Participation of children in clinical trials: UK, European and international legal perspectives on consent

The Declaration of Helsinki was, until recently, the leading international code on the conduct of clinical trials on human subjects. The Council of Europe's Convention on Human Rights and Biomedicine (1997) and the ICH guidelines for Good Clinical Practice (1996) represent a significant step towards increased harmonization of standards in the conduct of medical experiments on human subjects. But in spite of emerging areas of consensus, there remain important areas of unclarity and divergence. Medical practitioners involved in paediatric research in the UK are concerned about the lack of certainty in the law, particularly on the application of consent rules to emergency research. This paper examines UK, European and International norms on the participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.     

Legislation and review of medical research with minors in The Netherlands

In The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of nontherapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.     

The semblance of autonomy: treatment of persons with disabilities under the Uniform Health-Care Decisions Act

This Article illuminates the dangers of the Uniform Health-Care Decisions Act, which provides a set of model rules designed to clarify and expedite end-of-life health-care decisionmaking for incapacitated patients. The uniform commissioners and many scholars who have commented on the Act have touted the legislation as a model for defending patient autonomy. As this Article will reveal, the impression of autonomy is an illusion. In fact, the Act privileges the perspectives of the able-bodied over those of persons with disabilities, endangers the autonomy of incapacitated patients, and empowers proxy decisionmakers who have incentives to terminate treatment. These risks have become all the more significant with the rise of managed-care programs that create pressures to minimize care. After highlighting the serious risks to vulnerable patients under the Uniform Health-Care Decisions Act, the Article offers alternative rules and stronger safeguards to better protect patient autonomy and defend against wrongful health-care decisions. This Article urges states seeking improved end-of-life health-care procedures to codify these or similar protections in order to avoid the lethal shortcomings of the Uniform Health-Care Decisions Act.     

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.     

The Social Norms of Waiting in Line

This article examines the rules and practices of waiting in line as a system of informal order, showing that despite its reputation for drudgery, the queue offers rich insights about social norms and the psychology of cooperation. The article begins by investigating the implicit customs of physical waiting in line, uncovering the surprisingly complex unwritten rules (and exceptions) that give queues stability even in the absence of legal governance or state enforcement. Yet the prevailing norms literature typically explains informal order by reference to close‐knit groups that can impose sanctions on violators of extralegal rules. This raises a puzzle: Why do queue norms repeatedly produce informal, yet reliable, order among total strangers unlikely to interact again? This article answers this question by looking to social‐psychological research showing that people tend to be strong reciprocators rather than selfish utility maximizers. This model makes sense of both our tendency to defer to line norms as well as the disproportionate sanctions with which defectors from these norms meet.     

Real Property, Spontaneous Order, and Norms in the Gold Mines

This article contributes to the current debate about why people follow the law even when they are not subject to legal sanctions, as when there are no police and little danger of a lawsuit. Most recent scholarship in this area takes the form of norms theories, suggesting that social norms rather than laws shape behavior and that deviations from the norm are punished by either social or internal sanctions. Robert Sugden, however, proposes that order may develop "spontaneously" in the many areas of life where abiding by the rules minimizes the risk of costly confrontations with others and is thus in the interest of all parties. When this is true, the threat of little or no sanctions plays no role in regulating behavior. This article tests Sugden's theory against a simple property system, that of the California gold mines, in which individual miners held small claims subject to strict work requirements. The evidence of eyewitnesses shows that the stability of the regime did not depend on norms, but on the reasonable prediction that other claim holders would themselves stand up for their rights under the local mining code. Disputes about the rules and their application were submitted to arbitrators, whose decisions were accepted by the parties and did not need to be enforced. The California experience thus provides an example of a stable property regime for which game theory has a more satisfying explanation than do any of the norms theories.     

An Empowerment Theory of Legal Norms*

Abstract. Traditionally legal theorists, whenever engaged in controversy, have agreed on one point: legal norms are par excellence rules which impose obligations. The author examines this assumption, which from another perspective (that of constitutional law, for instance) appears less obvious. In fact, constitutional rules are commoniy empowering norms, norms which do not create duties but powers. To this objection many theorists would reply that empowering rules are incomplete and that they are to be understood as parts of duty-creating rules. A different position from this traditional stance is that defended in Kelsen's later writings, according to which the fundamental type of norm is the empowering norm. The author discusses Kelsen's three theories on the “ideal form” or structure of the legal norm, with special attention to the third of these, the empowerment theory.     

规范性文件的法律效力问题研究

我国有关法律将规范性文件与行政法规、规章相区别 ,将前者不作为法律规范看待 ,但又未提出区分二者的明确标准。事实上 ,行政法规、规章与创制性规范性文件的内容、规范效果及制定程序界限模糊 ,规范性文件还往往是法院在行政诉讼中的审查基准。从德、日、美等国的有关制度可以看出 ,法律规范与非法律规范的界限是是否规定公民的权利义务 ,是否具有外部规范性。就此而言 ,我国的创制性规范性文件是法律规范     

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.     

A Formal Model of Legal Argumentation

Abstract . The paper gives a formal reconstruction of some fundamental patterns of legal reasoning, intended to reconcile symbolic logic and argumentation theory. Legal norms are represented as unidirectional inference rules which can be combined into arguments. The value of each argument (its qualification as justified, defensible, or defeated) is determined by the importance of the rules it contains. Applicability arguments, intended to contest or support the applicability of norms, preference arguments, purporting to establish preference relations among norms, and interpretative arguments are also formalised. All those argument types are connected in a unitary model, which relates legal reasoning to the indeterminacy of legal systems, intended as the possibility to develop incompatible defensible arguments. The model is applied to permissive norms and normative hierarchies, and is implemented in a Prolog program.     

‘Customary internet-ional law’: Creating a body of customary law for cyberspace. Part 2: Applying custom as law to the Internet infrastructure

The shift in socio-economic transactions from real space to cyberspace through the emergence of electronic communications and digital formats has led to a disjuncture between the law and practices relating to electronic transactions. The speed at which information technology has developed require a faster, more reactive and automatic response from the law that is not currently met by the existing law-making framework. This paper suggests the development of special rules to enable Internet custom to form legal norms to fulfill this objective. In Part 2 of this article, I will construct the customary rules to Internet law-making that are applicable to electronic transactions by adapting customary international law rules; apply the suggested rules for determining customary Internet norms and identify some existing practices that may amount to established norms on the Internet, specifically practices relating to the Internet Infrastructure and Electronic Contracting.     

论我国医疗损害责任制度的修改与完善——以《民法典·侵权责任编草案(三审稿)》的规定为视角

我国正在起草和制定的《民法典·侵权责任编草案(三审稿)》修订和完善了医疗损害责任的部分规则,使医疗损害责任规则体系更具有科学性和可操作性。为了满足司法实践的需要,保持法律规范的先进性和前瞻性,有必要完善知情同意规则、规定医疗技术损害责任的认定标准和考虑的因素、多个医疗机构的损害责任、误诊损害责任、医师外出会诊损害责任、完善医疗产品责任、远程医疗损害责任、医疗机会丧失损害责任、医疗管理损害责任以及医疗损害限额赔偿责任等方面的法律规则。我国立法机关应当利用制定民法典的契机,采纳司法实务界和学术界提出的有效解决医疗损害责任纠纷的建议,修改和完善《侵权责任法》确立的医疗损害责任制度,构建科学的医疗损害责任法律体系,为健康中国战略目标的实现提供法律保障。     

Back to Basics: A Theory of the Emergence of Institutional Facts

In order to account for the mode of existence of social rules and norms, the author develops a theory of the emergence of institutional facts. Just as other kinds of institutional fact, rules and norms are meanings. Therefore, insight into the emergence of social rules and norms can be achieved by studying the recognition and the communication of meanings. Following accounts of meaning and factuality, institutional facts are characterized as unquestionable shared typifications. It is argued that, in becoming an institutional fact, a typification goes through two phases. First, it becomes a social habit. Second, this habit turns into an obligation by being objectified.     

The Syntax of Principles: Genericity as a Logical Distinction between Rules and Principles

Much has been said about the logical difference between rules and principles, yet few authors have focused on the distinct logical connectives linking the normative conditions of both norms. I intend to demonstrate that principles, unlike rules, are norms whose antecedents are linguistically formulated in a generic fashion, and thus logically described as inclusive disjunctions. This core feature incorporates the relevance criteria of normative antecedents into the world of principles and also explains their aptitude to conflict with opposing norms, namely that their consequents are fulfilled to varying extents more frequently than those of rules. I conclude that the property of genericity should be predicated to the norm antecedent of principles, more precisely to the hypothetical action. This is of paramount importance to explain, in terms of logical implication and exclusion, the expansibility of competing principles, in contrast with the exclusive character of conflicting rules.     

欠缺行为能力成年人保护的法律重构

本文所述欠缺行为能力成年人的含义与我国民法规定不同,它是指认知和判断能力完全障碍或者有一定的障碍的人,并不以成年精神病人为限。那些除成年精神病人（我国司法解释将其扩展为痴呆病人）外的欠缺意思行为的人,如酗酒成性、吸毒成瘾、不履行任何家庭责任的人,因为其理智判断幼稚,理性程度低下,缺乏控制自己行为能力,社会生活经验很不成熟,对较复杂的行为尚不能预料其应有的后果,不能有效地保护自己和相关家人。因此,法律应给予特别保护。     

Medical decision-making for incapacitated elders: A "therapeutic interests" standard

Some older individuals lack sufficient present cognitive and/or emotional ability to make and express autonomous decisions personally. In those situations, health-care providers routinely turn to available formal or informal surrogates who often must apply the best interests standard in making decisions for the incapacitated person. This article contends that defining the best interests standard of surrogate decision-making for older adults in terms of optimal or ideal choices (truly the patient's "best" interests) frequently sets out an unrealizable goal for surrogates to satisfy. Instead, a decision-making standard based on the incapacitated person's "therapeutic" interests is more realistic and hence more honest to adopt and apply from legal, ethical, and medical perspectives.     

The Fundamental Features of Legal Rationality

Abstract. The aim of this paper is to clarify the logical structure of a code connecting together some distinctions already introduced by different authors: a distinction between primary norms and secondary norms, the latter being implied by the provisions describing institutions in the indicative; a distinction between norms the content of which concerns a state and those the content of which concerns a behaviour which is itself function of several states; a distinction, among the primary norms, of the norms of competence by which a normative power can be delegated to an individual; lastly a distinction between regulative rules and constitutive rules.     

Guardianship for your own good: Improving the well-being of respondents and wards in the USA

Adult guardianship is a coercive exercise of the state's power over an innocent individual, justified only by: 1) the ward's incapacity; and 2) the need to protect the ward's well-being. The raison d'être of guardianship is to improve the well-being of the incapacitated ward. Studies of actual guardianship proceedings have long indicated serious ongoing concerns with the process. Repeated revisions of statutes have attempted to improve guardianship procedures, with some success. However, relatively little attention has been paid to the actual effect of guardianship on the well-being of respondents and wards, when the system functions as intended. The presumption that guardianship, when not abused, is in the best interests of an incapacitated adult is called into serious question by empirical research into the role of internal locus of control and autonomy on human well-being. Indeed, a wide range of data indicates that guardianship itself can have significant negative effects on the physical and mental well-being of respondents and wards. The guardianship system must be reformed to maximize the therapeutic effects of guardianship and to minimize the unnecessarily anti-therapeutic effects. I examine the effects of guardianship from a therapeutic jurisprudence perspective and propose and analyze modifications that could enhance the therapeutic effects of guardianship.