从辅助生殖技术的个案析要论知情同意的完善

结合在人类辅助生殖技术服务过程中发生的案例进行分析,就如何完善知情同意提出了一些见解.认为,医疗技术服务中,知情同意的完善必须注重两个环节,知情同意过程和签署知情同意书.这两个环节必须根据具体情况来进行实施,绝不能敷衍走过场.因此,相关医生对知情同意的认识和伦理监督就显得尤为重要.     

浅析医疗器械临床试验中知情同意的电子化管理

对现阶段医疗器械临床试验知情同意环节中,常见的知情同意书内容不完整、审核不统一、签署不规范、保管不重视、过程流于形式等问题进行了归纳总结,并就研究者、受试者在知情同意过程中违规现象和原因进行了探究与分析。究其原因在于当下临床试验知情同意环节监管不足。因此,管理者提出了电子化管理理念,并提出建立医疗器械临床试验管理系统、将虚拟现实和指纹识别技术应用于电子化管理等建议和措施,以期提高医疗器械临床试验中知情同意环节的监管质量。     

影响ICU护士落实“知情同意原则”原因及对策

重症监护（intensive care unit,ICU）医生越来越重视在诊疗活动过程中的知情同意权,各种重要诊疗活动都与患者和家属沟通,并取得口头或文字上的同意,但部分护理人员对知情同意原则不重视,在环节中落实不力,从而易引发护患纠纷。而保证患者获得知情同意权是护理人员必须落实的义务,护士的告知是维护患者知情同意权和...     

精准医学对传统知情同意原则的挑战

知情同意包括信息的告知、对信息的理解以及同意的自主性等几个重要环节。知情同意原则的这几个环节在精准医学情境中面临新的挑战。在精准医学中,由于风险和收益存在未知数,风险告知成为难题,告知范围具有不确定性,无法做到信息的充分告知;由于患者或受试者对信息的理解难度增加并影响传统知情同意模式的有效实施;同时,个人自主与群体自主之间面临冲突。在精准医学时代,应当对传统的知情同意原则进行补充,构建出新的知情同意原则的实践模式,以使其更好地发挥作用。     

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。     

生物医学研究的知情同意过程及知情同意豁免

知情同意并不仅仅是知情同意书签字,它是一个持续的决定过程,发挥着保护受试者权益的重要作用。对知情同意过程中的关键问题,包括谁可以获得知情同意、谁可以同意或授权参加研究、信息告知过程、受试者信息理解、受试者自愿选择过程、知情同意书签字及免除签字的情况进行了系统地介绍。知情同意是保护受试者的权利和自主性的基本原则,但在特殊情况下是可以豁免的,包括不具备获取知情同意可行性及急救研究两种特殊情况。     

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.     

乡村医生对知情同意与保密的认知态度调查分析

对河北省5个地区近800名乡村医生进行抽样调查显示,乡村医生对知情同意和保密的认知度较高。其中绝大多数医生能够在医疗实践中坚持知情同意和保密的伦理原则,但乡村地域文化和医疗服务的特点决定了乡村医生在履行知情同意时具有不同于城市的独特性。对乡村医生来说,应进一步明确知情同意中尊重患者选择权与乡村医生责任的关系,并通过有效沟通行使知情同意权及规范保密的具体内容,确保在医疗实践中更好地做到知情同意与保密。     

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.     

临床试验中知情同意的现状分析与对策

对目前临床试验中存在的知情同意主体行为失范、告知与知情过程流于形式、知情同意书存在缺陷以及签署欠规范等问题进行分析，提出规范知情同意的对策：加强教育与培训，规范主体行为；建立监管体系，实施三级质控；提高伦理审查质量，完善监督检查；开展试验质量评价，制订奖惩措施；完善临床试验立法，实现法制化管理。     

The emerging debate over the shape of informed consent: can the doctrine bear the weight?

Informed consent has traditionally focused on treatment-related issues. However, since the mid-1990s, courts have debated whether informed consent should be stretched to accommodate other concerns. For example, some courts have considered whether economic limitations on treatment availability must be made known to a patient as part of the informed consent process. Other courts have considered whether characteristics of the treatment provider (e.g., experience with a particular procedure) should be disclosed as part of informed consent. Consideration of these issues turns in large part on whether the information in question would be considered "material" to a decision to accept or reject treatment. This article discusses these developments, and suggests that expanding informed consent beyond treatment-related issues in some circumstances may erode trust in the clinical relationship, thus undermining one of the central values of the informed consent doctrine. It concludes with some suggestions on how research could inform this debate.     

Informed consent in the practice of group psychotherapy

Endorsed as part of ethical practice in group psychotherapy by professional organizations, informed consent is a process of communicating essential information about group treatment to patients so that they can make rational decisions about treatment-whether to enter and how to participate. Its benefits as well as necessary precautions are discussed. The design and implementation of the informed consent process for group is discussed in terms of who should obtain it, when it should occur, how it should be communicated, and what information should be considered for inclusion. Specific suggestions are included as well as a discussion of some potential ethical dilemmas.     

Patient Expectations of Benefit from Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type(e.g., ``On average, 5 out of every 100 patientswill benefit') can be confused with expressionsof uncertainty of the belief type (e.g.,``The chance that I will benefit is about80%'). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process.     

Informed consent: An overview

Over the past 25 years, obtaining informed consent for the performance of many medical procedures has become part of the practice of medicine. As opposed to the “duty to warn” that is enforced by the law, informed consent should be a cornerstone of a fully collaborative decision-making process, the elements of which are presented in this paper. The responsibility for this process rests upon health care institutions and financing arrangements, as well as upon physicians and courts. In response to emergencies, patient preferences, and public interests, the consent process is justifiably abbreviated. However, as presently articulated, the consent process treats communication too simplistically, is distorted by the way it is enforced in litigation, is inattentive to social justice issues, and is not integrated into the moral commitment of physicians.     

Black Boxing Restraints: The Need for Full Disclosure and Consent

In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families of treatment risks, we argue that physical interventions are an unvalidated treatment for aggressive and violent behavior and should be used only as a safety intervention. We focus our discussion on the informed consent issues for school aged children, adolescents, and emancipated minors and contend that if restraints are used they must pose less risk than the behavior they are trying to alleviate. We also opine that if restraints are misused by mental health or child welfare treatment settings, then their misuse may be considered a subject of a patient maltreatment, abuse, criminal or civil action. A central thesis of the article is that informed consent must be seen as an integral and dynamic process of treatment. We recommend strategies that gain parental permission and child assent, that view informed consent as a dynamic and individualized process that aids and supports the therapeutic relationship, and that stress the importance of simplicity and clarity.     

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。     

A Puzzle about Consent in Research and in Practice

In this paper, I will examine a puzzling discrepancy between the way clinicians are allowed to treat their patients and the way researchers are allowed to treat their subjects: in certain cases, researchers are legally required to disclose quite a bit more information when obtaining consent from prospective subjects than clinicians are when obtaining consent from prospective patients. I will argue that the proper resolution of this puzzling discrepancy must appeal to a pragmatic criterion of disclosure for informed consent: that what needs to be disclosed in order for consent to be valid depends on what the patient/subject needs to know in order to make a decision. I will then use this pragmatic criterion of disclosure to argue that when obtaining consent researchers should be permitted to omit the same information clinicians are, given certain qualifications. I will also examine how this puzzle forces us to confront some perhaps surprising truths about valid consent. My broader aim in this paper is to examine, not so much the puzzle itself, but rather what this particular puzzle can teach us about more theoretical issues surrounding informed consent.     

Stakeholders’ Opinions on the Implementation of Pediatric Whole Exome Sequencing: Implications for Informed Consent

Advances in whole genome and whole exome sequencing (WGS/WES) technologies have led to increased availability in clinical settings. Currently, there are few guidelines relating to the process and content of informed consent for WGS/WES, nor to which results should be returned to families. To address this gap, we conducted focus groups to assess the views of professionals, parents, and adolescents for the future implementation of WES. The discussions assessed understanding of the risks and benefits of WES, preferences for the informed consent discussion, process for return of results, and the decision-making role of the pediatric patient. Professional focus group participants included bioethicists, physicians, laboratory directors, and genetic counselors. Parent focus groups included individuals with children who could be offered sequencing due to a potential genetic cause of the child’s condition. On-line discussion groups were conducted with adolescents aged 13–17 who had a possible genetic disorder. We identified discrepancies between professionals and patient groups regarding the process and content of informed consent, preference for return of results, and the role of the child in decision-making. Professional groups were concerned with the uncertainty regarding professional obligations, changing interpretation in genomic medicine, and practical concerns of returning results over time. Parent and adolescent groups focused on patient choice and personal utility of sequencing results. Each group expressed different views on the role of the child in decision-making and return of results. These discrepancies represent potential barriers to informed consent and a challenge for genetic counselors regarding the involvement of pediatric patients in decision-making and return of results discussions.     

Further reflections on the impact of clinical writing on patients

Though it is unlikely that instituting universal guidelines will ever be possible for patient approval of the analyst's use of clinical material outside of the treatment setting, the author offers some supplementary refl ections to those already available in the literature. Broadly applied informed consent guidelines would increase the distortion that already exists in our clinical literature due to self-imposed restraints by writers. Moreover, the powerful irrational forces mobilized by consent in the dyad are not easily 'held' by traditional applicable legal categories. Metapsychological formulations of the intrapsychic and intersubjective impact of patient participation in the writing process on individual analytic dyads are needed. Notions of privacy protection, validation, dyadic co-construction, or writing-as-containment by a third as rationales for informed consent fail to encompass the transindividual and external sources of human identity and the ineradicable lack of unity in the unconscious. Nevertheless, theoretical affi nity and preferred technique may be mediating factors in positive outcomes of the consent process. Some paradigms not only accommodate more comfortably but also actively seek the intersubjective repercussions of informed consent. Asanalternativeorcomplementaryviewpoint, theauthoroffersthehypothesis that the clinical ramifi cations of either disguise or consent are not exclusively, nor even necessarily, concerned with what patients read about themselves, but what they assess or intuit-directly or indirectly through the material presented-of their analyst's unconscious strivings. To truly triangulate the clinical reporting project, it is wisest to consult the third ear of a colleague to assess the potential impact on patients on what might be being unconsciously transmitted by the analyst in the writing and the consent process     

知情同意在中医药临床诊疗中的应用思考

知情同意在中医药临床诊疗中的应用,医生要掌握知情同意的要素和方法,将中医药的不良反应及中医药特殊性告知病人,让病人的充分知情、自愿选择、实施同意。医疗机构也要承担推进知情同意应用的责任,开展不良反应监测、建立实施规范,教育和评估知情同意落实情况。