Acceptable Risks in Pediatric Research: Views of the US Public

BACKGROUND AND OBJECTIVES: Critics argue that it is unethical to expose children to research risks for the benefit of others, whereas many regulations permit “net-risk” pediatric research but only when the risks are minimal. In the present survey, we assessed whether the US public agrees with these views and whether the US public’s views regarding the acceptability of net-risk pediatric research are influenced by its social value. METHODS: A 15-minute survey of a nationally representative sample of US adults. Participants were randomly assigned to 1 of 4 hypothetical scenarios involving procedures that pose increasing levels of risk. To assess whether respondents’ views on the acceptability of the risks is influenced by the social value of the research, in each of the 4 scenarios we described the respective procedure being used in 3 studies with increasing levels of social value. RESULTS: A total 1658 of the 2508 individuals who were sent the survey link participated (response rate = 66.1%). Approximately 91% approved of a research blood draw in minors, and ∼69% approved of a research bone marrow biopsy. The proportion who indicated that the respective procedure was acceptable increased as the study’s social value increased. This effect was significantly stronger for studies which pose greater risks compared with studies with lower risks (P < .001). CONCLUSIONS: The vast majority of the US public supports net-risk pediatric research that poses minimal risk, and a majority supports net-risk pediatric research that poses somewhat greater risks, provided it has high social value. These findings offer important information for assessing when it is acceptable to conduct net-risk pediatric research.

The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study

Big data trends in health research challenge the oversight mechanism of the Research Ethics Committees (RECs). The traditional standards of research quality and the mandate of RECs illuminate deficits in facing the computational complexity, methodological novelty, and limited auditability of these approaches. To better understand the challenges facing RECs, we explored the perspectives and attitudes of the members of the seven Swiss Cantonal RECs via semi-structured qualitative interviews. Our interviews reveal limited experience among REC members with the review of big data research, insufficient expertise in data science, and uncertainty about how to mitigate big data research risks. Nonetheless, RECs could strengthen their oversight by training in data science and big data ethics, complementing their role with external experts and ad hoc boards, and introducing precise shared practices.

Direct participation of people with communication disabilities in research on poverty and disabilities in low and middle income countries: A critical review

Introduction An estimated 1 billion people with disabilities live in low and middle income countries, a population that includes people with communication disabilities (PwCD). PwCD are a heterogenous group with a wide range of abilities who may be underrepresented in research due to the communication demands involved in research participation. Methods A critical analysis of 145 studies from a previously published systematic review was undertaken with the aim of documenting the opportunities for direct participation of PwCD in research on poverty and disability in low- and middle- income countries. Results The key finding was the high risk of underrepresentation of PwCD in research on poverty and disability in LMICs, despite low rates of explicit exclusion (n = 8; 5.5%). A total of 366 uses of data collection tools were analysed (255 unique tools). The majority of data collection tools had high communication demands (92.9%), including those measuring disability (88.6%) and those assessing poverty (100%). Only 22 studies (15.2%) specifically included PwCD. A subset of these studies (n = 14) presented disaggregated data in a way that allowed for analysis of outcomes for PwCD, suggesting a clear intersection between poverty and communication disability, with findings related to general poverty indicators, reduced access to education, low levels of employment, and additional expenditure. Conclusions The findings suggest a systematic underrepresentation of PwCD in research on poverty and disability with substantial implications for future policy and program planning, directly affecting the availability and provision of services and resources for this population. A failure to provide adequate opportunity for participation of PwCD in research risks leaving those with communication disabilities behind in the pursuit of global poverty eradication.

Resting state EEG in youth with ASD: age, sex, and relation to phenotype

Background Identification of ASD biomarkers is a key priority for understanding etiology, facilitating early diagnosis, monitoring developmental trajectories, and targeting treatment efforts. Efforts have included exploration of resting state encephalography (EEG), which has a variety of relevant neurodevelopmental correlates and can be collected with minimal burden. However, EEG biomarkers may not be equally valid across the autism spectrum, as ASD is strikingly heterogeneous and individual differences may moderate EEG-behavior associations. Biological sex is a particularly important potential moderator, as females with ASD appear to differ from males with ASD in important ways that may influence biomarker accuracy. Methods We examined effects of biological sex, age, and ASD diagnosis on resting state EEG among a large, sex-balanced sample of youth with (N = 142, 43% female) and without (N = 138, 49% female) ASD collected across four research sites. Absolute power was extracted across five frequency bands and nine brain regions, and effects of sex, age, and diagnosis were analyzed using mixed-effects linear regression models. Exploratory partial correlations were computed to examine EEG-behavior associations in ASD, with emphasis on possible sex differences in associations. Results Decreased EEG power across multiple frequencies was associated with female sex and older age. Youth with ASD displayed decreased alpha power relative to peers without ASD, suggesting increased neural activation during rest. Associations between EEG and behavior varied by sex. Whereas power across various frequencies correlated with social skills, nonverbal IQ, and repetitive behavior for males with ASD, no such associations were observed for females with ASD. Conclusions Research using EEG as a possible ASD biomarker must consider individual differences among participants, as these features influence baseline EEG measures and moderate associations between EEG and important behavioral outcomes. Failure to consider factors such as biological sex in such research risks defining biomarkers that misrepresent females with ASD, hindering understanding of the neurobiology, development, and intervention response of this important population.

Decolonizing Research Ethics

Globally, there is widespread agreement that research involving indigenous peoples must be conducted with the consent, consultation, or collaboration of communities. However, there are practical challenges to implementing this ideal. This chapter critically engages with scholarship on research ethics in relation to indigenous communities, focusing on the challenges inherent in the global movement toward decolonizing methodologies and indigenous governance of research. The chapter presents recommendations for a decolonizing approach to research ethics. It emphasizes that research institutions need to take seriously that an indigenous group has the right to say “no” to research that has been deemed ethical by an institutional research ethics board. The authors argue further that this requires attention to the “politics of risk,” including the ways in which collective identity and research risks are co-constructed.

Categories Wise Analysis of Risk Assessment in Highway Projects using R.P.V. Method

To minimize the adverse effects of highway construction hazards, it becomes imperative to evaluate the risk before planning and manage the risks. From design and planning until the project is completed, risks factors are present everywhere. To improve the effectiveness of a highway construction project, it becomes necessary to reduce the risk factor to a defined assessment for timely, safe, and economical completion. Identifying, classifying, and assessing different hazards in the design of highway a project is the focus of this research. Risks from legal proceedings, such as contract disputes, disputes between the government and other parties, land acquisition, and so on, are assessed, and cases are reported. After that, a site survey will be conducted among professionals to evaluate the likelihood of an event and the risk of impact. Extreme, High, Medium, Low, and Minimum are the five risk classes that must be assigned to risk. Risk factors are also rated according to their severity. In order to reduce the cost of the project, the maximum probability of the event and the maximum impact risk must be minimized. The most significant risk is as follows: Money/Funds, Heritage issues, Concerns around mineral mining, Utilities were not moved in a timely manner, Skilled Labour, Cost of land acquisition is uncertain, Schedule for land acquisition.

Aerospace monitoring in the problems for assessment of geoecological risks for accidental spills of oil and petroleum products

Оценка геоэкологических рисков на объектах нефтегазового комплекса непосредственно связана с обеспечением безопасности территорий, на которых они расположены. Особенно тяжелые последствия воздействия на экологическое состояние территорий оказывают аварийные разливы нефти и нефтепродуктов. Решение данного класса задач требует оценки уровня аварийного разлива и его классификации с позиций возникновения чрезвычайной ситуации. В статье рассмотрена возможность замены традиционных визуальных методов оценки разливов на разработанные автоматизированные и автоматические способы, использующие для решения задач классификации материалов аэрокосмических съемок. Приведены результаты автоматической классификации изображений мониторинговых наблюдений, которые имели место при аварийном разливе дизельного топлива в г. Норильске, аварии танкера на морской акватории о. Маврикий и аварии сухопутного нефтепровода. Полученные результаты показали работоспособность разработанных методов и возможность их использования в задачах инвентаризации и паспортизации аварийных разливов нефти на суше и акваториях. Purpose. The aim of this work is to ensure the environmental safety of the territories where the accidental spills of oil and oil products have occurred. They have a significant negative impact on the environment of land and water areas. To minimize their impact and eliminate the consequences, an “emergency” regime is introduced in Russia. Depending on the level of the oil spill, it may cover both the territory of a separate facility and a region, and the entire state as a whole. Methods. Traditionally, an estimate of the level of a spill is determined based on the mass of the spilled oil through visual observations from aircraft or ground measurements at selected points. This approach does not allow an accurate assessment of the total area of pollution, the nature of pollution inside the oil slick, as well as the dynamics of its spread over time. To eliminate these limitations, it is proposed to use systems of aerospace monitoring observations and automatic measurements of oil slick parameters: area, composition and mass. To solve this problem, the method of “comparison with the reference standard” was used. Here, samples of color gradations of oil and oil product spill spots proposed in the Bonn Agreement of 2004 were prepared as reference standards. Results. The method was implemented using the experimental software complex AGIR-TM (Aerospace, Geoinformatics, Research, Risks-Technological Modules) which was developed at the Department of Geoecology of the Gubkin Russian State University of Oil and Gas (NRU). During the experimental testing of this method, the work was carried out to assess the accidental spill in the following cases diesel fuel in Norilsk (2020), oil on a tanker in the water area of Mauritius (2020) and oil in an oil pipeline (2012, 2017). The method provides the localization of the area spills along with the color correction (normalization), classification of the composition of oil and oil products and the through account of the investigated processes. The work results in determination for the area of the oil and oil products spill, its composition and weight. Conclusions. The article shows the relevance of solving problems related to the problem of liquidation of emergency spills of oil and oil products at the facilities of the oil and gas complex. The main approaches to aerospace monitoring observations and automatic interpretation of spill parameters are considered. The proposed approach is based on the use of “digital twins” that implement the transition from manual (visual) to automated and automatic modes for determining the parameters of an oil spill: area, composition and mass. The results presented in the article showed the efficiency of the proposed method and the possibility of its use in the tasks of assessing geoecological risks associated with accidental spills of oil and oil products on land and in water areas.

On-line pump for very low power heating or cooling system

The article presents the concept of a new circulation pump for low power heating or cooling system, dedicated to systems where it is necessary to ensure a slight liquid flow during periods of operation at a significantly low efficiency of the systems. The assumption for the construction of the new pump was the possibility of its installation in the pipeline axis. The proposed prototype design includes the application of a patented solution to relieve the axial force acting in a flow system [1,2]. Additionally, a new permanent magnet DC motor designed and manufactured for this pump was used. The design of the pump takes into account the requirement of maximum silence, which results from its intended use in close proximity to human habitation. The design of the pump has been tested numerically. The results of numerical tests are presented. The pump was made in the rapid prototyping technique in a 3D printer. The pump was built into a dedicated test stand with measuring instruments verified in terms of the quality of measurements. A series of measurements was made on the basis of which the flow characteristics of the pump were determined. During the research, risks for the operation of the new structure were identified, which will be taken care of in a further stage of the research, and the structure, after removing the defects, will be directed to production [3].