d’étudier et synthétiser les taux de complications rapportés et d’explorer la possibilité d’analyse de possibles facteurs prédictifs liés aux patients ou à la procédure en association avec des complications spécifiques. Méthodes : Une revue systématique a été exécutée à partir des bases de données Pubmed, Cochrane et Embase selon un ensemble de critères spécifiques pour assurer une évaluation précise des taux de complications; les données extraites ont été synthétisées par un modèle d’effets aléatoires et une méta-analyse des pourcentages. Résultats : Un total de 60 études a été inclus dans la méta-analyse, représentant 21 776 patients subissant une liposuccion esthétique. La plupart des études étaient observationnelles. Le taux global de complications était de 12% (IC à 95% : 8% à 16%). Après stratification selon des complications spécifiques, les incidences suivantes — parmi d’autres — ont été établies : irrégularités de contour a été établi à 2% (IC à 95% : 1% à 2%), sérome 2% (IC à 95% : 1% à 2%), hématome 1% (IC à 95% : 0% à 1%), infection du site opératoire 1% (IC à 95% : 1% à 2%), fibrose ou induration 1% (IC à 95% : 1% à 2%) et modification de la pigmentation 1% (IC à 95% : 1% à 1%). Une méta-régression visant à identifier des facteurs liés aux patients ou à la procédure pour les taux de complications les plus élevés s’est avérée infaisable, compte tenu de la nature des données disponibles. Conclusion : Globalement, la liposuccion a montré un relativement bas profil en termes de taux de complications. Il existe cependant une hétérogénéité considérable dans les publications étudiées, empêchant d’identifier des facteurs de risque prédictifs. Cela appelle à des efforts en vue de l’établissement d’un consensus sur des méthodes uniformisées de déclaration des résultats, mais la présente méta-analyse peut permettre aux praticiens de disposer d’une référence basée sur des constatations probantes pour améliorer le consentement éclairé et enrichir les lignes directrices cliniques, en particulier pour ce qui concerne l’incidence des complications fréquemment vues dans la liposuccion esthétique. En effet, les études, enquêtes et bases de données actuellement disponibles en sont dépourvues.

The ethical and regulatory oversight of any clinical activity related to human subjects is commonly determined based on its categorization as either clinical practice or research. Prominent bioethicists have criticized the traditional distinctions used to delineate these categories, calling them counterproductive and outmoded, and arguing that learning and clinical practice should be deliberately and appropriately integrated. Personalized trials represent a clinical activity with characteristics that overlap both categories, making ethical and regulatory oversight requirements less straightforward. When the primary intent of the personalized trial is to assist in the conduct of individualized patient care with an emphasis on protecting the clinical decision from the biases inherent in usual clinical practice, how should this activity be regulated? In this article, we will explore the ethical underpinnings of personalized trials and propose various approaches to meeting regulatory requirements. Instead of imposing standard research regulations on the conduct of all personalized trials, we recommend that personalized trialists and IRB panels should consider whether participation in a personalized trial results in any foreseeable incremental increase in risk to the participant compared with usual care. This approach may reduce regulatory barriers, which could promote more widespread uptake of personalized trials.

BACKGROUND: Deceased organ donation saves lives. Donation processes in New Zealand operate under an opt-in system, which requires consent from families of patients diagnosed with brain death or circulatory death while in the intensivecare unit. The donation demand and supply mismatch is a global phenomenon.
OBJECTIVE: The objective of this study was to understand the determinants of deceased organ donation decisions in the adult intensive care setting from the perspectives of staff and families.
METHODS: An integrative review based on Whittemore and Knafl\'s approach searched literature through databases CINAHL Plus, SCOPUS, Proquest Medline Ovid, and manual ancestry searches. Inclusion/exclusion criteria screened for pertinent literature, which were reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Selected studies were appraised using a generic scoring tool, and data were systematically extracted and coded onto spreadsheets using inductive, thematic analysis.
RESULTS: A total of 21 studies (12 qualitative, seven quantitative, two mixed methods) were included. Publication dates ranged from 1993 to 2021 from multiple countries (18 opt-in, three opt-out systems). Four overarching themes pertaining to families and staff were generated. Important knowledge related to families\' knowledge deficits around brain death, the purpose of ventilation, donation procedures, patients\' wishes, and staffs\' lack of training. Challenging communication highlighted miscommunications due to language choices and interrupted continuity of care during staff-family interactions. Internal determinants explored the cultural, spiritual, and emotional perspectives of families, while staff faced a sense of burden and conflicting values in delivering care between donors and recipients. External determinants related to the clinical environment impacting on grieving families, while for the staff, it explained concerns around resources and organisational processes.
CONCLUSIONS: Factors underpinning deceased organ donation are multifaceted and complex. Staff actions and families\' decisions are inextricably intertwined. Modifiable factors include a lack of formal training and communicational skills and environmental limitations of an intensive care setting.

BACKGROUND: The prevalence and complications of maternal obesity are well reported; with a hegemonic medicalised view leading to women\'s pregnant bodies being \'managed\'. We aimed to address current knowledge gaps by exploring the literature across research traditions and overtime to better understand the experiences of maternity care for women living with obesity, in relation to choice, consent and control.
METHODS: A systematic review using meta-narrative methods. Identification of studies included a scoping phase involving experts, hand searching and database browsing and a systematic searching phase. Seven databases (MEDLINE, MIDIRS, CINAHLComplete, Scopus, SocINDEX, PsycINFO, SPORTDiscuss) were searched with no date or geographical restriction. Non- English language studies were excluded. Two authors appraised quality prior to data extraction and synthesis. Data were tabulated, and women\'s experiences conceptualised in relation to choice, consent and control, first, by research tradition to reveal the unfolding storyline, secondly emergent narratives were synthesised into meta-themes.
RESULTS: Twenty-four studies were included, from six research traditions. Of these, twenty-one were qualitative, two were quantitative, and one study utilised a mixed method design. Studies spanned twenty-six years from 1994 to 2020. Across research traditions, four themes were evident, \'women\'s beliefs and experiences of weight\', \'social determinants\', \'being risked-managed\' and \'attitudes of caregivers\'. Over time, management of maternal obesity has moved from a focus on weight gain and diet as a woman\'s issue, to weight being pathological resulting in increased medicalisation, to a renewed focus on lifestyle through the public health arena. It suggests that lack of choice over care can reduce women\'s perception of control over their pregnancy and birth experience.
CONCLUSIONS: Increased medicalisation of maternal obesity, which includes defining and managing weight as pathological can limit women\'s choice and control over their maternity care. There is a need for national and local policy development which includes women in the process. It is important that women\'s views are heard, understood and acted upon so that a balance can be achieved, avoiding over medicalisation, yet ensuring mortality and morbidity risks are minimised.

Every day in EDs, clinicians are faced with situations where they need to decide whether to detain a patient for assessment and treatment. For patients who meet the relevant criteria, provisions of mental health legislation can be used. For other patients, clinicians often rely on so-called \'duty of care\'. This article briefly explores this complex area of law, including the relevant legislation, common law principles and grey areas. It also proposes an approach to decision-making in this area.

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited.
This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings.
A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis.
In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants\' willingness to share PHI (25/75, 33%) and participants\' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured.
There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.