Cervical manipulation--how might informed consent be obtained before treatment?

This article discusses methods and mediums of obtaining informed consent in physiotherapy clinical practice, specifically in relation to cervical manipulation. Whilst cervical manipulation is a useful method of treatment for spinal joint pain and dysfunction, it has also been shown to be ineffective or even positively harmful. Legal precedents have set boundaries for informing patients of such adverse consequences. However, a degree of uncertainty exists in the physiotherapy profession, as in other health care professions, as to how to obtain informed consent in a busy clinical setting in order to discharge the legal duties owed. Obtaining meaningful informed consent in clinical practice raises issues of patient comprehension, memory and decision-making capacity. A large quantity of research directed at enhancing patient understanding has been undertaken in recent years. The important findings are that a variety of communication methods and mediums need to be employed in both providing information and assessing patient understanding. A combination of verbal, written and audiovisual information provides patients with maximum opportunity to be involved in treatment decisions.     

Problems of long-term informed consent

This study addresses problems arising with informed consent for long-term maintenance pharmacotherapy. Obtaining patient consent to neuroleptic treatment, with the risk of tardive dyskinesia, has raised questions about long-term recall and the competence of psychiatric patients as a special population. The subjects were 32 adult outpatients, 16 were followed in the psychiatric clinic and 16 in the rheumatology, pulmonary, and neurology clinics. Structured interviews with these patients dealt with knowledge about relevant short-term and long-term medication side effects. Interview results were used to compare psychiatric and medical groups with respect to overall levels of comprehension. Two results were striking. 1. There was a remarkable similarity in the degree of comprehension between psychiatric and medical outpatient groups; this suggests that psychiatric patients need not be considered any less competent than medical outpatients in assimilating necessary medication information. 2. Patients in both groups were knowledgeable about short-term side effects, usually as a consequence of personal experience with them. However, their knowledge was consistently inadequate with regard to potential long-term side effects from their maintenance medication. Current informed consent doctrine may presume a degree of recall and comprehension beyond the capabilities of most patients. The development of an appropriate doctor-patient relationship that reconciles the need for consent with patient limitations remains an important challenge for clinicians.     

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。     

《侵权责任法》中患者近亲属知情同意评析

《侵权责任法》在患者知情同意制度中使用了“近亲属”这一概念,并在第五十五条提出：“不宜向患者说明的,应当向患者的近亲属说明。”此提法不仅与国外“病人自治”原则存有差异,而且“近亲属”这一概念范围也不明确。本文拟对第五十五条立法中所体现的“近亲属知情同意”的合理性以及“近亲属”这一概念使用的恰当性进行探讨。     

论医疗知情同意理论

知情同意作为一项有利于实现医疗目的的私法原则,具有其独立的利益设计和价值取向。告知说明义务的履行是实现知情同意原则的前提,而知情同意理论的要件是具体落实知情同意原则的关键,其中判断患者是否具备同意能力是知情同意的重要因素。但在适用知情同意原则时应注意识别几种例外情势。为了切实保障知情同意原则的实现,减少和防范医疗纠纷的发生,构建和谐的医患关系,有必要进一步完善我国知情同意理论体系。     

Competence to give informed consent for medical procedures

This study shows that referrals to psychiatry for evaluation for competence to give informed consent generally were made on patients who refused medical treatment. In this sample of referred patients, the only patients found to be incompetent to give informed consent were those with organic brain syndromes. No one with either schizophrenia or depression was found to be incompetent. It is possible that schizophrenic and depressed patients may generally be competent to give informed consent to medical treatment. This finding might be true notwithstanding the fact that many such patients have been found in other studies to be incompetent to consent to voluntary psychiatric treatment. For example, a patient may have delusions that others can read his mind and thoughts, but he still can understand that he needs dialysis for renal failure. Alternatively, it may be relatively rare that an emergency procedure is necessary before a patient's psychosis can be brought under control and consequently internists and surgeons themselves may prefer to wait. The significance of the results is unclear. Because of active interest in the doctrine of informed consent for psychiatric and medical patients by both physicians and attorneys and the few studies within this population, there is a strong need for more study regarding competence to give informed consent. Further study is especially important for psychotic patients for whom psychiatric consultation is not requested.(ABSTRACT TRUNCATED AT 250 WORDS)     

Informed consent for patient care--VA. Final rule

This document amends VA medical regulations concerning informed consent for patient care. It describes the requirements for obtaining and documenting informed consent. It also describes the types of treatments or procedures for which the patient's or surrogate's signature on a VA-authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patient rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision. authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patients rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision.     

Unwarranted variations in the quality of health care: can the law help medicine provide a remedy/remedies?

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed consent to assure that patient preferences are respected in choice of treatment; we suggest that the law adopt a standard of informed patient choice in which patients are invited, not merely to consent to a recommended treatment, but to choose the treatment that best advances their preferences. In the case of supply-sensitive care, we suggest that physicians who seek to adopt more conservative patterns of practice be protected under the "respectable minority" or "two schools of thought" doctrine.     

Informed consent issues in the cardiac transplantation evaluation

As consultation-liaison psychiatrists to a cardiac transplantation team, we have observed various informed consent issues that are particularly associated with evaluation for cardiac transplantation. We discuss complicating factors that relate to each component of informed consent and present the defense mechanism of denial as a barrier to making the decision to accept or refuse transplantation. Changes in the evaluation protocol could preclude existing impediments to provision of information and patient autonomy; however, certain intrapsychic issues must be recognized as ongoing clinical realities to be addressed as the doctrine of informed consent continues to evolve.     

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。     

论精神障碍者的知情同意权

随着精神医学的发展和世界人权运动的兴起，精神障碍者的知情同意权也得到社会普遍的重视，临床精神病学家也在积极探索精神障碍者的认知能力问题。从精神病科学和法学结合的角度来看，在对精神障碍者认知功能科学评定的基础上，有区别地保护精神障碍者的知情同意权才是当前可行的途径。     

The age of sexual consent

In 1899 the age of sexual consent in some American jurisdictions was 9 years. It has ranged from 7 to 21 years and at present the range is from 11 to 18 years. The age selected seems to be an arbitrary matter, the product of legislative compromise. The age of sexual consent should not be so early that little protection is provided for a child. Conversely, it should not be so late that a man can be held for statutory rape when the "victim" is fully capable of informed consent and readily acquiesced to a proposal or even invited a sexual relationship.     

司法何以如此尴尬——以一起医疗纠纷案件审理为例

不断增多的医疗纠纷及其引发的种种愤懑,使得各种利益纠葛、体制冲突、伦理诉求和法律管制之间形成了一种较之从前更为复杂而微妙的关系。对医患关系的社会调查显示,目前我国医患双方的关系并不融洽,双方缺乏高度的信任感,一旦患者未达到其预期的疗效,势必为双方的矛盾、冲突和纠纷埋下伏笔;医患双方在具体运用知情同意权法则时产生的强烈的错位,使得知情同意权在减少医患纠纷、构建高度信任基础上的医患和谐关系的功能大打折扣。而对实践中的一个真实案例的审理的剖析则反映出我国法律和司法在知情同意权方面是如此的苍白无力,使得知情同意法则的建立迫在眉睫。我国知情同意权法则的理想构架应该包括:知情同意权法则的基本原则,医生的告知义务,患者的同意以及违反告知义务的构成要件。     

Reconciling Autonomy and Beneficence in Treatment Decision-Making for Companion Animal Patients

This article explores how the concept of consent to medical treatment applies in the veterinary context, and aims to evaluate normative justifications for owner consent to treatment of animal patients. We trace the evolution of the test for valid consent in human health decision-making, against a backdrop of increased recognition of the importance of patient rights and a gradual judicial espousal of a doctrine of informed consent grounded in a particular understanding of autonomy. We argue that, notwithstanding the adoption of a similar discourse of informed consent in professional veterinary codes, notions of autonomy and informed consent are not easily transferrable to the veterinary medicine context, given inter alia the tripartite relationship between veterinary professional, owner and animal patient. We suggest that a more appropriate, albeit inexact, analogy may be drawn with paediatric practice which is premised on a similarly tripartite relationship and where decisions must be reached in the best interests of the child. However, acknowledging the legal status of animals as property and how consent to veterinary treatment is predicated on the animal owner’s willingness and ability to pay, we propose that the appropriate response is for veterinary professionals generally to accept the client’s choice, provided this is informed. Yet such client autonomy must be limited where animal welfare concerns exist, so that beneficence continues to play an important role in the veterinary context. We suggest that this ‘middle road’ should be reflected in professional veterinary guidance.     

Patient information on drug therapy. A problem of medical malpractice law: between product safety and user safety

Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.     

浅议《侵权责任法》生效后如何履行预防接种告知义务

我国法律规定医务人员具有预防接种法定告知义务,以保护受种者的知情同意权和自主选择权。2010年7月1日起生效的《侵权责任法》对该法定义务做出了更为明确和丰富的要求,其中规定了替代医疗方案的告知义。因此,预防接种过程中医务人员应将疫苗的品种等向受种者方予以全面告知。     

Decisional Capacity to Consent to Clinical Research Involving Placebo in Psychiatric Patients

Evidence from a few studies indicates the existence of several issues related to psychiatric patients' decisional capacity to give informed consent to clinical research. Clinicians often face difficulties in acquiring valid informed consent in clinical practice and even more so in drug trials. Participants often fail to fully understand or retain information regarding the actual implications of research protocols. The Brief Assessment for Consent to Clinical Research (BACO) was developed to investigate capacity to consent to clinical trials and further compare patients with schizophrenia and healthy comparisons' decisional capacity. A method to avoid possible confounding effects of choosing a treatment regarding a current disease was applied. The study groups were administered the BACO and the MacArthur Competence Assessment Tool for Clinical Research. Psychiatric patients performed poorer in comprehending, appreciating, and reasoning abilities, than their healthy counterparts. Impaired cognitive functioning and psychiatric symptoms severity were associated with reduced capacity to consent.     

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。     

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.     

知情同意原则下医疗过失损害赔偿责任的几个问题--从一起患者知情同意纠纷案说起

知情同意原则所保护的客体是自我决定权.知情同意原则下的损害赔偿责任不同于医疗事故损害赔偿责任.二者不能互相否认.医方违反知情同意原则的责任是一种侵权损害赔偿责任.该责任的构成要件可包括(1)医师存在法定的告知义务;(2)医师未能将对患者的决定产生实质性影响的风险/信息告知患者;(3)在告知不充分的情况下,患者由于选择了当前的治疗方案而受到伤害;(4)医师的义务违反与患者的伤害之间存在因果关系.其中,告知义务是否充分的判断应以处于同样情境的一个理性患者所需作为主要的标准;对信息"实质性"的判定应看一个与患者处于同一位置的合理审慎之人在决定是否对所建议的治疗做出同意时会对某一事实赋加重要性或将该事实作为一"决定性"影响因素加以考虑;在因果关系存无的认定上,则要考虑若患者被充分告知实情他是否会做出不同的选择决定.