A “Talent Agency” refers children for research: A case study

2021 ◽  
pp. 147775092110366
Author(s):  
David C Schwebel ◽  
Anna Johnston ◽  
Leslie A McClure
Keyword(s):  
Clinical Trial ◽  
Research Participation ◽  
Third Party ◽  
Ethical Standards ◽  
Undue Influence ◽  
Ethical Violations ◽  
Institutional Review ◽  
Study Results ◽  
Rate Of Learning

Objective Ethical standards state research participation must be voluntary and free of coercion and undue influence, but what if a third party appears to engage in research-relevant coercion, without the researchers’ knowledge? This case study describes this type of situation and its resolution. Methods We are engaged in a randomized clinical trial evaluating pedestrian safety with 7- and 8- years old. Depending on children's rate of learning, families receive up to $1275 for their time. We recently learned a third-party “talent agency,” a firm placing children in modeling and acting jobs, was referring families to our research with the expectation that families would share 20% of study reimbursements. Results We sensed clear impropriety, but identified no ethical violations on our part as researchers. Once paid a study reimbursement, participants can spend funds how they wish. We were concerned, however, that the third-party was exploitatively coercing families to participate. Conclusions We pursued four avenues to resolve the issue. First, we documented the situation to our university Institutional Review Board. Second, we contacted the talent agency and requested they stop referring families to our research. They agreed. Third, we retained children engaged in our study who were referred from the talent agency; removing them partway through the clinical trial could impact study results. In doing so, we explained that we were unaware of the talent agency referral and that they were not obligated by us to offer a portion of the study reimbursement to the talent agency. Last, we asked newly enrolled families about their referral source.

scholarly journals A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China

2021 ◽  
Author(s):  
Neal E. Storm ◽  
Wen Chang ◽  
Tzu-Chieh Lin ◽  
Jeff L. Lange ◽  
Brian Bradbury ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hong Kong ◽  
Clinical Practice ◽  
Real World ◽  
Controlled Trial ◽  
Real World Evidence ◽  
Study Results ◽  
Global Clinical Trial ◽  
Clinical Trial Program

AbstractOn June 23, 2020, Prolia® (denosumab) was approved by the National Medical Products Administration (NMPA) in the People’s Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is 普罗力, a transliteration from the English name “Prolia”, which has an implied meaning of “to give strength to everyone”— a suitable name for a potent anti-resorptive therapy. The approval was supported by a novel marketing authorization application (MAA) that included data from Prolia’s global clinical trial program establishing favorable efficacy and safety, augmented by results from a real-world evidence (RWE) study confirming the effectiveness and safety of Prolia in clinical practice within Taiwan and Hong Kong. Key constructs for this registration-quality RWE study included the fit-for-purpose assessment of data quality, methodology and quantitative assessment of potential biases, good practices of study conduct, and reproducibility of results. Using data from clinical practice in Taiwan and Hong Kong to evaluate the benefits versus risks of Prolia treatment in ethnic Chinese women with postmenopausal osteoporosis, the RWE study results for effectiveness were comparable to efficacy demonstrated in the global clinical trial program and results for safety were consistent with the incidence observed in global post-marketing safety studies. While RWE is often used to monitor postmarket safety of drug products, support health insurance coverage decisions, and inform clinicians on real-world use of medicines, it has not been widely used to support regulatory approval for new medicines in lieu of clinical bridging studies in countries where such studies are required. Well-conducted registrational RWE studies can play a pivotal role in complementing the totality of evidence presented in an MAA. The benefits of such an approach include avoiding the collection of additional placebo-controlled trial data in populations where adequate ethnic characterization of efficacy, effectiveness, and safety may already exist from postmarketing sources, and accelerate access for patients to innovative medicines in important regions. Here, we describe a regulatory case study of a novel MAA incorporating RWE that provided important evidence to confirm the benefit:risk of a new drug and facilitated a label expansion to a new patient population.

PROCESSING AND IMAGING OF MARINE SEISMIC DATA FROM THE JEQUITINHONHA BASIN (BAHIA, BRAZIL)

2016 ◽  
Vol 33 (3) ◽  
Author(s):  
Lourenildo W.B. Leite ◽  
J. Mann ◽  
Wildney W.S. Vieira
Keyword(s):  
Seismic Data ◽  
Sedimentary Basins ◽  
Study Results ◽  
Marine Seismic ◽  
Present Case Study

ABSTRACT. The present case study results from a consistent processing and imaging of marine seismic data from a set collected over sedimentary basins of the East Brazilian Atlantic. Our general aim is... RESUMO. O presente artigo resulta de um processamento e imageamento consistentes de dados sísmicos marinhos de levantamento realizado em bacias sedimentares do Atlântico do Nordeste...

come_NET

2018 ◽  
Author(s):  
Konstantin Aal ◽  
Anne Weibert ◽  
Kai Schubert ◽  
Mary-Ann Sprenger ◽  
Thomas Von Rekowski
Keyword(s):  
Social Media ◽  
Design Process ◽  
Participatory Design ◽  
Controlled Environment ◽  
Design And Implementation ◽  
Neighborhood Contexts ◽  
Study Results ◽  
Computer Club ◽  
Close Cooperation

The case study presented in this chapter discusses the design and implementation of an online platform, “come_NET,” in the context of intercultural computer clubs in Germany. This tool was built in close cooperation with the children and adult computer club participants. It was designed to foster the sharing of ideas and experiences across distances, support collaboration, and make skills and expertise accessible to others in the local neighborhood contexts. In particular, the participatory-design process involving the children in the computer clubs fostered a profound understanding of the platform structure and functionalities. The study results show how younger children in particular were able to benefit, as the closed nature of the platform enabled them to gather experience as users of social media, but in a safe and controlled environment.

scholarly journals Optimizing the Environmental and Economic Sustainability of Remote Community Infrastructure

2020 ◽  
Vol 12 (6) ◽  
pp. 2208 ◽  
Author(s):  
Jamie E. Filer ◽  
Justin D. Delorit ◽  
Andrew J. Hoisington ◽  
Steven J. Schuldt
Keyword(s):  
Environmental Impacts ◽  
Sustainability Assessment ◽  
Model Performance ◽  
Assessment Model ◽  
Remote Communities ◽  
Remote Community ◽  
Rural Villages ◽  
Sustainable Technologies ◽  
Study Results

Remote communities such as rural villages, post-disaster housing camps, and military forward operating bases are often located in remote and hostile areas with limited or no access to established infrastructure grids. Operating these communities with conventional assets requires constant resupply, which yields a significant logistical burden, creates negative environmental impacts, and increases costs. For example, a 2000-member isolated village in northern Canada relying on diesel generators required 8.6 million USD of fuel per year and emitted 8500 tons of carbon dioxide. Remote community planners can mitigate these negative impacts by selecting sustainable technologies that minimize resource consumption and emissions. However, the alternatives often come at a higher procurement cost and mobilization requirement. To assist planners with this challenging task, this paper presents the development of a novel infrastructure sustainability assessment model capable of generating optimal tradeoffs between minimizing environmental impacts and minimizing life-cycle costs over the community’s anticipated lifespan. Model performance was evaluated using a case study of a hypothetical 500-person remote military base with 864 feasible infrastructure portfolios and 48 procedural portfolios. The case study results demonstrated the model’s novel capability to assist planners in identifying optimal combinations of infrastructure alternatives that minimize negative sustainability impacts, leading to remote communities that are more self-sufficient with reduced emissions and costs.

scholarly journals A Novel Approach to Pharmacy Practice Law Instruction

Pharmacy ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 75
Author(s):  
Matthew Deneff ◽  
Lisa M. Holle ◽  
Jill M. Fitzgerald ◽  
Kathryn Wheeler
Keyword(s):  
Student Perceptions ◽  
Pharmacy Practice ◽  
Pharmacy Education ◽  
Survey Study ◽  
State Laws ◽  
Institutional Review ◽  
Novel Approach ◽  
Study Results ◽  
Course Changes ◽  
Main Component

Pharmacy law instruction is often taught as a didactic course; however practical application of pharmacy law is a main component of pharmacy practice. Technology-based simulations are becoming more frequently used to enhance didactic pharmacy education. The goal of this study was to evaluate the utility of and student perceptions on the usefulness of MyDispense community pharmacy simulation for additional law instruction that if successful might prompt curricular revamping. This Institutional Review Board–approved, two-year, qualitative, prospective, survey study was conducted in a case study class where students completed MyDispense exercises focused on common legal issues that arise in practice, both individually before and within groups during class. Participating students completed a qualitative survey directed at use of MyDispense for pharmacy law review, which included a series of close-ended questions graded on a Likert scale and open-ended questions thematically grouped. Thirty-eight (41%) and twenty-eight (31%) students completed surveys in 2017 and 2018, respectively. The majority of respondents felt exercises improved their understanding of pharmacy laws, focused on challenging areas, and were more interesting than additional lectures. However, certain topics were reported as irrelevant based on practice experiences or not ideal for simulation, and students desired exercises on state laws versus pharmacy policies. Students reported the MyDispense simulation exercises helped them to recall pharmacy laws and focus on topics that were challenging. These study results prompted curricular revamping to incorporate MyDispense throughout the curriculum for practice in recognizing and solving legal scenarios, along with didactic course changes.

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

Reintegration of Ex-Offenders Convicted of Violent Crimes into the Community in the Iranian Context: A Qualitative Study

2021 ◽  
pp. 0306624X2110226
Author(s):  
Mohammad Sabzi Khoshnami ◽  
Fardin Alipour ◽  
Maliheh Arshi ◽  
Hassan Rafiey ◽  
Mohhamad Hossein Javadi
Keyword(s):  
Social Capital ◽  
Qualitative Study ◽  
Structured Interviews ◽  
Violent Crimes ◽  
Institutional Review ◽  
Main Challenge ◽  
Improved Outcomes ◽  
Study Results ◽  
Reducing Recidivism ◽  
Iranian Context

Community reintegration of ex-offenders is a main issue for reducing recidivism. This article aims to explain the process of reintegration into the community based on the experiences of people who have been convicted of violent crimes in Iran. A qualitative study based on grounded theory was conducted in 2020 in Tehran/Iran. Data was collected through in-depth semi-structured interviews with 26 participants. An institutional review board approved the study. Results indicate that the “worry trap” is the main challenge that those convicted of violent crimes face upon reentry into society. If these individuals are provided with governmental and non-governmental services and support, they can move toward “restoring their lost social capital.” The “redefinition of an independent identity” is a consequence of released individuals’ struggle to restore their lost social capital. Further research exploring the causality of social capital and improved outcomes after release from prison and reentry to community is needed.

scholarly journals Seaports during the COVID-19 Pandemic: The Terminal Operators’ Tactical Responses to Disruptions in Maritime Supply Chains

Energies ◽  
2021 ◽  
Vol 14 (14) ◽  
pp. 4339
Author(s):  
Marta Mańkowska ◽  
Michał Pluciński ◽  
Izabela Kotowska ◽  
Ludmiła Filina-Dawidowicz
Keyword(s):  
Supply Chains ◽  
Global Economy ◽  
Research Study ◽  
Inductive Reasoning ◽  
Main Function ◽  
The Sustainable Development ◽  
Study Results ◽  
Multiple Case ◽  
Tactical Decisions

The world-wide crisis caused by the Coronavirus disease 2019 (COVID-19) pandemic had a significant impact on the global economy functioning and the sustainable development of supply chains. The changes also affected seaports being the key links of maritime supply chains. The purpose of the research study described in this article was to identify the sources and kinds of disruptions observed in various maritime supply chains as a result of the COVID-19 pandemic and their impact on the operations of various types of seaport terminals, namely those serving bulk (universal, specialised) and general cargoes (universal, specialised). An additional purpose was to identify the dependencies between the type of terminal and its main function, and the tactical decisions adopted by the particular terminals. The research was carried out using the multiple-case study method. The study covered some selected port terminals functioning in Polish seaports (Gdańsk, Szczecin, Świnoujście), applying direct, semi-structured in-depth interviews. The analysis of the results was carried out using the inductive reasoning method. The research study has shown that as a result of the COVID-19 pandemic some maritime supply chains ceased to exist, some of them were operating with decreased cargo volumes, while in other cases the transshipment volumes actually rose during the pandemic. Among terminal operators’ tactical responses to disruptions in maritime supply chains, there were pro-active and adaptive measures. Pro-active (offensive) measures included actions taken by an enterprise in order to engage in new maritime supply chains, and even participating in establishing new maritime chains in response to limitations caused by the pandemic. Adaptive (defensive) measures covered actions taken by the port terminals as a consequence of changes in the existing maritime supply chains, caused by the pandemic in the port’s foreland or hinterland. The research study results revealed that the terminals extent of engagement and tactical decisions related to the pandemic were depended on the type of terminal (universal or specialised) and its main function played within a supply chain.

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