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.     

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.     

Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to clarify that, within 30 days after the receipt of an IND for any clinical investigation involving an exception from informed consent, FDA will provide a written determination as to whether the investigation may begin. This action is intended to clarify a recent amendment to the IND regulations for clinical investigations involving an exception from informed consent that states that FDA will provide a written authorization within 30 days of receipt of the IND.     

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.     

The genomic data deficit: On the need to inform research subjects of the informational content of their genomic sequence data in consent for genomic research

Research subject consent plays a significant role in the legitimation of genomic research in Europe – both ethically and legally. One key criterion for any consent to be legitimate is that the research subject is ‘informed’. This criterion implies that the research subject is given all relevant information to allow them to decide whether engaging with a genomic research infrastructure or project would be normatively desirable and whether they wish to accept the risks associated with engagement. This article makes the normative argument that, in order to be truly ‘informed’, the research subject should be provided with information on the informational content of their genomic sequence data. Information should be provided, in the first instance, prior to the initial consent transaction, and should include: information on the fact that genomic sequence data will be collected and processed, information on the types of information which can currently be extracted from sequence data and information on the uncertainties surrounding the types of information which may eventually be extractable from sequence data. Information should also be provided, on an ongoing basis, as relevant and necessary, throughout the research process, and should include: information on novel information which can be extracted from sequence data and information on the novel uses and utility of sequence data. The article argues that current elaborations of ‘informed’ consent fail to adequately address the requirements set out in the normative argument and that this inadequacy constitutes an issue in need of a solution. The article finishes with a set of observations as to the fora best suited to deliver a solution and as to the substantive content of a solution.     

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.     

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 elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

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。     

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.     

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.     

Medical association calls for routine HIV testing of pregnant women

The Canadian Medical Association says that routine HIV testing of pregnant women is necessary because there are still babies being born with HIV infection. Critics respond that routine testing is the same as mandatory testing, that there is no reason to waive the requirement for informed consent accompanied by pre-test counselling, and that physicians need to do a better job of offering HIV testing to pregnant women.     

心外科手术后死亡医疗纠纷尸检分析

目的从尸检角度讨论心外科手术后死亡的死因及诊疗缺陷。方法按临床诊断、手术类型、死亡时间、死亡特点、尸检特点、纠纷特点、诊疗缺陷等方面,比较所选案例的临床、尸检资料特点。结果心瓣膜置换手术4例,冠心病冠脉搭桥手术1例,先心病大动脉转位手术1例。心肌梗死2例,心肌广泛损伤1例。心内膜感染2例,多器官功能衰竭1例。家属怀疑诊疗不当6例。诊疗缺陷主要为手术适应证、手术时机,手术器材的选用,手术操作,术后病情观察、处理不及时,对病情严重程度、手术风险及预后的告知不充分。结论尸检不仅能查明死因,还可帮助评价手术质量、术后处理的诊疗质量,对解决纠纷具有重要的辅助作用。     

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.     

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)     

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.     

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.     

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.     

患者知情同意权

让患者知情同意义务是近些年来在医疗诉讼过程中逐步从一般注意义务中分化出来的特殊注意义务。IC产生有其深刻的社会背景,医师在医疗行为时要对患者进行充分的告知并取得患者的同意以保障患者自我决定权的实现。     

Clothed and unclothed human figure drawings lead to more correct and incorrect reports of touch in children

Abstract

The purpose of the current study was to examine the effect of clothed and unclothed human figure drawings (HFDs) on children's reports of touch. Eighty 4/5-year-olds and 80 9/10-year-olds participated in a staged event in which measurements of their body parts (e.g. waistline) were taken. Specifically, they were touched on 10 different locations. Immediately or three weeks after the event, they had to report where they had been touched. Half of the children received a clothed HFD while the other half was provided with an unclothed HFD to assist children in their recall. When we compared children's recall before and after the presentation of a HFD, we found that clothed and unclothed HFDs significantly decreased the accuracy of children's reports of touch. So, although children reported more correct touches after the presentation of a HFD, they were also more likely to include more incorrect information in their reports of touch.