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1.
J Korean Med Sci ; 36(3): e31, 2021 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-33463097

RESUMO

The coronavirus disease 2019 pandemic has caused a breakdown in the healthcare system worldwide. The need to rapidly update guidelines in order to control the transmission in the population and for evidenced-based healthcare care has led to the need for timely, voluminous and valid research. Amid the quest for a vaccine and better therapies, researchers clamouring for information has led to a wide variety of ethical issues due to the unique situation. This paper aims to examine the positive and negative aspects of recent changes in the process of obtaining informed consent. The article outlines the various aspects, from history, previously described exemptions to consenting as well as those implemented during the pandemic and the current impact of virtual methods. Further, the authors make recommendations based on the outcome of suggested adjustments described in the literature. This article looks into increasing the awareness of physicians and researchers about ethical issues that need to be addressed to provide optimal care for patients while assuring their integrity and confidentiality.


Assuntos
Consentimento Livre e Esclarecido/ética , Editoração/ética , /prevenção & controle , /transmissão , Medicina Baseada em Evidências , Disparidades em Assistência à Saúde/ética , Humanos , Pandemias , Educação de Pacientes como Assunto/ética , Relações Médico-Paciente/ética
2.
Emerg Med Clin North Am ; 39(1): 217-225, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33218659

RESUMO

The emergency department is where the patient and potential ethical challenges are first encountered. Patients with acute neurologic illness introduce a unique set of dilemmas related to the pressure for ultra-early prognosis in the wake of rapidly advancing treatments. Many with neurologic injury are unable to provide autonomous consent, further complicating the picture, potentially asking uncertain surrogates to make quick decisions that may result in significant disability. The emergency department physician must take these ethical quandaries into account to provide standard of care treatment.


Assuntos
Lesões Encefálicas Traumáticas/terapia , Assistência Terminal/ética , Manuseio das Vias Aéreas/ética , Manuseio das Vias Aéreas/métodos , Beneficência , Morte Encefálica/diagnóstico , Lesões Encefálicas Traumáticas/diagnóstico , Serviço Hospitalar de Emergência/ética , Procedimentos Endovasculares/ética , Ética Médica , Humanos , Consentimento Livre e Esclarecido/ética , Prognóstico , Acidente Vascular Cerebral/terapia , Obtenção de Tecidos e Órgãos/ética
3.
Trials ; 21(1): 853, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33059771

RESUMO

OBJECTIVES: To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more). TRIAL DESIGN: This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint. PARTICIPANTS: Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil. INTERVENTION AND COMPARATOR: Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 µg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval. MAIN OUTCOMES: The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination. RANDOMISATION: There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive. BLINDING (MASKING): This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study. TRIAL STATUS: Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21st, 2020. The recruitment is expected to conclude in October 2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Betacoronavirus/genética , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinação/métodos , Vacinas/uso terapêutico , Adolescente , Adulto , Idoso , Betacoronavirus/imunologia , Brasil/epidemiologia , Estudos de Casos e Controles , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/virologia , Gerenciamento de Dados , Método Duplo-Cego , Feminino , Pessoal de Saúde/estatística & dados numéricos , Humanos , Incidência , Consentimento Livre e Esclarecido/ética , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Placebos/administração & dosagem , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Pneumonia Viral/virologia , Segurança , Terapias em Estudo/métodos , Resultado do Tratamento , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Adulto Jovem
4.
Trials ; 21(1): 875, 2020 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-33092632

RESUMO

OBJECTIVES: The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities. Secondary objectives are to demonstrate that CCP decreases the viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre in recipients. TRIAL DESIGN: This is a randomized, open-label, parallel group, phase II/III study with a superiority framework. The trial starts with a screening phase II designed with two-tailed alpha=0.2. In case of positive results, the trial will proceed in a formally comparative phase III (alpha=0.05). PARTICIPANTS: Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible. Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent. Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. The trial is being conducted at three reference COVID-19 centres in the middle of Italy. INTERVENTION AND COMPARATOR: Intervention: COVID-19 Convalescent Plasma (CCP) in addition to standard therapy. Patients receive three doses (200 ml/day on 3 consecutive days) of ABO matched CCP. Comparator: Standard therapy MAIN OUTCOMES: A. Primary outcome for Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. B. Primary outcome for Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. Secondary outcomes for Phase III: Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60). RANDOMISATION: Treatment allocation is randomized with a ratio 1:1 in both phase II and phase III. Randomization sequences will be generated at Fondazione Policlinico Gemelli IRCCS through the RedCap web application. Randomized stratification is performed according to age (under/over 80 years), and sex. BLINDING (MASKING): None, this is an open-label trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Phase II: 114 patients (57 per arm). Phase III: 182 patients (91 per arm) TRIAL STATUS: The trial recruitment started on May 27, 2020. The anticipated date of recruitment completion is April 30, 2021. The protocol version is 2 (May 10, 2020). TRIAL REGISTRATION: The trial has been registered on ClinicalTrials.gov (May 5, 2020). The Identifier number is NCT04374526 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Betacoronavirus/genética , Transfusão de Sangue/métodos , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus/imunologia , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Progressão da Doença , Feminino , Humanos , Imunização Passiva/efeitos adversos , Imunização Passiva/métodos , Consentimento Livre e Esclarecido/ética , Itália/epidemiologia , Masculino , Mortalidade/tendências , Pandemias , Pneumonia/diagnóstico por imagem , Pneumonia/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Tomografia Computadorizada por Raios X/métodos , Carga Viral/imunologia , Carga Viral/estatística & dados numéricos
9.
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
10.
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
11.
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
12.
PLoS One ; 15(8): e0237875, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32853218

RESUMO

While emerging digital health technologies offer researchers new avenues to collect real-time data, little is known about current ethical dimensions, considerations, and challenges that are associated with conducting digital data collection in research with minors. As such, this paper reports the findings of a scoping review which explored existing literature to canvass current ethical issues that arise when using digital data collection in research with minors. Scholarly literature was searched using electronic academic databases for articles that provided explicit ethical analysis or presented empirical research that directly addressed ethical issues related to digital data collection used in research with minors. After screening 1,156 titles and abstracts, and reviewing 73 full-text articles, 20 articles were included in this review. Themes which emerged across the reviewed literature included: consent, data handling, minors' data rights, observing behaviors that may result in risk of harm to participants or others, private versus public conceptualizations of data generated through social media, and gatekeeping. Our findings indicate a degree of uncertainty which invariably exists with regards to the ethics of research that involves minors and digital technology. The reviewed literature suggests that this uncertainty can often lead to the preclusion of minors from otherwise important lines of research inquiry. While uncertainty warrants ethical consideration, increased ethical scrutiny and restricting the conduct of such research raises its own ethical challenges. We conclude by discussing and recommending the ethical merits of co-producing ethical practice between researchers and minors as a mechanism to proceed with such research while addressing concerns around uncertainty.


Assuntos
Coleta de Dados , Ética em Pesquisa , Menores de Idade , Comportamento , Gerenciamento de Dados , Humanos , Consentimento Livre e Esclarecido/ética , Publicações , Risco , Mídias Sociais
13.
PLoS One ; 15(8): e0235618, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32756563

RESUMO

BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido/ética , Comitês de Ética em Pesquisa/ética , Ética em Pesquisa , Grupos Focais , Humanos , Pesquisa Qualitativa , Projetos de Pesquisa , Pesquisadores/ética , Bancos de Tecidos/ética
14.
Rev. bioét. derecho ; (49): l191-210, jul. 2020.
Artigo em Espanhol | IBECS | ID: ibc-192102

RESUMO

En el presente trabajo se efectúa una aproximación general a los reparos éticos que la investigación neurocientífica plantea, especialmente respecto de sus usos extralimitados en el proceso penal. Así pues, con el objetivo de regular un uso adecuado, respetuoso con los principios generalmente aceptados en el ámbito biomédico, se desarrolla una propuesta de regulación ética de esta materia que preceda a su uso probatorio en el ámbito forense


The present paper makes a general approach to the ethical concerns that neuroscientific research suggests, especially evaluating its overreaching uses in the criminal process. Therefore, with the objective of regulating an adequate use, a proposal of ethical regulation of this matter is made, which should precede its probative use in the forensic field


En el present treball es fa una aproximació general a les objeccions ètiques que la investigació neurocientífica planteja, especialment respecte al seus usos extralimitats en el procés penal. Així doncs, amb l'objectiu de regular un ús adequat, respectuós amb els principis generalment acceptats en l'àmbit biomèdic, es desenvolupa una proposta de regulació ètica d'aquesta matèria que precedeixi al seu ús probatori en l'àmbit forense


Assuntos
Humanos , Neuroimagem/ética , Defesa por Insanidade , Jurisprudência , Consentimento Livre e Esclarecido/ética , Neurociências/ética , Neurociências/instrumentação , Pessoalidade , Responsabilidade Social
16.
Scand J Trauma Resusc Emerg Med ; 28(1): 51, 2020 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-32513204

RESUMO

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: ClinicalTrials.gov (NCT03405766).


Assuntos
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
17.
Eur Heart J ; 41(22): 2109-2117, 2020 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-32498081

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus , Insuficiência Cardíaca , Pandemias , Pneumonia Viral , Projetos de Pesquisa/normas , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Europa (Continente) , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/terapia , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Segurança do Paciente , Seleção de Pacientes/ética
18.
PLoS One ; 15(6): e0234388, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32555664

RESUMO

There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants' use of consent discussions and information sheets when considering participating in clinical trials research. A qualitative, interview-based pilot study was designed in order to elicit, through dialogue, details of the reasons for participants' use of, and preferences regarding, different modes of information provision. Semi-structured interviews were undertaken with two different groups of patients who were participants in the Reinforcement of Closure of Stoma Site trial. The first group comprised newly-consented trial participants, who had been recruited up to 72 hours before our interview; the second group comprised patients attending a follow-up clinic 12 months after joining the trial. Thirteen participants were recruited in total: three newly-consented patients, and ten follow-up patients. The study found that participants' use of consent discussions to gain information about clinical trials was varied, and that they only minimally used information sheets after providing initial consent for the trial. Participants demonstrated varying degrees of knowledge about the trial, with some having forgotten that they were still involved in the trial. Participants reported a high level of trust in medical staff as a reason for not seeking more information about the trial. Some participants reported dissatisfaction with the timing of information provision. Some were amenable to novel ways of receiving trial information, such as web-based methods. The pilot study demonstrated the feasibility of a larger study into the provision of information to prospective clinical trial participants. The results suggest that considering alternative ways of providing information and the appropriateness of existing information provision may be acceptable to and useful for potential trial participants.


Assuntos
Ensaios Clínicos como Assunto/ética , Consentimento Livre e Esclarecido/ética , Estudos de Viabilidade , Humanos , Educação de Pacientes como Assunto/ética , Participação do Paciente , Seleção de Pacientes/ética , Projetos Piloto , Estudos Prospectivos , Pesquisa Qualitativa , Confiança
19.
J Med Ethics ; 46(8): 505-507, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32532825

RESUMO

COVID-19 is reducing the ability to perform surgical procedures worldwide, giving rise to a multitude of ethical, practical and medical dilemmas. Adapting to crisis conditions requires a rethink of traditional best practices in surgical management, delving into an area of unknown risk profiles. Key challenging areas include cancelling elective operations, modifying procedures to adapt local services and updating the consenting process. We aim to provide an ethical rationale to support change in practice and guide future decision-making. Using the four principles approach as a structure, Medline was searched for existing ethical frameworks aimed at resolving conflicting moral duties. Where insufficient data were available, best guidance was sought from educational institutions: National Health Service England and The Royal College of Surgeons. Multiple papers presenting high-quality, reasoned, ethical theory and practice guidance were collected. Using this as a basis to assess current practice, multiple requirements were generated to ensure preservation of ethical integrity when making management decisions. Careful consideration of ethical principles must guide production of local guidance ensuring consistent patient selection thus preserving equality as well as quality of clinical services. A critical issue is balancing the benefit of surgery against the unknown risk of developing COVID-19 and its associated complications. As such, the need for surgery must be sufficiently pressing to proceed with conventional or non-conventional operative management; otherwise, delaying intervention is justified. For delayed operations, it is our duty to quantify the long-term impact on patients' outcome within the constraints of pandemic management and its long-term outlook.


Assuntos
Infecções por Coronavirus/complicações , Tomada de Decisões/ética , Ética Médica , Cirurgia Geral/ética , Equidade em Saúde/ética , Pandemias/ética , Seleção de Pacientes/ética , Pneumonia Viral/complicações , Betacoronavirus , Infecções por Coronavirus/virologia , Análise Custo-Benefício , Inglaterra , Análise Ética , Teoria Ética , Humanos , Consentimento Livre e Esclarecido/ética , Obrigações Morais , Pneumonia Viral/virologia , Guias de Prática Clínica como Assunto , Ética Baseada em Princípios , Medição de Risco , Medicina Estatal , Cirurgiões , Procedimentos Cirúrgicos Operatórios
20.
J Med Ethics ; 46(9): 565-568, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32522812

RESUMO

The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.


Assuntos
Infecções por Coronavirus , Revelação/ética , Ética Médica , Alocação de Recursos para a Atenção à Saúde , Consentimento Livre e Esclarecido/ética , Pandemias , Pneumonia Viral , Beneficência , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Humanos , Autonomia Pessoal , Médicos , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Justiça Social , Padrão de Cuidado
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