部分中文医药杂志伦理保护措施的报告情况

对2002年之前和之后(2000年7月~2001年12月和2003年1月~2004年6月)对6种中文医药杂志发表的临床研究类文章进行比较,并对文中报告知情同意和伦理委员会批准情况的比例给予评价。     

注重全人群、全方位、全过程——论受试者知情同意伦理审查的强化

通过对医药学研究人体试验受试者知情同意的伦理审查发展现状的说明,分析现阶段知情同意伦理审查工作中存在流于形式,审查结果不够科学、客观和公正等问题。再结合医药学研究的发展需要,说明知情同意伦理审查的工作情况和不断发展的要求。提出对知情同意做到全人群、全方位、全过程的伦理审查的覆盖。并通过实施全人群、全方位、全过程的伦理审查的过程,提高人体试验受试者知情同意伦理审查水平,促进医药学研究和社会医学的发展。     

产前超声检查的医学伦理学思考

产前超声检查是指在妊娠期间应用超声检查技术检测母体内胎儿是否存在先天性缺陷和遗传性疾病,随着超声技术的迅速普及和发展,产前超声检查已成为产前诊断的不可缺少的有效手段之一。本文从医学与哲学的角度对产前超声检查的必要性、安全性、局限性以及相关医学伦理问题,如知情同意权、隐私权及人工流产等进行综合分析。     

医学期刊载文的伦理学审查情况分析——以《中国学校卫生》为例

通过查阅《中国学校卫生》近5年纸质期刊,查看文章“对象与方法”中有无“知情同意”或“获得伦理学审查”等信息。结果显示,获得伦理学审查或知情同意的文章884篇,各年份获得伦理学审查、知情同意及总体检出率差异均有统计学意义(χ²=366.29,43.58,219.83,P<0.01)。各年份获得伦理学审查、知情同意的心理学研究及总体检出率(χ²=107.55,16.80,58.66);获得伦理学审查的干预性研究及总体检出率(χ²=44.40,18.46);获得伦理学审查的涉及生物样本的研究检出率(χ²=17.47),差异均有统计学意义(P<0.01)。今后应不断加强引导和教育,加强科研人员及编辑的伦理意识。     

肤纹学研究的伦理问题

医学伦理学和遗传伦理学的原则同样适合肤纹学的研究.知情同意是肤纹学研究中必须要存在的程序和手续.对于肤纹学研究的检查、分析和保存所涉及的伦理学问题提出了意见.     

Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.     

癌症筛查中的医学伦理问题探究

癌症筛查是实现癌症早诊早治的有效手段。与临床医疗行为类似,癌症筛查存在医学伦理问题。根据当代医学伦理学自主、不伤害、有利和公正的四大基本原则,构建癌症筛查的医学伦理问题分析框架,对由癌症筛查技术本身直接引发的筛查受益与风险等实质伦理问题以及应用过程引发的知情同意、自主性、隐私性、分配公平性、社会包容与歧视等程序伦理问题进行探究。重视伦理问题,规避伦理风险,将提高癌症筛查受益,促进人群健康,需要多方利益相关者共同努力。

     

Psychology of the Informed Consent Process: A Commentary on Three Recent Articles

In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.     

基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题.通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢.     

探讨和完善生物医学期刊来稿中的伦理学问题

生物医学期刊来稿中最常见的伦理学问题就是受试者“知情同意”的问题。生物医学期刊通过提高编辑人员素质、加强医学伦理学宣传教育、对来稿严格把关以及协助科研机构建立和完善伦理学审查委员会,不断探讨和完善来稿中的伦理学问题,这不仅是对受试者负责,而且有利于医学科研人员素质的提高,有利于生物医学研究健康、有序的发展。     

Software informed consent: Docete emptorem, not caveat emptor

Should software be sold “as is”, totally guaranteed, or something else? This paper suggests that “informed consent”, used extensively in medical ethics, is an appropriate way to envision the buyer/developer relationship when software is sold. We review why the technical difficulties preclude delivering perfect software, but allow statistical predictions about reliability. Then we borrow principles refined by medical ethics and apply them to computer professionals.     

The Impact of Specific Psychotherapist Beliefs Regarding Managed Care on Prospective Psychotherapy Clients

The purpose of this study was to investigate the separate impact of each of thirteen therapist beliefs that, presented collectively, were previously found to have a significantly negative impact on prospective clients' attitudes toward managed care psychotherapy (Pomerantz, 2000). Participants in this study initially completed a brief questionnaire measuring their willingness to enter psychotherapy and their expectations regarding psychotherapy under managed care. Participants subsequently completed the same brief questionnaire again after being instructed to imagine seeing a hypothetical psychologist and being presented with the psychologist's supposed beliefs regarding managed care (which were actually derived from survey data by Murphy et al., 1998). Results suggest that almost every discrete therapist belief had a significantly negative impact on participants' attitudes toward managed care psychotherapy. Several specific therapist beliefs produced particularly salient negative effects. Implications regarding ethics and informed consent are discussed.     

基因组学研究免除具体知情同意的伦理挑战与审查实践

精准医学时代基因组学研究与临床的结合愈加紧密,研究规模和范围大大扩展。然而,机构既往采集保存样本和信息时征询知情同意的方式和质量不尽相同。指引研究者合法合理使用既往留存资源是伦理委员会面临的重要挑战。在适用国际和我国有关规范时,伦理审查应注意基因组信息的身份关联性、终身伴随性和族群相关性,不能仅以研究采样风险不大于最小风险、不免除知情同意增加研究难度为由批准研究者免除具体知情同意的申请,还应结合研究内容,从隐私保护、意外发现对资源提供者健康权益的影响等方面整体权衡个体和群体的风险受益,审慎决定。     

An Ethical Exploration of Barriers to Research on Controlled Drugs

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning.     

个体危机干预中的伦理学问题

在现代社会中,越来越多的人陷入了不同程度的心理危机中,个体危机干预技术正在得到越来越广泛的应用。个体危机干预是一种短程的心理治疗,在危机干预过程中,对干预对象的隐私权、知情同意权等问题尚未形成相应的伦理规范。为促进危机干预工作的健康发展,对这两个方面的伦理学问题加以讨论,尝试提出一些能够指导个体危机干预工作实践的伦理规范。     

Facilitating Informed Consent: A Multicultural Perspective

Respect for the dignity and autonomy of patients has long been a fundamental principle of ethical decision making. As a practical matter, a primary way of maintaining this ethical standard is by obtaining an individual’s informed consent prior to intervening or collecting data. By giving individuals clear information about alternative treatments and potential risks and benefits, the practitioner tries to ensure that the patient can make an informed choice. However, there are cases in which those seeking informed consent have very different values and belief systems from those whose consent is being sought. In this article we explore such discrepancies using informed consent with Navajo clients as an example, illustrate potential challenges with case examples, and propose ways in which ethical dilemmas may be successfully navigated.     

糖尿病与恶性肿瘤

糖尿病伴发恶性肿瘤的患者越来越多,两者并存时,相互作用,加重病情,预后不良,且有其一定的特点。二者都是消耗性疾病,免疫力低下,对化疗耐受性差,糖尿病的饮食控制与恶性肿瘤的营养支持又非常矛盾,因此治疗上有其一定的特殊性．这就要求我们用哲学上的具体问题具体分析的思想来正确认识其特点与治疗,在化疗过程中两者兼顾并注重药物、支持及心理等综合治疗,以达到最大限度的改善病情,提高病人的生存质量。     

对知情同意书和知情同意过程的探讨

在《医疗事故处理条例》实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程。签字的知情同意书不等于知情同意,知情同意书不等于“生死契约”。知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得。因此知情同意过程应该重要于知情同意书。医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式。     

我国公共卫生中的伦理学问题

在公共卫生研究中重点探讨了伦理审查、研究对象选择、知情同意、保护研究对象隐私、对研究对象的适当补偿等方面的伦理学问题;在公共卫生实践中重点探讨了传染病防治、疾病监测、计划免疫、疾病筛查及卫生资源配置领域中的伦理学问题。重视这些问题并参照一定的伦理学原则将有助于解决问题,更好地促进公共卫生事业的发展,促进人群健康。     

患者知情同意权实现的伦理思考与法律保护

随着医学科学的发展,患者的知情同意已是医学实践的一个基本伦理观念和原则,但是,它的实现不仅需要道德规范的约束,而且还需要法律的保护.