The concept of personality rights and their protection, as well as the view on provision of health services has changed a lot. In relation to recent development in the field of private law there is a need to examine the aspects of personality rights separatelyy and also in broughter context. This Master's thesis sets as its goal to follow the current legislation and to point out situations where the personality rights can be especially endangered. The second goal is to evaluate current legal issues in foreign countries of the protection of personality rights in relation to the provision of health services in order to see if there is a probability that Czech law will have to deal with similar problems in the future as well. In the first part the concept of personality rights and their protection is introduced. The aspects related to the provision of health services that may be especially endangered are highlighted. Also the possibilities of resolving situations where there is infringement of personality rights are presented. The second part, which is also the most comprehensive of the thesis, deals with the specific institutes that help the protection of the personality rights in the field of health services. These include primarily informed consent, the way of providing it and the consequences of...

Magister Legum - LLM / There is a growing interplay of competing realities facing the international community in the general areas of innovation, technological advancement and overall economic development. The highly industrialised wealthy nations, largely located on the Northern hemisphere are on the one hand undoubtedly at the forefront in global research, technology and infrastructure development. The developing and least developed countries on the other hand are mostly situated on the Southern hemisphere. They are not as wealthy or technologically advanced as their Northern counterparts, but are naturally endowed with unique variations of plant, animal and micro-organism species occurring in natural ecosystems, as well as the traditional knowledge on how to use these unique species. This knowledge has been adjudged to be responsible for the sustainable maintenance of the earth biodiversity. Increasing exploitation of biodiversity spurred on by the competing realities identified above, has left the earth in a present state of alarm with respect to the uncontrolled loss of biodiversity. The traditional knowledge of local peoples has significantly offered leads to research institutes from the North in developing major advancements in drugs, cosmetics and agriculture. Little or no compensation has however been seen to go back to the indigenous communities and countries that provide resources, and indicate various possibilities through their traditional knowledge to the use of such resources. Efforts by some biodiversity rich countries to ddress this trend through legislation developed in accordance with the principles of the Convention on Biological Diversity have been frustrated due to the inability to enforce their domestic laws outside their borders. Theft of genetic resources and its associated traditional knowledge from such countries has therefore remained a major challenge. Against this backdrop, and on the insistence of biodiversity-rich developing countries, an international regime on access and benefit sharing was negotiated and its final text adopted in 2010. This international regime is as contained in the Nagoya Protocol. This research sets out to examine whether the Nagoya Protocol offers a final solution to the protection of traditional knowledge associated with biodiversity in biodiverse countries. It further examines the importance of domestic legislation in achieving the objectives of the Protocol. The research has been tailored to African biodiverse countries, and seeks these answers within the context of Africa. / South Africa

Philosophiae Doctor - PhD / All research involving human subjects should be conducted in accordance to the general ethical principles of autonomy or respect for persons, beneficence and justice. Competent adults can exercise their autonomy and can choose to take on risk for the sake of others, therefore are able to protect their own interests while in the pediatric research the ‗best interests of the child‘ takes precedence over autonomy. In other words giving informed consent in the pediatric context, is not ‗who decides‟ but „what is the best decision for the child‟. Due to lack of consensus gold standard to guide researchers and assess the quality of parental informed consent in Botswana, the practical and ethical challenges posed in obtaining parental informed consent for child enrolment in pediatric HIV clinical trials were examined. The study aimed to determine the readability of the consent forms used in pediatric HIV clinical trials; assess communication methods, practices and perceptions of the trial staff regarding the informed consent process; assess the extent to which parents recall and understand the information disclosed to them and their satisfaction with the informed consent process as well as to identify and describe the reasons for parental approval to child enrolment into HIV clinical trial studies.

The aim of this dissertation is an analysis of the regulatory framework for the procurement and distribution of stem cells in South Africa. This research includes aspects of the law of obligations, medical law and human rights law as found in the Bill of Rights. More specifically however, this dissertation attempts to bring to attention the shortcomings of chapter 8 of the National Health Act. An examination is undertaken according to the multilayered approach and therefore the proposed regulatory framework is examined within a constitutional framework, an ethical framework, the framework as established by common law, in this case the doctrine of informed consent and lastly within the national legislation framework as found in the National Health Act of 2003 and the regulations made in terms of the Act. This dissertation further entails a brief comparative study of the regulatory mechanisms of the United Kingdom as entrenched in the Human Fertilisation and Embryology Act of 2008 and the Human Tissue Act of 2004 and as practiced by the Human Fertilisation and Embryology Authority and the Human Tissue Authority. The analysis in this dissertation firstly provides an overview of the clinical manifestations and science of stem cell technology. Secondly, the impact of the Constitution of the Republic of South Africa is discussed with particular reference to the Bill of Rights on stem cell research and therapy. The most noteworthy conclusion to be made in this regard is that the embryo is not the bearer of constitutional rights. The ethical guidelines which act as regulatory tools in this field are then discussed with attention to general ethical principles as provided for by the Health Professions Council of South Africa as well as the Medical research Council. The doctrine of informed consent further enjoys attention as it is discussed in context of medical research and key issues are addressed regarding the process of obtaining consent in context of stem cell technologies. Certain recommendations are then made pertaining to the minimum scope required for lawful consent. Lastly a critical analysis is made of chapter 8 of the National Health Act. The findings which are made here lead to further recommendations regarding the regulation of stem cells. / Dissertation (LLM)--University of Pretoria, 2011. / Public Law / unrestricted

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Le test prénatal non invasif (TPNI) est une technique de dépistage prénatal qui ne présente pas de risque accru de fausse couche, peut être effectué plus tôt dans la grossesse et est plus précis que les technologies existantes. Cependant, ces avantages peuvent contribuer à l’érosion de l’autonomie reproductive. Entre 2013 et 2017, une étude intitulée PEGASE a été menée, validant les performances et l'utilité du TPNI, ainsi qu’analysant les implications économiques, éthiques, juridiques et sociales de la technologie. Le présent mémoire est basé sur les données d’une enquête auprès des professionnels de santé (N = 184). Ce mémoire aborde la relation entre les attitudes des professionnels de santé concernant a) le "consentement éclairé" et b) le "consentement écrit" dans le contexte du TPNI. Il remet en question le récit établi dans la littérature, que les professionnels qui croient que le consentement écrit pour le TPNI n'est pas important croient également que les procédures de consentement pour le TPNI «devraient devenir moins rigoureuses» (1). Les données montrent que ce sont les professionnels qui se soucient de l'autonomie qui doutent de l'importance du consentement écrit. Cela contredit le récit cité ci-dessus. Les opinions des professionnels sur le «consentement écrit» ne peuvent donc pas être utilisées pour inférer leurs opinions sur l’importance du «consentement éclairé». Il est recommandé d’enquêter les professionnels de la santé sur des considérations particulières liées à la pratique, telles que celles enquêtées dans cette étude, plutôt que d’interroger les répondants sur des concepts académiques tels le «consentement» ou l’«autonomie». / Non-Invasive Prenatal Testing (NIPT) is a new generation of prenatal screening that poses no increased risk of miscarriage, can be performed earlier in the pregnancy, and is more accurate than previously existing technologies. These advantages, however, potentially contribute to eroding reproductive autonomy, already under threat from other screening methods. Between 2013 and 2017, a study titled PEGASUS was conducted, validating the performance and utility of NIPT, as well as studying the economic, ethical, legal and social implications of the technology. One of these activities was a series of surveys conducted throughout Canada in 2015-16. The present thesis is based on the data from the healthcare professionals’ survey (N=184). This thesis addresses the relationship between healthcare professionals’ beliefs regarding a) “informed consent” and b) “written consent” in the context of NIPT. It questions the established narrative in the bioethics literature, that professionals who believe written consent for NIPT is not important also believe consent procedures for NIPT “should become less rigorous” than those used for invasive prenatal testing (1). Data from the survey shows that it is precisely those professionals who care about reproductive autonomy considerations who doubt the importance of written consent for NIPT. This directly contradicts the narrative cited above. Professionals’ stated views on “written consent” thus cannot be used to infer their unstated views on the importance of “informed consent”. It is recommended to investigate particular practice-based considerations such as the ones in this study rather than querying survey respondents on scholarly concepts such as “consent” or “autonomy”.

Ce mémoire de maîtrise tente de répondre à la question suivante : quelle est la valeur de l’autonomie dans le domaine de la recherche biomédicale, et plus particulièrement dans le contexte des biobanques? Pour éclairer cette question, nous étudierons le concept d’autonomie dans deux domaines d’éthique appliquée : l’éthique de la recherche et l’éthique de la santé publique. Depuis la deuxième moitié du XXe siècle, le respect de l’autonomie individuelle est un principe programmatique de l’éthique de la recherche. Or, sa conceptualisation a été accusée d’être trop individualiste pour répondre aux enjeux qui caractérisent la recherche en santé d’aujourd’hui. En éthique de la santé publique, au contraire, l’autonomie individuelle prend une place moins prépondérante et fait droit à des dimensions sociopolitiques de l’autonomie qui ont été négligées par le domaine de l’éthique de la recherche. Ces dimensions mettent en lumière le rôle des institutions dans la promotion de l’autonomie tout comme l’importance pour les individus d’avoir la possibilité de participer à l’élaboration des politiques de santé qui les concernent pour réaliser leur autonomie. Le cas de la recherche en contexte de biobanques sera l’occasion d’appliquer ces différentes conceptualisations de l’autonomie à un domaine de recherche en pleine expansion qui se situe au carrefour de l’éthique de la recherche et de l’éthique de la santé publique. / This master's thesis attempts to answer the following question: what is the value of autonomy in biomedical research, and more particularly in the context of biobanks? To answer this question, we will study the concept of autonomy in two areas of applied ethics: research ethics and public health ethics. Since the second half of the 20th century, respect for individual autonomy has been a programmatic principle of research ethics. However, many authors consider this conceptualization to be too individualistic to respond to the challenges that characterize health research today. In public health ethics, on the contrary, individual autonomy takes a less preponderant role and acknowledges some socio-political dimensions of autonomy that have been neglected by the field of research ethics. These dimensions highlight the role of institutions in promoting autonomy as well as the need for individuals to have the opportunity to participate in the development of health policies in order to achieve their autonomy. Finally, the case study of biobanks will provide an opportunity to apply these different conceptualizations of autonomy to a rapidly expanding field of research located at the crossroads between research ethics and public health.

Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.

[pt] O objetivo geral desta dissertação é verificar a possibilidade de aplicação de regime jurídico diverso ao proposto pelo Código Civil a situações jurídicas existenciais que envolvem a tomada de decisão das crianças e adolescentes, sobretudo àquelas que envolvem decisão sobre o próprio corpo. Para tanto, há três objetivos específicos a serem desenvolvidos. O primeiro deles é a apresentação da teoria da capacidade jurídica e os direitos fundamentais da personalidade para compreender a perspectiva de disposição jurídica de direitos fundamentais da personalidade. Em continuidade o segundo objetivo é investigar a dignidade da pessoa humana como autonomia para verificar a aplicação de teorias que sustentem a autonomia privada da criança e do adolescente em situações jurídicas existenciais. Por fim, o terceiro objetivo é discutir a capacidade de agir da criança e do adolescente em situações jurídicas existenciais a partir de três casos concretos. Como conclusão geral sustenta-se a aplicação da teoria realista da capacidade de agir, aproximando os conceitos de titularidade e legitimidade sempre que a criança e o adolescente reunirem os requisitos para serem sujeitos do consentimento, devendo ser observados os critérios de validade do consentimento. Concluiu-se ainda que a teoria realista da capacidade de agir deva ser aplicada para dar voz e dignidade aos menores quando envolverem situações jurídicas existenciais de efeitos reversíveis de sorte que esta última conclusão criou três zonas de aplicação da teoria de modo a graduá-la para respeitar o processo de desenvolvimento maturacional do menor e assegurar, assim, sua dignidade. / [en] The general objective of this dissertation is to verify the possibility of applying a different legal regime than the proposed by the Civil Code to existential legal situations involving decision making of children and adolescents, especially those that involve decision about their own body. To this end, there are three specific objectives to be developed. The first is the presentation of the theory of legal capacity and the fundamental rights of personality in order to understand the perspective of legal provision of fundamental rights of personality. The second objective is to investigate the human dignity as autonomy to verify the application of theories to support the private autonomy of the child and adolescent in existential legal situations. Finally, the third objective is to discuss the ability to act of children and adolescents in existential legal situations from three specific cases. As a general conclusion it is sustained the application of realist theory s ability to act, bringing together concepts of ownership and legitimacy when children and adolescents meet the requirements to be subject of consent, and that the criteria of validity of the consent must be observed. It was also concluded that the realist theory of capacity to act should be applied to give voice and dignity to children and adolescents when they involve existential legal situations of reversible effects. So that the latter conclusion has created three areas of application of the theory in order to upgrade it to respect the process of maturational development of children and adolescents and thus ensure their dignity.

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