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1.
Rev. Odontol. Araçatuba (Impr.) ; 45(2): 15-23, maio-ago. 2024. tab, graf
Artigo em Português | LILACS, BBO - Odontologia | ID: biblio-1553276

RESUMO

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)


Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)


Assuntos
Consentimento Livre e Esclarecido , Termos de Consentimento , Preenchedores Dérmicos
2.
Br J Nurs ; 33(13): 644-645, 2024 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-38954448

RESUMO

Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.


Assuntos
Consentimento Livre e Esclarecido , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Humanos , Reino Unido
3.
Ghana Med J ; 58(1): 78-85, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38957285

RESUMO

Objective: Infertility remains a global challenge, with assisted reproductive technology (ART) progressively gaining relevance in developing countries, including Ghana. However, associated ethico-legal challenges have not received the needed policy attention. This study explored the legal and ethical challenges of ART practice in Ghana. Design: The study employed an exploratory phenomenological approach to examine ART in Ghana, focusing on ethics and law governing this practice. Participants: Respondents were ART practitioners, managers, facility owners, representatives of surrogacy/gamete donor agencies, and regulatory body representatives. Methods: A semi-structured interview guide was used to collect data.The in-depth interviews were audiotaped, and responses transcribed for analysis through coding, followed by generation of themes and sub-themes, supported with direct quotes. Results: It emerged that there are no ethical and legal frameworks for ART practice in Ghana, and this adversely affects ART practice. Ethical challenges identified border on informed consent, clients' privacy and clinical data protection, gamete donation issues, multiple gestations, single parenting, and social and religious issues. The legal challenges identified include the non-existence of a legal regime for regulating ART practice and the absence of a professional body with clear-cut guidelines on ART practice. In the absence of legal and ethical frameworks in Ghana, practitioners intimated they do comply with internationally accepted principles and general ethics in medical practice. Conclusion: There are no regulations on ART in Ghana. Legal and ethical guidelines are essential to the provision of safe and successful ART practices to protect providers and users. Governmental efforts to regulate Ghana need to be prioritized. Funding: This study had no external funding support. It was funded privately from researchers' contributions.


Assuntos
Técnicas de Reprodução Assistida , Humanos , Gana , Técnicas de Reprodução Assistida/ética , Técnicas de Reprodução Assistida/legislação & jurisprudência , Feminino , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Masculino , Entrevistas como Assunto , Gravidez , Infertilidade/terapia , Pesquisa Qualitativa
4.
Ceska Gynekol ; 89(3): 245-252, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38969521

RESUMO

Caesarean section on request, a request that we have been encountering more and more recently. This can be interpreted as a primary caesarean section performed as a request of the mother without any relevant obstetrical or other medical indications in order to avoid vaginal delivery. The most common reason for mothers' requests for caesarean section is the fear of childbirth and the associated pain. Currently, medicine recognises the patient's right to actively participate in the choice of treatment procedures, including methods of delivery. We have accepted patients' claim for various aesthetic surgical interventions, in case they provide informed consent. The same principle should be maintained for caesarean sections on request.


Assuntos
Cesárea , Humanos , Cesárea/psicologia , Feminino , Gravidez , Direitos do Paciente , Procedimentos Cirúrgicos Eletivos/psicologia , Consentimento Livre e Esclarecido
5.
J Law Med ; 31(2): 258-272, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38963246

RESUMO

This section explores the challenges involved in translating genomic research into genomic medicine. A number of priorities have been identified in the Australian National Health Genomics Framework for addressing these challenges. Responsible collection, storage, use and management of genomic data is one of these priorities, and is the primary theme of this section. The recent release of Genomical, an Australian data-sharing platform, is used as a case study to illustrate the type of assistance that can be provided to the health care sector in addressing this priority. The section first describes the National Framework and other drivers involved in the move towards genomic medicine. The section then examines key ethical, legal and social factors at play in genomics, with particular focus on privacy and consent. Finally, the section examines how Genomical is being used to help ensure that the move towards genomic medicine is ethically, legally and socially sound and that it optimises advances in both genomic and information technology.


Assuntos
Genômica , Disseminação de Informação , Humanos , Genômica/legislação & jurisprudência , Genômica/ética , Austrália , Disseminação de Informação/legislação & jurisprudência , Disseminação de Informação/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Privacidade Genética/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência
6.
J Law Med ; 31(2): 324-342, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38963248

RESUMO

Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that may not be readily apparent. Such risks include risks that threaten the patient's values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.


Assuntos
Responsabilidade pela Informação , Consentimento Livre e Esclarecido , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Responsabilidade pela Informação/legislação & jurisprudência , Idoso , Austrália , Tomada de Decisão Compartilhada
7.
Br J Community Nurs ; 29(7): 318-320, 2024 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-38963268

RESUMO

Consent is an essential part of healthcare practice, allowing patients to make autonomous decisions. However, this changes when a patient has mental incapacity or is unable to make decisions for themselves for a duration of time. This month's Policy column looks at some of the key principles of the Mental Capacity Act 2005, and how this can be applied in community nursing practice.


Assuntos
Consentimento Livre e Esclarecido , Competência Mental , Humanos , Competência Mental/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Reino Unido , Enfermagem em Saúde Comunitária/legislação & jurisprudência
9.
Trials ; 25(1): 452, 2024 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-38965542

RESUMO

BACKGROUND: Despite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies. METHODS: We describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women's College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial. DISCUSSION: This study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients. TRIAL REGISTRATION: The trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.


Assuntos
Consentimento Livre e Esclarecido , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Estudos Prospectivos , Seleção de Pacientes , Sujeitos da Pesquisa/psicologia , Fatores de Tempo , Feminino , Anestesia Geral
10.
Zhonghua Yi Xue Za Zhi ; 104(26): 2383-2385, 2024 Jul 09.
Artigo em Chinês | MEDLINE | ID: mdl-38978361

RESUMO

The establishment of clinical research resource platforms, including research databases and bio-sample library, is an important development in the field of clinical research. The international academic community proposes broad informed consent to regulate the ethical management of the issue. However, the broad informed consent fails to capture the main features of incomplete informed consent and authorization, misleads researchers and managers and leads to miss ethical management for clinical research projects. Therefore, the author proposes a named partial informed consent to improve ethical management for clinical research projects. Partial informed consent separates ethical management for establishing clinical research resource platforms and clinical research projects. After reviewing the legal and ethical foundation of clinical research ethics management, the author discussed the similarities and differences between project management and task management in the two informed consent solutions, the basis for approval of exempted informed consent signatures by the ethics committee, issues to be noted in the ethics management of multi-center research at the task level, and explained the substantive differences between broad informed consent and partial informed consent.


Assuntos
Consentimento Livre e Esclarecido , Humanos , Pesquisa Biomédica/ética , Ética em Pesquisa
11.
Neurosurg Rev ; 47(1): 268, 2024 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-38862774

RESUMO

Spontaneous intracerebral hemorrhage (ICH) might lead to devastating consequences. Nonetheless, subjective interpretation of life circumstances might vary. Recent data from ischemic stroke patients show that there might be a paradox between clinically rated neurological outcome and self-reported satisfaction with quality of life. Our hypothesis was that minimally invasive surgically treated ICH patients would still give their consent to stereotactic fibrinolysis despite experiencing relatively poor neurological outcome. In order to better understand the patients' perspective and to enhance insight beyond functional outcome, this is the first study assessing disease-specific health-related quality of life (hrQoL) in ICH after fibrinolytic therapy. We conducted a retrospective analysis of patients with spontaneous ICH treated minimally invasive by stereotactic fibrinolysis. Subsequently, using standardized telephone interviews, we evaluated functional outcome with the modified Rankin Scale (mRS), health-related Quality of Life with the Quality of life after Brain Injury Overall scale (QOLIBRI-OS), and assessed retrospectively if the patients would have given their consent to the treatment. To verify the primary hypothesis that fibrinolytic treated ICH patients would still retrospectively consent to fibrinolytic therapy despite a relatively poor neurological outcome, we conducted a chi-square test to compare good versus poor outcome (mRS) between consenters and non-consenters. To investigate the association between hrQoL (QOLIBRI-OS) and consent, we conducted a Mann-Whitney U-test. Moreover, we did a Spearman correlation to investigate the correlation between functional outcome (mRS) and hrQoL (QOLIBRI-OS). The analysis comprised 63 data sets (35 men, mean age: 66.9 ± 11.8 years, median Hemphill score: 3 [2-3]). Good neurological outcome (mRS 0-3) was achieved in 52% (33/63) of the patients. Patients would have given their consent to surgery retrospectively in 89.7% (52/58). These 52 consenting patients comprised all 33 patients (100%) who achieved good functional outcome and 19 of the 25 patients (76%) who achieved poor neurological outcome (mRS 4-6). The mean QOLIBRI-OS value was 49.55 ± 27.75. A significant association between hrQoL and retrospective consent was found (p = 0.004). This study supports fibrinolytic treatment of ICH even in cases when poor neurological outcome would have to be assumed since subjective perception of deficits could be in contrast with the objectively measured neurological outcome. HrQoL serves as a criterion for success of rtPa lysis therapy in ICH.


Assuntos
Hemorragia Cerebral , Qualidade de Vida , Humanos , Masculino , Feminino , Hemorragia Cerebral/cirurgia , Estudos Retrospectivos , Idoso , Pessoa de Meia-Idade , Resultado do Tratamento , Terapia Trombolítica/métodos , Consentimento Livre e Esclarecido , Idoso de 80 Anos ou mais
12.
PLoS One ; 19(6): e0304418, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38865296

RESUMO

OBJECTIVES: To study informed consent to midwifery practices and interventions during the second stage of labor and to investigate the association between informed consent and experiences of these practices and interventions and women's experiences of the second stage of labor. METHODS: This study uses an observational design with data from a follow-up questionnaire sent to women one month after giving birth spontaneously in the Oneplus trial, a study aimed at evaluating collegial midwifery assistance to reduce severe perineal trauma. The trial was conducted between 2018-2020 at five Swedish maternity wards and trial registered at clinicaltrials.gov, no NCT03770962. The follow-up questionnaire contained questions about experiences of the second stage of labor, practices and interventions used and whether the women had provided informed consent. Evaluated practices and interventions were the use of warm compresses held at the perineum, manual perineal protection, vaginal examinations, perineal massage, levator pressure, intermittent catheterization of the bladder, fundal pressure, and episiotomy. Associations between informed consent and women's experiences were assessed by univariate and multivariable logistic regression. FINDINGS: Of the 3049 women participating in the trial, 2849 consented to receive the questionnaire. Informed consent was reported by less than one in five women and was associated with feelings of being safe, strong, and in control. Informed consent was further associated with more positive experiences of clinical practices and interventions, and with less discomfort and pain from interventions involving physical penetration of the genital area. CONCLUSION: The findings indicate that informed consent during the second stage is associated with feelings of safety and of being in control. With less than one in five women reporting informed consent to all practices and interventions performed by midwives, the results emphasize the need for further action to enhance midwives' knowledge and motivation in obtaining informed consent prior to performance of interventions.


Assuntos
Consentimento Livre e Esclarecido , Segunda Fase do Trabalho de Parto , Tocologia , Humanos , Feminino , Gravidez , Adulto , Inquéritos e Questionários , Parto Obstétrico , Suécia , Adulto Jovem
13.
Acta Neurochir (Wien) ; 166(1): 266, 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38874628

RESUMO

Increased use of whole genome sequencing (WGS) in neuro-oncology for diagnostics and research purposes necessitates a renewed conversation about informed consent procedures and governance structures for sharing personal health data. There is currently no consensus on how to obtain informed consent for WGS in this population. In this narrative review, we analyze the formats and contents of frameworks suggested in literature for WGS in oncology and assess their benefits and limitations. We discuss applicability, specific challenges, and legal context for patients with (recurrent) glioblastoma. This population is characterized by the rarity of the disease, extremely limited prognosis, and the correlation of the stage of the disease with cognitive abilities. Since this has implications for the informed consent procedure for WGS, we suggest that the content of informed consent should be tailor-made for (recurrent) glioblastoma patients.


Assuntos
Neoplasias Encefálicas , Glioblastoma , Disseminação de Informação , Consentimento Livre e Esclarecido , Sequenciamento Completo do Genoma , Humanos , Glioblastoma/genética , Neoplasias Encefálicas/genética , Disseminação de Informação/métodos , Recidiva Local de Neoplasia/genética
14.
Ethics Hum Res ; 46(4): 2-16, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38944882

RESUMO

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.


Assuntos
Comitês de Ética em Pesquisa , Ética em Pesquisa , Consentimento Livre e Esclarecido , National Institutes of Health (U.S.) , Refugiados , Humanos , Estados Unidos , Consentimento Livre e Esclarecido/ética , América do Norte , Conflito de Interesses , Projetos de Pesquisa , Seleção de Pacientes/ética , Pesquisa Biomédica/ética , Menores de Idade , Guias como Assunto , Populações Vulneráveis
15.
Cancer Radiother ; 28(3): 290-292, 2024 Jun.
Artigo em Francês | MEDLINE | ID: mdl-38866651

RESUMO

Obtaining consent to care requires the radiation oncologist to provide loyal information and to ensure that the patient understands it. Proof of such an approach rests with the practitioner. The French Society for Radiation Oncology (SFRO) does not recommend the signature of a consent form by the patient but recommends that the radiation oncologist be able to provide all the elements demonstrating the reality of a complete information circuit.


Assuntos
Consentimento Livre e Esclarecido , Radioterapia (Especialidade) , Humanos , Termos de Consentimento/normas , França , Neoplasias/radioterapia , Relações Médico-Paciente , Radioterapia/métodos , Guias de Prática Clínica como Assunto
16.
Surg Endosc ; 38(7): 4024-4030, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38877318

RESUMO

INTRODUCTION: Improving surgical access in low- and middle-income countries is vital for the 5 billion people who lack safe surgical care. Tailoring a culturally sensitive approach to consent is essential for patient comprehension and comfort, thereby alleviating the effects of resource constraints and advancing equitable care. This study examines the consenting process for endoscopy at Kyabirwa Surgical Center in Kyabirwa, Jinja, Uganda, to assess patients' knowledge and attitudes as a potential barrier to participating in endoscopic procedures. METHODS: All adult upper endoscopy (EGD) and colonoscopy patients were recruited to participate in a survey of their demographics, knowledge, and attitudes toward their procedure. All patients received a standard consultation explaining the procedure and its risks and benefits. RESULTS: 75 patients were included; median age was 54 years and 56% (n = 42) were women. 92% (n = 69) of patients had never had an endoscopy before and 73% (n = 55) of patients were scheduled for an EGD while the remaining 27% (n = 20) were scheduled for a colonoscopy. Most patients 80% (n = 60) had a basic understanding of what an endoscopy is and 87% (n = 65) its diagnostic purpose. Few patients 15% (n = 11) knew of the most common side effects or if they would have a surgical scar 27% (n = 20). Overall, 46.7% (n = 35) of patients were moderately or severely fearful of getting an endoscopy. Additionally, 45.3% (n = 34) of patients were moderately or severely fearful of receiving anesthesia during their endoscopic procedure. Despite this fear, most patients 85.3% (n = 64) stated that they understood the benefits of the procedure either very well or extremely well. CONCLUSIONS: Most patients understood the role that an endoscopic procedure plays in their care and its potential benefits. Despite this, many patients continued to have high levels of fear associated with both the endoscopic procedure and with receiving anesthesia during their procedure. Future patient education should focus on addressing patients' fears and the risks of undergoing an endoscopy, which may improve the utilization of surgical services.


Assuntos
Colonoscopia , Compreensão , Consentimento Livre e Esclarecido , Humanos , Feminino , Uganda , Masculino , Pessoa de Meia-Idade , Adulto , Idoso , Conhecimentos, Atitudes e Prática em Saúde , População Rural , Adulto Jovem
17.
AAPS J ; 26(4): 72, 2024 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-38890152

RESUMO

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.


Assuntos
Ensaios Clínicos como Assunto , Termos de Consentimento , Indústria Farmacêutica , Estudos Transversais , Humanos , Ensaios Clínicos como Assunto/ética , Indústria Farmacêutica/economia , Consentimento Livre e Esclarecido , Sistema de Registros
18.
Trials ; 25(1): 391, 2024 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-38890748

RESUMO

BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback. METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase. RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases. CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.


Assuntos
Compreensão , Jogo de Azar , Folhetos , Educação de Pacientes como Assunto , Sujeitos da Pesquisa , Humanos , Jogo de Azar/psicologia , Irlanda , Sujeitos da Pesquisa/psicologia , Educação de Pacientes como Assunto/métodos , Conhecimentos, Atitudes e Prática em Saúde , Autorrelato , Reino Unido , Feminino , Letramento em Saúde , Masculino , Consentimento Livre e Esclarecido , Ensaios Clínicos como Assunto/métodos , Pessoa de Meia-Idade , Adulto , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Gigascience ; 132024 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-38837943

RESUMO

Genomic information is increasingly used to inform medical treatments and manage future disease risks. However, any personal and societal gains must be carefully balanced against the risk to individuals contributing their genomic data. Expanding our understanding of actionable genomic insights requires researchers to access large global datasets to capture the complexity of genomic contribution to diseases. Similarly, clinicians need efficient access to a patient's genome as well as population-representative historical records for evidence-based decisions. Both researchers and clinicians hence rely on participants to consent to the use of their genomic data, which in turn requires trust in the professional and ethical handling of this information. Here, we review existing and emerging solutions for secure and effective genomic information management, including storage, encryption, consent, and authorization that are needed to build participant trust. We discuss recent innovations in cloud computing, quantum-computing-proof encryption, and self-sovereign identity. These innovations can augment key developments from within the genomics community, notably GA4GH Passports and the Crypt4GH file container standard. We also explore how decentralized storage as well as the digital consenting process can offer culturally acceptable processes to encourage data contributions from ethnic minorities. We conclude that the individual and their right for self-determination needs to be put at the center of any genomics framework, because only on an individual level can the received benefits be accurately balanced against the risk of exposing private information.


Assuntos
Genômica , Humanos , Genômica/métodos , Genômica/ética , Segurança Computacional , Computação em Nuvem , Consentimento Livre e Esclarecido
20.
Hastings Cent Rep ; 54(3): 11-14, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38842906

RESUMO

For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as "informed consent." Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will "fix" the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called "better conversations." Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.


Assuntos
Consentimento Livre e Esclarecido , Relações Médico-Paciente , Humanos , Consentimento Livre e Esclarecido/ética , Relações Médico-Paciente/ética , Comunicação , Autonomia Pessoal , Procedimentos Cirúrgicos Operatórios/ética , Tomada de Decisões/ética
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