Regulations Update Research Articles

Singapore needs to update regulation of frozen egg donation after permitting social egg freezing.

With social egg freezing being permitted in Singapore, there is expected to be an accumulated surplus of unused frozen eggs (vitrified oocytes) available for donation in coming years. A comprehensive update of current healthcare regulations pertaining to frozen egg donation is needed to resolve various pertinent ethical issues. In particular, the issue of egg donor anonymity should be addressed, together with the lack of sharing of medical and family information about the donor to prospective recipient patients and donor-conceived offspring. Rigorous and comprehensive genetic testing of prospective egg donors must be mandated to protect the welfare of recipient patients. Older women above 35years of age should be required to have at least one child, before being allowed to donate their unused frozen eggs, to prevent any future regret and psychological problems of remaining childless, while being unsure of whether they have an unknown genetic offspring out there. New regulations drafted to address these ethical issues must also prevent potential conflicts of interests. For example, fertility doctors soliciting and encouraging former patients to donate their unused frozen eggs face an obvious conflict of interest, because additional medical fees will be earned by performing the egg donation procedure on other patients. A centralized donor registry should be established by the Singapore government to oversee the distribution and allocation of donated unused frozen eggs to infertile IVF patients. Such a registry could also facilitate sharing of vital health information about the donor to recipient patients and donor-conceived offspring.

A research and development roadmap to support applications of the enhanced BIOMASS methodology

The International Atomic Energy Agency has coordinated an international project addressing enhancements of methods for modelling the biosphere in post-closure safety assessments of solid radioactive waste disposal. This has resulted in the enhanced BIOMASS methodology that is described elsewhere in this special issue. To a large degree, the enhancements to the BIOMASS methodology arose from experience gained in applying the original methodology, both in the context of other international projects and in assessments of existing or proposed disposal facilities for solid radioactive wastes. Here, this experience is used, together with information on the status of solid radioactive waste disposal programmes worldwide, to identify opportunities for applying the enhanced methodology and for learning from those applications. This provides a basis for identifying research and development to support application of the enhanced methodology in a variety of environmental settings. These research and development requirements include aspects related to climate change under a variety of forcing scenarios, landform development in climatic regimes ranging from cold, polar to arid, tropical, modelling of groundwater flow and contaminant transport in surface-water catchments where both fractured rock and porous sediments are present, and studies of the transport of key radioisotopes of elements central to major biogeochemical cycles, such as those of carbon, chlorine, sulphur and iodine. In addition, some remarks are made on aspects of the application of the enhanced methodology that could imply review and updating of regulations and regulatory guidance, e.g. in relation to the definition of representative persons or groups to be considered in assessments and in respect of approaches to the assessment of radiological impacts on non-human biota. Furthermore, consideration is given as to how the scientific and technical experience that has been gained and methods that have been developed in the context of solid radioactive disposal facilities could support management of contaminated sites and legacy facilities that are likely to require long-term management and stewardship.

To the understanding of public health systems in Ukraine

The scientific article is devoted to the study of an important issue of public health in Ukraine. Today, the nation's health is a priority in the field of health care, both in terms of funding and regulation. This situation is due primarily to the COVID-19 pandemic. The paper defines the concept of "public health" and its normative guidelines. The legislation in the field of health care in terms of ensuring the functioning of the public health system is analyzed. Public health is seen as a system of measures aimed at preventing disease, physical and psychological conditions, increasing life expectancy and quality of life through epidemiological surveillance of health indicators. The factors that determine the urgency of public health at the present stage of development of Ukraine are outlined. Emphasis is placed on epidemiological surveillance as a component of public health, on disease prevention. The article considers health risks as the probability of adverse health effects (including death) that occur in the presence of factors of physical, biological or any other origin, including of unknown nature. proposals for priority steps in the systematic update of public health regulations have been made. Such regulation should take into account the experience of combating COVID-19 on the ability to monitor indicators and risks to public health at both national and international levels; on public health emergencies. And this should be done with an emphasis on the competencies of public authorities in the field of public health. Public health should be a priority in the implementation of health policy, which will reduce the burden on the public health system in the long run.

Evidence-based practice among Italian osteopaths: a national cross-sectional survey

BackgroundWhile evidence-based practice (EBP) is widely accepted across healthcare professions, research investigating its implementation in manual therapy professions such as osteopathy is limited. The primary aim of this study was to investigate Italian osteopaths’ attitudes, skills, and use of EBP. A secondary purpose was to understand the obstacles and enablers to EBP adoption in the Italian osteopathic context.MethodsA cross-sectional national survey was conducted (April to June 2020) among a sample of Italian osteopaths. Eligible participants were invited to complete the Italian-translated Evidence-Based practice Attitude and Utilization Survey (EBASE) anonymously online using various recruitment strategies, including email and social media campaigns. In addition to the three EBASE sub-scores (attitudes, skills and use), the demographic characteristics of the sample were considered.ResultsA total of 473 osteopaths responded to the survey. The sample appeared to represent the Italian osteopathic profession. The majority of participants had a favorable attitude toward EBP. Eighty-eight percent of respondents agreed that EBP was necessary for osteopathy practice and that scientific literature and research findings were beneficial to their clinical scenario (95%). Perceived skill levels in EBP were rated as moderate, with the lowest scores for items relating to clinical research and systematic review conduct. Apart from reading/reviewing scientific literature and using online search engines to locate relevant research papers, participant engagement in all other EBP-related activities was generally low. Clinical practice was perceived to be based on a very small proportion of clinical research evidence. The primary obstacles to EBP implementation were a dearth of clinical evidence in osteopathy, and poor skills in applying research findings. The primary enablers of EBP adoption were access to full-text articles, internet connectivity at work, and access to online databases.ConclusionsItalian osteopaths were largely supportive of evidence-based practice but lacked basic skills in EBP and rarely engaged in EBP activities. The updating of osteopathic training curriculum and professional formal regulation in Italy could provide a suitable framework to improve EBP skills and use.

Reforming the paramedic profession? Two weeks with paramedics in Germany

While paramedics in Anglo-American emergency medical services enjoy relative autonomy, paramedic practice in the Franco-German model deployed in Germany depends heavily on emergency physician input. Increasing demand, especially from low-acuity incidents, causes challenges in these countries. To address this, German politicians plan to implement extensive emergency care reforms and consider an update of regulations around paramedic practice. A 2-week placement allowed for practice observation, discussions with stakeholders and a review of various resources to identify current issues in Germany. These include legal discrepancies, significant local differences in scope of practice, limited career opportunities and influence on clinical guidelines. Although the update and reforms are intended to resolve some of these problems, a groundbreaking evolution of the profession from its current restrictions is not expected. Possible development of the emergency physician role and associated specialities as a response to emergency care challenges is less debated.

Housing for the greatest number

Addressing a broader vision, entitled “Housing for All”, this issue is dedicated to the welfare era, when governments across the world established ambitious housing programs to provide housing for the greatest number and improve the citizens’ living conditions, as a symbol of a modern and democratic society. This bold course of action involved radical changes in the built environment, through new approaches to architectural design and experiments in the use of materials and techniques, the creation of space, and social transformation. Nowadays, understanding how to deal with this legacy presents a major challenge, in a continuously changing context, from the technical obsolescence of buildings that no longer meet today’s demanding standards, or fast-moving sociocultural, political and economic values. The aim of this docomomo Journal 65 is to outline how these vast cultural and political ambitions were materialized in various countries, and to analyze the contemporary challenges they face. More than five decades later, are these buildings and neighborhoods resilient or obsolete? In addition to the changes that postmodern society has brought in ways of living, issues such as the demand for spatial and functional transformation, and the updating of regulations on fire, seismic stability, user safety and energy efficiency, are now part of the contemporary agenda. How can these sites be kept alive while satisfying sustainability and contemporary ideas of comfort?

Effects of the Covid-19 pandemic on labour markets in the western Balkans

Covid-19 has had a significant effect on labour market metrics across the globe. This article aims to contribute to the understanding of the pandemic’s adverse impact on labour markets in the western Balkans and the need to take appropriate measures to mitigate this effectively in the forthcoming period. Using a spread of data, we analyse and compare the distributional impacts of the pandemic recession in western Balkans labour markets in terms of the unemployment rate and the average annual growth in real minimum wages. Our analysis shows a significant deterioration of labour market trends - not least in comparison with the picture of 2019 which was broadly much more positive - which has led to increased government spending on social protection measures. This needs to be continued, not least as regards vulnerable individuals, including young people, as the pandemic continues its track. On the basis of our results, and to deal with the structural challenges presented by Balkans labour markets, there is a need for further reform and updating of regulation, social protection and policies in the labour market.

ABSTRACT AND ANNOTATION: UPDATING AND REVISION OF REGULATIONS AND REQUIREMENTS

The purpose of the article is to consider on the basis of state standards and requirements of the Ministry of Education and Science of Ukraine, the Higher Attestation Commission, how the interpretation and use of the abstract in scientific communication have changed, focusing on the abstract accompanyingthe scientific document (article). The research methodology is to apply a systematic approach to the interpretation of the abstract and annotation, given the chronology of the normalization of these concepts by different state standards. The article also implements the method of terminological analysis, as it isthe interpretation of the concepts of “abstract” and “annotation”, their characteristics formed the basis of the study. Scientific novelty. The article substantiates the need to harmonize the requirements of thecurrent Ukrainian legal framework for the design and presentation of the text of the abstract. Emphasis is placed on the inconsistency of state standards and regulations of relevant state institutions on the structure, content, and scope of articles. Conclusions. An analysis of state standards that contain interpretations,requirements for the design and scope of the annotation and abstract gives grounds to argue that these are two different concepts. The examples of interpretation of the abstract and annotation are given in the research, the comparative analysis of these two concepts showed obvious differences between them, which, in turn, should not lead to their synonymy or substitution. Nevertheless, in the editorial requirements of professional journals for scientific publications, the requirements of the Ministry of Education and Sciencefor the defense of dissertations, the boundaries between the concept of “abstract” and “annotation” are leveled, they become interchangeable. Thus, the problems of synonymization of the abstract and annotation outlined in the article, which exist today in the scientific environment of Ukraine, require scientificmethodicaland normative revision of norms and requirements, harmonization with modern international and European experience.

Recommendations for system update of strategy, economic and technological regulations of stakeholders 'activities of gas supply systems in Ukraine

Recommendations for system update of strategy, economic and technological regulations of stakeholders 'activities of gas supply systems in Ukraine

Use of the kinetically-derived maximum dose concept in selection of top doses for toxicity studies hampers proper hazard assessment and risk management

The KMD (kinetically-derived maximum dose) is an increasingly advocated concept that uses toxicokinetic data in the top dose selection for toxicity testing. Application of this concept may have serious regulatory implications though, especially in the European Union. The basic assumption is that the relationship between internal and external dose (IED) shows an inflection point where linearity transits into non-linearity due to saturation of underlying processes; top doses in toxicity tests should not be above the inflection point, provided human exposures are well below this point. A critical analysis of the KMD concept and its underlying assumptions shows, however, that the IED relationship is non-linear over the whole dose range, without any point of inflection. The KMD concept thus aims to estimate a non-existing point, rendering it invalid for use in toxicity testing. Moreover, the concept ignores the key question in toxicology: What kind of toxic effects occur at which doses? These and several other reservations against the KMD concept are discussed and illustrated with three existing applications of the KMD approach. Hence, we recommend to abolish the KMD concept for selecting top doses in toxicity testing. This requires the updating of regulations, guidance documents and OECD test guidelines.

Making sense of a new risk concept in the Norwegian petroleum regulations

In the 2015 petroleum regulations update, the Norwegian Petroleum Safety Authority (PSA-N) modified the risk definition, by highlighting uncertainty instead of probability as one of the core components of risk. Although much work has been conducted on how to assess and manage risk using an uncertainty-based risk perspective, the specific implications of such a risk perspective for a regulatory context have not been given equally attention. The paper seeks to bring new insights to this issue, by examining the extent of change in the PSA-N regulatory practices and strategies as a result of the new risk perspective, as well as identifying factors influencing the implementation processes within the organization. A sensemaking framework provides the foundation for the discussion.

Comparative analysis of policies regulating clinical trialsAnálisis comparativo de las políticas de reglamentación de los ensayos clínicos

RESUMOO presente trabalho comparou as regulamentações relativas à realização de ensaios clínicos no Brasil, Índia, Canadá e União Europeia, com objetivo de oferecer subsídios para uma avaliação da política regulatória brasileira. Para tanto, foi realizada uma análise documental em quatro etapas: estudo preliminar exploratório; estudo descritivo; categorização das informações; comparação dos conteúdos. Quanto às distinções entre a regulamentação brasileira e as dos demais casos, merecem destaque a existência de várias resoluções brasileiras sobre o tema, enquanto os demais países concentraram as informações em uma única regulamentação nacional; a não exigência de rastreabilidade dos medicamentos e de recolhimento e descarte dos medicamentos não utilizados quando um estudo é suspenso ou cancelado; e um tempo de aprovação para início do ensaio de 180 dias no Brasil (versus 30 dias na União e no Canadá, por exemplo). Isso sugere oportunidades para melhorias e atualização da regulamentação brasileira frente ao cenário internacional.

Territorial governance in Ukraine: constitutional and legal bases

Introduction. The aim of the article. The article examines the relevance of the study and specification of problems regarding the constitutional and legal foundations of territorial governance in Ukraine. They are considered in the context of reforming the administrative-territorial system, the system of territorial organization of public power, transformation of local self-government on the basis of decentralization of public power. Emphasis is placed on the notion of governance as a new paradigm for the development of public power and public management in the context of modern unitarism of Ukraine. Results. Investigation of the territorial aspects of governance requires reflection, analysis and clarification of a complex of issues. Among them, it is advisable to identify the following. 1. Theoretical and methodological principles of governance in its territorial dimension. 2. Actually territorial principles of governance in the disclosure of provisions on constitutional and legal understanding of territorial governance; establishment and development of the territorial governance system; territorial community governance, subregional and regional governance. 3. Foreign experience of territorial governance in the context of the European concept of good governance of territorial governance; regulatory and legal regulation of good governance in Council of Europe, European Union documents; implementation of good territorial governance in Ukraine in the conditions of preservation and development of its unitary principles. 4. Improvement of territorial governance in the process of realization of innovations of the state regional policy in the conditions of age-political confrontation, realization of administrative and administrative-territorial reforms in understanding of the constitutional aspects of transformation of territorial governance; transformation of territorial governance with decentralization of public power; governance of the reform of the administrative and territorial structure. Conclusions. These issues are actualized in the context of the modernization of the Constitution of Ukraine, the need for systematic updating of the constitutional regulation of the territorial organization of power, continuation of processes of decentralization of public power, unification of territorial communities, inter-municipal cooperation, changes in the system of administrative-territorial structure, the emergence of new entities, institutions of executive power.

Problems and Strengths in Psychiatric Nursing in Poland: Current Legal Regulations and Results of Survey

Introduction: National health resources are considered inadequate to meet the needs of Mental Health services in Poland due in part to insufficient funding. The status of the nursing profession is autonomous and independent, and one that bears much public trust. Nevertheless, psychiatric nursing is in deep crisis.Aim of the study: To determine the strengths and limitations of the psychiatric nursing system in Poland.Method: Participants of a major Psychiatric Nursing Conference in Poland were surveyed in terms of professional job satisfaction and current problems encountered in psychiatric nursing. Results were appropriately categorized and subjected to quantitative analysis.Results: There were 74 subjects, amounting to a 70% response rate who completed the study questionnaire. Problem areas were focused on how the mental health system is organized and on staff working conditions that included terms of employment and salaries. The main reasons for job satisfaction were those issues associated with the treatment process. Two participants replied that they were not satisfied.Discussion: The numerous problems encountered in Polish psychiatry nursing require further debate and the updating of legal regulations to increase funding. Recently introduced regulations on the minimal standards acceptable for nurse/bed ratios have however been postponed until 2021. The issues concerning job satisfaction have also been referred to in previous studies.Implication for practice: The crisis facing psychiatric nursing in Poland requires systemic changes in both legal regulations and financing. Notwithstanding, such professionals and their societies could facilitate the necessary changes through enhancing public debate and stimulating nursing-focused research.

Will the EU stay out of step with science and the rest of the world on plant breeding innovation?

Innovations in plant breeding like genome editing methods raised questions about the adequacy of established regulatory policies for plant breeding and biotechnology in view of these new breeding methods and the resulting products. Most countries follow the principle approach that only those plants will be regulated under biotech regulations that include a novel combination of genetic material following the Cartagena protocol. In contrast to this, the European Court of Justice interpreted the current EU biotech regulations in a way that these also apply to plants resulting from new mutagenesis breeding, even if these plants are indistinguishable from conventionally bred plants. This ruling created strong reactions and concerns stating that recent technical developments have made the EU GMO Directive no longer fit for purpose. The article describes ongoing policy developments on EU level that might result in an update of current regulations.

Financial reforms and banking system vulnerability: The role of regulatory frameworks

This paper aims at bringing new insights concerning the effect of financial reforms on banking system vulnerability. We show that the link between financial liberalization and banking crisis depends on the number of years since last regulatory reforms. Similarly, we show that updating regulations indirectly affect banking crisis according to the financial liberalization level. Then, we show that banking crisis can be largely explained by a gap between financial innovations and regulation update on a sample of 49 developed and developing countries from 1980 to 2010. Our empirical evidence supports that the regulatory environment is more important in developed countries as it reduces banking fragility perhaps because of highly-risky exchanged financial products. The effect of financial liberalization depends largely on the number of years since last reform. However, destabilizing effect of financial liberalization in developing countries cannot be neutralized by updating regulations and gets more obvious as regulations become older.

Institutional Optimization Strategy of Capital Investment Agency and One-Stop Integrated Service

Licensing is one way for business actors to formalize business. Without licensing, businesses are unable to move to the formal sector and get a variety of benefits such as coaching programs, tax incentives and getting credit or capital assistance, especially from banks and legal guarantees. Nevertheless, business operators consider that licensing services are still not optimal. Business actors' complaints include inefficient and effective services caused by weak institutional aspects. Institutional improvement of the Capital Investment Agency and the One-Stop Integrated Service (DPMPTSP) to reach the prime point will have an impact on the ease of service and improve the investment climate. The main method used in this study is the Regulatory Impact Assessment (RIA) supported using Regulatory Mapping (Regmap) to determine the regulatory map that contributes to the institutional aspects of DPMPTSP. The results of the analysis revealed that the root cause of the weakness of DPMPTSP's institutions was the absence of DPMPTSP's institutional improvement program. The root causes of these problems contribute to some of the problems in optimizing DPMPTSP institutions such as the Standard Operational Procedure (SOP) that is not updated, the lack of competence of the implementing apparatus, the delay in anticipating changes in regulations of the central authority. Alternative corrective actions from the results of the analysis are the devolution of authority for licensing services, preparation of guidelines for Standard Procedure Norms Criteria (NSPK), institutional regulation updates, preparation of local regulations related to institutional implementation, SOP formulation of licensing services, placement of technical human resources, and development of infrastructure facilities.

Securing Platinum-Group Metals for Transport Low-Carbon Transition

Summary Fuel cell technology is the key to transport low-carbon transition. It depends on the catalysis from platinum-group metals, the rarest metals on Earth. However, due to the limited reserve, it is critical to evaluate whether global platinum resources can meet the increasing demand. This paper aims to account whether current platinum resources can support future fuel cell vehicle deployment for 140 countries for the period 2000–2100 by establishing a technology-rich, bottom-up model. It is found that, under a wide range of scenarios, the primary resource demand is significantly lower than the supply capacity at the global level. This result confirms that fuel cell vehicles have the potential to significantly contribute to global decarbonization strategies. However, challenges exist at regional and national levels. Most regions will rely heavily on resource import from the few countries with substantial resource endowments but with political instability, implying potential supply risks.

Monetary Reform, Central Banks, and Digital Currencies

The modern debate about monetary reform has taken on a new twist with the development of private digital currencies employing distributed ledger payments technology. In order to consider the appropriate state response, we go back to first principles of money and finance and the case for financial regulation: to ensure provision of a safe money asset and a stable supply of credit within an inherently unstable financial system. We consider calls to privatize money or to restrict money issue to the state against the background of the increasing marketization of the financial sector and money itself. Following an analysis of private digital currencies, we then consider proposals for state issue of digital currency. It is concluded that the focus of attention should instead be on updating of regulation, not only to encompass digital currencies but also to address other innovations in the financial sector that generate credit and liquidity, in order to meet the needs of the real economy.

Exposure to Atmospheric Ultrafine Particles Induces Severe Lung Inflammatory Response and Tissue Remodeling in Mice.

Exposure to particulate matter (PM) is leading to various respiratory health outcomes. Compared to coarse and fine particles, less is known about the effects of chronic exposure to ultrafine particles, despite their higher number and reactivity. In the present study, we performed a time-course experiment in mice to better analyze the lung impact of atmospheric ultrafine particles, with regard to the effects induced by fine particles collected on the same site. Trace element and PAH analysis demonstrated the almost similar chemical composition of both particle fractions. Mice were exposed intranasally to FF or UFP according to acute (10, 50 or 100 µg of PM) and repeated (10 µg of PM 3 times a week during 1 or 3 months) exposure protocols. More particle-laden macrophages and even greater chronic inflammation were observed in the UFP-exposed mice lungs. Histological analyses revealed that about 50% of lung tissues were damaged in mice exposed to UFP for three months versus only 35% in FF-exposed mice. These injuries were characterized by alveolar wall thickening, macrophage infiltrations, and cystic lesions. Taken together, these results strongly motivate the update of current regulations regarding ambient PM concentrations to include UFP and limit their emission.