Search results for: regulatory frameworks

Authors: Yong Chen

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To understand the detailed molecular mechanisms of memory formation in engram cells is one of the most fundamental questions in neuroscience. Recent single-cell RNA-seq (scRNA-seq) and single-nucleus RNA-seq (snRNA-seq) techniques have allowed us to explore the sparsely activated engram ensembles, enabling access to the molecular mechanisms that underlie experience-dependent memory formation and consolidation. However, the absence of specific and powerful computational methods to detect memory-related genes (modules) and their regulatory relationships in the sc/snRNA-seq datasets has strictly limited the analysis of underlying mechanisms and memory coding principles in mammalian brains. Here, we present a deep-learning method named SCENTBOX, to detect memory-related gene modules and causal regulatory relationships among themfromsc/snRNA-seq datasets. SCENTBOX first constructs codifferential expression gene network (CEGN) from case versus control sc/snRNA-seq datasets. It then detects the highly correlated modules of differential expression genes (DEGs) in CEGN. The deep network embedding and attention-based convolutional neural network strategies are employed to precisely detect regulatory relationships among DEG genes in a module. We applied them on scRNA-seq datasets of TRAP; Ai14 mouse neurons with fear memory and detected not only known memory-related genes, but also the modules and potential causal regulations. Our results provided novel regulations within an interesting module, including Arc, Bdnf, Creb, Dusp1, Rgs4, and Btg2. Overall, our methods provide a general computational tool for processing sc/snRNA-seq data from case versus control studie and a systematic investigation of fear-memory-related gene modules.

Keywords: sc/snRNA-seq, memory formation, deep learning, gene module, causal inference

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Authors: Peter Fedichev

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We studied fundamental aspects of aging to develop a mathematical model of gene regulatory network. We show that aging manifests itself as an inherent instability of gene network leading to exponential accumulation of regulatory errors with age. To validate our approach we studied age-dependent omic data such as transcriptomes, metabolomes etc. of different model organisms and humans. We build a computational platform based on our model to identify the targets and biomarkers of aging to design new drugs against aging and age-related diseases. As biomarkers of aging, we choose the rate of aging and the biological age since they completely determine the state of the organism. Since rate of aging rapidly changes in response to an external stress, this kind of biomarker can be useful as a tool for quantitative efficacy assessment of drugs, their combinations, dose optimization, chronic toxicity estimate, personalized therapies selection, clinical endpoints achievement (within clinical research), and death risk assessments. According to our model, we propose a method for targets identification for further interventions against aging and age-related diseases. Being a biotech company, we offer a complete pipeline to develop an anti-aging drug-candidate.

Keywords: aging, longevity, biomarkers, senescence

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Authors: Kelly S. Parkinson, Katherine Y. Teh-White

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Futureye has a bespoke social licence to operate methodology which has successfully secured community approval and commercial return for fisheries which have faced regulatory and financial risk. This unique approach to fisheries management focuses on delivering improved social and environmental outcomes to support the fishing industry make steps towards achieving the United Nations SDGs. An SLO is the community’s implicit consent for a business or project to exist. An SLO must be earned and maintained alongside regulatory licences. In current and new operations, it helps you to anticipate and measure community concerns around your operations – leading to more predictable and sensible policy outcomes that will not jeopardise your commercial returns. Rising societal expectations and increasing activist sophistication mean the international fishing industry needs to resolve community concerns at each stage their supply chain. Futureye applied our tested social licence to operate (SLO) methodology to help Austral Fisheries who was being attacked by activists concerned about the sustainability of Patagonian Toothfish. Austral was Marine Stewardship Council certified, but pirates were making the overall catch unsustainable. Austral wanted to be carbon neutral. SLO provides a lens on the risk that helps industries and companies act before regulatory and political risk escalates. To do this assessment, we have a methodology that assesses the risk that we can then translate into a process to create a strategy. 1) Audience: we understand the drivers of change and the transmission of those drivers across all audience segments. 2) Expectation: we understand the level of social norming of changing expectations. 3) Outrage: we understand the technical and perceptual aspects of risk and the opportunities to mitigate these. 4) Inter-relationships: we understand the political, regulatory, and reputation system so that we can understand the levers of change. 5) Strategy: we understand whether the strategy will achieve a social licence through bringing the internal and external stakeholders on the journey. Futureye’s SLO methodologies helped Austral to understand risks and opportunities to enhance its resilience. Futureye reviewed the issues, assessed outrage and materiality and mapped SLO threats to the company. Austral was introduced to a new way that it could manage activism, climate action, and responsible consumption. As a result of Futureye’s work, Austral worked closely with Sea Shepherd who was campaigning against pirates illegally fishing Patagonian Toothfish as well as international governments. In 2016 Austral launched the world’s first carbon neutral fish which won Austral a thirteen percent premium for tender on the open market. In 2017, Austral received the prestigious Banksia Foundation Sustainability Leadership Award for seafood that is sustainable, healthy and carbon neutral. Austral’s position as a leader in sustainable development has opened doors for retailers all over the world. Futureye’s SLO methodology can identify the societal, political and regulatory risks facing fisheries and position them to proactively address the issues and become an industry leader in sustainability.

Keywords: carbon neutral, fisheries management, risk communication, social licence to operate, sustainable development

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Authors: George Kamil Kamal Abdelnor

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Every major educational institution has incorporated diversity, equity, and inclusion (DEI) principles into its administrative, hiring, and pedagogical practices. Yet these DEI principles rarely incorporate explicit language or critical thinking about disability. Despite the fact that according to the World Health Organization, one in five people worldwide is disabled, making disabled people the larger minority group in the world, disability remains the neglected stepchild of DEI. Drawing on disability studies and crip theory frameworks, the underlying causes of this exclusion of disability from DEI, such as stigma, shame, invisible disabilities, institutionalization/segregation/delineation from family, and competing models and definitions of disability are examined. This paper explores both the ideological and practical shifts necessary to include disability in university DEI initiatives. It offers positive examples as well as conceptual frameworks such as 'divers ability' for so doing. Using Georgetown University’s 2020-2022 DEI initiatives as a case study, this paper describes how curricular infusion, accessibility, identity, community, and diversity administration infused one university’s DEI initiatives with concrete disability-inclusive measures. It concludes with a consideration of how the very framework of DEI itself might be challenged and transformed if disability were to be included.

Keywords: cognitive disability, cognitive diversity, disability, higher education disability, Standardized Index of Diversity of Disability (SIDD), differential and diversity in disability, 60+ population diversity, equity, inclusion, crip theory, accessibility

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Authors: Lala Rukh, Muhammad Abbas Choudhary, Saddam Akber Abbasi

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In Pakistan, the privatization of major sector of the national economy i.e. power, telecom, and gas is very strongly advocated since 80s. With varying degree of progress made in these sectors, it has been the government’s approach that the privatization accelerates the sectorial growth, increases operational efficiency and attracts the foreign investment and is of special significance for developing economies. The gas sector was not an exception and the privatization in this sector has moved through various stages during this time within the realms of socio-political agenda. This paper presents the overview of the gas sector in the country. The Oil and Gas Regulatory Authority (OGRA) Ordinance and privatization commission policy position as depicted in the press briefings provides philosophical foundations to the privatization and sectorial restructuring in this paper. The role of the major players from privatization perspective is discussed with special reference to the importance of natural gas sector. The case study further discusses the economic regulations that are being adopted by utility regulators in Pakistan and elsewhere in the world and some issues that the Regulatory Authority will be concerned are outlined. Major operators in the gas sector including Oil & Gas Development Corporation (OGDC), Sui Northern Gas Pipelines Limited (SNGPL), Sui Southern Gas Pipelines Limited (SSGPL) is also presented.

Keywords: privatization, economic regulation, OGDCL, SSGCL, SNGPL

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Authors: Siti Zabedah Saidin, Aidi Ahmi, Azharudin Ali, Wan Norhayati Wan Ahmad

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In today's increasingly complex and interconnected world, the concept of sustainability has transcended mere corporate social responsibility, evolving into a fundamental driver of organizational behaviour and disclosure. This content analysis study delves into the Malaysian federal-level statutory bodies’ annual report for the year 2021, aiming to elucidate the extent of sustainability disclosures within the non-financial sections of these reports. The escalating global emphasis on sustainability has prompted organizations to embrace transparency as a means to demonstrate their commitment to environmental, social, and governance (ESG) considerations. Voluntary sustainability disclosure has emerged as a crucial channel through which organizations communicate their efforts, initiatives, and impacts in these areas, thereby fostering trust and accountability with stakeholders. The study aims to identify and examine the types of sustainability information disclosed voluntarily by the federal-level statutory bodies, concentrating on the non-financial sections of the annual reports. To achieve this, the study adopts a simplified disclosure index, a pragmatic tool that quantifies the extent of sustainability reporting in a standardized manner. Using convenience sampling, the study selects a sample of annual reports from the federal-level statutory bodies in Malaysia, as provided on their respective websites. The content analysis is centred on the non-financial sections of these reports, allowing for an in-depth exploration of sustainability disclosures. The findings of the study present the extent to which Malaysian federal-level statutory bodies embrace sustainability reporting. Through thorough content analysis, the study uncovered diverse dimensions of sustainability information, encompassing environmental impact assessments, social engagement endeavours, and governance frameworks. This reveals a deliberate effort by these bodies to encapsulate their holistic organizational contributions and challenges, transcending traditional financial metrics. This research contributes to the existing literature by providing insights into the evolving landscape of sustainability disclosure practices among Malaysian federal-level statutory bodies. The findings underline the proactive nature of these bodies in voluntarily sharing sustainability-related information, reflecting their recognition of the interconnectedness between organizational success and societal well-being. Furthermore, the study underscores the potential influence of regulatory guidelines and societal expectations in shaping the extent and nature of voluntary sustainability disclosures. Organizations are not merely responding to regulatory mandates but are actively aligning with global sustainability goals and stakeholder expectations. As organizations continue to navigate the intricate web of stakeholder expectations and sustainability imperatives, this study enriches the discourse surrounding transparency and sustainability reporting. The analysis emphasizes the important role of non-financial disclosures in portraying a holistic organizational narrative. In an era where stakeholders demand accountability, and the interconnectedness of global challenges necessitates collaborative action, the voluntary disclosure of sustainability information stands as a testament to the commitment of Malaysian federal-level statutory bodies in shaping a more sustainable future.

Keywords: voluntary disclosure, sustainability information, annual report, federal-level statutory body

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Authors: Nuhu Mohammed Gali, Kenichi Matsui

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Climate change poses a significant threat to agriculture and food security in Africa. The UNFCC recognized the need to address climate change adaptation in the broader context of sustainable development. African countries have initiated a governance system for adapting and responding to climate change in their Nationally Determined Contributions (NDCs). Despite the implementation limitations, Africa’s adaptation initiatives highlight the need to strengthen and expand adaptation responses. This paper looks at the extent to which South-South cooperation facilitates the implementation of adaptation actions between nations for agriculture and sustainable development. We conducted a literature review and content analysis of reports prepared by international organizations, reflecting the diversity of adaptation activities taking place in Sub-Saharan Africa. Our analysis of the connection between adaptation and nationally determined contributions (NDCs) showed that climate actions are mainstreamed into sustainable development. The NDCs in many countries on climate change adaptation action for agriculture aimed to strengthen the resilience of the poor. We found that climate-smart agriculture is the core of many countries target to end hunger. We revealed that South-South Cooperation, in terms of capacity, technology, and financial support, can help countries to achieve their climate action priorities and the Sustainable Development Goals (SDGs). We found that inadequate policy and regulatory frameworks between countries, differences in development priorities and strategies, poor communication, inadequate coordination, and the lack of local engagement and advocacy are some key barriers to South-South Cooperation in Africa. We recommend a multi-dimensional partnership, provisionoffinancialresources, systemic approach for coordination and engagement to promote and achieve the potential of SSC in Africa.

Keywords: climate change, adaptation, food security, sustainable development goals

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Authors: Charintorn Suwannawong, Tananpon Yavilas, Sopida Boonaneksap, Chotika Viriyarattanasak, Chairath Tangduangdee

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With increasing aging population and health conscious consumers, the demand for health promoting products such as functional foods, dietary supplements, and nutraceutical products has continuously increased in Thailand. Nevertheless, the strategic framework for regulatory functional food developments in Thailand is still unclear. The objective of this study was to survey stakeholders’ perspectives on three scopes, consisting of 1) the current status 2) obstacles, and 3) future trend for the development and production of functional foods in Thailand. A survey was conducted by interviewing ten experts from governmental organization, industrial sector and academic institute. The obtained results show that there is no established definition for functional foods in Thailand. There is a variety of raw materials that are capable to be potential ingredients for functional food production in Thailand and exported to global market. However, the scaling up technology into a commercial production is limited. Moreover, there is a need to establish the infrastructures, such as testing laboratory, and regulatory standards for quality control and ensuring product safety. This information is useful for government in the development of the strategic framework and policy statement on improvement of functional food industry in Thailand.

Keywords: functional foods, interview, perspective, Thailand

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Authors: Libo Jiang, Huan Li, Rongling Wu

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Ordinary differentiation equations (ODE) have proven to be powerful for reconstructing precise and informative gene regulatory networks (GRNs) from dynamic gene expression data. However, joint modeling and analysis of all genes, essential for the systematical characterization of genetic interactions, are challenging due to high dimensionality and a complex pattern of genetic regulation including activation, repression, and antitermination. Here, we address these challenges by unifying variable selection and game theory through ODE. Each gene within a GRN is co-expressed with its partner genes in a way like a game of multiple players, each of which tends to choose an optimal strategy to maximize its “fitness” across the whole network. Based on this unifying theory, we designed and conducted a real experiment to infer salt tolerance-related GRNs for Euphrates poplar, a hero tree that can grow in the saline desert. The pattern and magnitude of interactions between several hub genes within these GRNs were found to determine the capacity of Euphrates poplar to resist to saline stress.

Keywords: gene regulatory network, ordinary differential equation, game theory, LASSO, saline resistance

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Authors: Pavel Borodkin, Nikolay Khrennikov, Azamat Gazetdinov

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The problem of ensuring of VVER type reactor equipment integrity is now most actual in connection with justification of safety of the NPP Units and extension of their service life to 60 years and more. First of all, it concerns old units with VVER-440 and VVER-1000. The justification of the VVER equipment integrity depends on the reliability of estimation of the degree of the equipment damage. One of the mandatory requirements, providing the reliability of such estimation, and also evaluation of VVER equipment lifetime, is the monitoring of equipment radiation loading parameters. In this connection, there is a problem of justification of such normative parameters, used for an estimation of the pressure vessel metal embrittlement, as the fluence and fluence rate (FR) of fast neutrons above 0.5 MeV. From the point of view of regulatory practice, a comparison of displacement per atom (DPA) and fast neutron fluence (FNF) above 0.5 MeV has a practical concern. In accordance with the Russian regulatory rules, neutron fluence F(E > 0.5 MeV) is a radiation exposure parameter used in steel embrittlement prediction under neutron irradiation. However, the DPA parameter is a more physically legitimate quantity of neutron damage of Fe based materials. If DPA distribution in reactor structures is more conservative as neutron fluence, this case should attract the attention of the regulatory authority. The purpose of this work was to show what radiation load parameters (fluence, DPA) on all VVER equipment should be under control, and give the reasonable estimations of such parameters in the volume of all equipment. The second task is to give the conservative estimation of each parameter including its uncertainty. Results of recently received investigations allow to test the conservatism of calculational predictions, and, as it has been shown in the paper, combination of ex-vessel measured data with calculated ones allows to assess unpredicted uncertainties which are results of specific unique features of individual equipment for VVER reactor. Some results of calculational-experimental investigations are presented in this paper.

Keywords: equipment integrity, fluence, displacement per atom, nuclear power plant, neutron activation measurements, neutron transport calculations

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Authors: Isil Gazioglu, Abdulselam Ertas

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Aflatoxins (AFs) are secondary toxic metabolites of Aspergillus flavus and A. parasiticus. AFs can be absorbed through the skin. Potent carcinogens like AFs should be completely absent from cosmetics, this can be achieved by careful quality control of the raw plant materials. Regulatory limits for aflatoxins have been established in many countries, and reliable testing methodology is needed to implement and enforce the regulatory limits. In this study, ten medicinal plant samples (Bundelia tournefortti, Capsella bursa-pastoris, Carduus tenuiflorus, Cardaria draba, Malva neglecta, Malvella sharardiana, Melissa officinalis, Sideritis libanotica, Stakys thirkei, Thymus nummularius) were investigated for aflatoxin (AF) contaminations by employing an HPLC assay for the determination of AFB1, B2, G1 and G2. The samples were extracted with 70% (v/v) methanol in water before further cleaned up with an immunoaffinity column and followed by the detection of AFs by using an electrochemically post-column derivatization with Kobra-Cell and fluorescence detector. The extraction procedure was optimized in order to obtain the best recovery. The method was successfully carried out with all medicinal plant samples. The results revealed that five (50%) of samples were contaminated with AFs. The association between particular samples and the AF contaminated could not be determined due to the low frequency of positive samples.

Keywords: aflatoxin B1, HPLC-FLD, KOBRA-Cell, mycotoxin

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Authors: Omuvwie R. Ewien

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Palm oil production in Delta State, Nigeria, is a significant economic activity. However, ensuring its sustainability is crucial to mitigate environmental impacts, promote social equity, and maintain long-term economic viability. This abstract provides an overview of palm oil production sustainability in Delta State, focusing on environmental, social, and economic aspects. In terms of environmental sustainability, the impact of palm oil plantations on deforestation and biodiversity loss is explored. The adoption of sustainable land use practices and measures to reduce greenhouse gas emissions, such as conserving high conservation value areas and utilizing methane capture systems, are highlighted. Social sustainability considerations encompass the inclusion and empowerment of smallholders, ensuring fair labor practices and community engagement. Supporting small-scale farmers, promoting fair working conditions, and investing in local infrastructure and services are identified as key strategies. Economic sustainability is emphasized through yield improvement, efficiency, and value addition. Enhancing productivity and profitability for farmers, promoting downstream processing and market diversification, and building economic resilience is crucial for long-term sustainability. Government policies, including regulatory frameworks and public-private collaborations, play a pivotal role in promoting sustainable palm oil production. Enabling policies and partnerships with industry stakeholders and NGOs facilitates the adoption of sustainable practices. Challenges such as illegal activities, the need to balance economic development with environmental conservation, and leveraging technology for sustainability are discussed. The abstract concludes by emphasizing the importance of stakeholders' commitment to prioritize sustainable palm oil production in Delta State, Nigeria, for a sustainable future.

Keywords: palm oil production, environmental sustainability, community development, yield improvement, future outlook

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Authors: Jyothi Nagraj, Sudeshna Mukherjee, Rajdeep Chowdhury

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Autophagy has recently been linked with cancer cell survival post drug insult contributing to acquisition of resistance. However, the molecular signaling governing autophagic survival response is poorly explored. In our study, in osteosarcoma (OS) cells cisplatin shock was found to activate both MAPK and autophagy signaling. An activation of JNK and autophagy acted as pro-survival strategy, while ERK1/2 triggered apoptotic signals upon cisplatin stress. An increased sensitivity of the cells to cisplatin was obtained with simultaneous inhibition of both autophagy and JNK pathway. Furthermore, we observed that the autophagic stimulation upon drug stress regulates other developmentally active signaling pathways like the Hippo pathway in OS cells. Cisplatin resistant cells were thereafter developed by repetitive drug exposure followed by clonal selection. Basal levels of autophagy were found to be high in resistant cells to. However, the signaling mechanism leading to autophagic up-regulation and its regulatory effect differed in OS cells upon attaining drug resistance. Our results provide valuable clues to regulatory dynamics of autophagy that can be considered for development of improved therapeutic strategy against resistant type cancers.

Keywords: JNK, autophagy, drug resistance, cancer

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Authors: Jonathan Palatz Cedeño

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The paper will seek to examine the scope and limitations of the process of construction of ordinary and extraordinary migration regulatory tools of the countries of Latin America, due to the Venezuelan diaspora in Ibero-America (2015-2018). The analysis methodology will be based on a systematic presentation of the existing advances in the subject under a qualitative approach, in which the results are detailed. We hold that an important part of the Latin American countries that used to be the emitters of migrants have had to generate, with greater or lesser success both nationally and regionally, ordinary and extraordinary migration regulatory tools to respond to the rapid intensification of the current Venezuelan migratory flows. This fact beyond implementing policies for the reception and integration of this population marks a new moment that represents a huge challenge both for the receiving States and for the young Ibero-American institutional migration system. Therefore, we can say that measures to adopt reception and solidarity policies, despite being supported by organs of the multilateral system such as UNHCR and IOM, are not found as guidelines for national and regional action, at the expense of the reactions of the respective public opinions and the influence of what to do of the neighboring countries in the face of the problem.

Keywords: Venezuela, migration, migration policies and governance, Venezuelan diaspora

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Authors: Yoonjung An, Yongtae Park

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Offering a Product-Service System (PSS) is a well-accepted strategy that companies may adopt to provide a set of systemic solutions to customers. PSSs were initially provided in a simple form but now take diversified and complex forms involving multiple services, products and technologies. With the growing interest in the PSS, frameworks for the PSS development have been introduced by many researchers. However, most of the existing frameworks fail to examine various relations existing in a complex PSS. Since designing a complex PSS involves full integration of multiple products and services, it is essential to identify not only product-service relations but also product-product/ service-service relations. It is also equally important to specify how they are related for better understanding of the system. Moreover, as customers tend to view their purchase from a more holistic perspective, a PSS should be developed based on the whole system’s requirements, rather than focusing only on the product requirements or service requirements. Thus, we propose a framework to develop a complex PSS that is coordinated fully with the requirements of both worlds. Specifically, our approach adopts a multi-domain matrix (MDM). A MDM identifies not only inter-domain relations but also intra-domain relations so that it helps to design a PSS that includes highly desired and closely related core functions/ features. Also, various dependency types and rating schemes proposed in our approach would help the integration process.

Keywords: inter-domain relations, intra-domain relations, multi-domain matrix, product-service system design

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Authors: S. A. A. Nabeela Nasreen, S. Sundarrajan, S. A. Syed Nizar, Seeram Ramakrishna

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Metal-organic frameworks (MOFs) have attracted considerable interest due to its diverse pore size tunability, fascinating topologies and extensive uses in fields such as catalysis, membrane separation, chemical sensing, etc. Zeolitic imidazolate frameworks (ZIFs) are a class of MOF with porous crystals containing extended three-dimensional structures of tetrahedral metal ions (e.g., Zn) bridged by Imidazolate (Im). Selected ZIFs are used to separate solvent/solvent mixtures. A layer by layer formation of the nanocomposite of Zinc oxide (ZnO) and ZIF on a ceramic support using a solvothermal method was engaged and tested for target solvent/solvent separation. Metal oxide layer was characterized by XRD, SEM, and TEM to confirm the smooth and continuous coating for the separation process. The chemical composition of ZIF films was studied by using X-Ray absorption near-edge structure (XANES) spectroscopy. The obtained ceramic tube with metal oxide and ZIF layer coating were tested for its packing density, thickness, distribution of seed layers and variation of permeation rate of solvent mixture (isopropyl alcohol (IPA)/methyl isobutyl ketone (MIBK). Pervaporation technique was used for the separation to achieve a high permeation rate with separation ratio of > 99.5% of the solvent mixture.

Keywords: metal oxide, membrane, pervaporation, solvothermal, ZIF

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Authors: Mark E. Lokanan, Liz Lee

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This paper aims to examine the role of accountants as gatekeepers in anti-money laundering compliance in real estate transactions. The paper seeks to answer questions on ways in which accountants are involved in real estate transactions and mandatory compliance with regulatory authorities in Canada. The data for the study came from semi-structured interviews with accountants, lawyers, and government officials. Preliminary results reveal that there is a conflict between accountants’ obligation to disclose and loyalty to their clients. Accountants often do not see why they are obligated to disclose their clients' information to government agencies. The importance of the client in terms of the amount of revenue contributed to the accounting firm also plays a significant role in accountants' reporting decision-making process. Although the involvement of accountants in real estate purchase and sale transactions is limited to lawyers or notaries, they are often involved in designing financing schemes, which may involve money laundering activities. The paper is of wider public policy interests to both accountants and regulators. It is hard not to see Chartered Professional Accountant (CPA) Canada and government regulators using the findings to better understand the decision-making processes of accountants in their reporting practices to regulatory authorities.

Keywords: money laundering, real estate, disclosure, legislation, compliance

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Authors: Lynamata Chhun

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Human Rights enforcement in the newly independent countries like Asian and African has always been penetrating issues. In spite, the existing of the Universal Declaration of Human Rights (UDHR), regions like Africa and Asia where values and cultural norms far differ from the concept had formed their own Human Rights instruments to tackle Human Rights issues in their regions instead of embracing the concept of UDHR completely. ASEAN Human Rights Declaration is one of the examples. This paper aims to examine the enforcement of Human Rights in South East Asia in the context of ASEAN regional integration. Precisely, the author attempts to analyse the effectiveness in undertaking Human Rights issues in the region by applying both the existing international and regional frameworks using the Myanmar Rohingya Crisis as the case study. The methodology of the paper is qualitative analysis where cross-impact analysis is employed to examine the case study. It is anticipated that the main findings of this paper will illuminate how applicable the international instruments are in comparison to the regional instruments in apprehending the human rights issues and will shed light on how ASEAN and dialogue partners should cooperate in the future regarding with the challenging issues of Human Rights in the region.

Keywords: ASEAN Human Rights Declaration, ASEAN integration, ASEAN way, international and regional instruments, Universal Declaration of Human Rights

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Adiba Matin, Daniel Cabrera, Javiera Bellolio, Jasmine Stewart, Dana Gerberi (librarian), Nathan Cummins, Fernanda Bellolio

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OBJECTIVES: Artificial intelligence (AI) tools are becoming more prevalent in healthcare settings, particularly for diagnostic and therapeutic recommendations, with an expected surge in the incoming years. The bedside use of this technology for clinicians opens the possibility of disagreements between the recommendations from AI algorithms and clinicians’ judgment. There is a paucity in the literature analyzing nature and possible outcomes of these potential conflicts, particularly related to ethical considerations. The goal of this scoping review is to identify, analyze and classify current themes and potential strategies addressing ethical conflicts originating from the conflict between AI and human recommendations. METHODS: A protocol was written prior to the initiation of the study. Relevant literature was searched by a medical librarian for the terms of artificial intelligence, healthcare and liability, ethics, or conflict. Search was run in 2021 in Ovid Cochrane Central Register of Controlled Trials, Embase, Medline, IEEE Xplore, Scopus, and Web of Science Core Collection. Articles describing the role of AI in healthcare that mentioned conflict between humans and AI were included in the primary search. Two investigators working independently and in duplicate screened titles and abstracts and reviewed full-text of potentially eligible studies. Data was abstracted into tables and reported by themes. We followed methodological guidelines for Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). RESULTS: Of 6846 titles and abstracts, 225 full texts were selected, and 48 articles included in this review. 23 articles were included as original research and review papers. 25 were included as editorials and commentaries with similar themes. There was a lack of consensus in the included articles on who would be held liable for mistakes incurred by following AI recommendations. It appears that there is a dichotomy of the perceived ethical consequences depending on if the negative outcome is a result of a human versus AI conflict or secondary to a deviation from standard of care. Themes identified included transparency versus opacity of recommendations, data bias, liability of outcomes, regulatory framework, and the overall scope of artificial intelligence in healthcare. A relevant issue identified was the concern by clinicians of the “black box” nature of these recommendations and the ability to judge appropriateness of AI guidance. CONCLUSION AI clinical tools are being rapidly developed and adopted, and the use of this technology will create conflicts between AI algorithms and healthcare workers with various outcomes. In turn, these conflicts may have legal, and ethical considerations. There is limited consensus about the focus of ethical and liability for outcomes originated from disagreements. This scoping review identified the importance of framing the problem in terms of conflict between standard of care or not, and informed by the themes of transparency/opacity, data bias, legal liability, absent regulatory frameworks and understanding of the technology. Finally, limited recommendations to mitigate ethical conflicts between AI and humans have been identified. Further work is necessary in this field.

Keywords: ethics, artificial intelligence, emergency medicine, review

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Authors: Hien T. T. Ho, Tsunemi Watanabe

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The regulatory and market pressures on the restriction of nonylphenol and its ethoxylates in textile articles have confronted the textile manufacturers, particularly those in developing countries. This study aimed to examine the tentative behavior of the textile manufacturers in Vietnam from the perspectives of attitude and the perceptions of technical and organizational adaptabilities, risks, benefits, and barriers. Personal interviews were conducted with five technical specialists from four textile firms and one chemical supplier. The environmental regulatory and market situations regarding the chemical use in Vietnam were also described. The findings revealed two main opposing trends of chemical substitution depending on the market orientation of firms that governed the patterns of risk and benefit perception. The indirect influence of perceived adaptabilities on firm tentative behavior through perceived risks was elucidated, which initiated a conceptual model of firm’s behavior combining the organizational-based and the rational-based relationships. The intermediary role of non-governmental textile and garment industrial/ trade associations is highlighted to strengthen private firm’s informative capacity.

Keywords: firm behavior, institutional analysis, organizational adaptation, technical adaptation

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Authors: Khaleed Alsufyyan

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This doctoral research has been successfully approved by a specialist upgrade panel, and it presents the proposition that the KSA policy for combating maritime terrorism is inadequate and current governance frameworks, including laws, are insufficiently developed to respond effectively and fairly to maritime terrorism. It will examine the legal system in the KSA in terms of effectiveness fairness, as well as investigate this proposition to determine what factors have contributed to such a deficiency. The main focus of this research will draw upon the policies, laws, and practices of the KSA, as well as UK and international laws and policies, to assess whether it is feasible to apply them in the context of the KSA. This thesis will recommend strategies regarding maritime terrorism to enrich the legal and policy frameworks and address the current and future dynamics of maritime terrorism adequately. To derive suitable improvements, UK policies, laws, and practices will be considered for policy transfer purposes. As for studies focused on the KSA, since the KSA is a Muslim state, it will be important to assess the impact of Islamic Law or Sharia Law subject to the doctrines of fairness and effectiveness to comprehend how the KSA’s legal system operates and determine the boundaries it sets for the response to maritime terrorism. This thesis will propose that more reforms are needed to effectively and fairly deal with maritime terrorism based on the prevailing understanding of Sharia law. The research will address the international perspectives on the problem of maritime terrorism and international cooperation of the KSA regarding maritime terrorism and consider the need for further developments.

Keywords: maritime terrorism, maritime security, combat maritime terrorism in the KSA, protecting maritime transport against terrorism

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Authors: Muhammad Muhammad Suleiman

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The Nigerian political system has witnessed rising occurrences of election malpractice in the last decade. This has been due to election rigging and other forms of electoral fraud. In order to find a sustainable solution to this malpractice, the introduction of electronic voting (e-voting) has been suggested. This paper reviews the challenges, benefits, and issues associated with e-voting as a panacea for election malpractice in Nigeria. The review of existing literature revealed that e-voting can reduce the cost of conducting elections and reduce the opportunity for electoral fraud. The review suggests that the introduction of e-voting in the Nigerian political system would require adequate cybersecurity measures, trust-building initiatives, and proper legal frameworks to ensure its successful implementation. It is recommended that there should be an effective policy that would ensure the security of the system as well as the credibility of the results. Furthermore, a comprehensive awareness campaign needs to be conducted to ensure that voters understand the process and are comfortable using the system. In conclusion, e-voting has the potential to reduce the occurrence of election malpractice in the Nigerian political system. However, the successful implementation of e-voting will require effective policy interventions and trust-building initiatives. Additionally, the costs of acquiring the necessary infrastructure and equipment and implementing proper legal frameworks need to be considered.

Keywords: electronic voting, general election, candidate, INEC, cyberattack

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Authors: Hyunuk Kim, Yang No Yun, Muhammad Sohail, Jong-Ho Moon, Young Cheol Park

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Metal-organic frameworks (MOFs), which are emerging absorbents assembled from metal ions and organic ligands, have attracted attention for their permanent porosity and design of tunable pore size. These microporous materials showed interesting properties for CO₂ storage and separation. In particular, MOFs with high surface area and open metal sites showed the remarkable adsorption capacity and selectivity for CO₂. [Mg₂ (DOBDC)] (DOBDC = 2,5-dioxidobenzene-1,4-dicarboxylate) (MOF-74 or CPO-27) is a well-known absorbent showing an exceptionally high CO₂ sorption capacity at low partial pressure and room temperature. In this work, we synthesized [M₂(DOBDC)(DMF)₂] (M = Mg, Co, Ni) and determined their single-crystal structures by X-ray crystallography. The removal of coordinated guest molecules generates Lewis acidic sites and showed high CO₂ adsorption affinity. Both CO₂ adsorption capacity and surface area are much higher than reported values in literature. To fabricate MMMs, microcrystalline [M₂ (DOBDC)(DMF)₂] was synthesized by microwave reaction and dispersed in PDMS solution. The MMMs with a various amount of [M₂ (DOBDC)(DMF) ₂] in PDMS were fabricated by a solution casting method. [M₂ (DOBDC)(DMF)₂]@PDMS membrane showed higher CO2 permeability and CO₂/N₂ selectivity than those of PDMS. Therefore, we believe that MMMs combining polymer and MOFs provide new materials for CO₂ separation technology.

Keywords: metal-organic frameworks, mixed matrix membrane, CO2/N2 separation, polydimethylsiloxane (PDMS)

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Authors: David Sarpong, Waleed Khursheed, Ernest Danquah, Erin Murphy

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Shigella is a pathogenic bacterium responsible for shigellosis, a severe diarrheal disease that claims the lives of immunocompromised individuals worldwide. To develop therapeutics against this disease, an understanding of the molecular mechanisms underlying the pathogen’s physiology is crucial. Small non-coding RNAs (sRNAs) have emerged as important regulators of bacterial physiology, including as components of toxin-antitoxin systems. In this study, we investigated the role of RyfA in S. flexneri physiology and virulence. RyfA, originally identified as an sRNA in Escherichia coli, is conserved within the Enterobacteriaceae family, including Shigella. Whereas two copies of ryfA are present in S. dysenteriae, all other Shigella species contain only one copy of the gene. Additionally, we identified a putative open reading frame within the RyfA transcript, suggesting that it may be a dual-functioning gene encoding a small protein in addition to its sRNA function. To study ryfA in vitro, we cloned the gene into an inducible plasmid and observed the effect on bacterial growth. Here, we report that RyfA production inhibits the growth of S. flexneri, and this inhibition is dependent on the contained open reading frame. In-silico analyses have revealed the presence of two divergently transcribed sRNAs, RyfB1 and RyfB2, which share nucleotide complementarity with RyfA and thus are predicted to function as anti-toxins. Our data demonstrate that RyfB2 has a stronger antitoxin effect than RyfB1. This regulatory pattern suggests a novel form of a toxin-antitoxin system in which the activity of a single toxin is inhibited to varying degrees by two sRNA antitoxins. Studies are ongoing to investigate the regulatory mechanism(s) of the antitoxin genes, as well as the downstream targets and mechanism of growth inhibition by the RyfA toxin. This study offers distinct insights into the regulatory mechanisms underlying Shigella physiology and may inform the development of new anti-Shigella therapeutics.

Keywords: sRNA, shigella, toxin-antitoxin, Type 1 toxin antitoxin

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Authors: Jo Angouri, Charlotte Kennedy, Shawnea Ting, David Rawlinson, Matthew Booker, Nigel Rees

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Ambulance services need to balance the large volume of emergency (999 in the UK) calls they receive (e.g., West Midlands Ambulance Service reports per day about 4,000 999 calls; about 679,000 calls per year are received in Wales), with dispatching limited resource for on-site intervention to the most critical cases. The process by which Emergency Medical Dispatch (EMD) decisions are made is related to risk assessment and involves the caller and call-taker as well as clinical teams negotiating risk levels on a case-by-case basis. Medical Priority Dispatch System (MPDS – also referred to as Advanced Medical Priority Dispatch System AMPDS) are used in the UK by NHS Trusts (e.,g WAST) to process and prioritise 999 calls. MPDS / AMPDS provide structured protocols for call prioritisation and call management. Protocols/policy frameworks have not been examined before in the way we propose in our project. In more detail, the risk factors that play a role in the EMD negotiation between the caller and call-taker have been analysed in both medical and social science research. Research has focused on the structural, morphological and phonological aspects that could improve, and train, human-to-human interaction or automate risk detection, as well as the medical factors that need to be captured from the caller to inform the dispatch decision. There are two significant gaps in our knowledge that we address in our work: 1. the role of backstage clinical teams in translating the caller/call-taker interaction in their internal risk negotiation and, 2. the role of policy frameworks, protocols and regulations in the framing of institutional priorities and resource allocation. We take a multi method approach and combine the analysis of 999 calls with the analysis of policy documents. We draw on interaction analysis, corpus methodologies and thematic analysis. In this paper, we report on our preliminary findings and focus in particular on the risk factors we have identified and the relationship with the regulations that create the frame within which teams operate. We close the paper with implications of our study for providing evidence-based policy intervention and recommendations for further research.

Keywords: emergency (999) call, interaction analysis, discourse analysis, ambulance dispatch, medical discourse

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Authors: Max Plotnikov, Arkadius Schier

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To counteract climate change, the European Commission adopted the European Green Deal (EDG) in 2019. Some of the main objectives of the EDG are climate neutrality by 2050, decarbonization, sustainable mobility, and the shift from a linear economy to a circular economy in the European Union. The mobility turnaround envisages, among other things, the switch from classic internal combustion vehicles to electromobility. The aforementioned goals are therefore accompanied by increased demand for lithium-ion batteries (LIBs) and the associated logistics. However, this inevitably gives rise to challenges that need to be addressed. Depending on whether the LIB is transported by road, rail, air, or sea, there are different regulatory frameworks in the European Union that relevant players in the value chain must adhere to. LIBs are classified as Dangerous Goods Class 9, and against this backdrop, there are various restrictions that need to be adhered to when transporting them for various actors. Currently, the exchange of information in the value chain between the various actors is almost entirely paper-based. Especially in the transport of dangerous goods, this often leads to a delay in the transport or to incorrect data. The exchange of information with the authorities is particularly essential in this context. A solution for the digital exchange of information is currently being developed. Electronic freight transport information (eFTI) enables fast and secure exchange of information between the players in the freight transport process. This concept is to be used within the supply chain from 2025. Another initiative that is expected to improve the monitoring of LIB in this context, among other things, is the battery pass. In July 2023, the latest battery regulation was adopted in the Official Journal of the European Union. This battery pass gives different actors static as well as dynamic information about the batteries depending on their access rights. This includes master data such as battery weight or battery category or information on the state of health or the number of negative events that the battery has experienced. The integration of the battery pass with the eFTI platform will be investigated for synergy effects in favor of the actors for battery transport.

Keywords: battery logistics, battery passport, data sharing, eFTI, sustainability

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Authors: Tim Nedyalkov

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A business decision to move to the cloud brings fundamental changes in how an organization develops and delivers its Information Technology solutions. The accelerated pace of digital transformation across businesses and government agencies increases the reliance on cloud-based services. They are collecting, managing, and retaining large amounts of data in cloud environments makes information security and data privacy protection essential. It becomes even more important to understand what key factors drive successful cloud adoption following the commencement of the Privacy Amendment Notifiable Data Breaches (NDB) Act 2017 in Australia as the regulatory changes impact many organizations and industries. This quantitative correlational research investigated the governance, risk management, and compliance factors contributing to cloud security success. The factors influence the adoption of cloud computing within an organizational context after the commencement of the NDB scheme. The results and findings demonstrated that corporate information security policies, data storage location, management understanding of data governance responsibilities, and regular compliance assessments are the factors influencing cloud computing adoption. The research has implications for organizations, future researchers, practitioners, policymakers, and cloud computing providers to meet the rapidly changing regulatory and compliance requirements.

Keywords: cloud compliance, cloud security, data governance, privacy protection

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Authors: Chengwei Wang, Shuqing Xu, Philipp M. Schlüter

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The genus Ophrys is remarkable for its mimicry, flower-lip closely resembling pollinator females in a species-specific manner. Therefore, floral traits associated with pollinator attraction, especially scent, are suitable models for investigating the molecular basis of adaption, speciation, and evolution. Within the two Ophrys species groups: O. sphegodes (S) and O. fusca (F), pollinator shifts among the same insect species have taken place. Preliminary data suggest that they involve a comparable hydrocarbon profile in their scent, which is mainly composed of alkanes and alkenes. Genes encoding stearoyl-acyl carrier protein desaturases (SAD) involved in alkene biosynthesis have been identified in the S group. This study aims to investigate the control and parallel evolution of ecologically significant alkene production in Ophrys. Owing to the central role those SAD genes play in determining positioning of the alkene double-bonds, a detailed understanding of their functional mechanism and of regulatory aspects is of utmost importance. We have identified 5 transcription factors potentially related to SAD expression in O. sphegodes which belong to the MYB, GTE, WRKY, and MADS families. Ultimately, our results will contribute to understanding genes important in the regulatory control of floral scent synthesis.

Keywords: floral traits, transcription factors, biosynthesis, parallel evolution

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Authors: Neda Safari, Jacob Petersen-Perlman

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There are more than two million dams in the United States, and a considerable portion of them are either non-operational or approaching the end of their designed lifespan. However, this emerging trend is new, and the majority of dam sites have not undergone thorough research and assessments after their removal to determine the overall effectiveness of restoration initiatives, particularly in the case of large-scale dams that may significantly impact their surrounding areas. A crucial factor to consider is the lack of specific regulations pertaining to dam removal at the federal level. Consequently, other environmental regulations that were not originally designed with dam removal considerations are used to execute these projects. This can result in delays or challenges for dam removal initiatives. The process of removing dams is usually the most important first step to restore the ecological and biological health of the river, but often there is a lack of measurable indicators to assess if it has achieved its intended objectives. In addition, the majority of studies on dam removal are only short-term and focus on a particular measure of response. Therefore, it is essential to conduct extensive and continuous monitoring to analyze the river's response throughout every aspect. Our study is divided into two sections. The first section of my research will analyze the establishment and utilization of dam removal laws and regulations in the Condit Dam removal process. We will highlight the areas where the frameworks for policy and dam removal projects remain in need of improvement in order to facilitate successful dam removals in the future. In this part, We will review the policies and plans that affected the decision-making process to remove the Condit dam while also looking at how they impacted the physical changes to the river after the dam was removed. In the second section, we will look at the effects of the dam removal over a decade later and attempt to determine how the river's physical response has been impacted by this modification. Our study aims to investigate the Condit dam removal process and its impact on the ecological response of the river. We anticipate identifying areas for improvement in policies pertaining to dam removal projects and exploring ways to enhance them to ensure improved project outcomes in the future.

Keywords: dam removal, ecolocgical change, water related regulation, water resources

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