Research ethics paperwork: What is the plot we seem to have lost?

© 2004 BMJ Publishing GroupResearchers in the United Kingdom now have to submit their study proposals to local research ethics committees using a nationally standardised form. The form overcomes the problem of inconsistencies in the paperwork required by different committees.(1 2) It is incredibly long, however, and threatens to overwhelm both committees and investigators with paperwork.(2-4) The administrative burden is likely to be increased by the advent of a research management and governance framework for health and social care(5) and the requirement for ethical clearance for all research by students on humans, including their tissues or data.(6) Current trends are not sustainable in terms of time, money, or their impact on the environment, and it seems we have lost the plot. In this article, I examine how we can streamline the process

ABC of smoking cessation - Policy priorities for tobacco control

© 2004 BMJ Publishing Group Ltd.Although many countries have implemented strategies for reducing tobacco use at individual and population level, no country to date has adopted a truly comprehensive control programme. In addition, the tobacco industry and the strategies it uses to counteract policies on tobacco control and thereby maintain and develop its commercial markets have both continued to evolve. All communities therefore face at least some “unfinished business” in relation to tobacco control, and those working in smoking cessation need to be familiar with the necessary policy responses

Mining Sandboxes

Modern software is ubiquitous, yet insecure. It has the potential to expose billions of humans to serious harm, up to and including losing fortunes and taking lives. Existing approaches for securing programs are either exceedingly hard and costly to apply, significantly decrease usability, or just don’t work well enough against a determined attacker. In this thesis we propose a new solution that significantly increases application security yet it is cheap, easy to deploy, and has minimal usability impact. We combine in a novel way the best of what existing techniques of test generation, dynamic program analysis and runtime enforcement have to offer: We introduce the concept of sandbox mining. First, in a phase called mining, we use automatic test generation to discover application behavior. Second, we apply a sandbox to limit any behavior during normal usage to the one discovered during mining. Users of an application running in a mined sandbox are thus protected from the application suddenly changing its behavior, as compared to the one observed during automatic test generation. As a consequence, backdoors, advanced persistent threats and other kinds of attacks based on the passage of time become exceedingly hard to conduct covertly. They are either discovered in the secure mining phase, where they can do no damage, or are blocked altogether. Mining is cheap because we leverage fully automated test generation to provide baseline behavior. Usability is not degraded: the sandbox runtime enforcement impact is negligible; the mined behavior is comprehensive and presented in a human readable format, thus any unexpected behavior changes are rare and easy to reason about. Our BOXMATE prototype for Android applications shows the approach is technically feasible, has an easy setup process, and is widely applicable to existing apps. Experiments conducted with BOXMATE show less than one hour is required to mine Android applications sandboxes, requiring few to no confirmations for frequently used functionality.Moderne Software ist allgegenwärtig und zeitgleich unsicher. Dies stellt ein Risiko dar, welches Milliarden Menschen verwundbar gegenüber Schadsoftware macht und dessen Folgen sich bis hin zu Vermögensverlust und Lebensgefahr ausweiten können. Gegenwärtige Ansätze zur Gewährleistung der Sicherheit in Computerprogrammen gestalten sich entweder höchst kompliziert und aufwendig, beeinflussen massiv die Benutzbarkeit oder aber stellen sich als nicht effektiv genug gegen resolute Angreifer heraus. In dieser Arbeit präsentieren wir einen neuen Lösungsansatz, welcher die Sicherheit einer Applikation drastisch erhöht, zeitgleich sowohl kostengünstig als auch einfach einzusetzen ist und ferner nur minimalen Einfluss auf die Benutzbarkeit des Programmes nimmt. In einem neuartigen Verfahren kombinieren wir die Vorteile von etablierten Methoden der Testgenerierung, dynamischer Programmanalyse und kontrolliert restriktiver Laufzeitumgebung und stellen das Konzept des Sandbox Mining vor. Im ersten Schritt verwenden wir automatische Testgenerierung in der Mining Phase, um das Verhalten der Applikation zu erkunden und zu beobachten. In einer weiteren Phase verwenden wir eine sogenannte Sandbox, um jegliches bisher nicht beobachtete Verhalten der Applikation während des normalen Betriebes zu unterbinden. Bei Nutzung einer Applikation in solch einer Sandbox sind Nutzer somit geschützt vor plötzlicher Änderung des Verhaltens der Applikation im Vergleich zu dem bereits beobachteten Verhalten während der Testgenerierung. Folglich sind Hintertüren, komplexe, persistente Bedrohungen sowie andere Angriffe, welche auf der Verzögerung ihrer Durchführung beruhen außerordentlich schwer umzusetzen, ohne dass diese dabei entdeckt werden. Diese Bedrohungen werden entweder während der abgesicherten Mining Phase, in welcher sie keinen Schaden anrichten können, entdeckt oder werden während der Ausführung in der Sandbox verhindert. Der Mining-Prozess ist günstig in seiner Umsetzung, da das normale Verhalten des Programmes vollkommen automatisch erlernt wird. Zur gleichen Zeit bleibt die Benutzbarkeit des Programmes unbeeinflusst und der Mehraufwand der Laufzeitabsicherung durch die Sandbox vernachlässigbar gering. Ferner ist das erlernte Verhalten verständlich und in einem von Menschen lesbaren Format aufbereitet; daher sind jegliche unvorhergesehenen Änderungen im Verhalten des Programmes selten und einfach zu erklären. Unser BOXMATE Prototyp für Android Applikationen zeigt, dass das Verfahren technisch realisierbar ist, einen einfachen Einrichtungsprozess bietet und weitflächig anwendbar auf bestehende Applikation ist. Bei der Durchführung von Versuchen mit BOXMATE hat sich gezeigt, dass es weniger als eine Stunde bedarf um Sandboxes für Android Applikation zu generieren und es derweil nur wenige oder gar keine Konfirmation der Regeln für die häufig genutzten Funktionen erfordert

Biobank: Who'd bank on it?

The document attached has been archived with permission from the editor of the Medical Journal of Australia. An external link to the publisher’s copy is included

Epidural block and outcome after major surgery

The document attached has been archived with permission from the editor of the Medical Journal of Australia. An external link to the publisher’s copy is included.Paul S Myles, Ian Power and Konrad Jamrozi

Quality, morale and the new contract with GPs

In UK general practice the goodwill that has sustained the GP workforce is waning

The association between C-reactive protein concentration and depression in later life is due to poor physical health: results from the Health in Men Study (HIMS)

Background C-reactive protein (CRP) is a non-specific marker of inflammation that has been associated with depression and vascular disease, particularly in men. This study aimed to investigate the association between high CRP concentration and depression while taking physical health into account. Method A cross-sectional study of a community-dwelling sample of 5438 men aged 70+. Participants with scores 7 on the 15-item Geriatric Depression Scale (GDS-15) were considered to display clinically significant depressive symptoms. We measured the serum concentration of CRP with a high-sensitivity assay. The assessment of physical co-morbidity included three components: the Charlson weighted index, self-report of major health events on a standardized questionnaire, and the physical component of the 36-item Short-Form Health Survey (SF-36). Other measured factors included age, native language, education, a standardized socio-economic index, smoking, prior or current history of depression treatment, cognitive impairment (Mini-Mental State Examination score 3 mg/l had an increased odds ratio (OR) [1·59, 95% confidence interval (CI) 1·20–2·11] of being depressed compared to men with CRP 3 mg/l. This association became non-significant once we adjusted the analysis for the measures of physical co-morbidity and other confounding factors (OR 1·22, 95% CI 0·86–1·73). Conclusions The physiological mechanisms that lead to the onset and maintenance of depressive symptoms in older men remain to be determined, but CRP concentration is unlikely to play a significant role in that process.Osvaldo P. Almeida, Paul Norman, Graeme J. Hankey, Konrad Jamrozik and Leon Flicke

Association of Maternal Smoking and Alcohol Consumption with Young Adults' Cannabis Use: A Prospective Study

This 2006 study examined 1) whether maternal use of tobacco and consumption of alcohol when a child is 5 and 14 years of age predict cannabis use in young adults, and 2) whether this association is explained by possible confounding or mediating factors. Data were taken from a prospective birth cohort study of mothers and their children in Brisbane, Australia. This study was based on a cohort of 3,176 young adults who participated at the 21-year follow-up of the study and for whom data were available on maternal smoking and alcohol consumption 5 and 14 years after their birth. After controlling for possible confounders, the authors found that maternal smoking at 14 years was associated with frequent use of cannabis in offspring at 21 years, regardless of maternal smoking at 5 years. Children of mothers who drank more than one glass of alcohol at 5 years and continued at 14 years were more likely to use cannabis in early adulthood. The association between maternal substance use and offspring cannabis use was partially mediated by adolescent externalizing behavior and smoking measured at 14 years. Prevention programs that address maternal and adolescent tobacco use and adolescent externalizing behavior should be considered as strategies to reduce cannabis use by young adult

The Association of C-Reactive Protein and CRP Genotype with Coronary Heart Disease: Findings from Five Studies with 4,610 Cases amongst 18,637 Participants

Background: It is unclear whether C-reactive protein (CRP) is causally related to coronary heart disease (CHD). Genetic variants that are known to be associated with CRP levels can be used to provide causal inference of the effect of CRP on CHD. Our objective was to examine the association between CRP genetic variant +1444C>T (rs1130864) and CHD risk in the largest study to date of this association.Methods and Results: We estimated the association of CRP genetic variant +1444C>T (rs1130864) with CRP levels and with CHD in five studies and then pooled these analyses (N= 18,637 participants amongst whom there were 4,610 cases). CRP was associated with potential confounding factors (socioeconomic position, physical activity, smoking and body mass) whereas genotype (rs1130864) was not associated with these confounders. The pooled odds ratio of CHD per doubling of circulating CRP level after adjustment for age and sex was 1.13 (95% CI: 1.06, 1.21), and after further adjustment for confounding factors it was 1.07 (95% CI: 1.02, 1.13). Genotype (rs1130864) was associated with circulating CRP; the pooled ratio of geometric means of CRP level among individuals with the TT genotype compared to those with the CT/CC genotype was 1.21 (95% CI: 1.15, 1.28) and the pooled ratio of geometric means of CRP level per additional T allele was 1.14 (95% CI: 1.11, 1.18), with no strong evidence in either analyses of between study heterogeneity (I-2 = 0%, p>0.9 for both analyses). There was no association of genotype (rs1130864) with CHD: pooled odds ratio 1.01 (95% CI: 0.88, 1.16) comparing individuals with TT genotype to those with CT/CC genotype and 0.96 (95% CI: 0.90, 1.03) per additional T allele (I-2<7.5%, p. 0.6 for both meta-analyses). An instrumental variables analysis (in which the proportion of CRP levels explained by rs1130864 was related to CHD) suggested that circulating CRP was not associated with CHD: the odds ratio for a doubling of CRP level was 1.04 (95% CI: 0.61, 1.80).Conclusions: We found no association of a genetic variant, which is known to be related to CRP levels, (rs1130864) and having CHD. These findings do not support a causal association between circulating CRP and CHD risk, but very large, extended, genetic association studies would be required to rule this out