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)     

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)     

Liberty and tardive dyskinesia: informed consent to antipsychotic medication in the forensic psychiatric hospital

This paper addresses informed consent to antipsychotic medication of those incarcerated in a forensic psychiatric hospital. The ways in which the unique setting of the forensic psychiatric hospital impinge upon the three components of informed consent--information, voluntariness, and competency--are explored. Special attention is given to the risk-benefit ratio of receiving antipsychotic medication in terms of the liberty interests at stake--freedom of movement, that is, the effects of tardive dyskinesia, and freedom of space, that is, release from the forensic psychiatric facility.     

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.     

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.     

Recall from informed consent counselling for cataract surgery

The authors investigated the effect of giving written material on information recall from informed consent counselling for cataract surgery. Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre, South Australia, were prospectively enrolled. Systematic counselling for cataract surgery was provided, with a written copy of the content given to a randomly selected group of patients (n = 24). All subjects completed a questionnaire after counselling and again at two weeks after surgery to test their satisfaction with, and recall of, information provided. Patients were found to be satisfied with the amount of information they received and most were able to recall details about the cataract surgery procedure. However, many could not recall success rates or complication rates and only a minority could list any complication. The provision of written information did not significantly alter recall (p>0.05). Recall was significantly better immediately after counselling than two weeks after surgery (p<0.05). Younger patients also had significantly better recall (p<0.05). Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements.     

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。     

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.     

Research on medical records without informed consent

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.     

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。     

Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

What constitutes a psychiatric emergency: clinical and legal dimensions

In true medical emergencies, informed consent is presumed or implied without application of the usual standard. In the litigation over the right to refuse treatment in psychiatry, a limited right for involuntarily committed patients to refuse treatment has been upheld, absent a finding of a psychiatric emergency. Increasingly, clinicians may find that their sole extrajudicial option in instituting treatment over the patient's objection is in invoking a psychiatric emergency. The purpose of this communication is to discuss the clinical and legal issues in defining and invoking a psychiatric emergency in treatment refusal. The substantive and procedural issues in the use of the emergency exception in treatment refusal are discussed with recommendations for their use in clinical practice.     

Crisis and informed consent: analysis of a law-medicine malocclusion

Many individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.     

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.     

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。     

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。     

对《侵权责任法》第五十六条的理解与释义

目前,学界对《侵权责任法》第五十六条的释义基本上仍停留在字面解释,造成实际工作中难以操作。医疗机构在紧急情况下虽然抢救了患者,但仍可能需要承担违约赔偿责任。尝试对该条款进行扩充和限制解释,指导医疗机构在不能获得患者和其近亲属知情同意时,能把握好使用这种医疗特权的尺度。     

Medical: informed consent--designate health care professionals to obtain informed consent. Final rule

This document amends U.S. Department of Veterans Affairs (VA) medical regulations on informed consent. The final rule authorizes VA to designate additional categories of health care professionals to obtain the informed consent of patients or their surrogates for clinical treatment and procedures and to sign the consent form.     

Asylum seekers and informed consent--European perspective

For centuries, people of various nationalities from various States have sought asylum for varied reasons. These people seeking asylum can need medical care in the host country. In this article I would like to discuss to what extent informed consent is needed, and to what extent informed consent must be sought. The problem is discussed from the perspective of European international documents, mainly on those of the Council of Europe.     

Jones v. Gerhardstein: the involuntarily committed mental patient's right to refuse treatment with psychotropic drugs

The question of whether an involuntary committed mental patient has a fundamental right to refuse treatment with psychotropic drugs continues to be a subject of much debate. Over the past twenty-five years, psychotropic drugs have become the most common form of treatment for the mentally ill. For many patients, these drugs provide substantial benefits; for others, however, they produce severe, sometimes debilitating, side effects. Because of the possibility of serious harm to the patient and because of the potential for abuse of drug treatment by psychiatric staffs, the mental health bar generally has argued for increased procedural protection for mental patients. In Jones v. Gerhardstein, the Wisconsin Supreme Court responded to these concerns by requiring that a judicial hearing be held on the issue of a patient's competency to refuse treatment before the attending physician may administer medication without the patient's consent. This Note discusses the controversy between the legal and medical communities over treatment refusal by mentally ill patients in light of the impact of the Jones decision on institutional practice and on refusing patients. The author argues that the strictly rights-based analysis used by the Jones court has done little to benefit involuntarily committed mental patients. The author suggests alternative ways of approaching treatment refusal that might be more responsive to the distinctive needs of the mentally ill.