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1.
Front Public Health ; 10: 968168, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36091517

RESUMO

We describe relevant interfaces between law and psychiatry and current ethical and legal views and changes within the past decades. Ideas of patient autonomy and patients' rights have been major drivers of changes in legal frameworks. We describe developments in the areas of patient information and informed consent, involuntary placement and involuntary treatment, use of coercive measures, forensic psychiatry, digital mental health, data privacy, physician liability, suicide, assisted suicide, euthanasia, end of life decision-making, advance directives, legal and illegal drugs, and delegation and substitution of professional activities. There is no unidirectional pathway between law and ethics. Views, conflicts, and requirements differ between countries and within countries and will need to be balanced according to the societies' changing values also in the future.


Assuntos
Médicos , Psiquiatria , Diretivas Antecipadas , Humanos , Consentimento Livre e Esclarecido , Saúde Mental
2.
BMC Med Ethics ; 23(1): 93, 2022 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-36114493

RESUMO

BACKGROUND: Only a few studies have been conducted to assess physicians' knowledge of legal standards. Nevertheless, prior research has demonstrated a dearth of medical law knowledge. Our study explored physicians' awareness of legal provisions concerning informed consent and confidentiality, which are essential components of the physician-patient relationship of trust. METHODS: A cross-sectional study assessed attending physicians' legal knowledge of informed consent and confidentiality regulations. The study was conducted in nine hospitals in Dolj County, Romania. Physicians were given a questionnaire with ten scenarios and instructed to select the response that best reflected their practice. We assessed the responses of physicians who claimed their practice to be entirely legal. Their legal knowledge was evaluated by comparing their answers to applicable laws. We also calculated a score for the physicians who admitted to committing a legal breach. RESULTS: Of the 305 respondents, 275 declared they never committed any law violation. However, their median correct answer score was 5.35 ± 1.66 out of 10. The specialty was the strongest predictor of legal knowledge, with emergency physicians rating the lowest and non-surgical physicians scoring the highest. Physicians who worked in both private and public sectors were better knowledgeable about legal issues than those who worked exclusively in the public sector. Results indicate that physicians are aware of the patient's right to informed consent but lack comprehensive understanding. While most physicians correctly answered simple questions, only a tiny minority identified the correct solution when confronted with ethical dilemmas. The physicians who acknowledged breaching the law, on the other hand, had a slightly higher knowledge score at 5.45 ± 2.18. CONCLUSION: Legal compliance remains relatively low due to insufficient legal awareness. Physicians display limited awareness of legal requirements governing patient autonomy, confidentiality, and access to health data. Law should be taught in all medical schools, including undergraduate programs, to increase physicians' legal knowledge and compliance.


Assuntos
Consentimento Livre e Esclarecido , Médicos , Confidencialidade , Estudos Transversais , Humanos , Conhecimento
3.
Trials ; 23(1): 756, 2022 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-36068637

RESUMO

BACKGROUND: The number of interventions to improve recruitment and retention of participants in trials is rising, with a corresponding growth in randomised Studies Within Trials (SWATs) to evaluate their (cost-)effectiveness. Despite recognised challenges in conducting trials involving adults who lack capacity to consent, until now, no individual-level recruitment interventions have focused on this population. Following the development of a decision aid for family members making non-emergency trial participation decisions on behalf of people with impaired capacity, we have designed a SWAT to evaluate the decision aid in a number of host trials (CONSULT). Unlike in recruitment SWATs to date, the CONSULT intervention is aimed at a 'proxy' decision-maker (a family member) who is not a participant in the host trial and does not receive the trial intervention. This commentary explores the methodological and ethical considerations encountered when designing such SWATs, using the CONSULT SWAT as a case example. Potential solutions to address these issues are also presented. DISCUSSION: We encountered practical issues around informed consent, data collection, and follow-up which involves linking the intervention receiver (the proxy) with recruitment and retention data from the host trial, as well as issues around randomisation level, resource use, and maintaining the integrity of the host trial. Unless addressed, methodological uncertainty about differential recruitment and heterogeneity between trial populations could potentially limit the scope for drawing robust inferences and harmonising data from different SWAT host trials. Proxy consent is itself ethically complex, and so when conducting a SWAT which aims to disrupt and enhance proxy consent decisions, there are additional ethical issues to be considered. CONCLUSIONS: Designing a SWAT to evaluate a recruitment intervention for non-emergency trials with adults lacking capacity to consent has raised a number of methodological and ethical considerations. Explicating these challenges, and some potential ways to address them, creates a starting point for discussions about conducting these potentially more challenging SWATs. Increasing the evidence base for the conduct of trials involving adults lacking capacity to consent is intended to improve both the ability to conduct these trials and their quality, and so help build research capacity for this under-served population.


Assuntos
Consentimento Livre e Esclarecido , Projetos de Pesquisa , Adulto , Família , Humanos , Procurador , Ensaios Clínicos Controlados Aleatórios como Assunto , Incerteza
4.
J Law Med ; 29(3): 740-759, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36056664

RESUMO

This article undertakes an analysis of Australia's laws affecting human germline genome editing (HGGE). It draws on research from various ethical frameworks to analyse the values underpinning existing policy and which could underpin future approaches on HGGE. The article emphasises the importance of protecting egalitarianism, mitigating inequality risks, and ensuring stigmas around people with genetic conditions targeted by HGGE are not perpetuated. Doing so makes the philosophical case for a policy allowing HGGE for research use and considers the potential for limited clinical uses as we advance. The article recommends law reform in Australia in the form of an ongoing legislative review every three years, with the first review considering research and informed consent. The second considers appropriate clinical uses based on medical risk and what is agreed upon to be a list of considerations of a severe enough disease to be treated by HGGE. It gives examples of what the reform might look like, pending public engagement methodologies advocated. Finally, this article recommends considering ancillary legal issues raised by HGGE, including anti-discrimination and potential protections from liability.


Assuntos
Edição de Genes , Células Germinativas , Humanos , Consentimento Livre e Esclarecido , Princípios Morais , Tecnologia
5.
Ethics Hum Res ; 44(5): 32-41, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36047275

RESUMO

Research biopsies included in cancer clinical trials have the goal of advancing scientific understanding of the biological bases of cancer and its treatments, but may offer no prospect of direct benefit to participants and often pose more than minimal risk. The research community is examining the ethics of research biopsies increasingly often, especially when they are mandatory for study participation but do not support primary study objectives and thus are "nonintegral" to the study. Ethical concerns center on the limited scientific justification supporting some biopsies, risks to research participants, and the potential for coercion and therapeutic misconception during the informed consent process. There is also a lack of comprehensive oversight of research biopsies by regulatory agencies and institutions. This paper reviews these ethical concerns, discusses the scope of federal oversight, and suggests that institutional review boards (IRBs) should assume a larger role in ensuring the ethical conduct of research biopsies. It concludes with guidance to IRBs on how to weigh the risks, benefits, and acceptability of such biopsies in different contexts that is based on a framework the American Society of Clinical Oncology developed for the inclusion of research biopsies in oncology clinical trials.


Assuntos
Comitês de Ética em Pesquisa , Neoplasias , Biópsia , Humanos , Consentimento Livre e Esclarecido , Oncologia/métodos
6.
Ethics Hum Res ; 44(5): 42-48, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36047276

RESUMO

The use of a placebo has been considered the best method for controlling bias in a prospective randomized clinical trial and provides the most rigorous test of treatment efficacy for evaluating a medical therapy. Placebos commonly produce clinically important effects particularly in studies where the primary outcomes are subjective. Yet the potential beneficial or harmful effects of placebos are often not addressed in designing a clinical trial, calculating the sample size, seeking consent, or interpreting clinical trial results. In this manuscript, we use an actual study to indicate three approaches that might be considered in seeking informed consent for placebo-controlled trials, and we explore the fundamental ethical and scientific complexities involved with each.


Assuntos
Consentimento Livre e Esclarecido , Projetos de Pesquisa , Humanos , Estudos Prospectivos , Resultado do Tratamento
7.
Ethics Hum Res ; 44(5): 22-31, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36047277

RESUMO

Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction "broad consent" in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants.


Assuntos
Pesquisa Biomédica , Consentimento Livre e Esclarecido , Humanos , Pesquisadores
8.
BMC Med Ethics ; 23(1): 90, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36050689

RESUMO

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance arrangements between tissue providers and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a 'donation' or 'gift', and tissue providers are referred to as 'donors'. Because of the performative qualities of language, the effect of using 'donation' and 'donor' shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology.


Assuntos
Bancos de Espécimes Biológicos , Pesquisa Biomédica , Humanos , Consentimento Livre e Esclarecido , Idioma , Medicina de Precisão
9.
Prim Dent J ; 11(3): 98-103, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36073049

RESUMO

Dental practitioners are well versed in informing patients of the risks and benefits associated with dental extractions. The purpose of this service evaluation was to determine whether patients understood and recalled information relevant to their planned oral surgery procedure, prior to second stage consent.A questionnaire was distributed to patients who were attending for their elective treatment appointment. This explored their ability to recall the planned intervention, the modality of treatment (local anaesthetic, intravenous sedation, or general anaesthetic), understanding of alternative treatment options and the risks associated with the procedure. Completed responses were received from 29 of the distributed questionnaires (response rate=58%). The majority of patients were not aware of the following risks with their procedure: pain, bleeding, bruising, swelling, infection, damage to adjacent structures.Despite a well-documented consent form and comprehensive discussion, we identified that patients may not comprehend or recollect the risks associated with their dental extraction. As dental professionals we have a duty to seek ways to facilitate patient understanding and maximise their autonomy.


Assuntos
Odontólogos , Papel Profissional , Anestesia Geral/efeitos adversos , Humanos , Consentimento Livre e Esclarecido , Extração Dentária
11.
BMJ Open ; 12(8): e063236, 2022 08 29.
Artigo em Inglês | MEDLINE | ID: mdl-36038171

RESUMO

OBJECTIVES: Decentralised clinical trial activities-such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply-have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020. DESIGN: We ascertained the decentralised and on-site conduct for the following operational trial activities: participant outreach, prescreening, screening, obtaining informed consent, asynchronous communication, participant training, IMP supply, IMP adherence monitoring, CT monitoring, staff training and data collection. Results were compared for the public versus private sponsors, regions involved, trial phases and four time periods (the first and second half of 2019 and 2020, respectively). SETTING: Phases 2, 3 and 4 clinical drug trial protocols with a trial start date in 2019 or 2020 available from ClinicalTrials.gov. OUTCOME MEASURES: The occurrence of decentralised and on-site conduct of the predefined trial activities reported in CT protocols. RESULTS: For all trial activities, on-site conduct was more frequently reported than decentralised conduct. Decentralised conduct of the individual trial activities was reported in less than 25.6% of the 254 included protocols, except for decentralised data collection, which was reported in 68.9% of the protocols. More specifically, 81.9% of the phase 3 protocols reported decentralised data collection, compared with 73.3% and 47.0% of the phase 2 and 4 protocols, respectively. For several activities, including prescreening, screening and consenting, upward trends in reporting decentralised conduct were visible over time. CONCLUSIONS: Decentralised methods are used in CTs, mainly for data collection, but less frequently for other activities. Sharing best practices and a detailed description in protocols can drive the adoption of decentralised methods.


Assuntos
Consentimento Livre e Esclarecido , Inosina Monofosfato , Estudos Transversais , Coleta de Dados , Humanos , Fatores de Tempo
12.
BMJ Open ; 12(8): e060555, 2022 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-35981767

RESUMO

OBJECTIVE: To answer the question: Why do people consent to being vaccinated with novel vaccines against SARS-CoV-2? DESIGN: Representative survey. SETTING: Online panel. PARTICIPANTS: 1032 respondents of the general German population. METHOD: A representative survey among German citizens in November/December 2021 that resulted in 1032 complete responses on vaccination status, sociodemographic parameters and opinions about the COVID-19 situation. RESULTS: Almost 83% of the respondents were vaccinated. The major motivation was fear of medical consequences of an infection and the wish to lead a normal life again. The major motivation to be not vaccinated was the fear of side effects and scepticism about long-term effectiveness and safety. Sixteen per cent of vaccinated respondents reported some serious side effect, while more than 30% reported health improvements, mostly due to the relief of psychological stress and social reintegration. We also validated a 'Corona Orthodoxy Score-COS' consisting of seven items reflecting opinions on COVID-19. The scale is reliable (alpha=0.76) and unidimensional. The COS was a highly significant predictor of vaccination status and readiness to be vaccinated in a multivariable logistic regression model. Those who were vaccinated were more likely to live in smaller households (OR=0.82, p=0.024), had a higher income (OR=1.27, p<0.001), a higher COS score (OR 1.4, p<0.0001) and used less alternative media (OR=0.44, p=0.0024) and scientific publications (OR=0.42, p=0.011) as information sources. CONCLUSIONS: The major motives for being vaccinated are fear of medical symptoms and the wish to lead a normal life. Those not wanting to be vaccinated cite a lack of knowledge regarding long-term safety and side effects as reasons. This can likely only be overcome by careful and active long-term efficacy and safety monitoring.


Assuntos
Vacinas contra COVID-19 , COVID-19 , COVID-19/prevenção & controle , Vacinas contra COVID-19/uso terapêutico , Alemanha/epidemiologia , Humanos , Consentimento Livre e Esclarecido , SARS-CoV-2 , Inquéritos e Questionários , Vacinação
13.
Nursing ; 52(9): 20-21, 2022 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-36006746
15.
Sci Eng Ethics ; 28(5): 42, 2022 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-36042065

RESUMO

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary "consent design toolkit" and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.


Assuntos
Consentimento Livre e Esclarecido , Pesquisadores , Ética Médica , Humanos
16.
JAMA Netw Open ; 5(8): e2227650, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35980634

RESUMO

Importance: Opioid overdose rates continue to increase, and extant literature suggests that many individuals who use heroin were first introduced to opioids through a medical prescription. Objective: To explore patient experiences related to decisions regarding analgesia after an emergency department visit within the context of a randomized clinical trial aimed to test the efficacy of risk communication interventions on treatment preference, risk recall, and use of opioids. Design, Setting, and Participants: This qualitative study of 36 patients making decisions regarding analgesia included qualitative interviews with participants in 2 risk intervention groups. Interviews were audio recorded, transcribed, and edited to remove identifying information to protect the confidentiality of participants. Interviews were conducted from June 4, 2019, to August 6, 2019. We conducted thematic analysis from August to December 2019 using a mixed inductive and deductive approach. Participants received $20 in compensation. The study was conducted in 4 geographically diverse emergency departments in the United States. Participants were adults presenting to the emergency department with either musculoskeletal back or neck pain or kidney stone-related pain. Eligibility criteria included being aged 18 to 70 years, capable of providing informed consent, English speaking or having English comprehension, eligible for emergency department discharge within 24 hours of enrollment, and able to access email or a smartphone. Interventions: Participants enrolled from the main randomized clinical trial received 1 of 2 risk interventions: a probabilistic opioid risk tool or a narrative-enhanced probabilistic risk tool (ie, participants viewed eight 1- to 3-minute short videos of patients discussing their experiences with pain treatment and positive and negative experiences with opioid use). Main Outcomes and Measures: Factors reported by participants to have influenced their decision-making regarding acute pain and treatment. Results: Thirty-six participants were interviewed, 18 in the group who received the probabilistic risk tool alone and 18 in the group who received the additional narrative-enhanced probabilistic risk tool intervention. The median age was 38 years (range, 21-67 years), 22 individuals were female (61%), 14 were Black or African American (39%), and 14 were White (39%). Five themes emerged from the analysis in the following domains: the factors associated with the risk interventions; clinician paternalism; analgesia attributes and previous experiences; individual self-identity, attitudes, and values; and perceptions of clinician bias. Conclusions and Relevance: Most participants commented on the powerful lessons they learned from the risk interventions. More research is needed to understand how patients incorporate risk information into their decision-making process.


Assuntos
Dor Aguda , Analgésicos Opioides , Dor Aguda/tratamento farmacológico , Adulto , Analgésicos Opioides/efeitos adversos , Comunicação , Feminino , Humanos , Consentimento Livre e Esclarecido , Masculino , Manejo da Dor , Estados Unidos
18.
Malawi Med J ; 34(2): 143-150, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35991823

RESUMO

This special communication discusses the current legal and ethical requirements for informed consent to medical treatment of adults in Malawi. It analyzes the scope of the laws and code of ethics on professional discipline, including criminal privilege for surgeries and clarifies when insufficient disclosures entitle patients to compensation under civil law. Inconsistencies and uncertainties in the law are made apparent. It evaluates to which degree disclosure standards of other Commonwealth jurisdictions (e.g. the case of Montgomery) would be suitable for the health care setting of a country like Malawi that is characterized by shortages of resources, high illiteracy rates and a communitarian cultural context. Doctor-patient communication is not alien to African culture and part of sufficient informed consent. In order to balance the need for efficiency in health care delivery, accountability for quality care, fairness and effective patient-doctor communication the authors suggest to adopt the reasonable patient test only, if a defence of heavy workload on case-to-case basis is introduced at the same time. This does not dispense the need for organisational diligence on part of the institutional health care provider within its capacity.


Assuntos
Consentimento Livre e Esclarecido , Adulto , Humanos , Malaui
19.
Magn Reson Imaging Clin N Am ; 30(3): 553-563, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35995479

RESUMO

MRI is a vital examination in the emergency department, especially in patients with stroke, spinal cord compression, cardiovascular emergencies, appendicitis, and trauma. It is important to consider its underlying safety hazards because of its strong magnetic and radio frequency fields. Multiple resources are available to guide radiology departments on the safe functioning of an MRI site. Four-zone site layout, MR compatibility labeling, MR personnel training, detailed screening process, access control, and appropriate implementation of safety policies and procedures are all necessary to maintain a safe and hazard-free MR environment.


Assuntos
Imageamento por Ressonância Magnética , Serviço Hospitalar de Radiologia , Segurança de Equipamentos , Humanos , Consentimento Livre e Esclarecido , Imageamento por Ressonância Magnética/métodos
20.
Anesth Analg ; 135(3): 489-500, 2022 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-35977359

RESUMO

The goal of patient blood management (PBM) is to optimize clinical outcomes for individual patients by managing their blood as a precious and unique resource to be safeguarded and managed judiciously. A corollary to successful PBM is the minimization or avoidance of blood transfusion and stewardship of donated blood. The first is achieved by a multidisciplinary approach with personalized management plans shared and decided on with the patient or their substitute. It follows that the physician-patient relationship is an integral component of medical practice and the fundamental link between patient and doctor based on trust and honest communication. Central to PBM is accurate and timely diagnosis based on sound physiology and pathophysiology as the bedrock on which scientifically based medicine is founded. PBM in all disease contexts starts with the questions, "What is the status of the patient's blood?" "If there are specific abnormalities in the blood, how should they be managed?" and "If allogeneic blood transfusion is considered, is there no reasonable alternative therapy?" There are compelling scientific reasons to implement a nontransfusion default position when there is clinical uncertainty and questionable evidence of clinical efficacy for allogeneic blood transfusion due to known potential hazards. Patients must be informed of their diagnosis, the nature, severity and prognosis of the disease, and treatment options along with risks and benefits. They should be involved in decision-making regarding their management. However, as part of this process, there are multifaceted medical, legal, ethical, and economic issues, encompassing shared decision-making, patient choice, and informed consent. Furthermore, variability in patient circumstances and preferences, the complexity of medical science, and the workings of health care systems in which consent takes place can be bewildering, not only for the patient but also for clinicians obtaining consent. Adding "patient" to the concept of blood management differentiates it from "donor" blood management to avoid confusion and the perception that PBM is a specific medical intervention. Personalized PBM is tailoring the PBM to the specific characteristics of each patient. With this approach, there should be no difficulty addressing the informed consent and ethical aspects of PBM. Patients can usually be reassured that there is nothing out of order with their blood, in which case the focus of PBM is to keep it that way. In some circumstances, a hematologist may be involved as a patient's blood advocate when abnormalities require expert involvement while the primary disease is being managed.


Assuntos
Transfusão de Sangue , Tomada de Decisão Clínica , Preferência do Paciente , Transfusão de Sangue/ética , Humanos , Consentimento Livre e Esclarecido , Relações Médico-Paciente , Incerteza
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