RESUMO
An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.
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Comissão de Ética , Perfusão , Obtenção de Tecidos e Órgãos , Humanos , Obtenção de Tecidos e Órgãos/ética , Doadores de Tecidos/ética , Morte Encefálica , Transplante de Órgãos/ética , Transplante de Órgãos/legislação & jurisprudência , MorteRESUMO
BACKGROUND/AIMS: In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy). METHODS: A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials' activation pathway. The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods. The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. RESULTS: In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored. The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored. From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials' activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10). Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46). CONCLUSIONS: The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process. This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.
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Comissão de Ética , Projetos de Pesquisa , Humanos , Modelos Organizacionais , ItáliaRESUMO
Planned oocyte cryopreservation is an ethically permissible procedure that may help individuals avoid future infertility. Because planned oocyte cryopreservation is new and evolving, it is essential that those considering using it be informed about the uncertainties regarding its efficacy and long-term effects. This replaces the document of the same name, last published in 2017.
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Preservação da Fertilidade , Infertilidade , Humanos , Criopreservação/métodos , Reprodução , Infertilidade/diagnóstico , Infertilidade/terapia , Infertilidade/etiologia , Oócitos , Comissão de Ética , Preservação da Fertilidade/métodosRESUMO
The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed and counseled, but consanguineous arrangements or ones that simulate incestuous unions should be prohibited. Adult child-to-parent arrangements require caution to avoid coercion, and parent-to-adult child arrangements are acceptable in limited situations. Programs that choose to participate in intrafamilial arrangements should be prepared to spend additional time counseling participants and ensuring that they have made free, informed decisions. This document replaces the document of the same name, last published in 2017.
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Comissão de Ética , Mães Substitutas , Doadores de Tecidos , Humanos , Feminino , Masculino , Comissão de Ética/ética , Doadores de Tecidos/ética , Gravidez , Família , Técnicas de Reprodução Assistida/ética , Doação de Oócitos/éticaRESUMO
BACKGROUND: Physicians have to make countless decisions every day. The medical, ethical and legal aspects are often intertwined and subject to change over time. Involving an ethics committee or arranging an ethical consultation are examples of potential aids to decision making. Whether and how artificial intelligence (AI) and the large language model (LLM) of the company OpenAI (San Francisco, CA, USA), known under the name ChatGPT, can also help and support ethical decision making is increasingly becoming a matter of controversial debate. MATERIAL AND METHODS: Based on a case example, in which a female physician is confronted with ethical and legal issues and presents these to ChatGPT to come up with answers, the first indications of the strengths and weaknesses are ascertained. CONCLUSION: Due to the rapid technical development and access to ever increasing quantities of data, the utilization should be closely observed and evaluated.
Assuntos
Inteligência Artificial , Comissão de Ética , Feminino , Humanos , Tomada de Decisão Clínica , Tomada de Decisões , Ética MédicaRESUMO
Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.
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Comissão de Ética , Técnicas de Reprodução Assistida , Participação no Risco Financeiro , Humanos , Técnicas de Reprodução Assistida/ética , Técnicas de Reprodução Assistida/economia , Comissão de Ética/economia , Participação no Risco Financeiro/ética , Participação no Risco Financeiro/economia , Feminino , Consentimento Livre e Esclarecido/ética , Medicina Reprodutiva/ética , Medicina Reprodutiva/economia , Medicina Reprodutiva/normas , Seleção de Pacientes/ética , Gravidez , Infertilidade/terapia , Infertilidade/economia , Infertilidade/fisiopatologia , Infertilidade/diagnósticoRESUMO
INTRODUCTION: Limited data are available regarding the decision-making process for preventing gastrointestinal bleeding in patients at high risk of bleeding scheduled for percutaneous coronary intervention (HBPCI), especially due to the lack of a simple, accurate and sensitive methods for gastrointestinal injury detection. This randomised trial aims to assess the effects of early magnetically controlled capsule endoscopy (MCE) in patients with HBPCI for the prevention of gastrointestinal bleeding compared with conventional management. METHODS AND ANALYSIS: The Magnetic-Assisted Capsule Endoscopy Gastrointestinal bleeding Protection Strategy (MACE-GPS) is a multicentre, open-label, randomised controlled trial. Patients admitted for HBPCI will be randomised and placed into two study groups. In the early MCE group, 1228 patients will undergo MCE following admission to the hospital. If necessary, these patients may further undergo a multidisciplinary approach to determine treatment based on the MCE findings. A total of 1228 patients in the control group will undergo conventional treatment based on the attending cardiologist's interpretation of their clinical presentations. The primary end point is the incidence of gastrointestinal bleeding within 12 months of enrolment. ETHICS AND DISSEMINATION: The MACE-GPS trial has been approved by the ethics committees of all participating sites. Participant recruitment began in April 2023 and will be completed in April 2025, and the 1-year follow-up will be completed in April 2026. The study results will be disseminated through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2300070025.
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Endoscopia por Cápsula , Intervenção Coronária Percutânea , Humanos , Hemorragia Gastrointestinal , Grupos Controle , Comissão de Ética , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
A retraction notice is a formal announcement for the removal of a paper from the literature, which is a weighty matter. Xu et al. (Science and Engineering Ethics, 29(4), 25 2023) reported that 73.7% of retraction notices indexed by the Web of Science (1927-2019) provided no information about institutional investigations that may have led to the retractions, and recommended that Committee on Publication Ethics (COPE) retraction guidelines should make it mandatory to disclose institutional investigations leading to retractions in such notices. While this recommendation would add to the transparency of the retraction process, a blanket mandate as such could be potentially problematic. For research misconduct (RM)-positive cases, a mandatory investigative disclosure may be abused by some to deflect responsibility. More importantly, a mandatory disclosure could harm authors and institutions in RM-negative cases (i.e. those stemming from honest errors with no misconduct). I illustrate with case vignettes the potential epistemic injustice and confusion that a mandate for investigation disclosure in retraction notices could incur, and suggest a more nuanced approach to its implementation.
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Revelação , Má Conduta Científica , Engenharia , Comissão de ÉticaRESUMO
PURPOSE: The American College of Epidemiology (ACE) held its 2022 Annual Meeting, September 8-11, with a conference theme of 'Pandemic of Misinformation: Building Trust in Epidemiology'. The ACE Ethics Committee hosted a symposium session in recognition of the global spotlight placed on epidemiology and public health due to the COVID-19 crisis. The ACE Ethics Committee invited previous Chairs of the Ethics Committee and current President of the International Epidemiological Association to present at the symposium session. This paper aims to highlight the ethical challenges presented during the symposium session. METHODS: Three speakers with diverse backgrounds representing expertize from the fields of ethics, epidemiology, public health, clinical trials, pharmacoepidemiology, statistics, law, and public policy, covering perspectives from the U.S., Europe, and Southeast Asia were selected to present on the ethical challenges in epidemiology and public health applying a global theme. Dr. D. Weed presented on 'Causation, Epidemiology and Ethics'; Dr. C.M. Pandey presented on the 'Ethical Challenges in the Practice of Digital Epidemiology'; and Dr. J. Acquavella presented on 'Departures from Scientific Objectivity: A Cause of Eroding Trust in Epidemiology.' RESULTS: The collective goal to improve the public's health was a mutually shared theme across the three distinct areas. We highlight the common ethical guidance and principle-based approaches that have served epidemiology and public health in framing and critical analysis of novel challenges, including autonomy, beneficence, justice, scientific integrity, duties to the profession and community, and developing and maintaining public trust; however, gaps remain in how best to address health inequalities and the novel emergence and pervasiveness of misinformation and disinformation that have impacted the health of the global community. We introduce an ethical framework of translational bioethics that places considerations of the social determinants of health at the forefront. CONCLUSIONS: The COVID-19 pandemic required an expedited public health response and, at the same time, placed the profession of epidemiology and public health, its system, and structures, under the microscope like never before. This article illustrates that revisiting our foundations in research and practice and orienting contemporary challenges using an ethical lens can assist in identifying and furthering the health of populations globally.
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Bioética , COVID-19 , Humanos , Estados Unidos , Pandemias , Saúde Pública , Comissão de Ética , COVID-19/epidemiologiaRESUMO
INTRODUCTION: Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD. METHODS AND ANALYSIS: This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage. ETHICS AND DISSEMINATION: This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference. TRIAL REGISTRATION NUMBER: ChiCTR2300074554.
Assuntos
Comissão de Ética , Doença Pulmonar Obstrutiva Crônica , Humanos , Pressão Sanguínea , Exercício Físico , Frequência Cardíaca , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide, which is partly contributed to the increasing prevalence of COPD owning to a demographic shift towards an older population. Conversely, recent studies on COPD mortality that take this demographic shift in age into account find decreasing overall age-standardised COPD mortality rates over time. This decrease in the age-standardised COPD mortality rate is contributed advances in COPD diagnostics and treatment, decreasing smoking prevalence and general advances in medical care particularly in western countries. However, it is unknown if patients with COPD have experienced a comparable relative increase in survival in line with the general population.Hence, there is a need for longitudinal studies comparing trends in mortality in patients with COPD compared with matched non-COPD individuals from the background population. METHODS AND ANALYSES: This is a cohort study with a matched non-COPD comparator cohort. Data are retrieved from the Danish national registers. Data from multiple registries from 1983 to 2018 will be merged on an individual level using the 10-digit Civil Registration numbers that are unique to each citizen in Denmark. Time trends in mortality in patients with COPD compared with the matched comparator cohort will be examined in three study periods: 1983-1993, 1994-2007 and 2008-2018. ETHICS AND DISSEMINATION: The study is entirely based on registry data and ethical approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be published in peer-reviewed journals and reported at appropriate national and international conferences.
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Comissão de Ética , Doença Pulmonar Obstrutiva Crônica , Humanos , Estudos de Coortes , Extremidades , Dinamarca/epidemiologiaRESUMO
The pandemic significantly raised the stakes for the translation of bioethics insights into policy. The novelty, range and sheer quantity of the ethical problems that needed to be addressed urgently within public policy were unprecedented and required high-bandwidth two-way transfer of insights between academic bioethics and policy. Countries such as the United Kingdom, which do not have a National Ethics Committee, faced particular challenges in how to facilitate this. This paper takes as a case study the brief career of the Ethics Advisory Board (EAB) for the NHS Covid-19 App, which shows both the difficulty and the political complexity of policy-relevant bioethics in a pandemic and how this was exacerbated by the transience and informality of the structures through which ethics advice was delivered. It analyses how and why, after EAB's demise, the Westminster government increasingly sought to either take its ethics advice in private or to evade ethical scrutiny of its policies altogether. In reflecting on EAB, and these later ethics advice contexts, the article provides a novel framework for analysing ethics advice within democracies, defining four idealised stances: the pure ethicist, the advocate, the ethics arbiter and the critical friend.
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Bioética , Pandemias , Humanos , Comitês Consultivos , Eticistas , Comissão de Ética , ÉticaRESUMO
Clinicians should encourage disclosure between intimate partners but should maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where a member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible because of the lack of disclosure. This document replaces the previously published document of the same name, last published in 2018.
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Comportamento Sexual , Parceiros Sexuais , Humanos , Fertilidade , Consentimento Livre e Esclarecido , Revelação , Comissão de ÉticaRESUMO
Telemedicine has the potential to increase access to and decrease the cost of care. However, it also alters the nature of the physician-patient relationship and the interaction of patients with the healthcare system, which may limit access to care in some circumstances. Regardless of the modality of care delivery, the basic tenets of medical ethics and the obligations of physicians to their patients still hold.
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Telemedicina , Humanos , Ética Médica , Relações Médico-Paciente , Comissão de Ética , FertilidadeRESUMO
Abstract Experimental research with the use of animal models to represent a specific reality is a target of criticism by the population. This study analyzed the knowledge of elementary and high school students on experimental/animal research methods, official ethical guidelines/laws, and regulatory institutions. In total, 35 students answered an informative questionnaire with objective questions about the subject. Only 18 students (Group 1), attended a lecture on the subject. The questionnaire was reapplied to all 35 students. The analysis of the first questionnaire round showed rejection by 51.4% of the students toward the methods used in experimental research. Significant changes in answer patterns between the first and second evaluations were observed, with a decrease in the number of students who strongly disagree with the methods used in experimental research in Group 1 (38.8%) compared to Group 2 (88.2%). These data suggest that educational activities could increase the acceptance of experimental research by the community.
Resumen La investigación experimental en animales para representar una realidad específica es criticada por la población. Este estudio analizó el conocimiento de los alumnos de la primaria y la secundaria sobre los métodos de investigación experimental/animal, los lineamientos/leyes éticas oficiales e instituciones que reglamentan. Un cuestionario con preguntas objetivas sobre el tema fue respondido por 35 alumnos. Solo 18 alumnos (Grupo 1) asistieron a una conferencia sobre el tema. El cuestionario se aplicó nuevamente a 35 alumnos. El primer cuestionario mostró que el 51,4% de los alumnos rechazaban los métodos utilizados en la investigación experimental. Hubo cambios significativos en las respuestas entre la primera y la segunda evaluación, con menor número de alumnos que estaban totalmente en desacuerdo con los métodos de la investigación experimental en el Grupo 1 (38,8%) en comparación con el Grupo 2 (88,2%). Por tanto, las actividades educativas pueden incrementar la aceptación comunitaria de la investigación experimental.
Resumo A pesquisa experimental com uso de modelos animais para representar uma realidade específica é alvo de críticas por parte da população. Este estudo analisou o conhecimento de alunos do ensino fundamental e médio sobre métodos de pesquisa experimental/animal, diretrizes/leis éticas oficiais e instituições reguladoras. Ao todo, 35 alunos responderam a um questionário informativo com perguntas objetivas sobre o assunto. Apenas 18 alunos (Grupo 1) assistiram a uma palestra sobre o tema. O questionário foi aplicado novamente aos 35 alunos. A análise do primeiro questionário mostrou rejeição por 51,4% dos estudantes em relação aos métodos utilizados na pesquisa experimental. Observaram-se mudanças significativas nos padrões de resposta entre a primeira e a segunda avaliação, com diminuição do número de alunos que discordam totalmente dos métodos utilizados na pesquisa experimental no Grupo 1 (38,8%) em relação ao Grupo 2 (88,2%). Esses dados sugerem que atividades educativas podem aumentar a aceitação da pesquisa experimental pela comunidade.
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Vacinas , Comissão de Ética , Experimentação Animal , Desenvolvimento de MedicamentosRESUMO
Thousands of Palestinian prisoners are held in Israeli prisons without trial. For some of them, engaging in hunger strikes is the last resort in opposing unlawful detention and inhumane prison conditions. While mainstream bioethics deliberation, reasonable arguments, and international legal and medical professional declarations prohibit force-feeding, local ethical deliberations, professional medical guidelines, and legislation allow the use of medical judgment and clinical ethics committees to force-feed these prisoners. Until now, Israeli physicians have refused to do so, but this may change in the future. The international medical and bioethics communities need to stand behind these medical professionals, as well as prisoners. Clinical ethics committees in Israel must choose whether they serve the interests of these prisoner-patients and perhaps their political or human rights agenda, or whether they are subservient to an unjust, oppressive regime.
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Direitos Humanos , Prisioneiros , Humanos , Israel , Jejum , Prisões , Comissão de ÉticaRESUMO
The integrity of research findings and the safety of participants who voluntarily consent to participate in research studies must be assured through ethical approaches. Additionally, ethical guidelines and the ethics committee protect participants from unfair practices by the research team. Therefore, this study aims to assess the knowledge and attitudes toward the ethics committee and research ethical practices among the researchers of a diabetes institute in Kuwait. An anonymous survey was conducted through an online questionnaire using Microsoft Forms. The study had a response rate of 86%. Among the 55 participants in this study, 43 (78%) had ethics training. Researchers involved in more than four research projects were shown to have a much higher awareness of the ethics committee and its role than researchers involved in no projects. Approximately 90% of researchers had training in research ethics and were knowledgeable about informed consent forms and assent, as well as additional protections for vulnerable populations. Ninety-eight percent of respondents were of the view that an ethics committee was necessary. Our study concluded that most of the researchers at the institute were aware of the role of the ethics committee, and ethical principles. However, we recommend that continuous and customized training on research ethics should be provided.
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Comissão de Ética , Conhecimento , Humanos , Kuweit , Pesquisadores , Academias e InstitutosRESUMO
BACKGROUND: Physicians have to make countless decisions every day. The medical, ethical and legal aspects are often intertwined and subject to change over time. Involving an ethics committee or arranging an ethical consultation are examples of potential aids to decision making. Whether and how artificial intelligence (AI) and the large language model (LLM) of the company OpenAI (San Francisco, CA, USA), known under the name ChatGPT, can also help and support ethical decision making is increasingly becoming a matter of controversial debate. MATERIAL AND METHODS: Based on a case example, in which a female physician is confronted with ethical and legal issues and presents these to ChatGPT to come up with answers, the first indications of the strengths and weaknesses are ascertained. CONCLUSION: Due to the rapid technical development and access to ever increasing quantities of data, the utilization should be closely observed and evaluated.
Assuntos
Inteligência Artificial , Comissão de Ética , Feminino , Humanos , Tomada de Decisão Clínica , Tomada de Decisões , Ética MédicaRESUMO
INTRODUCTION: Perturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose-response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols. METHODS AND ANALYSIS: The study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1-6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2-5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior-posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00030805.