由谁来行使知情同意的权利:患者还是家属?

知情同意权是患者的一项基本权利,但是在我国目前的医疗实务中,该项权利却普遍地由患者的家属予以行使。本文围绕应当由谁来行使“有同意能力的患者”的知情同意权这一问题,由现行法的态度出发,从正反两个角度论证了应当由患者本人行使其知情同意权的观点。     

论知情同意的豁免

本文围绕医疗实务中的知情同意豁免，首先讨论了知情同意豁免规则的法律政策，详细分析了紧急情形豁免、治疗豁免、知情同意权的放弃和强制治疗这四种豁免情形，简述了医务人员在适用知情同意豁免规则时可能的法律责任。     

从《精神卫生法》看精神障碍患者的知情同意权

知情同意权是医患关系中的主要问题之一,新出台的《精神卫生法》在多个条文中明确规定了精神障碍患者的知情同意权,成为精神病患者知情同意权的基本法律依据。本文立足于知情同意权的一般法理,梳理《精神卫生法》中精神障碍患者知情同意权的法律规定,以此为基础探讨精神障碍患者知情同意权的基本内容。     

The doctrine of informed consent: a tale of two cultures and two legal traditions

In this article, the author compares and contrasts the notion of informed consent in medical decision making in the Western legal system with the traditional Jewish biblical legal system. Walter critically examines the philosophical underpinnings of disease and medical healing in both legal systems, and describes the practical consequences that emanate from the different ideologies in terms of the individual's rights of choice of treatment. She explains that the Western system is predicated on notions of individual autonomy and self determination. Patients therefore have the autonomous ability to select and direct their own medical therapy. By contrast, the traditional biblical system of law is based on the concept that the body does not belong to the individual. Instead, the body is given to man by God as a trust to respect and preserve. Therefore, the individual patients "has no absolute right to control his body and ... he has no real decision making power as to medical treatment choices." In the Jewish biblical tradition, consent is not necessary for obviously beneficial or obviously non-beneficial procedures; consent is only necessary in decisions with uncertain outcomes or when making choices between equal options. Patients are encouraged to seek the counsel of religious authorities and to conform to rabbinical interpretations of the traditional Jewish law.     

Race, religion, and informed consent--lessons from social science.

That minority patients have not figured at all in the literature about informed consent is an egregious omission which this article begins to repair. Moreover, the article demonstrates that by addressing identifiable harms which informed consent law now causes to racial, religious, and ethnic minority patients, the law may also better address many of the concerns legal commentators have been discussing for years with only majority patients in mind. Ironically, the solution to the discrimination felt by the excluded members of society may turn out to provide the remedy for the informed consent doctrine as a whole.     

Surrogacy,Identity, Parentage and Childrenʼs Rights – Through the Eyes of a Child

In this article I will focus on two important aspects of children's rights which are impacted by artificial reproductive technology (particularly surrogacy); being the rights to identity and the rights to legal parentage. The United Nations Convention on the Rights of the Child acknowledges the importance of a child's right to identity, to be protected from discrimination on the basis of the status or beliefs of the child's parents, legal guardians or family members. For many children born through surrogacy arrangements, they may have only one or no legally recognized parent. The adults caring for them may have parental responsibility orders but this falls well short of providing children with the benefits and protections that legal parentage does. The issue of identity can be complex. Increasingly, states have recognized the importance of children knowing the circumstances of their birth and being able to access biological and genetic information including medical information. From a child's perspective the issues of identity and parenthood are intertwined. Given the importance of identity, more needs to be done to ensure that identifying information about children born as a result of artificial reproductive technology is properly stored and readily accessible for these children. Denying a child legal parentage when there are no concerns about the care being provided by their parents cannot be justified when considered from a children's rights perspective.     

论人体器官移植的现代民法理论基础

器官移植是为医疗目的由器官供给人的捐赠行为、专门医疗机构器官摘取的协助行为和植入器官的治疗行为等构成的相互独立、相互联络的关联结合行为。作者从现代民法的角度 ,深入剖析了人体器官移植的理论基础 ,认为活人是具有法律人格的权利主体 ,故具有处置其人格利益的自己决定权 ;遗体和人体器官是物权法的客体 ,归属于生前的本人和继承法理下的其他人 ,在法律限制流通的范围内可由权利人进行处分 ;医方摘取器官行为只是医疗援助行为 ,器官植入行为可适用医疗服务合同法理 ;因存在利益衡量和公序良俗原则下的受害人知情同意 ,所以移植器官行为是阻却违法的行为     

Reproductive choices and informed consent: fetal interests, women's identity, and relational autonomy

In this Article, I describe and examine the severe shortcomings in women's autonomy in the context of reproductive choices in the medical arena. The reproductive choices I explore are those choices that involve gestation: abortion, fertility treatments, and interventions during pregnancy. Due to state and medical interests in the fetus, I describe how information conveyed to patients making reproductive choices is biased towards fetal interests, relies on female stereotypes, and is still conveyed with the objective authority of the medical profession. Moreover, reproductive choices implicate women's values and identity interests that reach beyond medical concerns, which are not part of the informed consent doctrine at all. The narrow, individualistic informed consent torts doctrine intended to protect patient autonomy does not do enough in this context to balance bias nor does it mandate discussion of important identity interests and values. Accordingly, I argue that when faced with reproductive choices, women are not provided the balanced and comprehensive information needed to promote their autonomy. In response to the breakdown in patient autonomy I describe, instead of leaving women alone to make choices or regulating in order to protect them from their choices, a broader framework for supporting reproductive choices should be established. In light of the interdependence of woman and fetus, as well as the broader social context shaping these decisions, I argue that a more contextual, relational perspective of autonomy should be the goal of informed consent in the context of reproductive choices. I suggest a number of reforms that aim to optimize patient autonomy from a relational perspective. I suggest a broad, deliberative doctor-patient consultation and legal reforms that create more balance between the pull towards intervention and fetal protection on the one hand, and non-intervention and protection of women's personal identity interests on the other.     

论医疗告知义务——以经济学和法学为视角

医疗告知是医疗单位在医疗过程中的一项法定义务,是以患者知情同意权为其理论基础,是判定医疗行为是否存在过失的一项重要标准。我国目前医疗实践中医疗纠纷频发的主要原因在于我国医疗告知义务立法不完善以及学界对医疗告知义务研究甚少。文章以经济学和法学为视角,从医疗告知义务之经济学基础、医疗告知义务之法学基础、医疗告知义务之履行及其评判标准等方面,结合我国立法现状,就医疗告知义务进行了深入研究,以期为我国医疗实践和司法实践提供理论根据。     

Excessive risk disclosure: the effects of the law on medical practice

This article examines the debate surrounding the challenging concept of informed consent. It argues whilst the English courts have effectively excluded the use of the tort of battery as an appropriate mechanism for protecting a patient's right to self-determination, they have left the law in a state of flux due to the uncertainties associated with categorising similar claims within negligence where the onus is on risk disclosure. This confusion may stem firstly from the fact that medical practitioners are unsure exactly which risks to disclose, and secondly, from the way in which both doctors and patients perceive the consent process. The paper suggests this disorder may be having a detrimental effect on medical practice as medical practitioners are taking it upon themselves to disclose excessive information, which patient's may not want or need. A suggestion is also made that in these situations, in order that the law truly respects self-determination, consideration must be given to the patient's desire to waive their right to informed consent.     

Reshaping informed consent in the biobanking context

In my article, I discuss the role of informed consent in the context of biobanking. I argue that the basic issue in understanding the role of the consent is one of identifying the interests at stake and determining which of these interests we intend to promote. The definition of the informational content represents only a consequential step. For this purpose, I analyse the legal status of human biological materials from three different perspectives: "material", "informational" and "relational". Informed consent produces different effects on each of these perspectives. From the material perspective, consent can influence the allocation of property rights over human tissue; from the informational point of view, consent is the legal instrument that permits control over personal data; while from the "relational" perspective, it is possible through consent to ensure that the person's personal beliefs are respected. The crucial point is that the legal effects that informed consent has on the three perspectives overlap. Therefore, in order to understand the role of informed consent holistically, in this article I analyse how these perspectives relate to each other. This analysis shows that the relationship between the perspectives can vary depending on the interests that we intend to promote. If we intend to promote the freedom of research, then the material dimension can prevail, whilst if we focus our attention on the interests of individuals then the informational and the relational dimensions will prevail. The challenge is to find a good balance between these two extremes.     

Developmental trends in adolescents' psychological and legal competence to consent to abortion

United States Supreme Court has affirmed the right of states to require parental consent or notice from minors seeking abortion. We examine an underlying presumption that minors are not competent to consent to abortion. Participants (N=75 age 13–21, seeking a pregnancy test at a women's medical clinic) completed an interview that was audiotaped and scored on four cognitive and volitional criteria of legal competence. Competence was compared in three age groups (≤15; 16–17; 18–21) for participants who considered abortion and for those who did not. Adolescents age 16–17 and adolescents ≤15, who considered abortion, appeared as competent as legal adults; only≤15-year-old adolescents who did not consider abortion appeared less competent. Regression analysis was used to identify psychosocial predictors of competence. Results challenge the presumption that minors are not competent. An alternate policy based upon informed consent and empowerment of minors as decision makers is proposed.     

患者不予签字同意的问题研究

知情同意是患者最基本的权利。知情同意一般分为四个环节:告知、知情、同意、签字。其中,"签字"是知情同意的最终行为方式。由于其在具体实践中常受到告知方式、理解能力、意识状态、法理缺陷等诸多因素的影响而突显出它的复杂性。我国于20世纪70年代后期开始将知情同意引入,并逐渐由医师执业道德范畴过渡到了法律规范的范畴。知情同意在我国发展的几十年中,最为典型的形式就是术前签字制度。文章将集中对患者不予签字同意进行分析和阐述,并从一般状态、患者或近亲属无明确意思表示以及紧急情况三个方面提出笔者的几点设想。     

The medically examined applicant for private insurance and his/her right to informed consent: a comparative analysis

Within the context of health and insurance law, an important question that arises is "to what extent is an applicant for private insurance truly capable of giving his/her 'free' and informed consent for a medical examination?". It should be borne in mind that it is the private insurer who requires a medical examination in order to gather medical information, and, moreover, that the insurer will not be inclined to conclude or carry out an insurance contract without this medical information. A distinction has to be made between not being free by legal coercion and not being (completely) free by factual circumstances. Exercising the right to informed consent involves exactly weighing up the consequences of the decision. Hence the applicant must be put in a position of being able to weigh up the consequences and take them into consideration.     

Patient termination of a life-sustaining medical device: Suicide or natural death?

Medical technology has made tremendous strides in extending the lives of patients who have suffered organ failure. Machines can now replace the function of the kidneys, the heart, and other vital organs. Much has been written about a patient's right to refuse or direct the withdrawal of medical treatment, especially at the end of life, under the guise of “death with dignity.” However, little attention has been paid to the situation where a patient elects to deactivate their life-sustaining medical device without a physician's involvement. This raises the challenging question of whether the patient's manner of death should be classified as suicide or natural. Surprisingly, common law, statutes, medical ethics, and public health practice are not in alignment on the answer. This article will explore the ramifications and far-reaching impact that such divergence has on the survivors and the medical community, as well as recommend corrective actions and practical approaches for the medical and legal practitioner.     

Abortion, breast cancer, and informed consent

The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering induced abortion. The article examines the relationship between this evidence and the elements of a medical malpractice claim alleging failure to obtain informed consent. The first part focuses on the elements of informed consent, which require the plaintiff to establish that the physician had a duty to disclose information, which he failed to disclose, that this failure to disclose was a legal cause of the plaintiff's decision to undergo the procedure, and the procedure was a legal cause of the plaintiff's injury. The second part compares two prevalent standards for determining which risks a physician has a duty to disclose. Part three reviews the scientific evidence of the abortion/breast cancer (ABC) link and explains why it survives both the Frye and the Daubert tests for admissibility of expert testimony. The fourth part assesses the materiality of the risk posed by the ABC link. Parts five and six discuss evidentiary issues and the possibility of punitive damage awards.     

韩国的医师说明义务与患者知情同意权

医师的说明义务与患者的知情同意权是医疗关系的核心内容,并成为医疗责任认定的主要依据。韩国对于这一对权利义务关系的认识经历了从传统医疗模式向人道模式的转变,使得患者从医疗关系的客体转变为主体。这一转变不仅改变了患者的地位,更体现出法律的进步。然而,单纯强调患者的知情同意权将会导致医师实施保守治疗,因此,平衡医师的说明义务与患者知情同意权之间的关系显得尤为重要。     

A proposal for cadaver organ procurement: routine removal with right of informed refusal

In order to alleviate the shortage of vital organs for transplant, we propose a system of routine removal of cadaver organs with an option of informed refusal by family. Unless an individual registered an objection during his or her lifetime, or unless the family objected to the procedure, clinicians would be permitted routinely to salvage vital organs for transplant. Our proposal charts a middle path between the current ineffective policy based on "encouraged voluntarism" and "presumed consent" policies that promise effectiveness at the cost of violating traditional ethical and legal principles. In this article, we analyze the failure of the current regime, articulate a policy of routine removal subject to the right of informed refusal, and defend this policy against several possible objections.     

The federal government and academic texts as barriers to informed consent

Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.