Drug Trials in Children: Ethical, Legal, and Practical Issues

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/97247/1/j.1552-4604.1994.tb01996.x.pd

Status of national research bioethics committees in the WHO African region

BACKGROUND: The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. METHODS: This is a descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ(2)) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. RESULTS: The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. CONCLUSION: In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research

Water incident related hospital activity across England between 1997/8 and 2003/4: a retrospective descriptive study

Every year in the United Kingdom, 10,000 people will die from accidental injury and the treatment of these injuries will cost the NHS £2 billion and the consequences of injuries received at home cost society a further £25 billion [1]. Non-fatal injuries result in 720,000 people being admitted to hospital a year and more than six million visits to accident and emergency departments each year [2]. Drowning is the second leading cause of unintentional injury mortality globally behind road traffic injuries. It is estimated that a total of 409, 272 people drown each year [3]. This equates to a global incident rate of 7.4 deaths per 100, 000 people worldwide and relates to a further 1.3 million Disability Adjusted Life Years (DALYs) which are lost as a result of premature death or disability [4]. 'Death' represents only the tip of the injury "iceberg" [5]. For every life lost from an injury, many more people are admitted to hospital, attend accident and emergency departments or general practitioners, are rescued by search and rescue organisations or resolve the situation themselves. It is estimated that 1.3 million people are injured as a result of near drowning episodes globally and that many more hundreds of thousands of people are affected through incidents and near misses but there are no accurate data [4]. The United Kingdom has reported a variable drowning fatality rate, the injury chart book reports a rate of 1.0 – 1.5 per 100,000 [6] and other studies suggest a rate as low as 0.5 per 100, 000 population [7] for accidental drowning and submersion, based on the International Classification of Disease 10 code W65 – 74, however, the problem is even greater and these Global Burden of Disease (GDB) figures are an underestimate of all drowning deaths, since they exclude drownings due to cataclysms (floods), water related transport accidents, assaults and suicide [3]. A recent study in Scotland highlighted this underestimation in drowning fatality data and found that the overall death rate due to drownings in Scotland 3.26 per 100,000 [8]. Even though drowning fatality rates in the United Kingdom vary, little is known about the people who are admitted to hospital after an incident either in or on water. This paper seeks to address this gap in our knowledge through the investigation of the data available on those admitted to NHS hospitals in England

Risks of High-Powered Motorcycles Among Younger Adults

Objectives. We assessed whether policies designed to safeguard young motorcyclists would be effective given shifts in ownership toward high-powered motorcycles. Methods. We investigated population-wide motor vehicle driver and motorcyclist casualties (excluding passengers) recorded in Britain between 2002 and 2009. To adjust for exposure and measure individual risk, we used the estimated number of trips of motorcyclists and drivers, which had been collected as part of a national travel survey. Results. Motorcyclists were 76 times more likely to be killed than were drivers for every trip. Older motorcyclist age-strongly linked to experience, skill set, and riding behavior-did not abate the risks of high-powered motorcycles. Older motorcyclists made more trips on high-powered motorcycles. Conclusions: Tighter engine size restrictions would help reduce the use of high-powered motorcycles. Policymakers should introduce health warnings on the risks of high-powered motorcycles and the benefits of safety equipment

Does the quality and outcomes framework reduce psychiatric admissions in people with serious mental illness? A regression analysis

BackgroundThe Quality and Outcomes Framework (QOF) incentivises general practices in England to provide proactive care for people with serious mental illness (SMI) including schizophrenia, bipolar disorder and other psychoses. Better proactive primary care may reduce the risk of psychiatric admissions to hospital, but this has never been tested empirically.MethodsThe QOF data set included 8234 general practices in England from 2006/2007 to 2010/2011. Rates of hospital admissions with primary diagnoses of SMI or bipolar disorder were estimated from national routine hospital data and aggregated to practice level. Poisson regression was used to analyse associations.ResultsPractices with higher achievement on the annual review for SMI patients (MH9), or that performed better on either of the two lithium indicators for bipolar patients (MH4 or MH5), had more psychiatric admissions. An additional 1% in achievement rates for MH9 was associated with an average increase in the annual practice admission rate of 0.19% (95% CI 0.10% to 0.28%) or 0.007 patients (95% CI 0.003 to 0.01).ConclusionsThe positive association was contrary to expectation, but there are several possible explanations: better quality primary care may identify unmet need for secondary care; higher QOF achievement may not prevent the need for secondary care; individuals may receive their QOF checks postdischarge rather than prior to admission; individuals with more severe SMI may be more likely to be registered with practices with better QOF performance; and QOF may be a poor measure of the quality of care for people with SMI

In Utero Exposure to Dioxins and Polychlorinated Biphenyls and Its Relations to Thyroid Function and Growth Hormone in Newborns

The aim of this study is to examine the association between transplacental exposure to dioxins/polychlorinated biphenyls (PCBs) and thyroid and growth hormones in newborns. We recruited 118 pregnant women, between 25 and 34 years of age, at the obstetric clinic. Personal data collected included reproductive and medical histories and physical factors. Clinicians gathered placental and umbilical cord serum upon delivery and carefully scored the 118 newborns, making both structural and functional assessments. We analyzed placentas for 17 polychlorinated dibenzo-p-dioxins and dibenzofurans and 12 dioxin-like PCB congeners with the World Health Organization–defined toxic equivalent factors, and six indicator PCBs by high-resolution gas chromatography and high-resolution mass spectrometry. We analyzed thyroid and growth hormones from cord serum using radioimmunoassay. Insulin-like growth factor (IGF)-1, IGF-binding globulin-3, and thyroxine × yroid-stimulating hormone (T(4) × TSH) were significantly associated with increased placental weight and Quetelet index (in kilograms per square meter; correlation coefficient r = 0.2–0.3; p < 0.05). Multivariate analyses showed independently and significantly decreased free T(4) (FT(4)) × TSH with increasing non-ortho PCBs (r = −0.2; p < 0.05). We suggest that significant FT(4) feedback alterations to the hypothalamus result from in utero exposure to non-ortho PCBs. Considering the vast existence of bioaccumulated dioxins and PCBs and the resultant body burden in modern society, we suggest routine screening of both thyroid hormone levels and thyroid function in newborns

A long-lasting measles epidemic in Maroua, Cameroon 2008-2009: mass vaccination as response to the epidemic.

A measles outbreak occurred in Maroua, Cameroon, from January 2008 to April 2009. In accordance with recent World Health Organization guidelines, an outbreak-response immunization (ORI) was conducted in January 2009. The aim of this study was to investigate the causes of the epidemic in order to guide vaccination strategies

The effects of symptom overreporting on PTSD treatment outcome

Background: It is often assumed that individuals with posttraumatic stress disorder (PTSD) who overreport their symptoms should be excluded from trauma-focused treatments. Objective: To investigate the effects of a brief, intensive trauma-focused treatment programme for ndividuals with PTSD who are overreporting symptoms. Methods: Individuals (n = 205) with PTSD participated in an intensive trauma-focused treatment programme consisting of EMDR and prolonged exposure (PE) therapy, physical activity and psycho-education. Assessments took place at pre- and post-treatment (Structured Inventory of Malingered Symptomatology; SIMS, Clinician Administered PTSD Scale for DSM-5; CAPS-5). Results: Using a high SIMS cut-off of 24 or above, 14.1% (n = 29) had elevated SIMS scores (i.e. ‘overreporters’). The group of overreporters showed significant decreases in PTSDsymptoms, and these treatment results did not differ significantly from other patients. Although some patients (35.5%) remained overreporters at post-treatment, SIMS scores decreased significantly during treatment. Conclusion: The results suggest that an intensive trauma-focused treatment not only is a feasible and safe treatment for PTSD in general, but also for individuals who overreport their symptoms