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。     

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.     

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.     

Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders

Ethical codes help guide the methods of research that involves samples gathered from “at-risk” populations. The current article reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent.     

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。     

Using Questions to Improve Informed Consent Form Reading Behavior in Students

Previous research shows that students often do not read informed consent forms to understand their rights (Pederson, Neighbors, Tidwell, & Lostutter, 2011). Four hundred fifty-eight students participated in an advertised temperament study that actually measured whether they noticed a manipulation within the consent form. Answering five questions about the form raised the percentage of students noticing the manipulation in multiple settings; however, overall rates were low. Fewer than 10% of ethnic minority students noticed the manipulation. If the goal of consent forms in higher education remains an informed decision, these results indicate the need for increased interaction within the consent process.     

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。     

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。     

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。     

Experimenter Characteristics and Word Choice: Best Practices When Administering an Informed Consent

The present research seeks to better understand research conditions in laboratory research, with special attention paid to the informed consent process and experimenter characteristics. The first study tested the impact of language perspective and experimenter demeanor upon participant retention of the informed consent information, attitudes toward the research project, and performance on experimental tasks. The second study examined the impact of experimenter attire. Across the two studies, our results suggest that there was no impact of language perspective, whereas the number of other participants in the laboratory, experimenter attire, and experimenter demeanor influence participant behaviors in the laboratory.     

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。     

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.