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1.
Recenti Prog Med ; 112(1): 13-14, 2021 01.
Artigo em Italiano | MEDLINE | ID: mdl-33512352

RESUMO

Informed consent for CoViD-19 vaccines can be considered a step that can help us focus on an increasingly burdensome problem for contemporary medicine: the difficult relationship of trust between citizens and academic medicine. Filling out forms full of useless information cannot replace the rebuilding of trust based on shared essential ethical principles. Trust needs to be protected by a transparent accountability, which can also decrease the threatening looming of lawsuits. Medicine must be safe, first and foremost, for the practitioner. He cannot practice it if he feels constantly in check, if the outcome of the treatment does not correspond to the wishes of those who request it.


Assuntos
Consentimento Livre e Esclarecido/psicologia , Relações Médico-Paciente , Confiança , Recusa de Vacinação/psicologia , Atitude Frente a Saúde , França , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Itália , Responsabilidade Legal , Opinião Pública , Recusa de Vacinação/legislação & jurisprudência
2.
Obstet Gynecol ; 136(4): 731-737, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925629

RESUMO

OBJECTIVE: To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy. METHODS: This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined. RESULTS: From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59). CONCLUSION: Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation. CLINICAL TRIAL REGISTRATION: ClinialTrials.gov, NCT01990612.


Assuntos
Cobertura do Seguro , Trabalho de Parto Induzido , Preferência do Paciente , Recusa de Participação , Adulto , Características da Família/etnologia , Feminino , Idade Gestacional , Humanos , Consentimento Livre e Esclarecido/psicologia , Trabalho de Parto Induzido/métodos , Trabalho de Parto Induzido/psicologia , Idade Materna , Avaliação de Resultados em Cuidados de Saúde , Paridade , Preferência do Paciente/economia , Preferência do Paciente/etnologia , Seleção de Pacientes , Gravidez , Recusa de Participação/etnologia , Recusa de Participação/psicologia , Recusa de Participação/estatística & dados numéricos
3.
Pediatrics ; 146(Suppl 1): S18-S24, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32737228

RESUMO

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.


Assuntos
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
4.
S Afr Fam Pract (2004) ; 62(1): e1-e4, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32787389

RESUMO

Medical practitioners are confronted daily with decisions about patients' capacity to consent to interventions. To address some of the pertinent issues with these assessments, the end-of-life decision-making capacity of a 72-year-old female with treatment-resistant schizophrenia and terminal cancer is discussed, as are the role of the treating clinician and the importance of health-related values. There is a recommendation that the focus of these assessments can rather be on practical outcomes, especially when capacity issues arise. This implies that the decision-making capacity of the patient is only practically important when the treatment team is willing to proceed against the patient's wishes. This shifts the focus from a potentially difficult assessment to the simpler question of whether the patient's capacity will change the treatment approach. Clinicians should attend to any possible underlying issues, instead of focusing strictly on capacity. Compared to the general populations people with serious mental illness (SMI) have higher rates of physical illness and die at a younger age, but they do not commonly access palliative care services. Conversations about end-of-life care can occur without fear that a person's psychiatric symptoms or related vulnerabilities will undermine the process. More research about palliative care and advance care planning for people with SMI is needed. This is even more urgent in light of the coronavirus disease-2019 (COVID-19) pandemic, and South African health services should consider recommendations that advanced care planning should be routinely implemented. These recommendations should not only focus on the general population and should include patients with SMI.


Assuntos
Tomada de Decisões , Competência Mental/psicologia , Neoplasias/psicologia , Psicologia do Esquizofrênico , Assistência Terminal/psicologia , Idoso , Betacoronavirus , Infecções por Coronavirus/psicologia , Feminino , Humanos , Consentimento Livre e Esclarecido/psicologia , Pandemias , Pneumonia Viral/psicologia , Esquizofrenia
5.
Acta bioeth ; 26(1): 91-100, mayo 2020. tab
Artigo em Inglês | LILACS | ID: biblio-1114602

RESUMO

PURPOSE: To estimate the influence of clinical and demographical information in the understanding of cataract surgery informed consent, identifying less understandable areas. To assess informed consent document concept. METHODS: Multiple-choice questionnaire was designed to collect information and to evaluate the understanding of cataract surgery and informed consent. An ordinary regression model was adjusted to express the effect of clinical and demographic variables to the questionnaire score. RESULTS: The study comprised 180 patients. Sex (female, p=0.404), non-ophthalmologist source of information (p=0.397), previous surgical history (p=0.571), not having a companion (p=0.396) nor the days since the signing of informed consent form (p=0.535) had no influence in the understanding of cataract surgery informed consent. Age (r=-0.083, p<0.001) and educational level (secondary studies r=1.845, p<0.001; tertiary studies r=4.289, p<0.001) showed statistical significance with greater strength of association educational level (OR secondary studies = 6.33, OR tertiary studies = 72.86) than age had (OR = 0.92). CONCLUSION: Patient's knowledge about cataract informed consent is influenced by age and educational level. The purpose and the risks, consequences of not performing surgery and postoperative indications are the least understood topics. Informed consent is seen as a forced legal obligation.


OBJETIVOS: estimar la influencia de la información clínica y demográfica en la comprensión del consentimiento informado de la cirugía de cataratas, identificando áreas menos comprensibles. Evaluar el concepto de "documento de consentimiento informad". MÉTODOS: el cuestionario de opción múltiple se diseñó para reunir información y evaluar la comprensión de la cirugía de cataratas y el consentimiento informado. Se ajustó un modelo de regresión ordinario para expresar el efecto de las variables clínicas y demográficas en la puntuación del cuestionario. RESULTADOS: El estudio abarcó 180 pacientes. Sexo (femenino, p = 0.404); fuente de información no oftalmológica (p = 0.397); historial quirúrgico previo (p = 0.571); no tener acompañante (p = 0.396), y los días desde la firma del formulario de consentimiento informado (p = 0,535), que no tuvo influencia en la comprensión del consentimiento informado en la cirugía de cataratas. La edad (r = -0.083, p <0.001) y el nivel educativo (estudios secundarios r = 1.845, p <0.001; estudios terciarios r = 4.289, p <0.001) mostraron significación estadística con una mayor fuerza del nivel educativo de asociación (OR estudios secundarios = 6.33, OR estudios terciarios = 72.86) que la edad (OR = 0.92). CONCLUSIÓN: El conocimiento del paciente sobre el consentimiento informado en cirugía de cataratas está influenciado por la edad y el nivel educativo. Los temas menos entendidos son el propósito y los riesgos, las consecuencias de no realizar la cirugía y las indicaciones postoperatorias. El consentimiento informado se considera una obligación legal forzada.


OBJETIVO: Estimar a influência de informações clínicas e demográficas na compreensão do consentimento informado para cirurgia de catarata, identificando áreas menos compreensíveis. Avaliar o conceito do documento de consentimento informado. MÉTODOS: Um questionário de múltipla escolha foi desenvolvido para coletar informações e avaliar a compreensão sobre cirurgia de catarata e de consentimento informado. Um modelo de regressão ordinária foi ajustado para expressar o efeito das variáveis clínicas e demográficas no escore do questionário. RESULTADOS: O estudo envolveu 180 pacientes. Sexo (feminino, p=0,404), fonte de informações não oftalmológica (p=0,397), história cirúrgica prévia (p=0,571), não ter um/a companheiro/a (p=0,396) nem os dias desde a assinatura do formulário de consentimento informado (p=0,535) tiveram influência na compreensão do consentimento informado para cirurgia de catarata. Idade (r=-0,083, p<0,001) e nível educacional (estudos secundários r=1,845, p<0,001; estudos terciários r=4,289, p<0,001) mostraram significância estatística, com maior força de associação para o nível educacional (OR estudos secundários = 6,33, OR estudos terciários = 72,86) que para a idade (OR = 0,92). CONCLUSÃO: O conhecimento do paciente sobre o consentimento informado para cirurgia de catarata é influenciado pela idade e nível educacional. O objetivo e os riscos, consequências, de não fazer a cirurgia e as indicações pós-operatórias são os tópicos menos compreensíveis. O consentimento informado é visto como uma obrigação legal compulsória.


Assuntos
Humanos , Masculino , Feminino , Idoso , Extração de Catarata/psicologia , Conhecimentos, Atitudes e Prática em Saúde , Extração de Catarata/ética , Estudos Transversais , Inquéritos e Questionários , Análise de Regressão , Fatores Etários , Paternalismo , Autonomia Pessoal , Escolaridade , Consentimento Livre e Esclarecido/psicologia , Consentimento Livre e Esclarecido/ética , Jurisprudência
7.
Soins Gerontol ; 25(141): 31-37, 2020.
Artigo em Francês | MEDLINE | ID: mdl-32200988

RESUMO

We wonder about the patient's perception relating to a request for informed and express free consent. We report interviews conducted with sixteen seniors who responded to a consent request while they were hospitalized in a geriatric department. Those patients had to give their opinion on the quality of the information received, their feeling of freedom and the perception of their consent or not. Making a qualitative study of the verbatim by an analysis using anchored theorization, we show the major influence of the freedom with the act of choice and the importance of supporting the patients to whom it is asked to consent.


Assuntos
Emoções , Consentimento Livre e Esclarecido/psicologia , Idoso , Serviços de Saúde para Idosos , Hospitalização , Humanos , Pesquisa Qualitativa
8.
Public Health ; 182: 51-52, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32171090

RESUMO

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.


Assuntos
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
9.
Support Care Cancer ; 28(11): 5353-5361, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32133543

RESUMO

PURPOSE: Patient-centered care (PCC) and shared decision-making (SDM) is advised within the English medical literature for its positive impact. The benefits of such approaches are said to foster increased trust, patient decision satisfaction, and even better outcomes. Looking at a Chinese cancer hospital, this research sought to understand how surgical decision-making was made among colorectal cancer patients. METHODS: Observations (n = 36) and semi-structured interviews (n = 24) were conducted with patients and family members. RESULTS: In the observations, 69.4% of the participating families made the decision to undergo surgery at the end of the consultation. In the interviews, three main themes emerged in regard to the characteristics in the family decision-making model, and they included three structural elements: the patient's sick role, family functional structure, and control of information. CONCLUSION: This study showed that the Chinese decision-making model is different from the western SDM model. In the Chinese context, family members dominated the decision-making process which raised concerns around informed consent. This may benefit patients insofar as receiving timely treatment in the short term but at the same time may be at the expense of limiting patient's autonomy. The promotion of a new model or a model encompassing family-centered care values may be more appropriate in clinical practice in China that can address the issues around informed consent.


Assuntos
Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/cirurgia , Tomada de Decisão Compartilhada , Tomada de Decisões/fisiologia , Assistência Centrada no Paciente , Adulto , Idoso , China/epidemiologia , Neoplasias Colorretais/patologia , Neoplasias Colorretais/psicologia , Compreensão , Família/psicologia , Feminino , Humanos , Consentimento Livre e Esclarecido/psicologia , Consentimento Livre e Esclarecido/estatística & dados numéricos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Satisfação do Paciente/estatística & dados numéricos , Assistência Centrada no Paciente/métodos , Assistência Centrada no Paciente/estatística & dados numéricos , Relações Médico-Paciente , Relações Profissional-Família , Encaminhamento e Consulta/estatística & dados numéricos , Confiança/psicologia , Adulto Jovem
10.
NeuroRehabilitation ; 46(2): 255-257, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32145004

RESUMO

BACKGROUND: Multiple sclerosis (MS) is one of the major causes of chronic neurologic disability in young adults. OBJECTIVE: To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes. METHODS: To summarize and to discuss the rehabilitation perspective on the published Cochrane Review "Information provision for people with multiple sclerosis" by Köpke S et al. RESULTS: 11 studies (with 1387 participants) with important clinical heterogeneity on the definitions of interventions and outcomes assessed were included, showing that information provision interventions vs optimized standard care probably slightly increase patients' knowledge and may make little or no difference to decision making and quality of life. CONCLUSIONS: It is very important to provide information to patients for informed consent and to increase their knowledge and decision-making capacity.


Assuntos
Tomada de Decisões , Consentimento Livre e Esclarecido/psicologia , Esclerose Múltipla/psicologia , Esclerose Múltipla/terapia , Qualidade de Vida/psicologia , Tomada de Decisões/fisiologia , Humanos , Consentimento Livre e Esclarecido/normas , Educação de Pacientes como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento
11.
Arch Dis Child Fetal Neonatal Ed ; 105(3): 310-315, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31427459

RESUMO

OBJECTIVE: To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios. METHODS: We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0. RESULTS: Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent. CONCLUSION: Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.


Assuntos
Atitude do Pessoal de Saúde , Estudos Clínicos como Assunto/ética , Salas de Parto/ética , Consentimento Livre e Esclarecido/ética , Unidades de Terapia Intensiva Neonatal/ética , Adulto , Idoso , Estudos Clínicos como Assunto/métodos , Estudos Clínicos como Assunto/psicologia , Salas de Parto/normas , Feminino , Humanos , Consentimento Livre e Esclarecido/psicologia , Consentimento Livre e Esclarecido/normas , Unidades de Terapia Intensiva Neonatal/normas , Masculino , Pessoa de Meia-Idade , Países Baixos , Pais , Estudos Prospectivos , Pesquisa Qualitativa
12.
J Autism Dev Disord ; 50(5): 1725-1747, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-30825084

RESUMO

Although informed consent is critical for all research, there is increased ethical responsibility as individuals with intellectual or developmental disabilities (IDD) become the focus of more clinical trials. This study examined decisional capacity for informed consent to clinical trials in individuals with fragile X syndrome (FXS). Participants were 152 adolescents and adults (80 males, 72 females) with FXS who completed a measure of decisional capacity and a comprehensive battery of neurocognitive and psychiatric measures. Females outperformed males on all aspects of decisional capacity. The ability to understand aspects of the clinical trial had the strongest association with the ability to appreciate and reason about the decision. Scaffolding improved understanding, suggesting researchers can take steps to improve decisional capacity and the informed consent process.


Assuntos
Tomada de Decisões , Síndrome do Cromossomo X Frágil/psicologia , Consentimento Livre e Esclarecido/psicologia , Adolescente , Adulto , Criança , Compreensão , Feminino , Humanos , Masculino , Princípios Morais , Fatores Sexuais , Adulto Jovem
13.
Public Health ; 178: 151-158, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31698137

RESUMO

OBJECTIVES: Expansion of newborn bloodspot screening (NBS) within England, which practices an informed consent model, justified examining acceptability and effectiveness of alternative consent models. STUDY DESIGN: Qualitative focus groups. METHODS: Forty-five parents and 37 screening professionals (SPs) participated. Data were analysed using thematic analysis. RESULTS: Parents and SPs initially appeared to have differing views about appropriate consent models. Most parents accepted assumed consent, if adequately informed; however, once aware of bloodspot storage, informed consent was wanted. SPs valued informed consent, but acknowledged it was difficult to obtain. Both samples wanted parents to be informed but were unclear how this could be achieved. Most parents felt NBS was not presented as optional. CONCLUSION: The simultaneous exploration of parents and SPs views, in real time is original. This rigour avoided the reliance on retrospective accounts which make it difficult to establish how decisions were made at the time. It is also unique in providing pre-interview consent models to drive the depth of data. It was rigorous in member checking. Findings suggested a preference for full disclosure of all information with some parents valuing this more than choice. Both samples queried whether current consent was sufficiently informed and voluntary. Results suggest differing tolerances of consent type if screening is solely for diagnostic purposes vs bloodspot storage. Results highlight the need for caution when examining consent model preferences without also checking knowledge, as opinions may be based on incomplete knowledge. Future research is needed to examine efficacy of proposed changes. FUNDING: National Institute for Health Research Health Technology Assessment HTAProgramme (11/62/02). TRIAL REGISTRATION: ISRCTN70227207.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente a Saúde , Pessoal de Saúde/psicologia , Consentimento Livre e Esclarecido/psicologia , Triagem Neonatal , Pais/psicologia , Adolescente , Adulto , Inglaterra , Feminino , Grupos Focais , Humanos , Recém-Nascido , Masculino , Modelos Teóricos , Pesquisa Qualitativa , Adulto Jovem
14.
Anesthesiology ; 132(1): 159-169, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31770142

RESUMO

BACKGROUND: Compassionate behavior in clinicians is described as seeking to understand patients' psychosocial, physical and medical needs, timely attending to these needs, and involving patients as they desire. The goal of our study was to evaluate compassionate behavior in patient interactions, pain management, and the informed consent process of anesthesia residents in a simulated preoperative evaluation of a patient in pain scheduled for urgent surgery. METHODS: Forty-nine Clinical Anesthesia residents in year 1 and 16 Clinical Anesthesia residents in year 3 from three residency programs individually obtained informed consent for anesthesia for an urgent laparotomy from a standardized patient complaining of pain. Encounters were assessed for ordering pain medication, for patient-resident interactions by using the Empathic Communication Coding System to code responses to pain and nausea cues, and for the content of the informed consent discussion. RESULTS: Of the 65 residents, 56 (86%) ordered pain medication, at an average of 4.2 min (95% CI, 3.2 to 5.1) into the encounter; 9 (14%) did not order pain medication. Resident responses to the cues averaged between perfunctory recognition and implicit recognition (mean, 1.7 [95% CI, 1.6 to 1.9]) in the 0 (less empathic) to 6 (more empathic) system. Responses were lower for residents who did not order pain medication (mean, 1.2 [95% CI, 0.8 to 1.6]) and similar for those who ordered medication before informed consent signing (mean, 1.9 [95% CI, 1.6 to 2.1]) and after signing (mean, 1.9 [95% CI, 1.6 to 2.0]; F (2, 62) = 4.21; P = 0.019; partial η = 0.120). There were significant differences between residents who ordered pain medication before informed consent and those who did not order pain medication and between residents who ordered pain medication after informed consent signing and those who did not. CONCLUSIONS: In a simulated preoperative evaluation, anesthesia residents have variable and, at times, flawed recognition of patient cues, responsiveness to patient cues, pain management, and patient interactions.


Assuntos
Anestesiologia/educação , Empatia , Consentimento Livre e Esclarecido/psicologia , Internato e Residência/métodos , Relações Médico-Paciente , Cuidados Pré-Operatórios/psicologia , Anestesiologia/métodos , Competência Clínica/estatística & dados numéricos , Feminino , Humanos , Masculino , Simulação de Paciente , Cuidados Pré-Operatórios/métodos
15.
BMC Med Ethics ; 20(1): 90, 2019 12 02.
Artigo em Inglês | MEDLINE | ID: mdl-31791312

RESUMO

BACKGROUND: Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. METHODS: From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. RESULTS: The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors' consent (26.4% vs. 11.4% among recipients). CONCLUSIONS: Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.


Assuntos
Pesquisa Biomédica/ética , Embrião de Mamíferos , Consentimento Livre e Esclarecido/psicologia , Doação de Oócitos/psicologia , Recuperação Espermática/psicologia , Doadores de Tecidos/psicologia , Adulto , Fatores Etários , Pesquisa Biomédica/normas , Tomada de Decisões , Feminino , Humanos , Consentimento Livre e Esclarecido/normas , Masculino , Doação de Oócitos/normas , Fatores Sexuais , Fatores Socioeconômicos , Recuperação Espermática/normas
17.
AMA J Ethics ; 21(11): E936-942, 2019 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-31742541

RESUMO

Consent to any experimental procedure, even when offered as therapeutic, involves extensive discussion between patient-subjects and clinician-researchers. Decision making should be shared with a focus on potential risks and benefits of enrolling in a protocol. Just as patients who underwent nonexperimental interventions might experience regret or reconsider autonomously made choices, patient-subjects who are undergoing or who have undergone experimental therapies should be afforded latitude to reconsider their decisions. Although clinician-researchers tend to be deeply invested in gathering data about patient-subjects' experiences, they are obligated to express respect for patient-subjects' fundamental right to stop being enrolled in research.


Assuntos
Tomada de Decisões/ética , Transplante de Mão/ética , Transplante de Mão/psicologia , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/psicologia , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde/ética , Autonomia Pessoal , Relações Profissional-Paciente/ética , Relações Pesquisador-Sujeito/ética , Respeito , Medição de Risco , Terapias em Estudo/ética , Terapias em Estudo/psicologia , Resultado do Tratamento , Incerteza
20.
J Dig Dis ; 20(12): 656-662, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31618520

RESUMO

OBJECTIVE: We conducted a randomized trial aiming at improving patients' informed consent for undergoing endoscopic retrograde cholangiopancreatography (ERCP) in clinical care by comparing the efficacy of an additional educational video to written informed consent with that of written informed consent alone. METHODS: This was a single-center, randomized controlled trial. Consecutive patients undergoing ERCP were randomized to a video education or a control group. An educational video detailing ERCP procedure plus standard written informed consent was administered to the video education group, while the control group reviewed standard written informed consent only. The primary outcome was the patients' perception of the risk or possibility of ERCP complications. Their perception of the benefits of ERCP, alternative treatments and overall satisfaction with the process of informed consent were also compared. RESULTS: In total 205 patients were included in the study (104 in the control group and 101 in the video education group). Patients' comprehension of ERCP-related complications in the video education group was significantly increased (P < 0.001), and these patients were more likely to correctly identify the incidence of such complications. Significantly more patients in the video education group were very satisfied with informed consent process (87.1% vs 76.0%, P = 0.040) and fewer patients needed additional explanations (31.7% vs 47.1%, P = 0.024). CONCLUSIONS: A supplementary educational video could greatly improve patient's understanding of ERCP procedure, in particular, its potential risks and complications, as well as their overall satisfaction with the process of informed consent (ClinicalTrials.gov no. NCT02810379).


Assuntos
Recursos Audiovisuais , Colangiopancreatografia Retrógrada Endoscópica , Consentimento Livre e Esclarecido , Educação de Pacientes como Assunto/métodos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Compreensão , Feminino , Humanos , Consentimento Livre e Esclarecido/psicologia , Consentimento Livre e Esclarecido/normas , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Melhoria de Qualidade , Medição de Risco , Gestão de Riscos/legislação & jurisprudência , Gestão de Riscos/métodos , Gestão de Riscos/normas
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