Reaching a Balance Between Privacy,Privilege and Planning: A Look at Barriers to Obtaining Information for Patients with Criminal Involvement

Persons with serious and persistent mental disorders present unique problems for the criminal justice system. The challenges are tremendous as courts venture into problem solving models, attempting to integrate mental health services with the criminal justice system. Gathering and accessing confidential information is often difficult. This article will identify and explore the legal issues related to obtaining such information.     

医疗纠纷处理的新情况和新问题

医疗纠纷案例的鉴定、诉讼、赔偿等方面的数据，反映出医疗纠纷数量持续且迅速增长的现象；医疗纠纷出现了一些新的类型和结构；医疗纠纷诉讼案的审理情况发生了较大的变化。医疗纠纷诉讼的审理应遵照过错归责原则，并坚持举证责任由原被告双方合理分担。通过讨论侵权行为法发展的一些重要趋势，分析了法律发展大环境与医疗纠纷现状之间的关系。     

Slot Machine Structural Characteristics: Creating Near Misses Using High Award Symbol Ratios

A near miss is a failure that was close to a win. In this paper we analyze the primary documents associated with a case that was brought before the Nevada Gaming Commission in 1988. This case resulted in the 1989 ruling that the proprietary computer algorithms used by one slot machine manufacturer to create a high number of near misses on the payline are “unacceptable,” whereas the use of virtual reel mapping to create near misses above and below the payline is acceptable. We show how, before and after 1989, slot machine manufacturers use virtual reels and a technique called “award symbol ratio” to create a high number of near misses above and below the payline and how this acceptable practice has the unintended effect of also creating near misses on the payline which can be explained by a software concept called feature interaction. The paper concludes with a discussion of the implications of near misses for problem gambling.     

U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems.     

依法加强对医疗废物的管理

论述了制定《医疗废物管理条例》的必要性和《医疗废物管理条例》的基本原则、思路,介绍了国际上医疗废物管理的状况和国务院颁发的《医疗废物管理条例》的主要内容。     

Shifting sands: the complexities and uncertainties of the evolving US regulatory,policy, and scientific landscape for biospecimen research

Human tissue biorepositories and the biospecimens they provide play a critical role in advancing research and medical care, especially in supporting research to develop precision medicine. However, advancements in genomics, informatics, and other sophisticated technologies and extensive biospecimen and data sharing have raised questions about how best to protect research participants. Complex ethical issues remain unresolved, such as the identifiability of biospecimens and associated data, the best consent models for future research, ownership and commercial use of biospecimens, and return of individual research results.This review summarizes the relevant US regulations and recent changes to them, as well as current and future ethical and policy issues related to biospecimen research. Because many issues remain unresolved, additional policy development will be needed. We discuss approaches for how researchers and other stakeholders can provide input to ensure that these policies will protect research participants while facilitating research important for scientific and medical advancements.     

Comparative analysis of national regulations concerning blood safety across Europe

In October 2001, representatives of 17 European countries (Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Italy, Macedonia, Romania, Slovenia, Spain, Turkey and UK) met in Sarajevo at a course organized by the European School of Transfusion Medicine to discuss their countries' regulations concerning different aspects of the safety of blood transfusion. Results are summarized in tables to facilitate comparisons. Most countries (13/17) have specific transfusion laws and 9/17 have hospital-based systems as opposed to national organizations. Quality assurance is common among investigated countries (14/17). Voluntary associations are responsible for donor promotion in the majority of countries (13/17). Exclusively, voluntary non-remunerated donors are found in 5/17 countries, whereas in the remaining ones, incentives, family replacement and remuneration are mechanisms stimulating blood donation. Medical doctors using official selection criteria are checking donor suitability in virtually all countries, which also perform main microbiological testing. Regulations on good clinical use of blood and derivatives are present in most countries but applied only in some. Although the data presented need to be interpreted with some caution, this preliminary analysis shows that, although some significant differences still exist, the majority of countries studied are moving in the same direction to ensure safety of their blood supply.     

化疗药物配制时是否严格遵守卫生防护规范所致职业危害的回顾性前瞻研究

目的 回顾分析化疗药物配制时是否严格遵守卫生防护规范所致职业危害的差异性.方法 按照既定标准随机选择吉林省肿瘤医院220名在职护士为调查对象,回顾过去半年是否严格遵守《抗肿瘤药物应用的卫生防护规范》进行抗肿瘤药物操作,从严格和未严格遵守防护规范护士中各随机选择73名护士分别作为标准组和非标准组研究对象,观察两组护士白细胞下降、脱发、皮肤过敏的出现人数,检测肝功能(ALT、AST)数值,比较两组护士相应指标之间的差异是否具有统计学意义.结果 标准组73名护士中,19例出现白细胞下降,15例出现脱发,18例出现皮肤过敏,ALT为(11.83±5.73)IU/L,AST为(18.11±3.70)IU/L;非标准组73名护士中,48例出现白细胞下降,28例出现脱发,39例出现皮肤过敏,ALT为(15.82±10.28)IU/L,AST为(20.65±4.70)IU/L,假设检验表明两组护士白细胞下降、脱发和皮肤过敏发生率以及肝功能(ALT、AST)观测值之间的差异均有统计学意义.结论 严格遵守《抗肿瘤药物应用的卫生防护规范》的护理人员能够有效降低职业危害,肿瘤化疗护士在应用抗肿瘤药物时要严格按照防护标准进行操作,管理人员应通过培训加强监管等手段增强其防护意识.     

Population impact of regulatory activity restricting prescribing of COX-2 inhibitors: ecological study

AIMS

To investigate impacts of withdrawal and regulatory advice regarding cyclooxygenase-2 (COX-2) inhibitors on UK population rates of gastrointestinal haemorrhage and acute myocardial infarction (MI).

METHODS

Ecological time series study of prescribing, mortality and hospital admission trends in people aged ≥55 years.

RESULTS

Withdrawal and regulatory advice limiting COX-2 inhibitor availability from 2004 were temporally associated with reversal of previously unfavourable trends in emergency MI admissions among people aged ≥65 years. Annual admission rate trends changed from +4.6% to −3.1% (P < 0.001) among women and from +2.1% to −3.8% (P= 0.003) among men. Absolute changes in average annual trend in the number of individuals aged ≥65 years admitted following MI were from +981 (1999–2004) to −819 (2004–2006) per year for women and from +713 to −995 for men. No change in trend was apparent among people aged 55–64 years, or in MI mortality trends. There was some suggestion of an unfavourable change in admission trends for gastrointestinal haemorrhage among 55−64-year-olds, although this appeared to occur prior to COX-2 inhibitor withdrawal/regulation by up to 2 years. These trends were not apparent in older people, or in gastrointestinal haemorrhage mortality rates.

CONCLUSIONS

Withdrawal/regulation of COX-2 inhibitors was temporally associated with a favourable reversal of population-level hospital admission trends in MI among people aged ≥65 years. Unfavourable reversal of previous declines in gastrointestinal haemorrhage admissions probably occurred before changes in COX-2 inhibitor availability. Withdrawal/ regulation of COX-2 inhibitors did not appear to have any adverse impact on population health and may have been beneficial.     

香港中成药注册管理工作概述

目的让更多的人了解香港中成药注册审评的规定与要求,以促进香港中药及中药新药的研究与开发。方法对香港中成药注册的政策法规和香港中成药过渡性注册及非过渡性注册的有关规定进行介绍和分析。结果与结论香港中成药注册管理虽起步较晚,但规范性文件已经制订,其注册管理工作将愈加严格和规范。