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.     

知情同意:困难和出路

自<纽伦堡法典>提出"人类受试者的自愿同意是绝对必要的"以来,经过四十多年的发展,知情同意已经成为生命伦理学的一个核心概念和标准.它被视为保护病人和受试者的有效武器.然而,伴随着知情同意原则在实践中的贯彻和普及,对于其难以操作和执行的抱怨也日趋频繁;同时,在理论上,生命伦理学界开始对知情同意所具有的理论基础是否具有普适性也提出了质疑,有人甚至大胆提出不需要知情同意原则的观点.     

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。     

知情同意的前世今生——基于《希波克拉底文集》的重新解读

知情同意与西方医学同根同源。知情同意理念根植于医学发展的长河中,只是原初的知情同意与现代知情同意有着不同的蕴涵,其目的是为了取得患者的理解与配合,最大限度地救治患者。在知情同意的过程中,承认医生在专业上的主导性,强调告知是医生自始至终的基本义务。它是一种基于对患者的关爱、救治而产生的知情同意,没有现代意义的权利外衣,但它有医生义务以及保护患者利益的内核。通说认为患者知情同意起源于20世纪中叶,传统医学模式中没有患者的知情同意是对医学的曲解与误读。     

急诊医疗中的知情同意问题

急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除。这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同。其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步。真正的原因是,知情同意在急诊治疗中往往以特殊或不同的形式表现出来。     

论知情同意的家庭主义模式

知情同意是生命伦理学的基本原则.中国语境下,知情同意的临床实践具有区别于西方个体模式的特点,即家庭主义模式.这种模式的产生植根于病人的脆弱性与依赖性、自主的内在联系,并受到儒家文化的深刻影响,其本质是一种家庭自主.在临床实践中,家庭主义模式有利有弊,我们应当发挥其优势,克服其弊端.     

急诊医疗中的知情同意问题

急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除.这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同.其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步.真正的原因是,知情同意在急诊治挝疗中往往以特殊或不同的形式表现出来.     

国内外产科麻醉知情同意热点问题概述

知情同意是医患关系的基石。产科向来是医疗纠纷高发地,随着医疗模式的转变,舒适化医疗的推行,产科麻醉需求越来越多,有效保障产科麻醉患者知情同意,降低医疗纠纷发生率,具有重要的现实意义。本文首先阐述了产科麻醉知情同意的内涵,然后就产妇是否具有同意能力、医生告知义务标准和内容、产科麻醉知情同意的形式、母婴权利矛盾等国内外热点问题进行了论述,以期为国内产科麻醉知情同意研究及临床实践提供参考。     

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。     

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.     

When clinical care is like research: the need for review and consent

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.     

Capacity to consent to research in schizophrenia: the expanding evidence base

Capacity to consent to research, fundamental to informed consent and thus vital to the ethical conduct of research, may be impaired among a variety of research populations. Until recently, relatively little empirical evidence has been available to inform discussion and policy-making regarding whose capacity should be assessed, what should be measured, and how it should be measured. Capacity to consent to research has emerged as a central topic in the field of "empirical ethics," an important area of biomedical research devoted to bringing evidence-based methods to the study of ethically salient issues in biomedical and biopsychosocial research. In this paper, empirical studies of capacity to consent to research are reviewed, with a particular focus on studies involving people with schizophrenia. These studies provide intriguing data regarding the nature, correlates, and modifiability of decisional abilities among potentially vulnerable research populations, including individuals with serious neuropsychiatric illnesses. Areas in need of further empirical ethics research are highlighted.     

Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.     

The concept of risk and responsible conduct of research

Assessment of risk is one of the key issues in the field of responsible conduct of research which covers discourses of research ethics and research integrity. The principle of minimizing risks and balancing of risks and benefits is one of the main requirements of research ethics. In addition, the content of informed consent that is another fundamental principle of research ethics derives from the assessment of risks and benefits related to a particular research project. Risk assessment also plays a crucial role in methodological design of the research project. This is an important point where research ethics and research integrity discourses overlap. Firstly, because the choice of a control group (e.g., placebo control) is a key ethical issue related to the protection of the research subjects' interests. Secondly, because the quality of the research data, that is one of the key elements of research integrity, is closely connected to the choice of research methodology as well. The problem of biased interpretation or manipulation of risk related features of biomedical research should also be taken into account. Despite the importance of the concept of risk to the field of biomedical research, its relevance has not yet attracted a sufficient attention in the responsible conduct of research debate.     

Complexity of ethical decision making in psychiatry

Psychiatric residents and psychiatrists have little difficulty in making judgments about a clinical course of action to take with patients. However, making ethical clinical decisions is more challenging, because psychiatric residents are usually provided little formal training in ethics. Further, many ethical dilemmas are complex, requiring knowledge of the psychiatric profession's ethics code, moral principles, law, and practice standards and of how they should be weighed in the decision-making process. The purpose of this article is to demonstrate this complexity in regard to the identification of potential ethical dilemmas, understanding the issues that these dilemmas raise, and formulating potential solutions to them. Two common but important areas of treatment in which ethical dilemmas arise (informed consent and competence of care) are used as examples for our presentation. The article demonstrates that to successfully engage in ethical analysis in psychiatry is impossible without substantial formal training in the process.     

关于知情同意的伦理与法律意义之辨析

尊重和自主是知情同意的伦理底线,行善是知情同意的伦理基础。知情同意并不是评判医疗行为是否符合伦理的金标准。伦理上的知情同意与法律上的知情同意,既有区别又相互联系,德法并济是有效履行知情同意的前提。     

Evaluating the therapeutic misconception

The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.     

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.     

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.