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.     

行政问责制的建立和完善

随着“问责风暴”开始向“制度问责”迈进,对行政问责制度的研究也越来越成为一个紧迫而现实的课题。本文从分析推行行政问责制的现实意义入手,指出了目前我国行政问责制存在的主要问题,着重从构建新的官场文化、理清党政关系、实行政务公开、强化异体问责、完善相关法律法规等五个方面阐述了如何完善行政问责制的基本思路。     

Insomnia, nightmare frequency, and nightmare distress in victims of sexual abuse: the role of perceived social support and abuse characteristics

In this study of victims of sexual abuse, the aim was to investigate the role of perceived social support and abuse characteristics in self-reported insomnia, nightmare frequency, and nightmare distress. Four hundred sixty Norwegian victims of sexual abuse completed a questionnaire assessing perceived social support, abuse characteristics, insomnia, nightmare frequency, and nightmare distress. Results show that higher levels of perceived social support were related to lower scores on all symptom outcome measures. Abuse involving oral, genital, or anal penetration was related to more insomnia symptoms. Longer duration of abuse and threatening conducted by the perpetrator were related to higher nightmare frequency, while threats and abuse involving penetration were related to higher degrees of distress associated with nightmares. In conclusion, the present study provides preliminary data indicating that perceived social support may affect the nature of sleep difficulties in sexual abuse victims. Also, more severe forms of sexual abuse are related to higher levels of sleep difficulties.     

Cognitive-behavioral skills,social supports,and child abuse potential among mothers of handicapped children

This study examined the relationship among cognitive functioning, social support networks, and risk for child abuse in a sample of 92 mothers of developmentally disabled children. Mothers found to be at highest risk for child abuse potential tended to score low on cognitive skills, social support networks, and life satisfaction. Beck Depression Inventory scores were found to explain 57% of the variance in the Child Abuse Potential Scores. Single mothers differed significantly from married mothers on child abuse potential, relationship satisfaction, community involvement, and loneliness. The authors discuss implications of the study and the need for future research with families of handicapped children.     

Speech, privacy, and the power of the purse: lessons from the abortion "gag rule" case.

In Rust v. Sullivan, 59 U.S.L.W. 4451 (1991), the US Supreme Court ruled that neither the privacy interests of family planning clients nor the 1st Amendment interests of their counselors prevented the government from banning all discussion of abortions in federally funded family planning clinics. In doing so, the Court also reaffirmed its view that the state and federal legislatures have virtually unlimited discretion in limiting or conditioning social welfare programs, a view having even greater long-term implications for American health policy than the implications of Rust for the constitutional protection of abortion. Rust upheld the Department of Health and Human Services' 1988 directive prohibiting the use of any funds from Title X of the Public Health Service Act (authorizing family planning programs) in programs where abortion is a method of family planning. This means that a clinician may lawfully respond to a client's inquiry about abortion only with a denial that abortion is an option. Thus, while allowing women the constitutional protection to chose an abortion, the Court has allowed the legislature to freely use the power of the purse to discourage or prevent the choice of abortion. Rust's greatest impact may well be in its acceptance of the enormous power wielded by the government over funded activities, especially in health policy. Justice Rehnquist believes there is not constitutional right to health, welfare, or any other government benefit; the legislative branches of the government cannot be required by judicial interpretation of the Constitution to provide any particular benefit or service to anyone. Even when the government chooses to fund a particular benefit, it is free to condition that benefit with virtually no judicially enforceable limits on that discretion.     

Patient Protection and Affordable Care Act; establishment of exchanges and qualified health plans; exchange standards for employers. Final rule, Interim final rule

This final rule will implement the new Affordable Insurance Exchanges ("Exchanges"), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.     

Morality, social norms and the rule of law as transaction cost-saving devices: the case of ancient Athens

The importance of the institutional framework for economic development is widely accepted today and it is duly stressed in the economic literature. The protection of property rights, the enforcement of contracts and an efficient legal system are the pillars of the contemporary rule of law. However, formal institutions cannot function without being internalized by the citizens and without the strong backing of social norms. Morality and social norms are the major elements of the informal institutional structure, the social capital, which is also critical for social welfare and economic development. In this paper we will discuss both the formal and the informal institutional framework of Ancient Athens, which was a free market society with economic problems similar to contemporary market societies. Athenians developed a highly sophisticated legal framework for the protection of private property, the enforcement of contracts and the efficient resolution of disputes. Such an institutional framework functioned effectively, cultivating trust and protecting the security of transactions. This entire system however was based on social norms such as reciprocity, the value of reputation and widely accepted business ethics. Conformity to social norms as well as moral behavior was fostered by social sanction mechanisms (such as stigma) and moral education. The Athenian example is a further proof of the importance of morality and social norms as transaction cost-saving devices even in quite sophisticated legal systems. Their absence or decline leads inevitably to the need for more regulation and litigation and to a growing preference for clear-cut rules instead of discretionary standards. Athenian law was pioneering in the development of rules and institutional mechanisms suitable for the reduction of transaction costs, many of them surviving in the most complex contemporary legal systems.     

Perception of family social climate and physical aggression in the home

Physical aggression between spouses is a serious social problem. This study was designed to determine if social climate is different in the homes where aggression occurs than in nonviolent homes. Students were asked to report whether physical aggression between spouses occurred in their homes during their last 2 years of high school. They were also asked to complete the Marlowe-Crowne Social Desirability Scale (MC-SDS) and the Family Environment Scale (FES). Each student protocol with reported conjugal violence was matched with another protocol with an identical score on the MC-SDS and on which physical aggression was not reported. A multivariate analysis of variance indicated that these two groups differed in their scores on the FES. A dominance hierarchy, openly expressed anger, conflict, and lack of organization were salient characteristics of homes where physical aggression occurred. Nonviolent families were characterized by spontaneous expression of feelings and problems, shared pleasurable activities and goals, and an emphasis on personal rights and freedoms.     

Policy feedback and public opinion: the role of employer responsibility in social policy

This study extends the literature on policy feedback and explores the extent to which public attitudes reflect learning from past government initiatives. We analyze the ways in which feedback mechanisms affecting public attitudes may differ from those earlier identified in the literature. We apply this general analytic framework to help explain variation in public attitudes toward private employer involvement in health care, explore possible causal pathways, and offer some preliminary empirical tests of these hypotheses. There are different levels of public support for the notion of employer obligation involving medical care, long-term care, and the treatment of substance abuse. Our evidence suggests that lessons about the performance of institutions in each of these policy domains represent the most important effect of existing policy on public attitudes. Furthermore, these differences correspond to what one would expect based on our model of policy feedback and cannot be explained by other plausible sources of policy legitimacy.     

BREXIT,democracy and the rule of law

This article employs the image of the antisyzygy, the yoking of opposites, as an analytical tool to understand the dynamic and unresolved tensions built into the very idea of the European Union. It describes the EU as a forming a supranational constitutional space which does not supersede nation states, but instead seeks to preserve their specific identities while promoting and protecting the fundamental values they are called upon to embody as liberal constitutional democracies. The article then critically examines constitutional developments in the UK subsequent to its decision to leave the European Union and suggests that, paradoxically, it may have been the European Union which held the post-War post-imperial United Kingdom together and, without it and outside it, we may anticipate the UK's imminent dissolution into its original constituent nations – Brexit leads inexorably to BreUK-up.     

权利合法行使与权利滥用——兼析华为公司集体辞职事件公司之行为

针对2007年底华为公司集体辞职事件中有关华为公司的行为定性,主要集中在,它的行为是合法行为还是权利滥用。论文先从理论上对权利合法行使与权利滥用进行界定并提出认定标准,后从实证角度对华为公司的行为展开分析,定性其行为构成权利滥用。     

Time is running out--the burdens and challenges of HIPAA compliance: a look at preemption analysis,the "minimum necessary" standard,and the notice of privacy practices

Ms. Guthrie's paper involves the final Privacy Regulations promulgated by the Department of Health and Human Services pursuant to HIPAA. Her thesis highlights three burdensome requirements which remain significant obstacles to the compliance date of April 14, 2003: (1) the need to undertake thorough preemption analyses, (2) lack of clarity surrounding the "Minimum Necessary Standard," and (3) confusion regarding the "Notice of Privacy Practices." Ms. Guthrie provides a close analysis of these three areas and offers several viable and persuasive alternatives to the associated burdens. She concludes that HHS must make several integral modifications and provide substantial and continuing guidance to covered entities in order for the Regulations to effectively achieve their purpose.     

Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule

The Food and Drug Administration (FDA) is amending the medical device regulations governing procedures for premarket notification, premarket approval, classification, performance standards development, banning devices, and availability of regulatory hearings to conform these procedures to applicable provisions of the Safe Medical Devices Act of 1990 (the SMDA). Its publication promotes clarity and certainty to regulated industry and thus fosters economic growth by correcting the provisions in FDA's existing regulations to conform them to the now-governing statutory provisions.