Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA…
Abstract
Purpose
Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue.
Design/methodology/approach
Expert review.
Findings
Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA.
Originality/value
Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.
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Gina Green, Hope Koch, Peter Kulaba, Shelby L. Garner, Carolin Elizabeth George, Julia Hitchcock and Gift Norman
The purpose of this paper is to understand how to build and implement information and communication technology (i.e. ICT) to help vulnerable people when significant social…
Abstract
Purpose
The purpose of this paper is to understand how to build and implement information and communication technology (i.e. ICT) to help vulnerable people when significant social, cultural and economic barriers exist between the stakeholders.
Design/methodology/approach
The authors followed an action research approach to design and implement a mobile health hypertension education application to help India's most vulnerable populations. The authors used interpretive analysis, guided by the sustainable livelihoods framework, to uncover key findings.
Findings
Successfully implementing information and communication technology for development (ICT4D) requires understanding that all stakeholders (i.e. donors, facilitators and the beneficiaries) have important assets to contribute. Facilitators play an important role in connecting donors to the beneficiaries and fostering cultural humility in donors so that the donors will understand the role beneficiaries play in success. Stakeholders may use the ICT4D in unintended ways that both improve the people's health and increase some beneficiaries' financial livelihood.
Research limitations/implications
This research expands the definition of information systems success when implementing ICT4D in resource-constrained environments. Success is more than creating an mHealth app that was easy for beneficiaries to use and where they learned based on a pre- and post-test statistical analysis. Success involved development in all the stakeholders impacted by the social innovation collaboration. For the beneficiary community, success included getting screened for noncommunicable diseases as a first step toward treatment. For the facilitator, success involved more resources for their community health program. Amongst the donors, success was a change in perspective and learning cultural humility.
Practical implications
Although universities encourage faculty to work in interdisciplinary research teams to address serious world problems, university researchers may have to exert considerable effort to secure contracts, approvals and payments. Unfortunately, universities may not reward this effort to build ICT4D and continue to evaluate faculty based on journal publications. When universities undertake social innovation collaborations, administrators should ensure responsive and flexible university processes as well as appropriate academic reward structures are in place. This need is heightened when collaborations involve international partners with limited resources and time needed to build relationships and understanding across cultures.
Social implications
This study discovered the importance of fostering cultural humility as a way of avoiding potential conflicts that may arise from cultural and power differences. Cultural humility moves the focus of donor-beneficiary relationships away from getting comfortable with “them” to taking actions that develop relationships and address vulnerabilities (Fisher-Borne et al., 2015). This research shows how the facilitator helped the donor develop cultural humility by involving the donor in various initiatives with the beneficiary community including allowing the donor to live in a dormitory at the hospital, work in an urban slum and visit health screening campus.
Originality/value
This study (1) extends the ICT4D literature by incorporating cultural humility into the sustainable livelihoods framework, (2) provides a contextual understanding of developing cultural humility in ICT4D projects with a complex group of stakeholders and (3) describes how facilitators become a catalyst for change and a bridge to the community. The culturally humble approach suggests revising the livelihood framework to eliminate words like “the poor” to describe beneficiaries.
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Current issues of Publishers' Weekly are reporting serious shortages of paper, binders board, cloth, and other essential book manufacturing materials. Let us assure you these…
Abstract
Current issues of Publishers' Weekly are reporting serious shortages of paper, binders board, cloth, and other essential book manufacturing materials. Let us assure you these shortages are very real and quite severe.
Kristen Sorocco, Joseph Mignogna, Michael R. Kauth, Natalie Hundt, Melinda A. Stanley, Elyse Thakur, Chelsea G. Ratcliff and Jeffrey A. Cully
The purpose of study was to assess the impact of an online training program for a brief cognitive-behavioral therapy (CBT) that integrated physical health management designed for…
Abstract
Purpose
The purpose of study was to assess the impact of an online training program for a brief cognitive-behavioral therapy (CBT) that integrated physical health management designed for use by mental health providers in the primary care setting.
Design/methodology/approach
In total, 19 providers from two Veterans Health Administration (VHA) medical centers completed online training as part of a larger trial. Statistical analyses compared provider self-reported CBT knowledge and abilities at pretraining, posttraining, and long-term follow-up. Additionally, data were collected on providers’ experiences of the training.
Findings
Providers’ baseline to post-training scores improved on general CBT knowledge and ability, as well as across 11 CBT principles and techniques. Post-training scores were maintained over time.
Research limitations/implications
A small sample size, sole focus on VHA data, and reliance on self-report measures are limitations of the study.
Practical implications
Qualitative data suggested training was feasible, acceptable, and potentially scalable; however, a one-size-fits-all approach may not be ideal.
Originality/value
Online training has potential for providing wider access to providers with limited access to traditional face-to-face training.
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Karon N. LeCompte and Michelle Bauml
We present an instructional strategy in which children utilize critical thinking skills to interpret images related to social studies concepts. To illustrate, we focus on teaching…
Abstract
We present an instructional strategy in which children utilize critical thinking skills to interpret images related to social studies concepts. To illustrate, we focus on teaching First Amendment freedoms; however, we encourage teachers to apply the strategy with other social studies concepts. Using visual media such as paintings and photographs to teach abstract social studies concepts can be especially helpful for teachers working with English language learners and young children. Suggested resources for locating images for classroom use are provided.
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Cynthia K. Riemenschneider, Laurie L. Burney and Saman Bina
With increased remote working, employers are concerned with employees’ commitment and compliance with security procedures. Through the lens of psychological capital, this study…
Abstract
Purpose
With increased remote working, employers are concerned with employees’ commitment and compliance with security procedures. Through the lens of psychological capital, this study aims to investigate whether strong organizational values can improve employees’ commitment to the organization and security behaviors.
Design/methodology/approach
Using Qualtrics platform, the authors conducted an online survey. The survey participants are college-educated, full-time employees. The authors used structural equation modeling to analyze 289 responses.
Findings
The results indicate perceived importance of organizational values is associated with increased organizational commitment and information security behavior. The authors find that psychological capital partially mediates these relations suggesting that employees’ psychological capital effectively directs employees toward an affinity for the organization and information security behavior. The results highlight the importance of organizational values for improving security behavior and organizational commitment. Second, the results suggest that psychological capital is an effective mechanism for this influence. Finally, the authors find that individual differences (gender, organizational level and education) are boundary conditions on their findings, providing a nuanced view of their results and offering opportunities for further investigation.
Originality/value
To the best of the authors’ knowledge, this study is the first to explore organizational values in relation to information security behaviors. In addition, this study investigates the underlying mechanism of this relationship by showing psychological capital’s mediating role in this relationship. Therefore, the authors suggest organizations create a supportive environment that appreciates innovation, quality services, diversity and collaboration. Furthermore, organizations should communicate the importance of these values to their employees to motivate them to have a stronger affective commitment and a more careful set of security behaviors.
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Aim of the present monograph is the economic analysis of the role of MNEs regarding globalisation and digital economy and in parallel there is a reference and examination of some…
Abstract
Aim of the present monograph is the economic analysis of the role of MNEs regarding globalisation and digital economy and in parallel there is a reference and examination of some legal aspects concerning MNEs, cyberspace and e‐commerce as the means of expression of the digital economy. The whole effort of the author is focused on the examination of various aspects of MNEs and their impact upon globalisation and vice versa and how and if we are moving towards a global digital economy.
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Tyler R. Morgan, Colin B. Gabler and Pamela S. Manhart
This paper lays the groundwork for future research in supply chain transparency in two ways. First, the authors delineate the construct and explore how it is shifting the business…
Abstract
Purpose
This paper lays the groundwork for future research in supply chain transparency in two ways. First, the authors delineate the construct and explore how it is shifting the business landscape. Second, the authors connect nine theories to the construct to guide future scholars in this growing research area.
Design/methodology/approach
The authors explore the practical implications for the future of supply chain transparency research through the application of nine theories: stakeholder theory; the technology acceptance model; transaction cost theory; commodity theory; competing values theory; ambidexterity; the natural-resource-based view of the firm; actor-network theory and neo-institutional theory. The authors also consider the blending of theories to provide further insights into the ways firms engage in supply chain transparency.
Findings
This analysis relates theories from several disciplines (i.e. marketing, supply chain management, economics, information systems and organizational behavior) to add theoretical insights to the concept of supply chain transparency, with suggestions for using these theories in conjunction to address complex emerging issues. The authors offer guidance and direction for cross-disciplinary research to help supply chain and logistics influence other fields.
Originality/value
Supply chain transparency is a boundary-spanning phenomenon swiftly proliferating multiple aspects of business. This research applies nine theoretical perspectives to guide future researchers and lays the foundation for managers looking to adopt transparency into their supply chains.