Participants' Understanding of the Process of Psychological Research: Informed Consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials

Scholars have debated the role that altruistic considerations play—and should play—in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) “the future” and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.     

口腔临床医疗实践中知情同意的实现

知情同意是一项重要的伦理学原则和患者自主权的具体表现形式。本文分析了在口腔临床医疗实践中知情同意存在的突出问题和原因,并探讨了实现的方法和途径。本文认为只有遵循全面、精确、真实的告知原则,让患者在充分理解的基础上做出自主地选择,才能保障知情同意原则的实现。     

临床麻醉中知情同意的思考

临床麻醉工作中,尊重患者自主权是知情同意的基础,知情同意反映了患者自主权与医学干涉主义之间的相互妥协.在信任基础上的知情同意,是患者自主权的最佳体现,也是对医学干涉主义的尊重,从而为患者的利益提供服务.     

临床麻醉中知情同意的思考

临床麻醉工作中,尊重患者自主权是知情同意的基础,知情同意反映了患者自主权与医学干涉主义之间的相互妥协。在信任基础上的知情同意,是患者自主权的最佳体现,也是对医学干涉主义的尊重,从而为患者的利益提供服务。     

肿瘤药品临床试验中的知情同意

肿瘤学的发展一直伴随抗肿瘤新药的研发与临床试验.获取受试者的知情同意是完成临床试验过程中最重要的一步.如何顺利而有效地获取知情同意并保护其合法权益不受侵犯成为研究者最为关注的话题.本文就如何解决这一过程中存在的问题进行了初步探讨.     

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.     

知情同意在我国临床医疗中的实施

知情同意在我国至少已倡导与实践了20年,由伦理要求上升到法律准则无疑是一个跨越式的进步。当前,医院落实知情同意的实践滞后于患者要求,除了主观方面的原因外,客观上存在知情同意与保护性医疗,病人自主权与医生处置权、医学对疾病的已知与未知等诸多盾与难点。要使知情同意在我国临床医疗中真正落实尚有许多工作要做;提高医务人员尊重病人权利的意识;完善执行知情同意的方式与程序;细化与知情同意的实施原则;营造良好的社会氛围,探索非西方环境下知情同意实现途径。     

浅析脑胶质瘤临床试验中知情同意的问题

通过对医院目前开展的脑胶质瘤临床试验知情同意过程中的观察,综合科室脑胶质瘤临床试验的开展情况,针对不同类型脑胶质瘤病人尤其是功能区受损以及伴有认知功能受限的病人,分析签署知情同意过程中存在的问题,经探讨并提出整改及解决办法。通过规范的签署知情同意,针对病情不同的脑胶质瘤受试者采取个体化签署知情同意,充分尊重受试者意愿,保证临床试验顺利进行,使受试者权益得到充分保障,促进临床试验规范、安全、有序的开展。

     

临床药品试验研究中的知情同意析要

临床药品试验研究的知情同意能否做好,事关能否更好地处理医疗及其研究中的利益冲突,和谐医(研究者)患(受试者)关系,真正地体现以患者和受试者为本的医学伦理、人道精神与行为.概要分析、讨论并提出了临床药品试验研究的知情同意的基本概念、要素以及问题的应对要略.     

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。     

知情同意实践的临床技术研究

学术界关于知情同意的争论一直十分激烈 ,涉及到了包括东西文化传统、宗教、法律、卫生经济、政治及医学科学技术等各个方面的问题 ,目前尚无一个可通约的理论原则。具体实践中的知情同意是一种伦理学技术 ,与基础理论研究有不同的要求 ,更注重如何利用现有的理论资源和法律工具合理地分析问题、解决问题 ,在其所属社区能作到为文化传统和绝大多数人所接受 ,并具有一定的稳定性。所以应从这个角度出发 ,讨论“知情同意”在中国临床实践中的意义、现状、存在的问题 ,医务人员如何制定应对策略等问题。着重于医方能做什么 ,应做什么和该怎样做…     

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.     

特异性免疫疗法在儿童哮喘治疗中的应用

支气管哮喘是儿童最常见的慢性呼吸道疾病,近年来发病呈逐年上升趋势。在儿童哮喘的治疗方案中,脱敏治疗是唯一从变态反应疾病的病因治疗可改变疾病进程的疗法。注射脱敏是传统的脱敏方法,儿童疗效优于成人,但由于采用注射的方式,使该方法一直应用于5岁以上的儿童。舌下脱敏治疗是90年代开始在国外进行应用的一种脱敏治疗方法,其安全性和有效性在国外已得到多项临床研究的证实,且其安全性在儿童要优于成人,因此舌下脱敏治疗为5岁以下年幼哮喘儿童的特异性免疫治疗提供了新的思路和治疗策略。     

Sign on the Dotted Line: The Informed Consent Process (ICP) as Induced Compliance1

We investigated the social implications of signing an informed consent form (ICF) on participant behavior. ICF research fails to consider that the decision to participate in research is a process that occurs in a social and cultural context. Understanding the meaning of giving consent in this social context is critical. In separate experiments, we found significantly greater agreement to return to complete a study and persistence at a task in participants who signed the ICF versus those who did not. Signing the ICF may be putting participants at risk of induced compliance with study protocols, rather than empowering them to withhold consent or withdraw. Future research should investigate the psychosocial factors affecting participants' decision making in the informed consent process.     

加强ART实施过程中知情同意及其方式探讨

通过分析新疆医科大学第一附属医院生殖助孕中心400余对接受辅助生殖技术治疗不育夫妇知情同意过程,观察不育夫妇知情同意满意度,发现采取的8种方式可以提高不育夫妇的知情同意满意度,分阶段、反复的信息告知同时结合个体化的咨询、答疑是知情同意的基础,也是辅助生殖技术实施过程中知情同意实施的较好的方式.     

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.     

On the Prospects of Collective Informed Consent

abstract    It has been suggested that collective informed consent procedures could be used in solving moral problems arising in connection with such collective arrangements as land use planning, business administration, and developing new technology. Critics have however argued that informed consent is not an appropriate method for collective moral decision-making for three reasons. Firstly, informed consent procedures only allow the affected parties to choose between rejecting and accepting certain predetermined options, while those parties should be allowed to take part in the decision-making process as a whole. Secondly, identifying the parties whose informed consent should be sought would in many cases be problematic. Thirdly, informed consent is a veto power concept, and granting all parties affected by a collective arrangement veto power as to its completion would make taking such collective action extremely difficult. In this article, it is argued that these criticisms do not undermine collective informed consent.     

Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process

The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.     

美国胃肠病学院结直肠癌筛查指南

本指南是对2000年美国胃肠病学院（ACG）结直肠癌（CRC）筛查建议的首次更新。cRc筛查包括癌症预防性检查和癌症检测性检查。从50岁起每10年检查一次结肠镜仍然是CRC筛查的首选策略。由于经济受限,并非所有的医院均可进行结肠镜检查;同时,也非所有的适宜人群都乐意接受出于筛查目的的结肠镜检查。