Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research among Substance Abusing Offenders

This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2-weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.     

Neuropsychological Functioning and Recall of Research Consent Information Among Drug Court Clients

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures.     

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.     

知情同意：从纽伦堡到赫尔辛基

知情同意被视为临床伦理学与研究伦理学的基本原则。大量的文献倡导提高同意的必要条件。据说,同意应当更加明确、具体。经验主义的证据显示,满足任何一方标准是极其困难的,有时是不可能的,因此,这些目标很难行得通。倡导知情同意不实际与不可能的要求,有极小的价值。讨论告知不能作为临床伦理学与研究伦理学的基本标准,知情同意可以最好视为病人与受试者以及其他人所能选择性放弃其他的义务,而不采取侵害性行为的一种方法。它提供了一种调节根本的义务的重要方式,这一义务是由尊重真正执行同意所需要的伦理标准与认识力的双方提供。     

A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest.     

对精神分裂症患者实施知情同意的护理告知程序

规范精神科护士对精神分裂症患者实施知情同意的告知程序。结合精神专科特点,参考有关文献,征得精神科医疗护理专家的意见并审定,确立了分阶段告知的程序。采用的告知方式有口头告知、书面告知、健康教育、咨询与答疑、个体化讨论与指导。多样化的告知方式增加了告知力度,彰显了人文关怀。分段告知程序显示了科学性与可操作性,对精神科护士履行告知义务具有指导性、实用性及可推广性。     

知情同意的临床实践存在的问题及对策

临床医疗实践中贯彻实施知情同意原则旨在保护病人的权益不受侵犯,然而知情同意原则实施起来并不简单,它常常会受到主客体两方面种种因素的制约,陷入意想不到的困境。分析了知情同意原则在实施过程中可能出现的一些难以回避的问题,并针对这些问题探讨了若干对策。     

医患不同角色群体对患者知情同意权的态度研究进展

概述目前国内外关于医患不同角色群体对患者知情同意权的态度的研究状况。现有的研究重点是关于癌症患者和精神分裂症患者的知情同意权问题,研究结果表明,患者、家属、医务人员三个不同角色群体的认知和态度存在明显差异;对普通疾病患者的知情同意权的认知和态度问题,目前国内尚缺乏比较全面系统的研究。     

美国与知情同意有关的一些问题

知情同意是医疗保健和医学研究的一个基本的伦理学要求。这两种情况中,当医学研究的知情同意标准比医疗保健要求更加严格时,知情同意包含了3种要素：（1）告知病人或受试者该研究的性质。包括益处,危险和其他有关内容;（2）确保病人受试者理解所提供的信息;（3）得到病人或受试者自愿的同意,没有能力参与知情同意的病人包括患痴呆和危重病等无决断 能力的病人,这些病人属弱势病人。如要获许对他们的疾病进行研究,我们必须制定保护弱势受试者有效的伦理政策,提出了关于对痴呆病人、危重病人,脑死亡病人研究的伦理学政策。     

Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. An earlier version of this paper was presented at: The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

A Study of the Impact of Informed Consent Procedures on Participant Responses in Trauma-Related Research

Researchers and ethics board members are often concerned about the possibility of adverse reactions to trauma-related research. While research has shown that participants in trauma-related studies rarely experience adverse reactions, mild short-term emotional distress is common. While a number of protections have been suggested to minimize risks for more vulnerable subgroups of participants, no research to date has tested how modifications to informed consent procedures may affect the data collected and participant reactions to the research. One-hundred and forty-five college students were separated into five conditions with different modifications to the informed consent procedures. Participants completed surveys on trauma experience, posttraumatic stress, coping, and reactions to research participation. The results showed no differences among the conditions on all outcome measures. It appears that modifications to informed consent procedures geared toward minimizing risk do not affect the quality of the data collected nor change reactions to participating in trauma-related research.     

ART知情同意的困境与对策

由于受到千百年来传统家庭观念及患者认知能力的影响,同时,由于辅助生殖技术(ART)的专业性、复杂性,ART技术应用的局限性、结果的不确定性以及诊治周期长、费用高等因素的存在,ART知情同意过程面临着困境。ART伦理管理落实真实知情同意的体现在对患者进行充分、全面、如实的信息告知,取得其配偶的同意和支持,完善的、个案化的文书签定,是ART伦理管理落实真实知情同意的体现。     

Prepackaged Tour Versus Personal Journey: The Meaning of Informed Consent in the Context of the Teacher-study Group

This article discusses the specific ethical dilemma of obtaining informed consent and ensuring confidentiality and participant well-being while conducting a qualitative research study with novice ESL teachers in a Teacher Study Group. The discussion outlines their process of resolution of the ambiguities inherent in the research process – in essence the researchers’ personal journey of discovery. The article concludes with the broader implications for making the research process more transparent for other academic researchers working in the field of language-teacher cognition.     

谈医疗行为中患者知情同意权的实现

目前,关于患者的知情同意权的讨论引起了众多医院管理者的关注。对知情同意与医疗行为的矛盾冲突进行探讨,提出医疗行为为中实现患者知情同意的对策及伦理原则。     

A Survey of Genetic Counselors' Use of Informed Consent Documents for Prenatal Genetic Counseling Sessions

Thirty six members of the Prenatal Diagnosis Special Interest Group of the National Society of Genetic Counselors were interviewed about their use of informed consent documents for the genetic counseling component of their prenatal genetic counseling sessions and their perceptions of the utility and feasibility of such documents. Major findings include (1) None of the genetic counselors currently used a consent document describing the genetic counseling component of the session itself; (2) Only three participants stated that they had ever used an informed consent document for this component of the session; (3) They disagreed about the importance and usefulness of such a document; (4) There was variability in their reported likelihood of using a document if one were available; (5) There was a fair amount of agreement about the types of information to include on an informed consent document for genetic counseling; over half of the sample endorsed 8 of 10 topics; and (6) Participants identified 10 obstacles to using such a document. Recommendations for genetic counseling practice, policy, and research are given.     

患者拒绝签署紧急手术知情同意书的处理对策

签署手术知情同意书是医方履行告知义务,保障医患双方合法权益的一种重要手段。当患者病情需要紧急手术但患者或其家属拒绝签署手术知情同意书时,医院面临错失抢救时机和巨大的医疗风险,甚至可能因此成为被告。结合我院临床工作中的成功经验,探讨医院如何在尽可能抢救患者生命的情况下,规避相关法律风险。     

X线伤害:先天性心脏病介入治疗知情同意的盲点

随着先天性心脏病介入治疗快速发展,受X线照射的患儿日益增多。而X线照射的危害并未受到临床医生的重视,家属也没有充分的知情同意。     

知情同意权在手术同意书中的法律探讨——李丽云死亡案引发的思考

李丽云因为丈夫拒签手术同意书而造成“一尸两命”的事件,“拒签”事件击中了医疗法规知情同意权在医疗实施过程中的软肋。如何保护病人的生命权、被救助权和手术权,如何让医院救死扶伤而没有后顾之忧,建议政府部门应该建立相应的“国家担保”制度,使病人得到最为及时有效的抢救和治疗。以免类似的悲剧再次发生。     

知情同意对危重病患者心理影响的现状研究

探讨知情同意对危重病患者的心理影响。根据知情同意实施现状,将患者分为患者知情组、家属知情组,采用问卷调查和访谈相结合的方法对两组知情同意前、后的心理状况进行评估和比较。采取自愿方式及适宜的告知方法由患者本人知情同意,患者的心理状况与选择家属知情同意的患者无明显区别。     

签署知情同意书有助于改善医患关系

当前医疗活动中由于缺乏人文关怀、患者对医务人员信任度下降以及医患之间信息不对称,导致现阶段医疗投诉以及医疗纠纷逐年上升,投诉和纠纷内容多样且性质趋于严重复杂。在签署医疗知情同意书时,适时给予病人情感上的关爱,重视病人心理需求,采取医学技术与人文关怀相结合的医疗活动,有助于在现代医学模式基础上构建和谐的医患关系。