Malpractice issues in heart transplantation

As organ transplantation procedures become accepted as standard medical practice, it is anticipated that the frequency of liability claims against transplant care providers will increase. This article examines current statutory and common law analyses of malpractice issues in transplantation, with particular attention given to issues of informed consent as they arise both for the organ donor and donee.     

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。     

From both sides now: informed consent, organ transplantation, and family-based disclosure

Drawing on the legal and social development of the right of individual patients to give informed consent to medical treatment, this article explores some implications of heroic life-saving measures in medicine that are made possibly by unprecedented advances in medical technology. Talcing cardiac transplantation as its primary example, the article examines the broader effects, both short-term and long-term, on family members as well as on the patient of this and similar types of heroic treatment. The author then offers a novel legal theory: where the heroic measure holds the risk of serious or life threatening changes, not just for the patients themselves but for their intimately connected family members as well, those members ought to have a legal right to participate in the informed consent process. The author sketches the contours of such a right and defends it in the face of various objections that may be made to it. I've looked at life from both sides now from win and lose, and still somehow it's life's illusions I recall. I really don't know life at all. (“Both Sides Now,” on Colors of the Day: The Best of Judy Collins, Electra Records 1972)     

手术签字与患者的知情同意权

由于我国现今法律法规未能明确手术签字与患者知情同意之间的关系 ,使得医院和患者之间的权利义务关系不甚明确。随着医疗市场的进一步规范 ,我们有必要尽快地明确手术签字与患者知情同意权之间的关系。文章从手术签字与患者知情同意及医院免责之间的关系等五个关键性问题入手对两者的关系作了阐述。     

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.     

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)     

告知后同意规则的法律构造

在具有侵袭性的医疗行为中,医师负有告知义务,以患者得以了解的语言,告知病人病情、治疗方案、各方案可能的的风险,以及不治疗的后果等。告知义务的履行应采取理性患者的标准。告知义务也有例外。医师违反告知后同意义务并非直接侵害了患者的健康权,而是侵害了患者的自我决定权或自我决定法益,它将可能进一步引起对患者健康权的侵害,造成患者人身损害。     

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。     

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.     

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     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

Informed consent utilizing satellite imagery in forestry carbon trading with North Korea

Informed consent can assist in mitigating investment risks associated with forestry carbon trading in North Korea by supporting corporate responsibility. Scientific developments for collecting information necessary to informed consent far outpace the development of inter-Korean regulatory frameworks. This paper seeks to identify how the intersection of legal and technological disciplines can foster informed consent, through the responsible application of satellite data. The permanent record of standard satellite remote-sensing systems demonstrates its capability of presenting area-wide visual evidence of forest conditions. Such data are essential to initiating informed consent, establishing a carbon stock baseline, detecting and quantifying rates of land-cover change, and quantifying above-ground biomass stocks as specified in the Kyoto Protocol. This research could be a valuable reference for utilizing the capabilities of satellites with informed consent obligations in North Korea by suggesting the provision of realistic informed consent mechanisms.     

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。     

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.     

Xenotransplantation: consent, public health and charter issues

There is a growing body of literature and commentary analyzing the ethical and public policy concerns associated with xenotransplantation. While this technology holds great promise to provide an almost limitless supply of organs for transplantation, there remains grave concern about possible public health ramifications. As a result, it has been recommended that patients who undergo xenotransplantations will need to agree, inter alia, to a lifetime of close health monitoring, participation in an international database and autopsy upon death. It has been suggested that this agreement would transform the nature of informed consent into a "binding contract." Though such draconian measures are understandable given the magnitude of the risks involved, would existing common law and legislation allow their implementation? This paper analyzes relevant Canadian consent and public health law in the context of the xenotransplantation. Canada is a country with a particularly rich body of informed consent jurisprudence--jurisprudence firmly rooted (rightly or not) in the ethical principle of autonomy. In this climate, many of the suggested monitoring strategies would find little support from Canadian law. Before xenotransplantations proceed, policy makers must be sensitive to the legal barriers which exist to the implementation [of] effective public health measures. Effective surveillance programs will require novel approaches to consent and the enactment of specific public health laws.     

论患者隐私权保护——兼论侵害“告知后同意”之请求权基础

隐私权已从传统消极防御面向发展到兼具积极支配面向,主要包括四项权能:隐私隐瞒权、隐私利用权、隐私维护权和隐私支配权.《侵权责任法》第62条、第61条、第55条和第56条对应以上四种权能并共同构筑了患者隐私权范畴.患者隐私支配权需要借助于对患者的“告知后同意”实现,告知的内容应当包括医师同时兼具的研究者身份与潜在利益冲突.“告知后同意”虽然可以作为一种法益或者注意义务之违反得到救济,但作为某种权利得到保护系必然趋势,这种权利应是隐私权而非自主权.侵害患者“告知后同意”之隐私权的请求权基础应为第6条第1款,涉及赔偿责任时应适用特别规定第55条第2款,所涉损害主要系精神损害.     

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.     

Data protection in Europe – Academics are taking a position

CLSR welcomes occasional comment pieces on issues of current importance in the law and technology field. The current debate on the Commission's proposal for a new data protection framework includes a plethora of very specific issues. As important as these may be, it should not be overlooked that the very principles of data protection are at stake at the moment. Given the lobby efforts to exclude large parts of today's data processing from the ambit of the proposed Regulation, to weaken the principle of informed consent, and to broaden the exceptions for “legitimate interests”, we want to stress that data protection in Europe needs to be strengthened, and that this can be achieved without threatening innovation and legitimate business models.     

A qualitative examination of ethical and legal considerations regarding dating violence

Despite the increased attention to dating violence among adolescents and young adults, limited information is available on ethical and legal considerations specific to this population. Therefore, this qualitative study explores 21 trainees' and practitioners' conceptualization of ethical and legal issues pertaining to adolescent dating violence. Data are collected through focus groups included as part of an ethics and legal issues seminar. Six themes are identified to illustrate ethical and legal issues concerning dating violence: knowledge, client welfare, counseling interventions, informed consent and disclosure, barriers, and counselor reactions.     

Medical devices; exception from general requirements for informed consent. Interim final rule

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.