Strict Legal Regulations Research Articles

Intraoperative Creation of Tissue-Engineered Grafts with Minimally Manipulated Cells: New Concept of Bone Tissue Engineering In Situ.

Transfer of regenerative approaches into clinical practice is limited by strict legal regulation of in vitro expanded cells and risks associated with substantial manipulations. Isolation of cells for the enrichment of bone grafts directly in the Operating Room appears to be a promising solution for the translation of biomedical technologies into clinical practice. These intraoperative approaches could be generally characterized as a joint concept of tissue engineering in situ. Our review covers techniques of intraoperative cell isolation and seeding for the creation of tissue-engineered grafts in situ, that is, directly in the Operating Room. Up-to-date, the clinical use of tissue-engineered grafts created in vitro remains a highly inaccessible option. Fortunately, intraoperative tissue engineering in situ is already available for patients who need advanced treatment modalities.

Should risk-averse investors target the portfolios of socially responsible companies?

Research background: Companies are required to implement Corporate Social Responsibility (CSR) policies to mitigate the adverse social and environmental effects of their activities and gain legitimacy in the eyes of society. Sustainability initiatives are costly for companies but, at the same time, they are important value-creation drivers. Retail and institutional investors are increasingly choosing portfolios based on CSR performance. However, the relationship between CSR and market beta has hardly been studied at all in the literature, and no direct comparison of the U.S. and European markets has been conducted. Purpose of the article: The two fundamental variables that define an investment are return and risk, and the appropriate risk-return combination depends on the profile of the investors. This research aims to analyze the relationship between CSR and market risk, understood as price volatility and measured by market beta in the U.S. and European markets. Methods: Companies listed in the S&P 500 and Euro Stoxx 300 indexes from 2015 to 2019 were examined using OLS regressions with instrumental variables (IV) and fixed effects panel data. Findings & value added: The results show that those companies with higher CSR have betas below the market index in the U.S. market as well as lower volatility, and are, therefore, more appropriate choices for risk-averse investors. However, this relationship was not confirmed in the European market. This difference may be justified by two reasons: 1) The non-adherence of the United States to the Kyoto Protocol, resulting in less strict legal regulations than in Europe; 2) In the U.S. market, betas are more aggressive, while in the European market they are more defensive, with little margin for reduction. This research contributes to the current state of knowledge by providing empirical evidence that social, environmental, and corporate governance sustainability practices reduce stock volatility in the U.S. capital market, which is highly relevant for private and institutional investors who make their investments based on moral criteria. The results are current and reliable since they cover a broad and recent period for two of the most important stock market indexes.

Pharmaceuticals in the Aquatic Environment: A Review on Eco-Toxicology and the Remediation Potential of Algae.

The pollution of the aquatic environment has become a worldwide problem. The widespread use of pesticides, heavy metals and pharmaceuticals through anthropogenic activities has increased the emission of such contaminants into wastewater. Pharmaceuticals constitute a significant class of aquatic contaminants and can seriously threaten the health of non-target organisms. No strict legal regulations on the consumption and release of pharmaceuticals into water bodies have been implemented on a global scale. Different conventional wastewater treatments are not well-designed to remove emerging contaminants from wastewater with high efficiency. Therefore, particular attention has been paid to the phycoremediation technique, which seems to be a promising choice as a low-cost and environment-friendly wastewater treatment. This technique uses macro- or micro-algae for the removal or biotransformation of pollutants and is constantly being developed to cope with the issue of wastewater contamination. The aims of this review are: (i) to examine the occurrence of pharmaceuticals in water, and their toxicity on non-target organisms and to describe the inefficient conventional wastewater treatments; (ii) present cost-efficient algal-based techniques of contamination removal; (iii) to characterize types of algae cultivation systems; and (iv) to describe the challenges and advantages of phycoremediation.

Endocrine Disruptors in Baby Formulas: A Literature Review

Baby formulas are foods designed and marketed for feeding babies. The use of baby formulas is increasing worldwide due to various reasons. In parallel, there is increasing concern about endocrine disrupting compounds (EDCs) in baby formulas. EDCs cover a large class of compounds able to interact with the endocrine system. EDCs can disrupt many different hormones, so they are linked to numerous adverse outcomes in human health. Babies are more sensitive to environmental toxins than adults. In this review, the type and amount of some EDCs in the composition of baby formulas in addition to their effects on health are examined. The evaluation of EDCs in baby formulas, which are considered a source for EDCs, has become necessary. Soy-based baby formulas are seen as a source of phytoestrogens for newborns. Organohalogens are high in especially milk-based. Pesticides are generally below the maximum limits. Phthalate levels vary depending on the package content of baby formulas. The phthalate level is higher in formulas with metal packaging. Although bisphenol A (BPA) exposure decreases with the spread of BPA-free packaging, it should be kept in mind that even very low exposures can cause significant health problems. With strict legal regulations, melamine exposure has decreased considerably. Given the susceptibility of babies to EDCs, it is essential to closely monitor the EDCs content of baby formulas.

TO THE QUESTION OF LEGAL RESTRICTION OF FREEDOM IN VIRTUAL REALITY

The steady development of information technology immerses masses of people in the virtual world. The impersonal virtual reality created by the Internet space gives a person a feeling of complete freedom, not limited by social norms and rules. The idea of absolute impunity in the virtual world leads to negative consequences that turn into real administrative misdemeanors and criminal offenses. As an example, the authors consider Internet calls for unauthorized rallies in defense of Alexei Navalny, which took place in Russia in january 2021 (the calls were distributed through the applications TikTok, Instagram, VKontakte, Telegram). The involvement of minors in various «death groups», primarily in the «Blue Whale» suicidal «game», which is implemented on the social network «Vkontakte» is also analyzed.
 The problem of human behavior in the virtual world is considered in the article through the prism of the relationship between law and freedom and the peculiarities of their implementation through modern network resources in a new digital system of relations. The authors argue that the virtual space, like the real world, is in dire need of strict legal regulation. The absence of legal restrictions on freedom on the Internet by the state can lead to tragic consequences.

Взаимосвязь уровня профессионального выгорания и стрессоустойчивости у сотрудников отдела охраны с различными сроками службы

The current state of the features of the professional activity of correctional officers is considered one of the most difficult and dangerous, especially for services that perform non-military services with weapons. The fact that employees have firearms with them during their service radically distinguishes their official duties from the work of other departments and services. As practice shows, even employees with long seniority may not always correctly anticipate and prevent the occurrence of crisis situations that may arise in circumstances specific to criminal enforcement activities: continuous readiness to act in an extreme situation (hostage-taking, escapes, riots, group disobedience, etc.), an increased level of danger to human life and health (the likelihood of using weapons to kill). All of the above places special requirements on the training of this category of employees, including psychological. Of no small importance is the development of the mental stability of the employees of the security department of the penitentiary service to the stress factors of professional activity, such as strict legal regulations, service with weapons, high responsibility for decisions made, service in any weather conditions, violation of sleep and wakefulness, etc.

Barriers and Facilitators for Implementing a National Guideline to Foster the Responsible Use of Residual Biospecimens and Data in Health Research.

Residual biospecimens that are stored in hospitals' diagnostic specimen archives can be used for scientific research under strict legal and ethical regulations. In the Netherlands, a Code of Conduct governs responsible secondary use of residual biospecimens. However, implementation of this Code seems to be challenging. This study aims to explore the most important factors that facilitate or hinder the implementation of the Code. In addition, it investigates what is needed to further foster the responsible use of residual biospecimens. A mixed-methods design was used. Questionnaires were sent out to pathologists, patient information centers, physicians, researchers, data protection officers (DPOs), members of research ethics committees, and members of the boards of directors of all hospitals in the Netherlands (81 hospitals). To further investigate the barriers and facilitators, interviews were conducted with pathologists, patient information centers, physician-researchers, DPOs, review boards, research coordinators, and quality managers of pathology departments. In total, 246 respondents filled out the questionnaire and 36 interviews were conducted. Major barriers for implementing were a lack of resources (time, money), a lack of attention for responsible use, and a lack of practical knowledge (knowing what to do, where to go with questions). In contrast, the perception that implementing the Code was necessary, either by the respondent or by colleagues, was considered "a driver" for implementation. Practical instruments such as checklists and roadmaps were considered necessary to foster implementation; however, the creation of such instruments was hindered by a lack of clear-cut answers regarding legal aspects. Therefore, more clarity and harmonization on how to interpret both the Code and legislation regarding secondary use were considered necessary.

Frozen in Translation: Biobanks as a Tool for Cancer Research

In the context of translational cancer research, biobanks are key infrastructures that provide high quality biological samples, coupled with relevant clinical and pathological information. This role can only be successfully accomplished through the implementation of standardized procedures that ensure proper collection, handling, processing, storage and recording of tissue samples, following strict legal and ethical regulations. Biobank networking is fundamental for dissemination of good practices and to help in the establishment of new infrastructures that improve the assessment of heterogeneity among tumor types and across patient cohorts. Growing demands for large number of homogenously preserved tumor tissue samples can only be met through a more intense cooperation among biobanks, facilitated by networks that foster cooperation at international level. The potential of biobanks as fundamental tools for translational cancer research can only be achieved through a concerted effort from biobankers, researchers, legislators and tissue donors that may allow for improved sample exchange.

Smart contracts: between freedom and strict legal regulation

ABSTRACT This paper aims to show that computer software known as ‘smart contract' can help achieve various goals. First, the software can be used as a means of executing a traditional contract. Second, smart contracts may help enforce the law. Third, the software can act as a means of concluding and executing a contract. In this case, a smart contract can replace a written one. Consequently, the entire contractual practice moves into cyberspace, and we observe total ‘dematerialisation' of contractual relations. Fourth, a smart contract can be used to enforce a court decision. Since the paper focuses on the contractual aspect of this technological innovation, the authors believe that a smart contract should be understood as a computer program serving as an external form for any type of contract. Such a contract can only be blockchain-based, because the blockchain technology ensures commencement, automatic execution, and termination of civil obligations in cyberspace. Based on the authors’ concept of a smart contract, this paper offers recommendations to eliminate legal and operational risks that arise when users of digital financial services conclude and execute smart contracts. The paper suggests ways to improve customer supervision of activities performed by operators and administrators of operating platforms.

Clinical trials in lymphoid malignancies: current status, and future issues

The standard of care for lymphoid tumors has been established and is continually being updated, using the evidence generated through clinical research and development, including multicenter phase III trials. The Japan Clinical Oncology Group-Lymphoma Study Group is a multicenter research group that has been developing treatments for lymphoid malignancies for >40 years. This group is fully equipped with a system that guarantees a high level of scientific accuracy and quality and has produced considerable evidence based on the results of phase III trials. There are currently several issues in advancing clinical research. The strict legal regulation by the clinical trial act would be a burden for researchers in conducting clinical researches. From the perspective of developing a standard of care, researchers should always be aware of the difference in the significance between investigator-led and sponsor-led clinical trials that are intended to gain regulatory approval. Incorporating patient opinions from the early stages of treatment development and implementing genomic medicine are considered important issues for promoting clinical research.

The application of headspace gas chromatographic method for the determination of ethyl alcohol in craft beers, wines and soft drinks

The increasing interest of consumers in the still-developing craft beer market and the strict tax-related legal regulations concerning alcoholic beverages require precise methods for quality control. Determination of ethyl alcohol concentration was performed in 167 samples of alcoholic beverages (craft beers, soft drinks, wines, and cider). We applied headspace gas chromatography using a dual column/dual flame ionization detector (HS-GC-FID/FID), a technique routinely used in forensic toxicology. The method was linear in range, from 0.01 to 20.0%, with a coefficient of determination of 0.999 (R2). The limit of quantification was 0.01%; the detection limit was 0.003%. Furthermore, very good validation parameters were achieved (precision and accuracy below 5%). The samples were analyzed for compliance with EU standards and recommendations of The Beer Judge Certification Program. Moreover, the content of trace quantities of volatile compounds and fusel alcohols (1-propanol, 2-propanol, acetone, and acetaldehyde) was found in the majority of alcoholic beverages.

Probation officers’ discretionary decisions in responding to probation violations: The case of Lithuania

This paper investigates Lithuanian probation officers’ discretionary decisions on probation violations under strict legal regulation. Based on a quantitative survey, this paper analyses hypothetical discretionary decisions according to the type of violation committed by the probationer. The relationship between discretionary decisions and variables such as the probationer’s risk level and sociodemographic characteristics are also analysed. The study revealed that, despite strict legal regulations, which generally require severe action for probation violations, probation officers tend to make more lenient decisions. The study also found that violation type, offender risk level, and probation officer’s age are potential predictors of discretionary decisions.

Privacy-Preserving Collaborative Analytics on Medical Time Series Data

Medical time series data analytics based on dynamic time warping (DTW) greatly benefits modern medical research. Driven by the distributed nature of medical data, the collaboration of multiple healthcare institutions is usually necessary for a sound medical conclusion. Among others, a typical use case is disease screening for public health, where multiple healthcare institutions wish to collaboratively detect over their joint datasets the patients whose medical records have similar features to the given query samples. However, sharing the medical data faces critical privacy obstacles with the increasingly strict legal regulations on data privacy. In this article, we present the design of a novel system enabling privacy-preserving DTW-based analytics on distributed medical time series datasets. Our system is built from a delicate synergy of techniques from both cryptography and data mining domains, where the key idea is to leverage observations on the advancements in plaintext DTW analytics (e.g., clustering and pruning) to facilitate the scalable computation in the ciphertext domain, through our tailored security design. Extensive experiments over real medical time series datasets demonstrate the promising performance of our system, e.g., our system is able to process a secure DTW query computation over 15K time series sequences in 34 minutes.

DEVELOPMENT OF PRIVATE EDUCATION IN UKRAINE: SECOND HALF OF XIX-EARLY XX CENTURY

The article reveals the leading factors in the development of private education in Ukraine in the second half of the XIX - early XX century. It was found that the second half of XIX - early XX century becomes a period not only of social, scientific, national revival, but also a period of rapid development of private education. The purpose of the article is to reveal the leading factors in the development of private education in Ukraine in the second half of the XIX - early XX century. The historical-logical method made it possible to determine the socio-political and social features of social development and their impact on the development of private education in Ukraine in this historical period; constructive-genetic method made it possible to determine the socio-historical and cultural-pedagogical prerequisites for the development of private education in Ukraine in the second half of the XIX - early XX century and others. The leading area of implementation of pedagogical innovations in this period was a private school, which was explained by the strict legal regulation of the state educational system and at the same time the lack of real steps by the government to modernize it. The key innovations of the pedagogical concept in the innovative activities of a private institution were: the priority of the pupil's personality, the integration of family and school, increasing the requirements for the teacher, who must act as the personification of an active and creative personality. It is established that the leading factors in the development of private education in Ukraine in the second half of the XIX - early XX century were: the presence of legislative regulation of private education; establishment of public-state character of organizational bases of their activity; manifestation of public initiative in the opening of private educational institutions; taking into account in the organizational and substantive aspects of the activities of private schools the social and economic needs of the country's development.

Perlindungan Hukum terhadap Data Pribadi Pengguna Jasa Transportasi Online

Technological developments have brought an impact on all community activities, one of which is the emersion of online transportation services such as those provided by Gojek, Grab, Uber, and others which do not only provide the services of riding but also the services of the delivery of goods, food and others. Using online transportation services requires users to download the application and register themselves. However, the personal data of the service users are often misused by drivers for certain reasons and purposes. To overcome and anticipate this, a strict legal regulation appearing as the legal umbrella to protect each online transportation user from misuse of their personal data by the driver is necessary. This study examines the forms of legal protection for users of online transportation services. Conducted in the design of normative legal research, the study makes use of articles and paragraphs of the laws on transportation and several other related laws. The results of the study indicate that legal protection for users of online transportation services from misuse of their personal data takes the form of repressive legal protection. Online transportation service users are permitted to file a civil suit to the online transportation service provider and to file a direct criminal suit regarding the acts of the driver, not on behalf of the online transportation service provider. Efforts to resolve the dispute-causing acts of misuse of personal data of online transportation service users can be made through deliberations, arbitration and courts. The three forms of settlement are in accordance with Article 45 Paragraph (1), (2) of the Indonesian Basic Agrarian Law and Article 6 of the Arbitration Law. Regarding the act of arbitrary canceling the use of online transportation services by service users appears a crucially urgent object to be studied from a legal perspective in the next studies.

PREVENTIVE EFFORTS ON TERRORISM CRIMINAL MANAGEMENT IN INDONESIA


 
 
 Terrorism is a crime against humanity (Crime Against Humanity), and is a serious threat to the sovereignty of each country because terrorism is an international crime that poses a danger to security, world peace and detrimental to the welfare of the community needs to be done in a planned and sustainable eradication so that human rights many can be protected and held in high esteem. Terrorism has been rife in various countries including in Indonesia, many causes of terrorism in Indonesia are examples such as weak rules in Indonesia, Indonesia's defense system is also considered weak and there are those who support the occurrence of terrorism in Indonesia. In order for terrorism not to occur in Indonesia, rules must be made relating to terrorism that will cause people or perpetrators to commit acts of terrorism. Apart from its legal rules, efforts that can be done by the government are by improving the legal system or renewing the legislation system concerning terrorism and forming a body / apparatus specifically dealing with terrorism. With the establishment of a strict legal regulation, the apparatus or a strict legal entity to deal with terrorism, it is not difficult to commit terrorism in Indonesia. Many want to become terrorists in Indonesia because they are enticed by entering heaven, a luxurious life and a comfortable life in Indonesia, if the rules, legal apparatus and legal system are still weak then terrorism will be difficult to handle in Indonesia.
 
 

Mining machinery and environmental regulations of countries worldwide

The purpose of the work is to analyze the problems of using mining machines with diesel engines, the exhaust gases of which have a harmful effect on human health and the environment. Research methodology. The environmental problems arising from the use of mining machines, and environmental standards governing the use of diesel engines in different countries of the world are analyzed. Results. Environmental protection is one of the most important problems of humanity, since people’s lives, their health and well-being depend on its solution. The mining industry operates a huge amount of equipment with diesel engines: mining trucks, excavators, drilling rigs and other mining machines. Engine exhaust fumes contain toxic elements that have a significant impact on human health and the environment. The gas pollution of the working atmosphere entails the need to stop the quarry, and the deterioration of visibility on the highway also causes a partial or complete shutdown of the equipment until the content of harmful substances in the air drops to normal. Today, environmental requirements for a car engine are priority, so the global engine industry is aimed not only at increasing their performance, but also at significantly improving their environmental performance. The problem of air pollution by harmful substances contained in the exhaust of diesel engines is becoming global. To solve it requires the joint efforts of many countries. International conventions and the adoption of relevant standards serve as a tool for rapprochement in this area. Conclusions. Most countries in Europe, Asia and America are guided by similar standards for the content of harmful substances in exhaust gases. The EU in this regard is a kind of authority: it most often updates these indicators and implements strict legal regulation. Other countries are following this trend and are also updating emission standards.

Suicide as an insurance accident

This paper constitutes an attempt at the analysis of provisions of the Civil Code regarding suicide in an insurance contract. The aim of the paper is to analyse the economic aspect of a suicidal death. Regardless of this analysis, a few aspects related to death by suicide in the insurance industry have been indicated. In this paper, the author also analysed the German legal system conception. Therefore, the method of examining applicable laws and the legal- comparative methods have been used herein. The main conclusion drawn up on the grounds of the conducted research is that strict legal regulations are not compatible with suicide as a complex psychological and social process.

IMPROPER HEALTHCARE MARKETING: GERMAN AND UKRAINIAN EXPERIENCE IN PREVENTION

Introduction: Improper healthcare marketing is a part of institutional corruption in the pharmaceutical markets, which causes significant harm to public health. Legal measures are an importent component of the mechanism for preventing this phenomenon. The aim: The purpose of the article is to raise awareness and stimulate serious discussion about the necessity to improve the preventative role of law in the field of healthcare marketing by adjusting liability for offenses in this area. Materials and methods: This study is based on the analysis of international law, medical and criminal legislation, juridical practice, criminal and medical law legal doctrine, physicians survey results and expert interviews. Dialectical, comparative, analytic, synthetic and system analyses research methods were used, also for interpretation purposes. Results: The study showed the effectiveness of the US fight against improper healthcare marketing by applying millions and billions of fines to the largest pharmaceutical companies in the world, which led to a reduction in corruption in this sphere. Legal restrictions on the activities of medical sales representatives of pharmaceutical companies are justified by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as well as in the German legislation (Medicinal Products Act). An analysis of Articles 299a and 299b of the German Criminal Code (StGB), as well as the practice of their application, showed their effectiveness. Still, there are problems in delimiting these offenses from the legal provision of drug information. The lack of anti-corruption regulation of drug promotion in Ukraine negatively affects the situation in this area. Conclusions: The legal mechanism for the prevention of improper healthcare marketing at the national level should include the following measures: a) strict legal regulation of the rules for the promotion of medicines; b) anti-corruption restrictions on the activities of medical sales representatives of pharmaceutical companies; b) the criminal liability of pharmaceutical companies for corruption in the implementation of healthcare marketing; c) the criminal liability of representatives of pharmaceutical companies and Healthcare professionals (HCPs) for active and passive briberies; d) legal support for professional self-regulation aimed at creating ethical standards of conduct in the pharmaceutical markets.

Freedom of expression in multicultural societies: Political cartooning in Europe in the modern and postmodern eras

Abstract At the intersection of modern cultural and political history, security studies and debates about freedom of expression and international human-rights law, this article aims to contribute to a better understanding of political cartooning and its implications in multicultural societies of Europe, which have shifted in a geographical, cultural, normative, communicational, political and many other respects through the last two centuries. Through comparison of the Serbian cartoons from late nineteenth-century Croatia and the recent Danish cartoons of the Prophet Mohammad, the article reveals that both modern and postmodern European cartoons have been centred around equally discriminatory narratives: a 'clash of civilizations' and 'racialization of religion'. Since open racial stereotyping in cartoons became illegal in the postmodern international regulations, traditional discriminatory practices of cartooning have shifted towards subtle, 'liquid' racism. This decodes some of the twelve Danish cartoons as ambiguous strategies of racialization of Muslim immigrants in Europe (as 'terrorists' and 'others') but also as hate speech which is illegal in the European Union, and member states of the Council of Europe. The author concludes that the most current European and international regulations of hate speech, whether concerning offline media or online media, actually protect free speech. While a truly clear-cut regulation of liquid racism might remain problematic in Europe (and the world) due to the lack of a universally accepted definition of hate speech, neither strict legal regulations nor different definitions of hate speech could diminish the role of political cartooning as a viable free speech platform in the multicultural landscape of Europe. Ultimately, what diminishes its viability is the enduring lack of diversity in the creation of visual satire, which could and should reflect the multicultural reality of communities, politics and societies in Europe.