Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.     

Survival analysis: A survey

This paper is a survey of statistical methods used to analyze the length of time until a specified event occurs. These models have often been used to analyze the survival times (i.e., time until death) of medical patients, and so the term survival analysis is natural. In criminology, the main application of these models has been to analyze the time until recidivism, but many other applications are possible. The paper summarizes the statistical literature on survival analysis, and describes its applications in criminology. The methods are illustrated by an application to the prediction of time until recidivism for a sample of North Carolina prison releasees.     

Toxicological analysis after asphyxial suicide with helium and a plastic bag

A 23-year-old man was found on a raised hide in lying position, the head wrapped in a plastic bag connected with a helium gas cylinder by a polypropylene tube. The autopsy did not show any specific findings nor did the routine toxicological analysis reveal significant information regarding the cause of death (BAC 0.9 mg/g, diphenhydramine 0.81 μg/ml in heart serum). For the detection of helium in the lungs, gas samples from both lungs were collected by a method ensuring minimal dilution. Gas analyses were performed using a GC–MS with a split–splitless injector and a headspace syringe. As carrier gas the commonly used helium was replaced by nitrogen. Helium was found in clearly elevated concentrations in gas samples from both lungs. Therefore, suffocation by breathing helium enriched, and thus oxygen deficient atmosphere, can strongly be assumed as the cause of death.     

The Trade Union Movement and the European Union: Judgment Day

Abstract: The trade union movement faces a challenge to the legality of transnational collective action as violating economic freedoms in the EC Treaty. How are disparities in wages and working conditions among the Member States to be accommodated? Are national social models protected? Does the internal market allow for trade union collective action? How does EU law affect the balance of economic power in a transnational economy? What is the role of courts in resolving economic conflicts? This article analyses the responses to these questions as referred to the European Court of Justice by the English Court of Appeal and offers some conclusions. The purpose is to highlight the different positions adopted by the old Member States and the new accession Member States as regards the underlying substantive issues, and the options available to the Court of Justice in answering the questions posed.     

Managing generic competition and patent strategies in the pharmaceutical industry

Legal context: The income streams of originating pharmaceutical manufacturersare under pressure as never before, from increasing R&Dcosts, regulatory pressures, and competition from generic manufacturers.This article examines the various strategies which originatingpharmaceutical manufacturers have adopted in response to thesethreats. Key points: The authors consider various strategies, including SupplementaryProtection Certificates, life-cycle management (‘evergreening’),second pharmaceutical use claims, trade marks, and the use ofdata exclusivity and interim injunctions, in order to prolongthe protection given to existing products, and to manage competitionfrom generic manufacturers. Practical significance: The authors also include two real-life case studies in orderto illustrate the practical applications of the strategies discussedin the article.     

School violence prevention measures: School officials' attitudes about various strategies

Concern about school violence has been escalating in recent years. A variety of strategies are used in efforts to prevent violence in schools. These remedies can be classified as legal, interactionist, and physical remedies. Legal remedies refer to laws, like the reasonable suspicion to search strategy that allows school officials to search and seize contraband. Interactionist remedies refer to practices that encourage students and other school officials to communicate more openly with school officials about possible cases of violence. Physical remedies refer to strategies that involve altering the school environment in an effort to prevent violence. This study considered the way that 138 school officials from the Commonwealth of Virginia defined the usefulness of these strategies. Attention was also given to whether certain factors contribute to the officials' assessments of the efficacy of each prevention strategy. Results of the study showed that the interactionist, and then legal remedies are believed to be the most useful, while physical remedies are perceived as the least useful strategies. The study uncovered differences of opinion based on racial lines. As an example, more Blacks than Whites were more likely to describe metal detectors as a very useful strategy. Implications of the study are provided.