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Chiropr Man Therap ; 28(1): 60, 2020 11 04.
Artigo em Inglês | MEDLINE | ID: mdl-33148281


BACKGROUND: The COVID-19 pandemic has seen the emergence of unsubstantiated claims by vertebral subluxation-based chiropractors that spinal manipulative therapy has a role to play in prevention by enhancing the body's immune function. We contend that these claims are unprofessional and demonstrate a disturbing lack of insight into the doctrine of informed consent. As such it is timely to review how informed consent has evolved and continues to do so and also to discuss the attendant implications for contemporary health practitioner practice. We review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. We argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered. The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. We discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending "inhouse" products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings. CONCLUSION: Ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.

Quiroprática/legislação & jurisprudência , Revelação/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Pandemias/legislação & jurisprudência , Betacoronavirus , Infecções por Coronavirus , Humanos , Pneumonia Viral
Clin Ter ; 171(5): e401-e406, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32901782


INTRODUCTION: The study in question starts from a general analysis of Law n. 219/2017 and then to deepen the patient's right to self-determination, which is exercised through the expression of an informed consent to medical therapy. The analysis refers in particular to the patient's decision-making autonomy, the professional autonomy of the doctor and his consequent responsibility. MATERIALS AND METHODS: This study examines the art. 5 of the Law n. 219/2017, where the Legislator has defined the theme of shared planning of care. The authors compare the Advance Treatment Provisions (Article 4 - Law No. 219/2017) and the Shared Care Planning, to then examine the emerging relationship of care between doctor and patient. RESULT: The relationship of care must be related to the patient's willingness to decide on his future and to the technical and scientific information that the doctor is required to give. CONCLUSION: In conclusion, the Authors highlight the innovative content of the shared care plan, emphasizing the importance for a patient suffering from a chronic and progressive disease to be actively involved in formulating their own therapeutic plan.

Consentimento Livre e Esclarecido/legislação & jurisprudência , Direitos do Paciente/legislação & jurisprudência , Humanos , Itália , Administração dos Cuidados ao Paciente , Participação do Paciente , Autonomia Pessoal
Pediatrics ; 146(Suppl 1): S18-S24, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32737228


With a few notable exceptions, adolescents do not possess the legal authority to provide consent for or refuse medical interventions. However, in some situations, the question arises regarding whether a mature minor should be permitted to make a life-altering medical decision that would be challenged if made by the minor's parent. In this article, I explore what we currently know about the adolescent brain and how that knowledge should frame our understanding of adolescent decision-making. The prevailing approach to determining when adolescents should have their decisions respected in the medical and legal context, an approach that is focused on establishing capacity under a traditional informed consent model, will be reviewed and critiqued. I will suggest that the traditional model is insufficient and explore the implications for the adolescent role in health care decision-making.

Desenvolvimento do Adolescente , Encéfalo/crescimento & desenvolvimento , Tomada de Decisão Clínica , Doença de Hodgkin/tratamento farmacológico , Consentimento Livre e Esclarecido/psicologia , Recusa do Paciente ao Tratamento/psicologia , Adolescente , Comportamento do Adolescente/psicologia , Fatores Etários , Feminino , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Competência Mental/legislação & jurisprudência , Competência Mental/psicologia , Mães , Patient Self-Determination Act , Autonomia Pessoal , Recusa do Paciente ao Tratamento/legislação & jurisprudência , Estados Unidos
Rev. bioét. derecho ; (49): 155-171, jul. 2020.
Artigo em Português | IBECS | ID: ibc-192100


Este artigo debate as inovações trazidas com o Código Civil e Comercial argentino, junto a um paralelo com o Estatuto da Pessoa com Deficiência no Brasil, cujas leis se adequaram à Convenção de Nova York de 2006. A pesquisa partiu da análise de documentos normativos e autores de direito civil e bioética, de forma a questionar como se efetivará a manifestação de vontade dos doentes mentais na relação médico-paciente. Para tanto, será abordado inicialmente quais mudanças ocorreram na capacidade civil no ordenamento jurídico argentino. Após, discutir-se-á a relação entre autonomia e competência e sua configuração na relação médico-paciente, para após adentrar-se no consentimento dos doentes mentais. Por fim, comparar-se-á o tratamento dado a tais indivíduos com dois países

Este artículo analiza las innovaciones del Código Civil y Comercial argentino, haciendo un paralelo con el Estatuto de la Persona con Discapacidad en Brasil, cuyas leyes se adecuaron a la Convención de Nueva York de 2006. La investigación partió del análisis de documentos normativos y autores de derecho civil y bioética, para cuestionar cómo se efectúa la manifestación de voluntad de los enfermos mentales en la relación médico-paciente. Para ello, se abordará qué cambios ocurrieron en la capacidad civil en el ordenamiento jurídico argentino. Luego se discutirá la relación entre autonomía y competencia y su configuración en la relación médico-paciente, para después adentrarse en el consentimiento de los enfermos mentales. Por último, se comparará el tratamiento dado a tales individuos en ambos países

This article discusses the innovations brought with the Argentine Civil and Commercial Code, along with a parallel with the Statute of the Person with Disabilities in Brazil, whose laws were in line with the New York Convention of 2006. The research was based on the analysis of documents normative and authors of civil law and bioethics, in order to question how the manifestation of will of the mentally ill in the doctor-patient relationship will take place. To do so, it will be initially addressed what changes have occurred in civil capacity in the Argentine legal system. Afterwards, the relationship between autonomy and competence and its configuration in the doctor-patient relationship will be discussed, after entering into the consent of the mentally ill. Finally, the treatment given to such individuals with two countries will be compared

Aquest article analitza les innovacions del Codi Civil I Comercial argentí, fent un paral·lel amb l'Estatut de la Persona amb Discapacitat al Brasil, les lleis del qual es van adequar a la Convenció de Nova York de 2006. La investigació va partir de l'anàlisi de documents normatius I autors de dret civil I bioètica per qüestionar com s'efectua la manifestació de voluntat dels malalts mentals en la relació metge-pacient. Per a això, s'abordarà quins canvis van ocórrer en la capacitat civil en l'ordenament jurídic argentí. Després es discutirà la relació entre autonomia I competència I la seva configuració en la relació metge-pacient, per després endinsar-se en el consentiment dels malalts mentals. Finalment, es compararà el tractament donat a aquests individus als dos països

Humanos , Deficiência Intelectual/epidemiologia , Relações Médico-Paciente , Pessoas Mentalmente Doentes/legislação & jurisprudência , Direitos Civis , Consentimento Livre e Esclarecido/legislação & jurisprudência , Argentina , Autonomia Pessoal , Competência Clínica/legislação & jurisprudência , Brasil
Scand J Trauma Resusc Emerg Med ; 28(1): 51, 2020 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-32513204


BACKGROUND: Clinical research in severely ill or injured patients is required to improve healthcare but may be challenging to perform in practice. The aim of this study was to analyse barriers and challenges in the process of including critically ill patients in clinical studies. METHODS: Data from critically ill patients considered for inclusion in an observational study of venous thromboembolism in Norway were analysed. This included quantitative and qualitative information from the screening log, consent forms and research notes. RESULTS: Among 279 eligible critically ill patients, 204 (73%) were omitted from the study due to challenges and barriers in the inclusion process. Reasons for omission were categorised as practical in 133 (65%), medical in 31 (15%), and legal or ethical in 40 (20%) of the patients. Among 70 included patients, 29 (41%) consents were from patients and 41 (59%) from their next of kin. Several challenges were described herein; these included whether patients were competent to give consent, and which next of kin that should represent the patient. Furthermore, some included patients were unable to recall what they have consented, and some appeared unable to separate research from treatment. CONCLUSIONS: Barriers and challenges in the inclusion process led to the omission of near three out of four eligible patients. This analysis provided information about where the problem resides and may be solved. The majority of challenges among included patients were related to issues of autonomy and validity of consent. TRIAL REGISTRATION: (NCT03405766).

Estado Terminal/terapia , Dalteparina/uso terapêutico , Fibrinolíticos/uso terapêutico , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Seleção de Pacientes/ética , Adulto , Feminino , Humanos , Masculino , Noruega
N Z Med J ; 133(1515): 97-103, 2020 05 22.
Artigo em Inglês | MEDLINE | ID: mdl-32438381


The role of the external clinical advisor is critical to the adjudication of complex claims in the processes of the Accident Compensation Corporation (ACC). This is particularly true of claims for treatment injury that occur during birth, which are often very complicated. In most cases external clinical advisors are non-treating doctors, whose opinion strongly guides the hand of ACC. This viewpoint considers the impact of the role of the external clinical advisor by using extracts from an external clinical advisor's report to show how a power imbalance can be enacted in ACC decision making processes. Also considered are the way that the normal checks and balances in the system, particularly those provided by the Health & Disability Commissioner, are bypassed in most cases. Finally, a recommendation is made to potential external clinical advisors to precisely following the standards set by the Medical Council in all cases when writing reports for ACC.

Traumatismos do Nascimento/etiologia , Compensação e Reparação/legislação & jurisprudência , Prova Pericial/normas , Papel do Médico , Lesões Encefálicas/etiologia , Criança , Tomada de Decisões , Prova Pericial/legislação & jurisprudência , Feminino , Transtornos do Crescimento/complicações , Humanos , Doença Iatrogênica , Recém-Nascido , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , Nova Zelândia , Osteocondrodisplasias/complicações , Gravidez , Complicações na Gravidez/etiologia
Bone Joint J ; 102-B(5): 550-555, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32349593


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.

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
Anaesthesia ; 75(9): 1229-1235, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32329902


In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.

Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Doadores de Tecidos/ética , Doadores de Tecidos/legislação & jurisprudência , Humanos , Reino Unido , Estados Unidos
Public Health ; 182: 51-52, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32171090


OBJECTIVE: Informed consent (IC) principles are often overlooked aspects in debates about national screening programs. This short communication examines the Danish approach to IC in decision-making about screening participation. STUDY DESIGN: A descriptive approach is adopted in linking present screening practices with Danish regulation about IC and international ethical principles. METHODS: To ascertain the extent to which screening procedures come up to IC requirements, the article adopts a review approach by examining relevant Danish national legislation including ministerial orders as well as international ethical codes. RESULTS: The article finds that, although Danish legislation as well as international IC principles generally stipulates a decision-making process requiring oral communication, current procedures largely rely on one-way communication through written information available from leaflets, web sites, etc. Screening programs seem to have established no general formula to qualify healthcare users' understanding of data underlying their choice whether to be screened. CONCLUSION: The deviance from common IC principles may reduce healthcare quality, pose a safety problem, and challenge healthcare users' ability to exercise autonomy.

Comunicação , Tomada de Decisões , Consentimento Livre e Esclarecido/ética , Programas de Rastreamento , Participação do Paciente/psicologia , Dinamarca , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/psicologia , Autonomia Pessoal , Qualidade da Assistência à Saúde
G Ital Cardiol (Rome) ; 21(4): 306-308, 2020 Apr.
Artigo em Italiano | MEDLINE | ID: mdl-32202564


The Italian law 219/2017, enacted on January 31, 2018, regulates patients' informed consent, personalized care planning and advance directives. The law provides for patient's self-determination in all phases of life. This also applies to patients suffering from chronic, progressive, terminal disease such as heart failure. In fact, the clinical and psychosocial trajectory for heart failure patients demands an interdisciplinary, systemic approach. Advance directives should be tailor-made to patient's needs and dynamically updated through the course of the disease according to patient's and family informed and shared decision-making. Healthcare professionals will require education and training to stay up to the task both clinically, psychologically and emotionally.

Diretivas Antecipadas/legislação & jurisprudência , Cuidadores , Consentimento Livre e Esclarecido/legislação & jurisprudência , Ordens quanto à Conduta (Ética Médica) , Tomada de Decisões , Humanos , Itália , Autonomia Pessoal , Assistência Terminal
Rev. bioét. derecho ; (48): 41-59, mar. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-192077


Desde su origen, la Medicina Intensiva y la Bioética han compartido un desarrollo común, reforzándose entre ambas. Los límites de la tecnología, el cambio en la relación clínica, el respeto a las preferencias de los pacientes, han generado distintos conflictos éticos entre profesionales, pacientes y familiares. El objetivo del presente artículo es analizar como los pacientes que ingresan en las unidades de cuidados intensivos pueden participar en la toma de decisiones sobre actuaciones presentes (consentimiento informado) o futuras (voluntades anticipadas) e identificar el papel tanto del profesional sanitario como de la familia durante todo el proceso

Since its origin, Intensive Medicine and Bioethics have shared a common development, reinforcing each other. The limits of technology, the change in the clinical relationship, and respect for patients' preferences have generated different ethical conflicts between professionals, patients and family members. The objective of this article is to analyze how patients admitted to intensive care units can participate in decision-making about present (informed consent) or future (advance directives) actions and to identify the role of both the health professional and the family during the whole process

Des del seu origen, la Medicina Intensiva i la Bioètica han compartit un desenvolupament comú, reforçant-se mútuament. Els límits de la tecnologia, el canvi en la relació clínica, el respecte a les preferències dels pacients, han generat diferents conflictes ètics entre professionals, pacients i familiars. L'objectiu del present article és analitzar com els pacients que ingressen en les unitats de vigilància intensiva poden participar en la presa de decisions sobre actuacions presents (consentiment informat) o futures (voluntats anticipades) i identificar el paper tant del professional sanitari com de la família durant tot el procés

Humanos , Consentimento Livre e Esclarecido/ética , Unidades de Terapia Intensiva , Diretivas Antecipadas/ética , Tomada de Decisões/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Diretivas Antecipadas/legislação & jurisprudência , Relações Profissional-Família/ética , Bioética
Georgian Med News ; (298): 175-180, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32141874


The purpose of this article is to analyze the main medical, legal, and ethical issues and challenges of euthanasia in the digital age. The methods that were used in this study are historical, logical, empirical, as well as comparative legal method for comparison of laws and practices of the EU and post-Soviet countries, including Ukraine. This choice determined by the fact that both groups of countries have common features and relations, while the features of their development affect approaches to regulating such sensitive and potentially open to abuse problems as euthanasia. There is no final legal answer as to whether to legalize, decriminalize or prohibit euthanasia in any of its forms. The features and legal terms of active and passive, voluntary and non-voluntary euthanasia and assisted suicide, especially for psychiatric and minor patients were researched, as well as conflicting arguments, which include individual autonomy, right to choose, the opportunity to get rid of suffering, as well as undermining the practice of palliative care, abuse in cases of vulnerable and dependent patients, moral burden on the doctors. The issue of control of the practice of euthanasia is complicated, given the extent to which it is possible to obtain informed consent, establish criteria for suffering and hopelessness, check the persistence, conviction and validity of requests for euthanasia, especially in the digital era. The potential legislation and judicial practice should provide for strict and effective guarantees, respect for the beliefs of each person and the right not to participate in any contentious practices, the balance of human rights and social values.

Eutanásia , Suicídio Assistido , Eutanásia/ética , Eutanásia/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Princípios Morais , Cuidados Paliativos , Suicídio Assistido/ética , Suicídio Assistido/legislação & jurisprudência , Ucrânia
Clin Ter ; 171(2): e94-e96, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32141477


End-of-life decisions are an emergent issue for bioethical debates and practical concerns among health professionals. On December 2017, Italy enacted a new law named "Rules about informed consent and advance directives", which promotes the relationship of care in a fiduciary sense through the implementation of a correct and exhaustive information. It is also prescribed to record in writing all the patients' decisions about consent or refusal. Furthermore, the law explicitly forbids unreasonable therapeutic obstinacy for terminal patient, legitimizing deep palliative sedation. Finally, the law establishes the use of "advance directives" as a written document by which adults and capable people can express their wishes regarding health treatments and diagnostic tests in anticipation of a possible future incapacity. The law provides that doctors must comply with these directives, unless they appear clearly incongruous or not corresponding to the patient's current clinical condition.

Diretivas Antecipadas/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Assistência Terminal/legislação & jurisprudência , Adulto , Tomada de Decisões , Humanos , Itália
Bioethics ; 34(3): 306-317, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32100330


This paper is an analysis of the limits of family authority to refuse life saving treatment for a family member (in the Chinese medical context). Family consent has long been praised and practiced in many non-Western cultural settings such as China and Japan. In contrast, the controversy of family refusal remains less examined despite its prevalence in low-income and middle-income countries. In this paper, we investigate family refusal in medical emergencies through a combination of legal, empirical and ethical approaches, which is highly relevant to the ongoing discussion about the place of informed consent in non-Western cultures. We first provide an overview of the Chinese legislation concerning informed consent to show the significance of family values in the context of medical decision-making and demonstrate the lack of legal support to override family refusal. Next, we present the findings of a vignette question that investigated how 11,771 medical professionals and 2,944 patients in China responded to the family refusal of emergency treatment for an unconscious patient. In our analysis of these results, we employ ethical reasoning to question the legitimacy of family refusal of life-sustaining emergency treatment for temporarily incompetent patients. Last, we examine some practical obstacles encountered by medical professionals wishing to override family refusal to give context to the discussion.

Tomada de Decisões , Tratamento de Emergência , Família , Valores Sociais/etnologia , Recusa do Paciente ao Tratamento/ética , Recusa do Paciente ao Tratamento/legislação & jurisprudência , China , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Competência Mental/legislação & jurisprudência