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1.
Bone Joint J ; 102-B(5): 550-555, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32349593

RESUMO

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of "failure to warn", i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on "failure to warn" and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550-555.


Assuntos
Consentimento Livre e Esclarecido/legislação & jurisprudência , Imperícia/legislação & jurisprudência , Procedimentos Ortopédicos/legislação & jurisprudência , Medicina Estatal/legislação & jurisprudência , Austrália , Alemanha , Humanos , Consentimento Livre e Esclarecido/ética , Medicina Estatal/ética , Decisões da Suprema Corte , Reino Unido , Estados Unidos
2.
Monaldi Arch Chest Dis ; 90(1)2020 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-32268719

RESUMO

Severe COVID-19 illness is characterised by the development of Acute Respiratory Distress Syndrome (ARDS), for which the mainstay of treatment is represented by mechanical ventilation. Mortality associated with ARDS due to other causes is in the range of 40-60%, but currently available data are not yet sufficient to draw safe conclusions on the prognosis of COVID-19 patients who require mechanical ventilation. Based on data from cohorts of the related coronavirus-associated illnesses, that is to say Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), prognosis would seem to be worse than ARDS due to other causes such as trauma and other infections. Discussion of prognosis is central to obtaining informed consent for intubation, but in the absence of definitive data it is not clear exactly what this discussion should entail.


Assuntos
Tomada de Decisão Clínica/ética , Infecções por Coronavirus/terapia , Pandemias , Pneumonia Viral/terapia , Respiração Artificial/ética , Síndrome Respiratória Aguda Grave/terapia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/mortalidade , Humanos , Consentimento Livre e Esclarecido/ética , Intubação Intratraqueal , Pandemias/ética , Pneumonia Viral/epidemiologia , Pneumonia Viral/mortalidade , Prognóstico , Respiração Artificial/mortalidade , Síndrome Respiratória Aguda Grave/etiologia , Síndrome Respiratória Aguda Grave/mortalidade
4.
Anesthesiology ; 132(1): 44-54, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31789635

RESUMO

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência , Austrália , Inglaterra , Humanos , Internacionalidade , Risco , Estados Unidos
5.
Recurso educacional aberto em Espanhol | CVSP - Argentina | ID: oer-3882

RESUMO

1º Jornada «Derecho a la Salud», organizada por el CVSP Nodo Argentina, la Sala de Derecho a la Salud del Colegio de Abogados de Córdoba y la Escuela de Salud Pública y Ambiente de la Facultad de Ciencias Médicas–UNC. La misma se llevó a cabo el día 4 de diciembre del corriente año en el Salón Rojo de la Secretaría de Graduados en Ciencias de la Salud FCM-UNC. La jornada contó con la presencia de Profesionales de la Salud, Profesionales del Derecho, alumnos de postgrado de las Carreras de Ciencias Médicas, Derecho y Ciencias Sociales y público en general. Conferencia dictada por la Prof. Dra.Susana Vanoni. Directora del CIEIS – Hospital Nacional de Clínicas . FCM.UNC.


Assuntos
Fontes de Financiamento de Pesquisa , Consentimento Livre e Esclarecido/ética , Comitês de Ética em Pesquisa/legislação & jurisprudência
6.
Cuad. bioét ; 30(100): 303-313, sept.-dic. 2019.
Artigo em Espanhol | IBECS | ID: ibc-185243

RESUMO

El derecho a la información clínica y el consentimiento informado como expresión práctica del principio de autonomía, son conquistas legales en España de finales del siglo XX que se han trasladado a la normativa deontológica médica. Se estudia el ritmo de ese traslado. Revisión histórica de los diferentes códigos de deontología médica desde la Guerra Civil, buscando la presencia de estas ideas en ella. Hasta el código de 1979 la idea de información clínica no aparece en la normativa deontológica vigente y el consentimiento lo hace en casos muy restringidos. A partir de esa fecha su aparición es progresiva en los sucesivos códigos. Actualmente ambas ideas están completamente desarrolladas en la normativa deontológica española. La Deontología médica ha asumido como suyas las ideas de información al paciente y consentimiento in-formado. Este ha sido un proceso largo en el tiempo que ha cambiado en buena medida la orientación deontológica para las relaciones médico-enfermo. En estos aspectos, la Deontología médica pasa, de hacer hincapié en la prudencia del médico, a subrayar el deber de informar y de dar amplio espacio a las decisiones del paciente, al que reconoce como un agente moral autónomo y reflexivo, capaz de tomar sus propias decisiones sobre su salud


In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, see-king the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health


Assuntos
Humanos , História do Século XX , Sistemas de Informação em Saúde/ética , Sistemas de Informação em Saúde/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Teoria Ética , Sociedades Médicas/ética , Ética Clínica , Consentimento Livre e Esclarecido/legislação & jurisprudência , Códigos de Ética/legislação & jurisprudência , Códigos de Ética/tendências , Sociedades Médicas/legislação & jurisprudência
7.
J Clin Ethics ; 30(4): 303-313, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31851621

RESUMO

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.


Assuntos
Face/cirurgia , Transplante de Face/ética , Consentimento Livre e Esclarecido/ética , Cirurgia Plástica/ética , Confidencialidade , Ética Médica , Transplante de Face/psicologia , Feminino , Humanos
8.
Rev Med Chil ; 147(8): 1029-1035, 2019 Aug.
Artigo em Espanhol | MEDLINE | ID: mdl-31859968

RESUMO

Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.


Assuntos
Ética em Pesquisa , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Sujeitos da Pesquisa , Chile , Humanos
11.
Heart Surg Forum ; 22(5): E423-E428, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31596724

RESUMO

Although many believe that the phrase "First, do no harm" was part of the Hippocratic Oath, in fact it was not. This phrase, often written in Latin ("Primum non Nocere"), seems to have first appeared in medical writing in the 17th century. However, it is obvious that many therapeutic interventions do cause at least some harm with hopes of benefitting patients in the long run. This balancing of initial harm in hope of eventual benefit is never more apparent than in the case of invasive procedures, though other examples abound, such as the administration of chemotherapy. The ethical concept of nonmaleficence, which traces its origins to the concept of primum non nocere, accurately acknowledges the concept of the need to strive to do more good than harm. Thus, it is apparent that, in a surgical operation, the surgeon is proposing to cause harm, initially, to the patient in hopes of creating an outcome that results in more good than harm. Therefore, the process of obtaining consent from the patient for a surgical operation acknowledges the fact that harm will, in fact, be inflicted on that patient, with the hope that, on balance, this harm will result in a greater overall good for the patient. It is for this reason that the modern concepts of informed consent have developed.


Assuntos
Juramento Hipocrático , Consentimento Livre e Esclarecido , Procedimentos Cirúrgicos Operatórios , Comunicação , Documentação , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Educação de Pacientes como Assunto , Cuidados Pré-Operatórios , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Resultado do Tratamento , Recusa do Paciente ao Tratamento , Revelação da Verdade
14.
Hu Li Za Zhi ; 66(5): 72-79, 2019 Oct.
Artigo em Chinês | MEDLINE | ID: mdl-31549383

RESUMO

Child abuse is a sensitive research topic. Improving the health of the victims of abuse through research, rights protection, and preemption of harm are important and debatable ethical issues. The ethical considerations related to research into child abuse cover two dimensions: 1) using children as subjects and 2) concerns regarding the physical and mental health of children who are targeted by related research. This paper focuses on several common ethical issues in the field of child abuse research, starting from the formulation of the research problem, sampling, data collection, and results reporting. Ethical issues include obtaining informed consent, assuring the autonomy of maltreated children and adults with childhood abuse histories, ensuring a sense of control and safety during data collection, and establishing the role of researchers as mandated reporters. As a researcher, rigorous research design and methodology and self-preparation on the issue of childhood trauma and abuse are essential in order to reduce the risk of harm to victims. This paper is intended to provide suggestions for researchers and institutional review board committees to assess the ethics of conducting research on sensitive issues.


Assuntos
Maus-Tratos Infantis , Ética em Pesquisa , Criança , Humanos , Consentimento Livre e Esclarecido/ética
15.
BMC Res Notes ; 12(1): 493, 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31391107

RESUMO

OBJECTIVES: The aim of the study was to identify reasons for protocol deviations during conduct of large epidemiological surveys despite training of field workers, validating clinicians, and providing field supervisory support. Enquiries focused on breaches of recruitment procedures, privacy, confidentiality, and informed consent. The case study was a household survey conducted in Ile-Ife, Nigeria. RESULTS: The study reveals that despite training of field workers, providing supervisory support, and conducting validation exercises, protocol deviation still occurred. Measures to improve internal research validity during the conduct of surveys can minimise but not eliminate protocol deviations. Individual and environmental factors increase the risk for protocol deviation. Individual factors include personal bias against adherence to elements of the protocols, and pressure to meet personal recruitment targets to maximise remuneration. These pressures increase the risk of breaching study participants' recruitment process. Environmental pressures resulted from low research literacy that made it possible for field workers not to consent participants and for participants not to prioritise privacy. The use of electronic data collection enhanced data security. A key recommendation from the study was that improved field supervision will reduce the risk for protocol violation.


Assuntos
Características da Família , Fidelidade a Diretrizes/ética , Seleção de Pacientes/ética , Inquéritos e Questionários , Adulto , Viés , Segurança Computacional/ética , Confidencialidade/ética , Feminino , Humanos , Consentimento Livre e Esclarecido/ética , Masculino , Pessoa de Meia-Idade , Nigéria , Guias de Prática Clínica como Assunto , Privacidade
17.
Nurse Res ; 27(2): 26-30, 2019 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-31468885

RESUMO

BACKGROUND: Internet-based research is increasing in popularity, but concerns remain about ethical issues and guidance is sparse in relation to generating data using online forums. AIM: To describe and discuss ethical considerations concerning the collecting of data through online forums by using the authors' research exploring women's views and experiences of birth plans. DISCUSSION: Using online discussion forums helped to generate data rapidly. However, ethical concerns required attention throughout the study. The authors engage with debates about the public/private nature of online research, the complexities of ensuring consent in this context is informed, and questions about anonymity and confidentiality, where data are traceable and identifiable through search engines. CONCLUSION: Research undertaken using online forums generates ethical issues similar to those seen in 'real world' studies. IMPLICATIONS FOR PRACTICE: Researchers need to explore how the designs of their studies are affected by issues such as ensuring informed consent and mitigating for the publicly viewable and searchable nature of the data obtained.


Assuntos
Atitude Frente a Saúde , Confidencialidade/ética , Coleta de Dados/ética , Consentimento Livre e Esclarecido/ética , Internet , Parto , Decepção , Ética em Pesquisa , Feminino , Humanos , Gravidez , Gestantes , Pesquisa Qualitativa , Pesquisadores/ética , Reino Unido
18.
Int J Med Inform ; 129: 242-247, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31445262

RESUMO

INTRODUCTION: Passive data refers to data generated without the active participation of the subject. This includes data from global positioning systems and accelerometers or metadata on phone call and text activity. Although the potential healthcare applications are far-reaching, passive data raises numerous ethical challenges. MATERIALS AND METHODS: We performed a systematic review to identify all ethical concerns, normative standpoints, and underlying arguments related to the use of passive data in healthcare. RESULTS: Among the various challenges discussed in the ethical literature, informational privacy, informed consent, and data security were the primary focus of the current debate. Other topics of discussion were the evaluation and regulation of products, equity in access, vulnerable patient groups, ownership, and secondary use. CONCLUSION: No clear ethical framework has been established that stimulates passive data-driven innovation while protecting patient integrity. The consensus in the ethical literature, as well as the parallels with similar concerns and solutions in other fields, can lay a foundation for the construction of an ethical framework. The future debate should focus on conflicts between two or more ethical, technical, or clinical values to ensure a safe and effective implementation of passive data in healthcare.


Assuntos
Coleta de Dados/ética , Assistência à Saúde/ética , Consenso , Consentimento Livre e Esclarecido/ética , Propriedade , Privacidade
19.
BMC Med Ethics ; 20(1): 55, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-31370847

RESUMO

BACKGROUND: Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection. METHODS: A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. RESULTS: The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. CONCLUSION: The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.


Assuntos
Pesquisa Biomédica/ética , Termos de Consentimento/normas , Consentimento Livre e Esclarecido/normas , Doenças Raras/terapia , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Termos de Consentimento/ética , Humanos , Consentimento Livre e Esclarecido/ética
20.
Rev Invest Clin ; 71(4): 217-225, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31448777

RESUMO

Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.


Assuntos
Pesquisa Biomédica/ética , Ética em Pesquisa , Sujeitos da Pesquisa , Populações Vulneráveis , Viés , Pesquisa Biomédica/organização & administração , Humanos , Consentimento Livre e Esclarecido/ética , Pesquisadores/ética , Pesquisadores/organização & administração
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