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.     

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.     

Critical care research and informed consent

The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.     

Health Information Technology and the Idea of Informed Consent

During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent's proper role in a health care environment in which electronic information sharing holds primary importance. This article discusses current implementation of the doctrine within health information exchange networks; the relationship between informed consent and privacy; the variety of ways that the concept is referenced in discussions of information sharing; and challenges that surround incorporation of the doctrine into the evolving HIT environment. The article concludes by reviewing the purpose behind the traditional obligation to obtain informed consent and the possibility of maintaining its relevance in the new environment.     

The future of informed consent in British common law

Within the common law world, the use of the term informed consent implies the American doctrine. Informed consent as a doctrine is not part of the law in the United Kingdom. However, it is possible to predict a way forward in disclosure cases yet to be heard in the courts of the United Kingdom. These predictions are based on current developments in the common law in the United Kingdom as well as those in Canada and Australia, on the European Convention on Human Rights and Biomedicine and on trends within the medical profession itself in the light of the Bolam test.     

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.     

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.     

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 in the electroconvulsive treatment of geriatric patients.

The past 15 years have been marked by an increasingly stringent regulatory atmosphere regarding the administration of ECT, leading to delays in treatment and declines in usage. Regulatory changes requiring judicial intervention in clinical decisions are driven by the notion that only the courts can provide adequate due process protections when legal rights and clinical need conflict. We retrospectively reviewed the documentation of the informed consent process for 62 geriatric patients receiving ECT to assess the degree to which clinicians conformed to the spirit of the informed consent doctrine in a state that allows significant clinical discretion in decisions to administer ECT to patients lacking decisional capacity. In the eight cases in which the patient's decisional capacity was questioned, we found appropriate documentation of the patient's failure to comprehend his condition or the proposed treatment, evidence of a high degree of family involvement in decision making, and extensive use of outside consultants to document decisional incapacity and the need for treatment. Evidence of family participation in decision making was present for a high percentage of cases in which decisional capacity was unquestioned. Our review demonstrated high compliance with the procedural safeguards contained in the state regulation and with the spirit of the informed consent doctrine.     

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.     

Legal prerequisites for clinical trials under the revised Declaration of Helsinki and the European Convention on Human Rights and Biomedicine.

Biomedical research is a perennially controversial subject. While the provisions of the Revised Declaration of Helsinki enjoy world-wide acceptance, they are increasingly placed in question--not least by the Council of Europe's Bioethics Convention, which allows non-therapeutic research in restricted cases on those incapable of giving informed consent. Taking as its starting-point the fundamental conflict between the general interest in research and the individual interests of the patients concerned, this article analyses the conditions under which medical experimentation on human beings is permissible. The article recognises the model of risk/benefit analysis and the doctrine of informed consent as equally valid core principles which do not conflict with restricted, non-therapeutic research, whether on patients who lack the capacity to consent or in placebo-controlled trials.     

LAWYER'S DUTY TO DISCUSS ALTERNATIVE DISPUTE RESOLUTION IN THE BEST INTEREST OF THE CHILDREN

Alternative dispute resolution (ADR) has been championed for its power to devise agreements that meet the parents' and the children's needs and for its ability to encourage parties to work together, eventually leading to stable agreements. The Model Rules of Professional Conduct do not create any ethical duty to advise, suggest, or encourage lawyers to discuss ADR with their domestic relations client. In the medical field, patients are given a choice of treatment under the informed consent doctrine, but there is no analogous doctrine in the legal field. The Model Rules of Professional Conduct should be revised to reflect the best interests of children, as well as client choice. Clients, specifically parents in domestic relation matters, are entitled to know their options, and lawyers should be obligated to provide them with the information that will enable them to make informed decisions–decisions that will benefit their children and ultimately our nation.     

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.     

To act or not to act, that is the question: informed consent in a criminal perspective

Some years ago the doctor was seen as the one who "knows better", and it was absolutely unconceivable that the patient could refuse the suggested treatment or even ask any questions about it. Differently, nowadays doctors face demands to keep their patients informed and can even be sued when they act without patient knowledge and consent. On the patient's side this new paradigm does not necessarily legitimate euthanasia--still criminally forbidden in most parts of the world--but allows some kind of personal power over body, health and life, materialized in advance directives. On the doctor's side, it entails a change in the list of good medical practices, imposing the doctrine of informed consent and the prohibition of dysthanasia.     

死后人工生殖的民法问题研究——兼谈台湾地区人工生殖立法新趋向

死后人工生殖打破知情同意法则,违反人工生殖目的,危及子女最佳利益.未来人工生殖立法应在满足生育自由的同时,尊重人性尊严,关怀后代福祗.建议严禁死后取精,严禁死后人工生殖.     

人体组织提供者法律保护模式之建构

在我国民法界，在如何保护人体组织提供者利益问题上尚有分歧，但一般认为，与人体分离后的组织和器官为“物”。基于知情同意的人格保护模式可以有效地保护人体组织提供者就组织的分离、使用和处置进行控制的权利，能达到我国目前的财产保护学说所需要的效果，单辟一个不完整的财产权利价值不大。更重要的是，启用知情同意和人格保护的制度有利于保护人的尊严和自主权，能与各国所倡导的无偿捐赠模式达到一致，且能促进利他主义价值观和社会凝聚力，副作用较小但益处却不小，应得到优先考虑。知情同意原则的不断发展将使其发挥更大的作用。主张基于知情同意的人格保护和无偿捐赠并不排斥人体组织提供者就商业后续开发主张利益分享。     

人脸识别技术中的个人信息保护——兼论动态同意模式的建构

人脸识别技术在现有应用场景中已经被证明了其便捷性和高效性,但是,围绕该技术自身准确性、安全性、伦理性和合法性等问题的争议也从未停息。2020年我国"人脸识别第一案"引发公众及学界关注与讨论,急需在快速扩散的技术应用中,寻找信息法益保护模式。完善人脸识别技术中个人信息保护模式的可能性如下:第一,坚持"合法、正当、必要"原...     

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.     

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.     

Informed consent or institutionalized eugenics? How the medical profession encourages abortion of fetuses with Down syndrome

Many women are unprepared to make prenatal decisions about fetuses diagnosed with Down Syndrome because of societal pressures to have "normal" children, a negative view of persons with disabilities by many in society, a fear of legal liability by those in the medical community, the lack of genuine informed consent before undergoing genetic testing and abortion, and the failure of non-directive pre-abortion counseling in the medical community. Moreover, medical professionals fail to communicate correct and unbiased information before and during the genetic screening, diagnostic testing, and abortion decision-making process. This article addresses the contributing factors and causes that ultimately lead to a lack of informed consent and a very high abortion rate for fetuses diagnosed with Down Syndrome.