Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 38.404
Filtrar
1.
Rev. bioét. derecho ; (50): 353-368, nov. 2020.
Artigo em Espanhol | IBECS | ID: ibc-191362

RESUMO

El presente estudio ofrece una investigación sistemática, exhaustiva y actualizada del tratamiento de datos personales relativos a la salud de los ciudadanos afectados y/o potencialmente afectados por la situación excepcional derivada del COVID-19. Para ello, y tomando en consideración toda la normativa, general y sectorial, aplicable en materia de protección de datos y de sanidad, se procede al análisis de las bases legitimadoras procedentes y de las excepciones que, aplicables a situaciones de emergencia sanitaria como la actual, habilitan el tratamiento atendiendo a la naturaleza de quien intervenga como responsable, haciendo especial énfasis en el interés público perseguido por las Administraciones Públicas y en el interés vital del propio interesado


This study offers a systematic, exhaustive and updated investigation of the processing of personal data relating to the health of citizens affected and/or potentially affected by the exceptional situation resulting from COVID-19. For this purpose, and taking into account all the general and sectorial regulations applicable to data protection and health issues, it analyses the legitimate bases and the exceptions that, applicable to health emergency situations such as the present one, allow the processing according to the nature of the controller, with special emphasis on the public interest pursued by the Public Administrations and the vital interest of the data subject


El present estudi ofereix una investigació sistemàtica, exhaustiva I actualitzada del tractament de dades personals relatives a la salut dels ciutadans afectats i/o potencialment afectats per la situació excepcional derivada de la COVID-19. Per aquest motiu I tenint en compte tota la normativa, general I sectorial, aplicable en matèria de protecció de dades I de sanitat, es procedeix a l'anàlisi de les bases legitimadores procedents I de les excepcions que, aplicables a situacions d'emergència sanitària com l'actual, habiliten el tractament atenent a la naturalesa de qui intervingui com a responsable, fent especial èmfasi a l'interès públic perseguit per les administracions públiques I en l'interès vital de la persona interessada


Assuntos
Humanos , Emergências , Privacidade , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Pandemias , Consentimento Livre e Esclarecido , Legislação como Assunto
2.
Rev. bioét. derecho ; (50): 407-423, nov. 2020. tab, graf
Artigo em Português | IBECS | ID: ibc-191365

RESUMO

O processo de consentimento informado para participação de pesquisa com seres humanos visa fornecer as informações adequadas ao indivíduo possibilitando que este tome a decisão de participar de maneira voluntária, livre de pressões externas. A possibilidade de remuneração poderia interferir na voluntariedade deste processo de consentir. O presente estudo objetivou avaliar percepção de influência da remuneração monetária por meio de simulações de pesquisa que variam em nível de risco (Bioequivalência e de Fase I) e tipo de remuneração monetária (com e sem). Participaram do estudo 80 voluntários. Os resultados sugerem que a remuneração não constituiu uma interferência na voluntariedade do processo de consentimento, visto que participantes aceitaram convite para participar da primeira pesquisa para a qual foram convidados e não se sentiram influenciados indebidamente


El proceso de consentimiento informado para la participación de sujetos humanos en investigación tiene por objeto dar la información adecuada al individuo, permitiendo que tome la decisión de participar de manera voluntaria y libre de presiones externas. La posibilidad de remuneración podría interferir en la voluntariedad de este proceso de consentir. El presente estudio evalúa la percepción de la influencia de la remuneración monetaria a través de simulaciones de investigación que varían en nivel de riesgo (Bioequivalencia y de Fase I) y tipo de remuneración monetaria (con y sin). Participaron del estudio 80 voluntarios. Los resultados sugieren que la remuneración no constituyó una interferencia en la voluntariedad del proceso de consentimiento, ya que los participantes aceptaron una invitación para participar en la primera encuesta a la que fueron invitados y no se sintieron influenciados incorrectamente


El procés de consentiment informat per a la participació de subjectes humans en recerca té per objecte donar la informació adequada a l'individu, permetent que prengui la decisió de participar de manera voluntària I lliure de pressions externes. La possibilitat de remuneració podria interferir en la voluntarietat d'aquest procés de consentir. El present estudi avalua la percepció de la influència de la remuneració monetària a través de simulacions de recerca que varien en nivell de risc (Bioequivalencia I de Fase I) I tipus de remuneració monetària (amb I sense). Van participar de l'estudi 80 voluntaris. Els resultats suggereixen que la remuneració no va constituir una interferència en la voluntarietat del procés de consentiment, ja que els participants van acceptar una invitació per a participar en la primera enquesta a la qual van ser convidats I no es van sentir influenciats incorrectament


The process of informed consent for research participation with human beings aims to provide appropriate information to individuals enabling him or her to make the decision to participate voluntarily, free of external pressures. The possibility of remuneration could interfere in the willingness to consent. The present study aims to evaluate the perception of influence of the monetary payment through research simulations that vary in the level of risk (Bioequivalence and Phase I) and type of monetary payment (with and without). Eighty volunteers participated in the study. The results suggest that remuneration did not interfere with the willingness of the consent process, as participants accepted an invitation to participate in the first research option to which they were invited to and did not feel undue influence


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Pesquisa Biomédica/economia , Remuneração , Decisões , Consentimento Livre e Esclarecido , Ética em Pesquisa , Fatores Socioeconômicos
4.
Ned Tijdschr Tandheelkd ; 127(9): 487-491, 2020 Sep.
Artigo em Holandês | MEDLINE | ID: mdl-33011754

RESUMO

The character of a consent for treatment is not a mere hobby for lawyers; it also has consequences in daily practicein the Netherlands, particularly if it concerns questions of who should prove what in proceedings. In general, consent agreements can be divided into an obligation to achieve results and an obligation to use reasonable endeavours. In oral healthcare, there is usually a question of an obligation to use reasonable endeavours, in which professional standards must play a leading role in the behaviour of the dentist; and here there have been a number of recent developments, such as an increase in the number of (clinical) guidelines and the acceptance of wish fulfilling medicine, under strict conditions. It is concluded that recent developments in the dentist's requirement to provide evidence in proceedings have definitely not made things simpler.


Assuntos
Medicina , Odontólogos , Humanos , Consentimento Livre e Esclarecido , Países Baixos
5.
Soins Psychiatr ; 41(328): 12-15, 2020.
Artigo em Francês | MEDLINE | ID: mdl-33039084

RESUMO

We need to go back to the time of alienist doctors to understand the interest of the care programme established in 2011. In fact, the psychiatric clinic requires professionals to accompany the patient over time, while accepting the variability of suffering. In this context, this system proposes an alternative to full in-patient care while preserving the aspect of compulsory treatments. Caring for the patient, acquiring their consent while preserving their rights is a real challenge for the psychiatrist and their team.


Assuntos
Continuidade da Assistência ao Paciente/organização & administração , Consentimento Livre e Esclarecido , Transtornos Mentais/terapia , Psiquiatria , Humanos
6.
Soins Psychiatr ; 41(328): 30-31, 2020.
Artigo em Francês | MEDLINE | ID: mdl-33039089

RESUMO

Claude Finkelstein, president of the Fédération nationale des associations d'usagers en psychiatrie, has drawn up an inventory of care programmes, nine years after their establishment. In particular, she highlights the experience of patients and their familes regarding this system. The pitfalls concern the systematic search for the healthcare proxy and some application methods in the follow-up. Prospects for improvement should be discussed to give value to the interest of such programmes for the subjects.


Assuntos
Consentimento Livre e Esclarecido , Transtornos Mentais/terapia , Humanos
8.
N Z Med J ; 133(1522): 138-143, 2020 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-32994624

RESUMO

The Health and Disability Code precludes any research involving a competent patient without the informed consent of the participant. A learning health system requires rigorous evaluation of both new and established clinical practice, including low-risk components of usual care pathways. When comparing two accepted practices, the only way to control for unknown confounders is by randomisation. In some limited circumstances, particularly when comparing groups or clusters of patients, this comparison can only practicably be undertaken without consent. The current Code impedes a learning health system and is detrimental to the health of New Zealanders. It urgently needs updating.


Assuntos
Consentimento Livre e Esclarecido , Sistema de Aprendizagem em Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções por Coronavirus , Registros Eletrônicos de Saúde , Humanos , Sistema de Aprendizagem em Saúde/legislação & jurisprudência , Sistema de Aprendizagem em Saúde/normas , Nova Zelândia , Pandemias , Pneumonia Viral , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Encaminhamento e Consulta
9.
S Afr Med J ; 110(7): 629-634, 2020 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-32880337

RESUMO

Pandemics challenge clinicians and scientists in many ways, especially when the virus is novel and disease expression becomes variable or unpredictable. Under such circumstances, research becomes critical to inform clinical care and protect future patients. Given that severely ill patients admitted to intensive care units are at high risk of mortality, establishing the cause of death at a histopathological level could prove invaluable in contributing to the understanding of COVID-19. Postmortem examination including autopsies would be optimal. However, in the context of high contagion and limited personal protective equipment, full autopsies are not being conducted in South Africa (SA). A compromise would require tissue biopsies and samples to be taken immediately after death to obtain diagnostic information, which could potentially guide care of future patients, or generate hypotheses for finding needed solutions. In the absence of an advance written directive (including a will or medical record) providing consent for postmortem research, proxy consent is the next best option. However, obtaining consent from distraught family members, under circumstances of legally mandated lockdown when strict infection control measures limit visitors in hospitals, is challenging. Their extreme vulnerability and emotional distress make full understanding of the rationale and consent process difficult either before or upon death of a family member. While it is morally distressing to convey a message of death telephonically, it is inhumane to request consent for urgent research in the same conversation. Careful balancing of the principles of autonomy, non-maleficence and justice becomes an ethical imperative. Under such circumstances, a waiver of consent, preferably followed by deferred proxy consent, granted by a research ethics committee in keeping with national ethics guidance and legislation, would fulfil the basic premise of care and research: first do no harm. This article examines the SA research ethics framework, guidance and legislation to justify support for a waiver of consent followed by deferred proxy consent, when possible, in urgent research after death to inform current and future care to contain the pandemic in the public interest.


Assuntos
Infecções por Coronavirus/epidemiologia , Cuidados Críticos/ética , Estado Terminal/terapia , Mortalidade Hospitalar , Consentimento Livre e Esclarecido/ética , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Causas de Morte , Infecções por Coronavirus/prevenção & controle , Cuidados Críticos/legislação & jurisprudência , Estado Terminal/mortalidade , Países em Desenvolvimento , Feminino , Humanos , Controle de Infecções/organização & administração , Unidades de Terapia Intensiva/ética , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Determinação de Necessidades de Cuidados de Saúde , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Medição de Risco , África do Sul , Populações Vulneráveis/estatística & dados numéricos
10.
S Afr Med J ; 110(7): 635-639, 2020 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-32880338

RESUMO

Research is imperative in addressing the COVID-19 epidemic, both in the short and long term. Informed consent is a key pillar of research and should be central to the conduct of COVID-19 research. Yet a range of factors, including physical distancing requirements, risk of exposure and infection to research staff, and multiple pressures on the healthcare environment, have added layers of challenges to the consent process in COVID-19 patients. Internationally, the recognition that consent for COVID-19 research may be imperfect has led to a range of suggestions to ensure that research remains ethical. Drawing on these guidelines, we propose a consent process for COVID-19 research in the South African context that combines individual consent with delayed and proxy consent for individuals who may be temporarily incapacitated, combined with key principles that should be considered in the design of a consent process for COVID-19 research.


Assuntos
Infecções por Coronavirus/epidemiologia , Bases de Dados Factuais/ética , Guias como Assunto , Consentimento Livre e Esclarecido/ética , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Controle de Doenças Transmissíveis/normas , Infecções por Coronavirus/prevenção & controle , Países em Desenvolvimento , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , África do Sul
11.
Rev Med Suisse ; 16(708): 1790-1795, 2020 Sep 30.
Artigo em Francês | MEDLINE | ID: mdl-32997448

RESUMO

Medical care of adults with disabilities, especially those with intellectual disabilities, can be ethically difficult. Several questions arise frequently. Can we administer a life-saving treatment that could impact negatively the patient's quality of life when the patient isn't able to give consent? During this Covid-19 period, can the use of chemical or physical restraints be considered as mistreatment, whereas the aim is to protect others? These are situations where the ethical question holds a central role. Although each clinical situation is unique, this article highlights, through four clinical cases, the ethical principles that should guide physicians in their decision-making process.


Assuntos
Tomada de Decisão Clínica/ética , Infecções por Coronavirus/psicologia , Infecções por Coronavirus/terapia , Pessoas com Deficiência , Deficiência Intelectual , Pneumonia Viral/psicologia , Pneumonia Viral/terapia , Qualidade de Vida , Adulto , Infecções por Coronavirus/epidemiologia , Humanos , Consentimento Livre e Esclarecido/ética , Pandemias , Pneumonia Viral/epidemiologia , Restrição Física/ética
13.
Rev Prat ; 70(4): 371-374, 2020 Apr.
Artigo em Francês | MEDLINE | ID: mdl-32877087

RESUMO

Medical responsibility: what records should be kept of medical procedures? Quality information is nowadays required to enable patients to understand and accept the treatments proposed to them and to be involved in the choices of the team to which they have entrusted themselves. This is "informed consent". It is up to the doctor to give all the necessary information to the patient during an individual discussion, which he must take care to keep records of. Thus, he will be able to retrace the medical procedures and establish the reality of the information given to his patient. Thus, the doctor must always keep a written record proving and detailing this information, which will allow him to retrace the medical procedures taken and thus establish the veracity of the information given to his patient. However, we must recognize how difficult it is to convey traumatic message, to explain the incomprehensible, to "decode" scientific language, to announce the irreversible. It is therefore imperative, insofar as the duty to provide information will be discussed in each case of liability, to be concerned with proving the content of the information given, in accordance with a demanding but protective deontology for both doctor and patient. This article returns to the essential questions regarding information: why inform? Who proves what? How to inform and prove it? ¼.


Assuntos
Consentimento Livre e Esclarecido , Humanos , Masculino
14.
Rev Prat ; 70(2): 218-221, 2020 Feb.
Artigo em Francês | MEDLINE | ID: mdl-32877145

RESUMO

Pediatric informed consent in medical care and research. The obligation to obtain informed consent from a patient prior to any care does not depend solely on the personal ethics of the practitioner. It is defined and framed by law. However, innumerable legal difficulties emanate from the simple fact that the subject is a child, a vulnerable person who must be protected, and that this protection is exercised under the aegis of the parental authority. If in most cases there is an alliance with the holders of parental authority, the views sometimes diverge. The article lists the most frequently observed cases in clinical practice and the way in which the french Public Health Code plans to solve them. Problems specific to research are discussed. Difficulties for consent about off-label prescribing are briefly exposed.


Assuntos
Consentimento Livre e Esclarecido , Pais , Criança , Humanos
18.
Prim Dent J ; 9(3): 59-63, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32940592

RESUMO

With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.


Assuntos
Comunicação , Consentimento Livre e Esclarecido , Tomada de Decisões , Odontologia , Humanos
19.
J Korean Med Sci ; 35(36): e329, 2020 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-32924344

RESUMO

BACKGROUND: The number of clinical trials conducted in Korea continues to increase and an increasing proportion focus on severe and rare incurable diseases. After the start of the severe acute respiratory syndrome, coronavirus disease 2019 (COVID-19), Korea Centers for Disease Control and Prevention (KCDC) developed guidelines to prevent the spread of infection. This study evaluated the impact of COVID-19 and the KCDC guideline on the conduct of clinical research in Korea. The purpose was to develop recommendations on how to minimize the risk of infection while enabling subjects to take part in the trials if no better alternative treatment options were available. METHODS: The impact on subject's scheduled visits and major milestones of clinical trials in Korea were measured by conducting a survey among clinical project manager (CPMs) working at global clinical research organization. The policy on monitor's access to hospital and site initiation meetings was investigated through correspondence with clinical trial center of 39 hospitals. The Top 25 pharmaceutical companies' official press and public clinical trial registry database were used to analyze companies' trial strategy during the pandemic and COVID-19 clinical research status, respectively. RESULTS: Of 85 CPMs, 12% reported that trial subjects' scheduled visits had been affected in their project. Monitors' access to hospital for source data verification was restricted at all sites in February 2020. Accordingly, 43% of 105 CPMs reported that the COVID-19 epidemic had an effect on study major milestones and data cleaning and database lock accounted for > 60% of milestones affected. In addition, 87% sites advised not to have site initiation meetings and 52% pharmaceutical companies suspended recruitment or new study start-up due to the pandemic. On the other hands, the number of COVID-19 related clinical trials increased rapidly in Korea and worldwide, with investigator-initiated trials accounting for 47% and 63% of all trials locally and globally, respectively. Most trials were phase 2 and were in the recruitment stage. CONCLUSION: The COVID-19 and the KCDC guideline influenced all parties involved in clinical trials in Korea. In order to ensure the safety and well-being of trial subjects during the pandemic, new approaches are required for clinical trials to respond to the impact actively. Method of non-contact is developed to replace and supplement the face-to-face contact and alternatives to reduce the travel is introduced to decrease the risk of infection for all trial participants in whole trial process. The relevant regulations should be developed and the guidelines for foreign countries need to be adopted in accordance with the situation in Korea. COVID-19 trial is rapidly increasing worldwide and continuous support of health authorities, regulation, and facilities is required for developing the treatments with protecting all trial participants.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Continuidade da Assistência ao Paciente , Infecções por Coronavirus/epidemiologia , Indústria Farmacêutica , Comitês de Ética em Pesquisa , Fidelidade a Diretrizes , Humanos , Controle de Infecções , Consentimento Livre e Esclarecido , Estudos Multicêntricos como Assunto , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , República da Coreia/epidemiologia , Projetos de Pesquisa , Pesquisadores , Viagem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA