Informed consent

知情同意
  • 文章类型: Journal Article
    同意偏见是生物医学研究中的一种选择偏见,其中同意研究的人与不同意的人系统不同。它在精准医学研究中特别重要,因为这些研究的复杂性阻碍了某些亚组的理解,信任,并同意这项研究。因为同意偏见扭曲了研究结果,并导致研究利益的不公平分配,学者们提出了两种减少同意偏见的方案:改革现有的同意模式和完全取消同意要求。这项研究利用现有数据探索了在观察性研究中放弃同意的可能性,因为如果加强隐私保护,与临床试验相比,它们对参与者的风险更小。建议在未经同意的情况下,进行安全性增强和数据保护影响评估等数据保护机制,以保护观察性研究参与者的数据隐私。
    Consent bias is a type of selection bias in biomedical research where those consenting to the research differ systematically from those not consenting. It is particularly relevant in precision medicine research because the complexity of these studies prevents certain subgroups from understanding, trusting, and consenting to the research. Because consent bias distorts research findings and causes inequitable distribution of research benefits, scholars propose two types of schemes to reduce consent bias: reforming existing consent models and removing the consent requirement altogether. This study explores the possibility of waiving consent in observational studies using existing data, because they involve fewer risks to participants than clinical trials if privacy safeguards are strengthened. It suggests that data protection mechanisms such as security enhancement and data protection impact assessment should be conducted to protect data privacy of participants in observational studies without consent.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    在中国法律的法律背景下,遗传数据是复杂权利的客体。在私法层面,基因数据包含个人信息,因此受到《民法典》和《个人信息保护法》的保护;在公法层面,遗传数据是体现公共利益和国家利益的重要遗传资源,这也应受到生物安全法和数据安全法等公共法律的约束。最近发布的"人类遗传资源管理条例"对审批和备案程序进行了细化,以促进我国遗传数据的利用。目前,中国仍然缺乏足够的基因数据隐私保护,“知情同意”和“匿名化”系统无法有效工作。在改进的道路上,我们应该打破个人主义的约束,从三个层面加强基因数据隐私保护:制定专门立法,发挥团体组织和公益诉讼制度的功能。
    In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued Regulation on the Administration of Human Genetic Resources have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the \"informed consent\" and \"anonymization\" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: English Abstract
    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.
    研究资源平台,包括研究数据库和生物样本库的建立,是临床研究领域的重要进展。国际学术界提出广泛知情同意签字(以下简称泛知情)以规范该类研究的伦理管理。但泛知情解决方案没有体现建立知情告知和同意授权不完整的主要特征,存在误导研究者和管理者,进而可能导致课题研究伦理管理缺位的问题。为此,本文提出部分知情同意授权解决方案,将资源平台建设与课题研究的伦理管理彻底分离,形成两个独立的伦理管理模块,分别纳入临床研究伦理管理框架。在回顾临床研究伦理管理法理基础和伦理基础的前提下,本文分析了项目管理与课题管理的异同、伦理委员会批准豁免知情同意签字的基础、课题层面的多中心研究伦理管理中需要注意的问题,解读了广泛知情同意签字和部分知情同意授权的背后实质内涵及操作层面的差异。.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:美学医学,一个有争议的临床医学分支,以其高度商业化而闻名,面临许多冲突,特别是在一些发展中国家。全球美学医药行业需要加强其法律和监管框架以及风险管理系统。
    目的:本文旨在全面直观地分析美容医学领域与监管和法律问题相关的学术成果,并找出其发展趋势和研究热点。
    方法:采用WebofScienceCoreCollection检索相关研究,经过选择,共产生602篇研究文章。利用文献计量法和CiteSpace,这项研究分析了主要国家,机构,作者,期刊,热点,前沿,以及这个领域的趋势。
    结果:研究结果表明,发表的论文数量迅速增加。美国以131篇研究论文和最高的中间中心地位成为领先的贡献者。确定了11个关键词集群,“青春期”和“办公室手术”是最新的话题。我们还分析了医学美学法律研究的趋势和前沿。
    结论:越来越强调知情同意的重要性,医学美学领域的研究已逐渐扩展到个人美容程序之外。管理体制更加全面,此外,指南和医疗法律不断公布,随着研究转向涵盖患者的整体视角,医疗美容提供者,以及监管当局对医学美学的监管和立法研究。本文还对未来的研究和应用提出了一些创新方向。
    BACKGROUND: Aesthetics medicine, a controversial branch of clinical medicine known for its high degree of commercialization, faces numerous conflicts, particularly in some developing countries. The global aesthetics medicine industry requires enhancements of its legal and supervision framework and risk management systems.
    OBJECTIVE: This paper aimed to provide a comprehensive visual analysis of academic achievements related to regulatory and legal issues in the field of aesthetic medicine and to identify its development trends and research hotspots.
    METHODS: The Web of Science Core Collection was employed to retrieve relevant studies, resulting in a total of 602 research articles after selection. Utilizing bibliometric methods and CiteSpace, this study analyzed the primary countries, institutions, authors, journals, hotspots, frontiers, and trends in this domain.
    RESULTS: The findings indicated rapid increases in the number of published papers. The United States emerged as the leading contributor with 131 research papers and the highest intermediate centrality. Eleven keyword clusters were identified, with \"adolescence\" and \"office-based surgery\" being the most recent topics. We also analyzed the trends and frontiers of legal research in medical aesthetics.
    CONCLUSIONS: The importance of informed consent has been increasingly emphasized, and research in the field of medical aesthetics has been gradually expanding beyond individual cosmetic procedures. The management system has become more comprehensive, moreover, guidelines and medical laws have been continually published, with research shifting toward a holistic perspective that encompasses patients, medical aesthetic providers, and regulatory authorities in the study of medical aesthetics regulation and legislation. This paper also proposes some innovative directions for future research and applications.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:互联网社区已成为研究人员进行定性研究以分析用户观点的重要来源,态度,以及公共卫生方面的经验。然而,很少有研究使用社交媒体数据评估定性研究中的伦理问题。
    目的:本研究旨在回顾利用公共医疗保健社交媒体数据进行定性研究的伦理考虑报告。
    方法:我们对从互联网社区挖掘文本的研究进行了范围审查,并于2010年至2023年5月31日在同行评审期刊上发表。这些研究,仅限于英语,被检索以评估报告的道德批准率,知情同意,和隐私问题。我们搜索了5个数据库,也就是说,PubMed,WebofScience,CINAHL,科克伦,和Embase。灰色文献从谷歌学者和OpenGrey网站得到补充。使用定性方法从互联网社区中挖掘文本以医疗保健主题为重点的研究被认为是合格的。使用标准化数据提取电子表格进行数据提取。使用PRISMA-ScR(系统审查的首选报告项目和范围审查的Meta分析扩展)指南报告研究结果。
    结果:在4674个标题之后,摘要,全文进行了筛选,包括108项有关互联网社区文本挖掘的研究。近一半的研究发表在美国,从2019年到2022年的更多研究。只有59.3%(64/108)的研究寻求伦理批准,45.3%(49/108)提到知情同意,只有12.9%(14/108)的研究明确获得知情同意.报告知情同意的研究中约有86%(12/14)获得了参与者/管理员的数字知情同意。而14%(2/14)没有描述用于获得知情同意的方法。值得注意的是,70.3%(76/108)的研究包含用户的书面内容或帖子:68%(52/76)包含逐字引用,而32%(24/76)的人解释了这些报价是为了防止可追溯性。然而,16%(4/24)的引用引用的研究没有报告的解释方法。此外,18.5%(20/108)的研究使用汇总数据分析来保护用户的隐私。此外,不同国家(P=.02),包含用户书面内容的论文(直译和转述引文)与不包含用户书面内容的论文(P<.001)之间的报告伦理认证率不同.
    结论:我们的范围审查表明,在使用社交媒体数据的定性研究中,道德考虑因素的报告被广泛忽略;此类研究在引用用户报价时应更加谨慎,以维护用户隐私。Further,我们的审查显示,我们需要详细的信息,了解获得知情同意的预防措施和解释以减少潜在的偏见.对道德考虑的国家共识,例如道德认可,知情同意,和隐私问题需要使用互联网社区的社交媒体数据进行医疗保健的定性研究。
    BACKGROUND: The internet community has become a significant source for researchers to conduct qualitative studies analyzing users\' views, attitudes, and experiences about public health. However, few studies have assessed the ethical issues in qualitative research using social media data.
    OBJECTIVE: This study aims to review the reportage of ethical considerations in qualitative research utilizing social media data on public health care.
    METHODS: We performed a scoping review of studies mining text from internet communities and published in peer-reviewed journals from 2010 to May 31, 2023. These studies, limited to the English language, were retrieved to evaluate the rates of reporting ethical approval, informed consent, and privacy issues. We searched 5 databases, that is, PubMed, Web of Science, CINAHL, Cochrane, and Embase. Gray literature was supplemented from Google Scholar and OpenGrey websites. Studies using qualitative methods mining text from the internet community focusing on health care topics were deemed eligible. Data extraction was performed using a standardized data extraction spreadsheet. Findings were reported using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines.
    RESULTS: After 4674 titles, abstracts, and full texts were screened, 108 studies on mining text from the internet community were included. Nearly half of the studies were published in the United States, with more studies from 2019 to 2022. Only 59.3% (64/108) of the studies sought ethical approval, 45.3% (49/108) mentioned informed consent, and only 12.9% (14/108) of the studies explicitly obtained informed consent. Approximately 86% (12/14) of the studies that reported informed consent obtained digital informed consent from participants/administrators, while 14% (2/14) did not describe the method used to obtain informed consent. Notably, 70.3% (76/108) of the studies contained users\' written content or posts: 68% (52/76) contained verbatim quotes, while 32% (24/76) paraphrased the quotes to prevent traceability. However, 16% (4/24) of the studies that paraphrased the quotes did not report the paraphrasing methods. Moreover, 18.5% (20/108) of the studies used aggregated data analysis to protect users\' privacy. Furthermore, the rates of reporting ethical approval were different between different countries (P=.02) and between papers that contained users\' written content (both direct and paraphrased quotes) and papers that did not contain users\' written content (P<.001).
    CONCLUSIONS: Our scoping review demonstrates that the reporting of ethical considerations is widely neglected in qualitative research studies using social media data; such studies should be more cautious in citing user quotes to maintain user privacy. Further, our review reveals the need for detailed information on the precautions of obtaining informed consent and paraphrasing to reduce the potential bias. A national consensus of ethical considerations such as ethical approval, informed consent, and privacy issues is needed for qualitative research of health care using social media data of internet communities.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    在病程早期进行口服治疗,鼓励更好的健康结果。获得知情同意是医疗实践的重要组成部分,保护患者的合法权益,指导医学伦理实践。在实践中,同意在不同的背景下意味着不同的事情。氟化银二胺(SDF)和氟化银(SF)正在成为流行和成本有效的方法来管理龋齿病变,然而,引起黑色变色的病变治疗。获得知情同意和同意对于任何牙科治疗都是至关重要的-并且与SDF/SF治疗具有特定的相关性。
    本文的目的是描述某些国家/地区的牙科护理知情同意法规,关注有特殊医疗保健需求的儿童和患者。与来自13个国家的牙科专业人员的便利样本共享了一项在线调查。对信息进行了探索,并比较了同意过程。
    研究结果表明,在医疗实践的知情同意方面存在差异。在坦桑尼亚,南非,印度,肯尼亚,马来西亚和巴西的年龄是能力和自我同意能力的决定因素。在其他国家,其他因素与年龄一起考虑。例如,在新加坡,联合王国,和美国的吉利克能力原则是适用的。许多国家/地区的法律法规没有规定牙医何时可以否决一般同意为患者的“最佳利益”行事。
    建议在全球范围内澄清牙医可能为患者的“最佳利益”行事时,并产生该指南以指示什么构成牙科紧急情况。收集的见解提供了有关获得知情同意的国际惯例的见解,并确定了需要改变的领域,为有特殊需要的儿童和患者提供更有效和更道德的治疗。建议进行更大的后续研究,以包括更多或所有国家。
    UNASSIGNED: Conducting oral treatment early in the disease course, is encouraged for better health outcomes. Obtaining informed consent is an essential part of medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine. In practice, consent means different things in different contexts. Silver Diamine Fluoride (SDF) and Silver Fluoride (SF) is becoming popular and cost effective methods to manage carious lesions, however, cause black discolouration of lesions treated. Obtaining informed consent and assent is crucial for any dental treatment-and has specific relevance with SDF/ SF treatments.
    UNASSIGNED: The aim of this paper is to describe informed consent regulations for dental care in a selection of countries, focusing on children and patients with special health care needs. An online survey was shared with a convenience sample of dental professionals from 13 countries. The information was explored and the processes of consent were compared.
    UNASSIGNED: Findings suggest that there are variations in terms of informed consent for medical practice. In Tanzania, South Africa, India, Kenya, Malaysia and Brazil age is the determining factor for competence and the ability to give self-consent. In other countries, other factors are considered alongside age. For example, in Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Many countries\' laws and regulations do not specify when a dentist may overrule general consent to act in the \"best interest\" of the patient.
    UNASSIGNED: It is recommended that it is clarified globally when a dentist may act in the \"best interest\" of the patient, and that guidance is produced to indicate what constitutes a dental emergency. The insights gathered provide insights on international practice of obtaining informed consent and to identify areas for change, to more efficient and ethical treatment for children and patients with special needs. A larger follow up study is recommended to include more or all countries.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:急性肾损伤(AKI)是术后的主要后果,影响老年患者的预后。目前尚无有效的预测或干预措施来预测或预防AKI的发生。
    目的:手术过程中肾组织氧饱和度(RSO2)的动态变化研究不足,我们打算探索不同的运动轨迹及其与术后AKI的关系。
    方法:这是一项次要分析,包括在知情同意下接受开放式肝切除术的老年患者的数据。进行潜在类别混合模型(LCMM)方法以通过不同时间点生成术中肾组织RSO2的轨迹。主要结果是术后7天AKI。进行单因素和多因素回归分析以确定肾组织RSO2的不同轨迹与AKI风险之间的关系。同时,比较不同时间点肾组织RSO2的预测效能,寻找潜在的干预时机。
    结果:92例患者中有14例(15.2%)发生了术后AKI。有两种不同的肾组织RSO2轨迹,44.6%产生“高向下”轨迹,55.4%产生“持续高”轨迹。具有“高向下”轨迹的患者术后AKI的风险明显高于另一组(未调整OR[赔率比]=3.790,95%CI[置信区间]:1.091-13.164,p=0.036;调整后的OR=3.973,95%CI1.020-15.478,p=0.047)。肾组织RSO2“高向下”轨迹识别AKI的预测性能为71.4%的敏感性和60.3%的特异性。此外,肾组织RSO2在肝闭塞期的敏感性方面表现出最低水平和最佳结果,可能被视为“关注时间”。
    结论:接受肝切除术的老年患者可能会出现肾组织RSO2的高向下轨迹,表明AKI的风险更高,最低的水平是在肝闭塞期间确定的。这些发现可能有助于为将来早期识别肾功能恶化提供潜在的候选人并指导干预措施。
    BACKGROUND: Acute kidney injury (AKI) is a major postoperative consequence, affecting prognosis of older patients. Effective prediction or intervention to predict or prevent the incidence of AKI is currently unavailable.
    OBJECTIVE: Dynamic changes of renal tissue oxygen saturation (RSO2) during surgery process are understudied and we intended to explore the distinct trajectories and associations with postoperative AKI.
    METHODS: This was a secondary analysis including data for older patients who underwent open hepatectomy surgery with informed consent. Latent class mixed models (LCMM) method was conducted to generate trajectories of intraoperative renal tissue RSO2 through different time points. The primary outcome was postoperative 7-day AKI. The univariate and multivariate regression analysis were performed to identify the relationship between distinct trajectories of renal tissue RSO2 and the risk of AKI. Meanwhile, the prediction efficacy of renal tissue RSO2 at different time points was compared to find potential intervention timing.
    RESULTS: Postoperative AKI occurred in 14 (15.2%) of 92 patients. There are two distinct renal tissue RSO2 trajectories, with 44.6% generating \"high-downwards\" trajectory and 55.4% generating \"consistently-high\" trajectory. Patients with \"high-downwards\" trajectory had significantly higher risk of postoperative AKI than another group (Unadjusted OR [Odds Ratio] = 3.790, 95% CI [Confidence Interval]: 1.091-13.164, p = 0.036; Adjusted OR = 3.973, 95% CI 1.020-15.478, p = 0.047, respectively). Predictive performance was 71.4% sensitivity and 60.3% specificity for \"high-downwards\" trajectory of renal tissue RSO2 to identify AKI. Furthermore, the renal tissue RSO2 exhibited the lowest level and the best results in terms of the sensitivity during the hepatic occlusion period, may be considered as a \"time of concern\".
    CONCLUSIONS: Older patients undergoing hepatectomy may show high-downwards trajectory of renal tissue RSO2, indicating a higher risk of AKI, and the lowest level was identified during the hepatic occlusion period. These findings may help to provide potential candidates for future early recognition of deterioration of kidney function and guide interventions.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Editorial
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:基于知情同意原则,医生必须充分告知患者并尊重他们的医疗决定。在中国,然而,家庭成员通常在患者的知情同意中起特殊作用,这创造了一个独特的“医生-家庭-病人”模式的医患关系。我们的研究针对年轻医生,调查他们在这样一个模型中可能遇到的道德困境,以及他们对知情同意中家庭角色的态度。
    方法:制定了一份问卷,包括一般人口统计学特征,履行充分告知的义务,谁会被告知,以及决策中的伦理困境。我们总共招募了421名医生来完成这份问卷,其中368人符合本研究的年龄要求。交叉制表和皮尔逊卡方检验用于分析分类变量患者类型之间的差异,并且p值<0.05被认为具有统计学意义。
    结果:我们的数据显示,只有20名医生(5.40%)在告知患者严重病情时表示“仅告知患者就足够了”。其余参与者将确保通知家人。当面对具有决策能力的老年患者时,数据有统计学差异(3.8%;P<0.001)确保家庭成员被告知的主要原因在参与者中不同.此外,当家庭成员要求医生为了患者的最大利益而隐瞒患者的医疗状况时,270名医生(73.4%)会同意并与家人合作。当涉及老年患者时,也有类似的比例(79.6%)。
    结论:(1)中国医生特别注意告知患者家属,这可能不符合患者的最佳利益。(2)中国医生对待成人(但不是老年)患者和老年患者在告知家庭成员时有所不同。(3)当家庭成员要求医生为了患者的最大利益而向患者隐瞒信息时,“大多数人选择遵守要求,虽然这可能会给他们带来痛苦。
    Based on the principle of informed consent, doctors are required to fully inform patients and respect their medical decisions. In China, however, family members usually play a special role in the patient\'s informed consent, which creates a unique \"doctor-family-patient\" model of the physician-patient relationship. Our study targets young doctors to investigate the ethical dilemmas they may encounter in such a model, as well as their attitudes to the family roles in informed consent.
    A questionnaire was developed including general demographic characteristics, the fulfillment of the obligation to fully inform, who will be informed, and the ethical dilemmas in decision-making. We recruited a total of 421 doctors to complete this questionnaire, of which 368 met the age requirements for this study. Cross tabulation and Pearson\'s chi-squared test were used to analyze the differences between types of patients for categorical variables, and a p-value < 0.05 was considered statistically significant.
    Our data shows that only 20 doctors (5.40%) stated \"informing the patient alone is sufficient\" when it comes to informing patients of their serious conditions. The rest of the participants would ensure that the family was informed. When facing elderly patients with decision-making capacity, the data was statistically different (3.8%; P < 0.001) The primary reason for ensuring that family members be informed differs among the participants. In addition, when family members asked doctors to conceal the patient\'s medical condition for the best interests of patients, 270 doctors (73.4%) would agree and cooperate with the family. A similar proportion (79.6%) would do so when it comes to elderly patients.
    (1) Chinese doctors pay extra attention to informing the patient\'s family, which may not be in the patient\'s best interests. (2) Chinese doctors treat adult (but not elderly) patients and elderly patients differently when it comes to informing family members. (3) When family members request that doctors withhold information from patients \"in the best interest of the patient,\" the majority choose to comply with the request, although this may cause them distress.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号