暂无摘要。

UNASSIGNED: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice.
UNASSIGNED: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice.
UNASSIGNED: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group.
UNASSIGNED: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified.
UNASSIGNED: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

BACKGROUND: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process.
OBJECTIVE: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form.
METHODS: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed.
RESULTS: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form.
CONCLUSIONS: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

BACKGROUND: Artificial intelligence (AI) holds the potential to revolutionize medicine, offering vast improvements for plastic surgery. While human physicians are limited to one lifetime of experience, AI is poised to soon surpass human capabilities, as it draws on limitless information and continuous learning abilities. Nevertheless, as AI becomes increasingly prevalent in this domain, it gives rise to critical ethical considerations that must be addressed by professionals.
METHODS: This work reviews the literature referring to the ethical challenges brought on by the ever-expanding use of AI in plastic surgery and offers guidelines for its application.
RESULTS: Ethical challenges include the disclosure of use of AI by caregivers, validation of decision-making, data privacy, informed consent and autonomy, potential biases in AI systems, the opaque nature of AI models, questions of liability, and the need for regulations.
CONCLUSIONS: There is a lack of consensus for the ethical use of AI in plastic surgery. Guidelines, such as those presented in this work, are needed within each discipline of medicine to respond to important ethical considerations for the safe use of AI.
METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Administrative data are generated when educating, licensing, and regulating future physicians but these data are rarely used beyond their pre-specified purposes. The capacity necessary for sensitive and responsive oversight that supports the sharing of administrative medical education data across institutions for research purposes needs to be developed.
A pan-Canadian consensus-building project was undertaken to develop agreement on the goals, benefits, risks, values, and principles that should underpin inter-institutional data-driven medical education research in Canada. A survey of key literature, consultations with various stakeholders and five successive knowledge synthesis workshops informed this project. Propositions were developed, driving subsequent discussions until collective agreement was distilled.
Consensus coalesced around six key principles: establishing clear purposes, rationale, and methodology for inter-institutional data-driven research a priori; informed consent from data generators in education systems is non-negotiable; multi-institutional data sharing requires special governance; data governance should be guided by data sovereignty; data use should be guided by an identified set of shared values; and best practices in research data-management should be applied.
We recommend establishing a representative governance body, engaging trusted data facility, and adherence to extant data management policies when sharing administrative medical education data for research purposes in Canada.
Des données administratives sont générées dans le cadre de la formation des médecins, d’octroi de permis d’exercice et de réglementation des activités professionnelles, mais ces données sont rarement utilisées au-delà de leurs objectifs prédéfinis. Il convient de créer un système de supervision réactif et sensible aux risques pour permettre le partage de données relatives à l’enseignement médical entre établissements à des fins de recherche.
Une initiative pancanadienne de recherche de consensus a été réalisée pour parvenir à un accord sur les objectifs, les avantages, les risques, les valeurs et les principes qui devraient sous-tendre la recherche interinstitutionnelle sur l’enseignement médical à l’aide des données existantes. Ce projet s’est appuyé sur une analyse de la littérature scientifique, sur des consultations avec diverses parties prenantes et sur cinq ateliers successifs de synthèse des connaissances. Des discussions ont été menées sur la base de propositions formulées préalablement jusqu’à la cristallisation d’un accord collectif.
Un consensus s’est dégagé autour de six principes clés : la création a priori d’objectifs, d’une logique et d’une méthodologie clairs pour la recherche interinstitutionnelle fondée sur les données; l’obtention, sans exception, du consentement éclairé des personnes concernées par la collecte de données dans les systèmes d’éducation; la création d’un cadre de gouvernance visant spécifiquement le partage des données entre établissements; le respect, dans ce cadre, de la souveraineté des données; l’utilisation des données fondée sur un ensemble de valeurs partagées; et l’application des meilleures pratiques en matière de gestion des données de recherche.
En vue du partage des données administratives relatives à l’enseignement médical à des fins de recherche au Canada, nous recommandons la création d’une instance de gouvernance représentative ainsi que l’utilisation d’infrastructures fiables et le respect des politiques existantes régissant la gestion des données.

Massively parallel sequencing techniques, such as whole exome sequencing (WES) and whole genome sequencing (WGS), may reveal unsolicited findings (UFs) unrelated to the diagnostic aim. Such techniques are frequently used for diagnostic purposes in pediatric cases of developmental delay (DD). Yet policy guidelines for informed consent and return of UFs are not well equipped to address specific moral challenges that may arise in these children\'s situations.
In previous empirical studies conducted by our research group, we found that it is sometimes uncertain how children with a DD will develop and whether they could come to possess capacities for autonomous decision-making in the future. Parents sometimes felt this brought them into a Catch-22 like situation when confronted with choices about UFs before undergoing WES in trio-analysis (both the parents\' and child\'s DNA are sequenced). An important reason for choosing to consent to WES was to gain more insight into how their child might develop. However, to make responsible choices about receiving or declining knowledge of UFs, some idea of their child\'s future development of autonomous capacities is needed. This undesirable Catch-22 situation was created by the specific policy configuration in which parents were required to make choices about UFs before being sequencing (trio-analysis). We argue that this finding is relevant for reconfiguring current policies for return of UFs for WES/WGS and propose guidelines that encompass two features. First, the informed consent process ought to be staged. Second, differing guidelines are required for withholding/disclosing a UF in cases of DD appropriate to the level of confidence there is about the child\'s future developmental of autonomous capacities.
When combined with a dynamic consent procedure, these two features of our guidelines could help overcome significant moral challenges that present themselves in the situations of children undergoing genomic sequencing for clarifying a DD.

BACKGROUND: As a relatively new field, dissemination and implementation research has not been included as a separate study design category for ethical consideration compared with clinical and social/behavioral research, yet it should be based on unique study designs, targets of intervention, and corresponding risks.
METHODS: Research teams conducting dissemination and implementation research have raised important questions related to the responsible conduct of research such as collecting informed consent, site monitoring, identifying and mitigating risks of unintended consequences, and adverse event ascertainment and reporting in dissemination and implementation research. In this commentary, we highlight the need for guidance and consensus standards on ethical issues in dissemination and implementation research and describe some ethical domains and relevant questions in dissemination and implementation research. Additionally, we propose a process for conceptual development and a research agenda to create consensus standards for the responsible conduct of research for dissemination and implementation research.
CONCLUSIONS: Thorough research is needed to understand the depth of ethical issues in dissemination and implementation research. A consensus-seeking process will be needed to develop new bioethical standards that carefully identify, measure, and mitigate unintended consequences in dissemination and implementation research.

The British Transplantation Society (BTS) \'Guideline on transplantation from deceased donors after circulatory death\' has recently been updated and this manuscript summarises the relevant recommendations from chapters specifically related to law, ethics, donor consent and informing the recipient.

UNASSIGNED: The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.
UNASSIGNED: The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.
UNASSIGNED: After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion.
UNASSIGNED: Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders.
UNASSIGNED: Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient\'s specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.

This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, assent and dissent to assess the individual\'s judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis.
UNASSIGNED: The online version contains supplementary material available at 10.1007/s41649-023-00240-x.