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.     

Consent,commercialisation and benefit-sharing

This article considers two issues in relation to the increasing commercial exploitation of biological materials: first, whether the consent of the individual who is the source of biological material is needed for the material to be used commercially; and secondly, whether the source has any right to share in the profits. Whilst the legal requirement for consent to commercial use is uncertain, the overwhelming view from ethical statements suggests that such consent is appropriate. With regard to profit-sharing, source individuals have no legal right to share in the profits of commercial exploitation of their sample. However, there is support in some ethical statements for benefit-sharing with source individuals and their communities.     

M.D. Physicians of Southwest Louisiana, Inc.; analysis to aid public comment--FTC. Proposed consent agreement

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint that accompanies the consent agreement and the terms of the consent order--embodied in the consent agreement--that would settle these allegations.     

Lowering the age of consent: Legal,ethical, and clinical implications of adolescent-directed therapy

This article discusses a recently enacted Colorado law that aims to reduce the youth suicide rate by lowering the age of consent for psychotherapy from age 15 to age 12. The author discusses the challenges therapists face when young adolescents seek therapy without parental consent in cases involving interparental conflict. Suggestions for managing adolescent-directed therapy are offered.     

Capabilities,capacity, and consent: sexual intimacy in the Court of Protection

This article uses original data from research at the Court of Protection to explore capacity to consent to sex in practice. It argues that the approach under the Mental Capacity Act 2005 fails to place appropriate focus on consent as central to understanding sexual capacity. The capabilities approach to justice is then used to demonstrate the limitations of the existing legal approach to capacity to consent to sex, and to argue that the protective focus of the legal test would be better centred on the social risks resulting from non‐consensual sex and exploitation. Finally, the article argues that, rather than focusing on a medicalized approach to understanding sexual intimacy, an analysis based on capabilities theory provides conceptual tools to support arguments for additional resources to help disabled people to realize their rights to sexual intimacy.     

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.     

Consent,Legitimation, and Dysphoria

Ideals of consent and consensuality are rapidly displacing ideals of legality as the demarcation of lawful from unlawful, legitimate from illegitimate, and good from bad.  This is a particularly pronounced trend in the areas of sexual and reproductive rights and ethics.  Consensual sex has almost completely displaced marital sex as the demarcation of not only criminal from laudatory sex but also good from bad sex.  Likewise, the consensuality of a pregnancy is increasingly the demarcation of a celebrated rather than mourned pregnancy, rather than its marital province.  This development is justly celebrated as a breakthrough in women's rights and equality, but it carries costs.  This essay develops some of the limits and perils of an over-reliance on consent and consensuality as the primary criterion of the morality of sex and reproduction.  Consent is not always a trustworthy guide to wellbeing, for both general reasons, and reasons specific to sexual and reproductive life.     

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。     

论任意侦查标准之构建

如何区分任意侦查与强制侦查是侦查研究中最为基础的问题之一,同时也是任意侦查原则与强制侦查法定主义研究中最为核心的问题。有关任意侦查的界限与标准,在日本学界先后存在"有形力说"、"侵犯权益说"、"综合判断说"等不同观点,美国经同意搜查规则中对"同意"的认定则为日本诸种学说有益的补充。对于任意侦查的界限与标准应从主观与客观两个方面进行构建。     

论刑法上承诺之正当化根据及其司法适用

本文从刑法上承诺之正当化根据入手,重点研究了中国刑法理论以及刑事审判关于被害人承诺的理解和处理案件的基本立场。承诺之正当化的根据乃是意思自治;在中国,被害人承诺是一种超法规的正当化事由;没有达到法定年龄的人的同意是无效承诺;重型精神病人无论是同意和他人发生性关系,还是同意他人拿走自己的财物等,其"同意"都不能排除相对行为人的强奸或盗窃等行为的犯罪性。中国刑法学一般将基于认识错误的承诺分为"事实错误"与"动机错误"两类。事实错误不能排除相对行为人之行为的犯罪性,动机错误则可以排除相对行为人之行为的犯罪性。     

The Human Transplantation (Wales) Act 2013: an Act of Encouragement,not Enforcement

The Human Transplantation (Wales) Act became law in Wales in September 2013. The Act aims to increase deceased donor organ and tissue donation in Wales by introducing a ‘soft opt‐out’ system to replace the previous requirement of express ‘appropriate’ consent under the Human Tissue Act 2004. Adults dying in Wales (with certain exceptions) will be ‘deemed’ to consent to donation, unless evidence of their objection is produced, and a duty is imposed on Ministers to promote transplantation and inform the public through awareness campaigns about how to choose the deemed status or opt out. Although a welcome development, these campaigns may obscure the effects of deemed consent, especially in the context of generally rising UK donation rates. There may also be problems of legal interpretation and of integration with the ‘opt‐in’ laws in the rest of the UK. In the absence of any statutory duty to retrieve all lawfully donated organs, the apparently restricted influence of donor relatives is likely to remain effectively dominant.     

Towards a better consent form

The medical profession is in the habit of using a standard "consent form" to record a patient's consent to medical therapy, particularly for a surgical operation. This article explores how to design a consent form to avoid the many traps to be found in the law of consent.     

mHealth and data protection – the letter and the spirit of consent legal requirements

In this article, the role of consent is discussed in the framework of fundamental rights and in the context of mobile health technologies (mHealth), such as smart phones, mobile phones or tablet/palm-held computing devices to provide healthcare. The authors surmise how, in practice, although there will be more emphasis on informed consent formally, there will be less space for genuine individual consent. This betrays a focus more on the letter of consent rules in data protection than their spirit. This risks reducing consent to a tick box operation in a manner analogous to consumer transactions, something manifestly unsuitable for consent, even if only in informational terms, during medical procedures.     

Constructive “Consent”: A Problematic Fiction

The law and society occasionally impute consent to an agent despite a clear lack of actual consent. A common type of such ‘fictitious consent’ is constructive consent. In this practice, we treat an agent as if she consented to Φ because she did Ψ. By examining how constructive consent operates in law (monitoring inmate phone calls and blood alcohol concentration testing on unconscious drivers) and daily life (physical contact in public spaces), I show that our treatment of agents in these cases bears no normatively relevant resemblance to consent because it is grounded in values and concerns other than autonomy. Thus, the practice may diminish the very autonomy consent proper seeks to promote. Hiding this potential for conflict creates the risk moral concerns will not be appropriately balanced when deciding on the permissibility of an action. We thus ought to be explicit that such cases don’t involve consent and its common justification.     

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。     

Victimless Conduct and the Volenti Maxim: How Consent Works

This article examines the normative force of consent, explaining how consent works its “moral magic” in transforming the moral quality of conduct that would otherwise constitute a wrong against the consenting person. Dempsey offers an original account of the normative force of consent, according to which consent (when valid) creates an exclusionary permission. When this permission is taken up, the moral quality of the consented-to conduct is transformed, such that it no longer constitutes a wrong against the consenting person. Building on this account of how consent works, Dempsey identifies two sets of cases in which consent fails to transform the moral quality of one’s conduct: cases in which one is consent-insensitive to the rational force of another’s consent, and cases in which one acts for sadistic reasons.     

The impact of a verbal warning on police consent search practices

This article explores the impact of requiring a verbal warning prior to a police request for consent to search a suspect's automobile. The United States Supreme Court expressed concern that requiring a verbal warning prior to a consent request would make consent searches impossible for the police. Twenty-seven months of motor vehicle stop data (N = 800) was analyzed during periods where a verbal warning was and was not required prior to a consent request. The findings did not support the conclusion that a verbal warning would cause a substantial decrease in consent searches. A slight increase in the volume of consent requests was observed after the police were required to administer the warning.     

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.     

Abortion, breast cancer, and informed consent

The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering induced abortion. The article examines the relationship between this evidence and the elements of a medical malpractice claim alleging failure to obtain informed consent. The first part focuses on the elements of informed consent, which require the plaintiff to establish that the physician had a duty to disclose information, which he failed to disclose, that this failure to disclose was a legal cause of the plaintiff's decision to undergo the procedure, and the procedure was a legal cause of the plaintiff's injury. The second part compares two prevalent standards for determining which risks a physician has a duty to disclose. Part three reviews the scientific evidence of the abortion/breast cancer (ABC) link and explains why it survives both the Frye and the Daubert tests for admissibility of expert testimony. The fourth part assesses the materiality of the risk posed by the ABC link. Parts five and six discuss evidentiary issues and the possibility of punitive damage awards.