Data and Safety Monitoring Boards: Some Enduring Questions

Data Safety and Monitoring Boards (DSMBs) have been referred to as a "growth industry," and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to change. The recently appointed director of the Office for Human Research Protections (OHRP), Jerry Menikoff, is on record as regarding current practices — where consent forms often promise what the DSMB has been assembled to specifically not provide — as constituting fraudulent behavior. That is, a subject may inherently rely on, to their detriment, information that has been misrepresented in the consent document. In this paper, we assemble some of the enduring questions and top them off with Menikoff's tour de force to present what we hope will be a compelling argument to require that consent forms fairly represent what the DSMB will do — and not do — with trial data as they accumulate. We argue that DSMBs should be used only in rare circumstances, and question the practice of precluding principal investigators from DSMB membership, but our main thrust is to ensure that DSMBs, when used at all, are properly described in trial consent forms.     

GSR2005--continuity of the ENFSI proficiency test on identification of GSR by SEM/EDX.

Within the framework of the ENFSI Expert Working Group "Firearms" a proficiency test on the detection and identification of GSR by energy-dispersive scanning electron microanalysis (SEM/EDX) is carried out in a 2 years term. The latest test was performed in 2005/2006 and was denoted as GSR2005. Seventy-five laboratories from 28 countries participated in this proficiency test and submitted in total 83 independent data-sets. The participating laboratories were requested to determine the total number of PbSbBa containing particles on a synthetic test sample following their own laboratory specific methods of automated GSR particle search and detection by SEM/EDX. Furthermore size and position of the detected particles had to be reported by the laboratories and were evaluated statistically. The results were compiled by means of z-scores according to the IUPAC and EURACHEM guidelines-assessing individual laboratory achievements (inter-laboratory) as well as intra-laboratory performance-and were compared to the results of the previous proficiency test run GSR2003 (1). The comparison shows that there is a noticeable improvement in the method's detection capability.     

Fatal intoxication due to tramadol alone: case report and review of the literature

Poisoning may also lead to both coma and multiple organ failure, also in youngsters without a known major medical history. As not all toxic agents are routinely screened when a poisoning is suspected, it is useful to consider less frequently encountered poisons in certain cases. We describe the occurrence of asystole and multiple organ failure which occurred in a young man after a suspected tramadol overdose. The tramadol concentration on admission in the ICU was indeed 8 microg/ml (mg/l), far above the therapeutic range. Subsequently, the patient developed severe acute liver failure, finally leading to death. Post-mortem toxicology did not reveal any other poison responsible for this unfavourable course as only very high serum and tissue tramadol and desmethyltramadol concentrations were found. Only a few fatal poisonings attributable to tramadol alone, as observed in our case, have been reported. An overview of these cases is presented.     

Legal Education,Institutional Skills and European Union Opinions

A cluster of issues in the context of legaleducation shows the importance of legalsemiotics: new forms of citizenship, new ideas on e-education, the recent design ofe-educational programs that focus the featuresof institutional life, the concept of a`learning society' are this cluster's elements.Opinions of European Union Institutions stimulate to conceive modern society in thelight of these issues. It leads to theformulation of a fifth freedom in the Union,(after freedom of persons and goods, servicesand capital) which is the freedom toparticipate in a ``learning society'. Thepractice of that freedom leads to developinge-educational programs for institutionalskills.     

Reiterating the Literal

International Journal for the Semiotics of Law - Revue internationale de Sémiotique juridique - Taking the letter of the law literally would equal the death of our hopeand expectation that law...     

The marriage license as a hitting license: A comparison of assaults in dating,cohabiting, and married couples

There are many studies of marital and dating violence. However, methodological differences between these studies make it difficult to determine differences in the nature and extent of physical assault between marital status groups. This paper helps fill that gap by analyzing data from two surveys: a study of 526 dating couples at a large midwestern university, and a study of a national probability sample of 5005 married and 237 cohabiting couples. The results show that cohabiting couples have a higher rate of assault than dating and married couples. These findings persist after controls for age, education, and occupational status are introduced. Violence is also more severe in cohabiting than dating or married couples. A number of factors may account for the more frequent violence in cohabiting relationships. These include social isolation, the issue of autonomy and control, and the investment in the relationship.     

The Political Economy of Crisis Management in East–Central European Countries

The financial and economic crisis in the Central and East European countries raised the profile of economic policy themes that relate to the role of taxation and state spending. The key policy differences related to public budgets and support for a demand stimulus. Responses fall broadly into two categories that we link to a social-democratic and a neo-liberal response. The distinction indicates that the policy responses were linked to the party affiliation of the government on the left–right spectrum. There were some remarkable common trends that cannot be explained by the logical requirements of the economic situation alone. There are differences in timing and in severity, but every country has at some point moved towards a policy of balancing the budget by making cuts. In all cases there were cuts in benefits for marginal groups in society and a switch towards indirect rather than direct taxes. These carry clear distributional implications.