This master thesis analyzes how biobanks are working in the United Kingdom and Lithuania, also what legislation exists in each country to support the biobanking process, research. While analyzing the international and national legislation, scientific articles related to biobanks, it is clear that there is a need to achieve that the biobanks would work in the best and effective way, but at the same time maintaining fundamental principles (consent, data protection and etc.), which are the key to whole biobanking process. Ethics Committees already playing a key role in making sure that these principles are maintained, and will play even more bigger role going forward.
This master thesis analyzes how biobanks are working in the United Kingdom and Lithuania, also what legislation exists in each country to support the biobanking process, research. While analyzing the international and national legislation, scientific articles related to biobanks, it is clear that there is a need to achieve that the biobanks would work in the best and effective way, but at the same time maintaining fundamental principles (consent, data protection and etc.), which are the key to whole biobanking process. Ethics Committees already playing a key role in making sure that these principles are maintained, and will play even more bigger role going forward.
Legal regulation of ethical review of biomedical research (exclusively research on humans) will be overviewed in this master thesis. Historic development of regulation of research on humans and reasons of establishment of research ethics committees are analyzed in the first chapter. Concept and complexity of biomedical research is discussed in the second chapter. The third chapter is devoted to analyze existing legal regulation of clinical trials in European Union and Lithuania, its problematic aspects are presented. In the fourth chapter, ethical review system of biomedical research in Lithuania and its efficiency are discussed. By pointing to the main changes that are made, new clinical trials Regulation No. 536/2014 is reviewed in the last chapter.
Legal regulation of ethical review of biomedical research (exclusively research on humans) will be overviewed in this master thesis. Historic development of regulation of research on humans and reasons of establishment of research ethics committees are analyzed in the first chapter. Concept and complexity of biomedical research is discussed in the second chapter. The third chapter is devoted to analyze existing legal regulation of clinical trials in European Union and Lithuania, its problematic aspects are presented. In the fourth chapter, ethical review system of biomedical research in Lithuania and its efficiency are discussed. By pointing to the main changes that are made, new clinical trials Regulation No. 536/2014 is reviewed in the last chapter.
Aim of the study. To analyze the opportunities of co-operation between health care institutions and the state controlling institutions. Methods. The survey of workers of Kaunas county health care institutions was accomplished during 2009 December - 2010 February. Questionnaires were filled-in and returned by 68 respondents of the 55 Kaunas county health care institutions (response rate 66,7%). For the assessment of the statistical relationships Chi square (χ2) criteria was used; Z-test was used for the comparison of two proportions. Differences were considered as statistically significant at p<0,05 level. Results. Kaunas county health care workers (86,8%) mostly collaborate with regional sickness insurance funds, at least with Lithuanian medical ethics committee (4,4%). Health care workers assess work of the state controlling institutions: very good (5,9%), well (38,2%), an average (51,5%), negative (4,4%). Cooperation with the state controlling institutions is preceded several times a month. Information is often transferred by e-mail to the state controlling institutions. Older workers and men often co-operate with the state controlling institutions in non-formal way. Respondents who are satisfied in supervising with the state controlling institutions are more satisfied with aspects of the issues. Only one third of the respondents received information from the state controlling institutions timely. Respondents under the age of 35 and over the age of 43 years were satisfied with the efficiency of solving problems. Health care workers emphasized the lack of information related to legislation. Health care workers employed in private institutions are not looking for new ways or forms of co-operation with the state controlling institutions. Cooperation could be improved by using innovative information technologies. Health care workers indicated the need for the common data base with the state controlling institutions. Conclusions. Most of the respondents co-operate with regional sickness insurance funds, at least with of Lithuanian medical ethics committee. The majority of the health care workers assessed the state controlling institutions as an average. Most of the respondents are not satisfied with flexibility of the state controlling institutions in solving problems.
Aim of the study. To analyze the opportunities of co-operation between health care institutions and the state controlling institutions. Methods. The survey of workers of Kaunas county health care institutions was accomplished during 2009 December - 2010 February. Questionnaires were filled-in and returned by 68 respondents of the 55 Kaunas county health care institutions (response rate 66,7%). For the assessment of the statistical relationships Chi square (χ2) criteria was used; Z-test was used for the comparison of two proportions. Differences were considered as statistically significant at p<0,05 level. Results. Kaunas county health care workers (86,8%) mostly collaborate with regional sickness insurance funds, at least with Lithuanian medical ethics committee (4,4%). Health care workers assess work of the state controlling institutions: very good (5,9%), well (38,2%), an average (51,5%), negative (4,4%). Cooperation with the state controlling institutions is preceded several times a month. Information is often transferred by e-mail to the state controlling institutions. Older workers and men often co-operate with the state controlling institutions in non-formal way. Respondents who are satisfied in supervising with the state controlling institutions are more satisfied with aspects of the issues. Only one third of the respondents received information from the state controlling institutions timely. Respondents under the age of 35 and over the age of 43 years were satisfied with the efficiency of solving problems. Health care workers emphasized the lack of information related to legislation. Health care workers employed in private institutions are not looking for new ways or forms of co-operation with the state controlling institutions. Cooperation could be improved by using innovative information technologies. Health care workers indicated the need for the common data base with the state controlling institutions. Conclusions. Most of the respondents co-operate with regional sickness insurance funds, at least with of Lithuanian medical ethics committee. The majority of the health care workers assessed the state controlling institutions as an average. Most of the respondents are not satisfied with flexibility of the state controlling institutions in solving problems.
As the Constitution of the Lithuanian SSR of April 20, 1978 established the right of citizens to profess any religion, it also declared that state and schools are to be separated from the church. These clauses were enforced by assessing the activities of clergymen in society. To that end, Oversight committees for religious sect compliance under the city and regional executive committees of the Councils of the People's Deputies were established, which were supposed to investigate the activities of clergymen according to set guidelines. These oversight committees would audit the activities clergymen carried out with children and youth, making sure that special services were not held for minors and that minors were not employed in the assistance of the clergy. The committees also ensured that no activities were aimed at parents, women and other special groups. A particular effort was made to identify the types of sermons delivered during service: whether the content was religious, political, on ethics and morality, and whether it conflated religion and nationality. The committees filed reports providing excerpts from specific sermons and identified the clergymen who delivered them. The committees were not only in charge of documenting violations but also had to take certain preventive measures – group and individual conversations with clergymen about lawful conduct during worship, lectures on such topics at places of employment, as well as meetings with school teachers. In addition to inspecting the content of religious activities, governmental institutions audited the finances of the church and clergy. Matters of property, financial resource management, its proper use and other issues were decided by the executive offices of the church and oversight committees. [.]
As the Constitution of the Lithuanian SSR of April 20, 1978 established the right of citizens to profess any religion, it also declared that state and schools are to be separated from the church. These clauses were enforced by assessing the activities of clergymen in society. To that end, Oversight committees for religious sect compliance under the city and regional executive committees of the Councils of the People's Deputies were established, which were supposed to investigate the activities of clergymen according to set guidelines. These oversight committees would audit the activities clergymen carried out with children and youth, making sure that special services were not held for minors and that minors were not employed in the assistance of the clergy. The committees also ensured that no activities were aimed at parents, women and other special groups. A particular effort was made to identify the types of sermons delivered during service: whether the content was religious, political, on ethics and morality, and whether it conflated religion and nationality. The committees filed reports providing excerpts from specific sermons and identified the clergymen who delivered them. The committees were not only in charge of documenting violations but also had to take certain preventive measures – group and individual conversations with clergymen about lawful conduct during worship, lectures on such topics at places of employment, as well as meetings with school teachers. In addition to inspecting the content of religious activities, governmental institutions audited the finances of the church and clergy. Matters of property, financial resource management, its proper use and other issues were decided by the executive offices of the church and oversight committees. [.]
As the Constitution of the Lithuanian SSR of April 20, 1978 established the right of citizens to profess any religion, it also declared that state and schools are to be separated from the church. These clauses were enforced by assessing the activities of clergymen in society. To that end, Oversight committees for religious sect compliance under the city and regional executive committees of the Councils of the People's Deputies were established, which were supposed to investigate the activities of clergymen according to set guidelines. These oversight committees would audit the activities clergymen carried out with children and youth, making sure that special services were not held for minors and that minors were not employed in the assistance of the clergy. The committees also ensured that no activities were aimed at parents, women and other special groups. A particular effort was made to identify the types of sermons delivered during service: whether the content was religious, political, on ethics and morality, and whether it conflated religion and nationality. The committees filed reports providing excerpts from specific sermons and identified the clergymen who delivered them. The committees were not only in charge of documenting violations but also had to take certain preventive measures – group and individual conversations with clergymen about lawful conduct during worship, lectures on such topics at places of employment, as well as meetings with school teachers. In addition to inspecting the content of religious activities, governmental institutions audited the finances of the church and clergy. Matters of property, financial resource management, its proper use and other issues were decided by the executive offices of the church and oversight committees. [.]
The object of the master's thesis is an informed consent of a person for any kind of medical intervention. The main aim of the research is to analyze the issue of consent as a fundamental principle of human rights protection in the field of biomedicine. The main objectives are: to determine the correlation and interaction between the Oviedo Convention and the European Convention on Human Rights; to specify the sources and necessary requirements of consent; to consider historical and modern contexts of sterilization as a form of personal autonomy intervention; to determine significance and criteria of the consent validity in the context of applying sterilization measures to persons belonging to a vulnerable group; to examine the current systems of organ donation and their legal implementation; to identify the legal basis of presumed and informed consent systems as well as their strengths and weaknesses; to analyze presumed consent system in the framework of the European Court of Human Rights. The implementation of these tasks has led the author of this work to a conclusion that, despite the fact that no special mechanisms for the protection of rights related to biomedicine have yet been established at the universal or regional level, effective results have been achieved within the Council of Europe and the European Union. The informed consent of a person is a primary principle, the absence of which will prevent any kind of intervention. Its demand is based on the principle of autonomy, that is to say, respect for a person's ability to make their own decisions about their body. Informing person in a proper way is a crucial element of consent. In certain cases, medical intervention may be performed without the patient's consent. Forced or compulsory sterilization constitute a gross violation of human rights and medical ethics and can be considered as acts of torture and cruel, inhuman or degrading treatment. The main components of this problem are: the lack of adequate legal remedies to obtain redress; the impunity of those who unlawfully perform sterilization; the lack of respectful and effective communication between medical practitioners and women in obtaining informed consent, and the need for an independent committee to examine the full extent of the harm caused by involuntary sterilization. Nowadays, the issue of organ and tissue donation of human origin is regulated by two legal systems (presumed consent and informed consent). Both systems are aimed at solving the problem of shortage of donor organs. However, the system of informed consent is the one which is recognized as more successful because on the one hand it respects personal autonomy and on the other – public interest expressed by an act of good will on the part of the donor. At the same time, one of the main reasons for criticism of the system of presumed consent is that the removal of organs without explicit consent is a violation of bodily integrity and, as a result, autonomy.
The object of the master's thesis is an informed consent of a person for any kind of medical intervention. The main aim of the research is to analyze the issue of consent as a fundamental principle of human rights protection in the field of biomedicine. The main objectives are: to determine the correlation and interaction between the Oviedo Convention and the European Convention on Human Rights; to specify the sources and necessary requirements of consent; to consider historical and modern contexts of sterilization as a form of personal autonomy intervention; to determine significance and criteria of the consent validity in the context of applying sterilization measures to persons belonging to a vulnerable group; to examine the current systems of organ donation and their legal implementation; to identify the legal basis of presumed and informed consent systems as well as their strengths and weaknesses; to analyze presumed consent system in the framework of the European Court of Human Rights. The implementation of these tasks has led the author of this work to a conclusion that, despite the fact that no special mechanisms for the protection of rights related to biomedicine have yet been established at the universal or regional level, effective results have been achieved within the Council of Europe and the European Union. The informed consent of a person is a primary principle, the absence of which will prevent any kind of intervention. Its demand is based on the principle of autonomy, that is to say, respect for a person's ability to make their own decisions about their body. Informing person in a proper way is a crucial element of consent. In certain cases, medical intervention may be performed without the patient's consent. Forced or compulsory sterilization constitute a gross violation of human rights and medical ethics and can be considered as acts of torture and cruel, inhuman or degrading treatment. The main components of this problem are: the lack of adequate legal remedies to obtain redress; the impunity of those who unlawfully perform sterilization; the lack of respectful and effective communication between medical practitioners and women in obtaining informed consent, and the need for an independent committee to examine the full extent of the harm caused by involuntary sterilization. Nowadays, the issue of organ and tissue donation of human origin is regulated by two legal systems (presumed consent and informed consent). Both systems are aimed at solving the problem of shortage of donor organs. However, the system of informed consent is the one which is recognized as more successful because on the one hand it respects personal autonomy and on the other – public interest expressed by an act of good will on the part of the donor. At the same time, one of the main reasons for criticism of the system of presumed consent is that the removal of organs without explicit consent is a violation of bodily integrity and, as a result, autonomy.
The state governance model is established by Constitution. In the Constitution of the Republic of Lithuania, there is a separate section dedicated to local self-governance and its management, that shows not only the state's recognition of local self-governance, but also the principles of local self-governance mentioned in the Constitution of the Republic of Lithuania. There are sixty separate territorial administrative units in Lithuania, which are guaranteed the right of self-governance, which is implemented by municipal councils elected during secret elections. After the frst direct elections of mayors held on March 1, 2015, even in sixteen municipalities (Birštonas municipality, Druskininkai municipality, Ignalina district municipality, Jonava district municipality, Kaunas district municipality, Lazdijai district municipality, Marijampolė municipality, Neringa municipality, Pagėgiai municipality, Palanga municipality, Pasvalys district municipality, Rietavas municipality, Šakiai municipality, Šalčininkai municipality, Vilkaviškis district municipality, Vilnius district municipality) one of the political parties or political organizations (movements) in the municipalities and districts of Lithuania won an absolute majority, which further emphasizes the importance of securing the rights of the minority (opposition).The Constitutional Court of the Republic of Lithuania has also noted that taking into account the fact that the Constitution of the Republic of Lithuania implies the defense of the parliamentary minority, the minimum requirements for the protection of the opposition of the Lithuanian parliament, as well as the fact that the recognition of parliamentary opposition is an essential element of pluralistic democracy. The Statute of the Lithuanian parliament (Seimas) may establish guarantees of opposition activities: certain places and positions in the committee, opposition leader status, initiation of work places and commissions, etc. The systematic appraisal of the provisions of the Law on Local Self-Government of the Republic of Lithuania shows that the obligation to form in each municipality the Control Committee, the Anti-Corruption and Ethics commissions, whose candidacy is delegated by the municipal council's opposition, is one of the ways provided by the legislator to ensure the minority rights recognized in pluralistic democracy in self-governance. As there are 60 separate territorial administrative units (municipalities) in the Republic of Lithuania, in which there is a different demographic and political situation, different regulation of municipal councils, composition of municipal councils, therefore different management traditions are formed in them. In the absence of a suffcient defnition of minority rights of municipal councils, which ensure the possibilities of opposition activities, the medium develops into oligarchic tendencies. The poor control of decisions taken by municipal councils and administrative actions as well as a flawed legislative framework make it possible to form situations in which the democratic values and the protection of individual rights and freedoms are threatened. The abundance of the problems of the legal regulation of municipalities is indicated by the fact that since 1994, the Law on Local Self-Government of the Republic of Lithuania has been amended even 124 times. In the Constitution of the Republic of Lithuania (25th October 1992), a separate section is devoted to local selfgovernance and its management. This is understood as the importance given by the state to self-governance, as an independent state of governance, which unconditionally depends on legal regulation. Therefore, this article overviews the gaps in the legal regulation and the political problems that affect the principles of democracy and the system of leverage and balance between the majority of municipal councils and minorities in the local selfgovernance of the Republic of Lithuania. In each municipal council, the presence of an opposition (minority) is not only a normative phenomenon, but also a necessary expression of democracy. In essence, the opposition has two main functions: frstly, this does not allow one party to entrench and curtails government selfshness as well as helps to maintain the constitutional model of governance. Secondly, because the political decisions are not perfect, the opposition points out the mistakes and shortcomings of the governance. Opposition works as an instrument to restrict governance and cultivate social peace. Depending on the subject matter, the aim and objectives of the research paper, the document analysis method was used for data collection and analysis. Data sources are as follows: National legislation, European Union and international legal acts, rulings of the Constitutional Court of the Republic of Lithuania, current Case law, related scientifc works, and offcial statistical indicators. The method of systematic analysis is applied in complex examination of legal norms and relevant jurisprudence in the aspect of ensuring the rights of minority municipal councils. The monitoring method was used in making proposals for the improvement of the Law on Local Self-Government of the Republic of Lithuania. The author of the article has accumulated practical experience in the area of legal regulation of local selfgovernance of the Republic of Lithuania, starting from 2011 until now as a member of the municipal council. The method of summarizing was used to summarize the collected and analyzed research data and to formulate conclusions and suggestions.
The state governance model is established by Constitution. In the Constitution of the Republic of Lithuania, there is a separate section dedicated to local self-governance and its management, that shows not only the state's recognition of local self-governance, but also the principles of local self-governance mentioned in the Constitution of the Republic of Lithuania. There are sixty separate territorial administrative units in Lithuania, which are guaranteed the right of self-governance, which is implemented by municipal councils elected during secret elections. After the frst direct elections of mayors held on March 1, 2015, even in sixteen municipalities (Birštonas municipality, Druskininkai municipality, Ignalina district municipality, Jonava district municipality, Kaunas district municipality, Lazdijai district municipality, Marijampolė municipality, Neringa municipality, Pagėgiai municipality, Palanga municipality, Pasvalys district municipality, Rietavas municipality, Šakiai municipality, Šalčininkai municipality, Vilkaviškis district municipality, Vilnius district municipality) one of the political parties or political organizations (movements) in the municipalities and districts of Lithuania won an absolute majority, which further emphasizes the importance of securing the rights of the minority (opposition).The Constitutional Court of the Republic of Lithuania has also noted that taking into account the fact that the Constitution of the Republic of Lithuania implies the defense of the parliamentary minority, the minimum requirements for the protection of the opposition of the Lithuanian parliament, as well as the fact that the recognition of parliamentary opposition is an essential element of pluralistic democracy. The Statute of the Lithuanian parliament (Seimas) may establish guarantees of opposition activities: certain places and positions in the committee, opposition leader status, initiation of work places and commissions, etc. The systematic appraisal of the provisions of the Law on Local Self-Government of the Republic of Lithuania shows that the obligation to form in each municipality the Control Committee, the Anti-Corruption and Ethics commissions, whose candidacy is delegated by the municipal council's opposition, is one of the ways provided by the legislator to ensure the minority rights recognized in pluralistic democracy in self-governance. As there are 60 separate territorial administrative units (municipalities) in the Republic of Lithuania, in which there is a different demographic and political situation, different regulation of municipal councils, composition of municipal councils, therefore different management traditions are formed in them. In the absence of a suffcient defnition of minority rights of municipal councils, which ensure the possibilities of opposition activities, the medium develops into oligarchic tendencies. The poor control of decisions taken by municipal councils and administrative actions as well as a flawed legislative framework make it possible to form situations in which the democratic values and the protection of individual rights and freedoms are threatened. The abundance of the problems of the legal regulation of municipalities is indicated by the fact that since 1994, the Law on Local Self-Government of the Republic of Lithuania has been amended even 124 times. In the Constitution of the Republic of Lithuania (25th October 1992), a separate section is devoted to local selfgovernance and its management. This is understood as the importance given by the state to self-governance, as an independent state of governance, which unconditionally depends on legal regulation. Therefore, this article overviews the gaps in the legal regulation and the political problems that affect the principles of democracy and the system of leverage and balance between the majority of municipal councils and minorities in the local selfgovernance of the Republic of Lithuania. In each municipal council, the presence of an opposition (minority) is not only a normative phenomenon, but also a necessary expression of democracy. In essence, the opposition has two main functions: frstly, this does not allow one party to entrench and curtails government selfshness as well as helps to maintain the constitutional model of governance. Secondly, because the political decisions are not perfect, the opposition points out the mistakes and shortcomings of the governance. Opposition works as an instrument to restrict governance and cultivate social peace. Depending on the subject matter, the aim and objectives of the research paper, the document analysis method was used for data collection and analysis. Data sources are as follows: National legislation, European Union and international legal acts, rulings of the Constitutional Court of the Republic of Lithuania, current Case law, related scientifc works, and offcial statistical indicators. The method of systematic analysis is applied in complex examination of legal norms and relevant jurisprudence in the aspect of ensuring the rights of minority municipal councils. The monitoring method was used in making proposals for the improvement of the Law on Local Self-Government of the Republic of Lithuania. The author of the article has accumulated practical experience in the area of legal regulation of local selfgovernance of the Republic of Lithuania, starting from 2011 until now as a member of the municipal council. The method of summarizing was used to summarize the collected and analyzed research data and to formulate conclusions and suggestions.
