A research report submitted to the Faculty of Health Sciences, Steve Biko Centre for Bioethics, University of the Witwatersrand, in partial fulfillment of the requirements for the degree of Master of Science in Medicine In the field of Bioethics and Health Law Johannesburg, 2011 / Although Human Biological Materials (HBMs) are invaluable resources in biomedical research, they have not been without controversy in collaborative research between developed and developing countries. The normative arm of the study compared the key ethical issues in the laws, regulations and guideline documents of developed and developing countries with regard to the use, collection, storage, export and benefit-sharing of HBMs in collaborative research with developed countries. The empirical arm of the study examined how investigators and a Research Ethics Committee (REC) at a South African institution addressed these ethical issues, implemented national and international frameworks with regard to the use of HBMs. The majority of sponsors (59.6%, 90/151) in the study were from the USA compared to other developed countries (p=0.0001) with the bulk (65.84%) of the funds (R517.19 million) allocated for HIV research. HBMs for storage was obtained largely from adults (80.8%, 122/151) compared to children (12.6%, 19/151) [p <0.0001]. Whilst the principle investigators (PIs) of all 151 protocols informed the REC of their intent to store HBMs, only 87.4% (132/151) of PIs informed research participants (P <0.0001). In 47.7% (72/151) and 71.5 % (57/151) of protocols research participants were informed of the location and duration of storage, respectively, compared to 86% (130/151) and 19.25% (29/151) informing the REC (p < 0.0001), respectively. In 98% (149/151) of protocols informed consent (IC) was obtained from research participants with 76.8% (116/151) of protocols soliciting broad consent compared to specific consent (21.2%, 32/151) [p < 0.0001]. In the remaining 2% (3/151) of protocols IC for storage was not obtained. In 69.5% (105/151) of protocols confidentiality was maintained by a code and in 9.35% (14/151) of protocols HBMs was anonymised [p < 0.0001]. Significantly more protocols informed the REC (90/151, 59.6%) than the research participants (67/151, 44.4%) that HBMs will be exported (p= 0.011). Separate consent forms were not available for 60.9% (92/151) of protocols as per the requirement REC’s standard operating procedures (SOP). In 74% (51/69) of protocols the rationale for export was to access specialised laboratories (74%, 51/69) that were not available locally. Export permits were not available for 73.2% (109/151) of protocols. Where export permits were available, there were more exports to the USA (31/42, 73.8%) than to Europe (26.2%, 11/42) [p < 0.0001]. In the majority of protocols research participants were not informed of benefit sharing from any discoveries (129/151, 85.4%) or commercialisation (123/151, 81.5%) of products derived from their HBMs. Material Transfer Agreements (MTAs) were not available for 94.7% (143/151) protocols. Whilst 122/151(80.8%) protocols disclosed the amount of funds available from the sponsors for the research to the REC, not a single PI made such disclosures to the research participants (p < 0.0001). The varied definitions of what constitutes HBMs, the different terminologies used to describe identifiability, confidentiality, the different models of informed consent and different standards of ownership in the various national and international frameworks are characterised by a maze of definitions, laws, regulations and guidelines that are confusing, conflicting and defy generalisation. International and national laws, regulations and guidelines are fragmented and lack harmonisation. Most developing countries are in favour of severe restrictions on the use of their HBMs in collaborative research with developed countries. The protocols in the empirical study did not adequately address the inter-related ethical issues of export, storage, IC, commercialisation and benefit sharing derived from HBMs that are currently the subject of intense debate and controversy and central to the access to HBMs in collaborative research with developed countries. Because the empirical study is limited by the use of a convenient sample, the results cannot be generalised to other RECs in South Africa. Nevertheless, the data gives some credibility to the anecdotal evidence that HBMs are leaving the country unaccounted for without export permits and MTAs in place. Given the long delays in harmonizing and publishing new regulations and changes, outdated regulations and regulatory frameworks create opportunities for the proliferation of undesirable and unethical practices. Omissions in the RSA regulatory and ethical frameworks with regard to HBMs and Tissue Biobanking are concerning and require urgent action.

Economics promotes market mechanisms for the efficient use of resources in satisfying human want, yet market mechanisms are apparently unable to provide adequate health care and thereby satisfy a need central to a person’s well-being. This research report looks at the views of Amartya Sen and particularly his ideas of distributive justice and capability. It also considers some of the insights that economics provides for an understanding of the apparent limitations that occur in health care provision. The findings point towards a curtailed view of what may reasonably be obtained and a recognition that only limited agreement on any arrangement for health care provision may be possible within society. Sen’s capability approach provides a pertinent and expansive measure of a person’s well-being and freedom; it should not be ignored in any evaluation of well-being or the acceptability of any policy purporting to improve well-being.

This research report provides the reader with an overview of the current state of Earth as far as global warming and climate change is concerned. I describe how global warming is largely a consequence of humanoid behaviour from our past to our present behaviour focusing on self-centred materialism and consumerism. In the current economic paradigm, selfishness has become a prized commercial resource as humans continue to plunder, dominate and use earth’s resources with impunity. I explain ways in which the traditionally conceived views humans had concerning nature, including support by some religions, are changing, albeit slowly. This is accomplished by looking at changes in some concepts in two of the world’s major religions: Christianity and Islam. I describe the current physical state of the environment as the resource for human life. Because of its current state, I look at the importance of an ethical view of the environment. My major focus though is on the ways in which the emergence of the concept of international environmental law and its principles such as equitable utilization and apportionment have relevance and may prove to be the best deterrent in the attempt to stem global warming. I conclude this overview by making suggestions and recommendations concerning the Kyoto protocol - and how global warming can be tackled through an effective legal regimen.

South African medical schemes (health insurance or medical aid) companies offer insurance to the general public in the form of a multitude of different schemes. Each scheme has its own unique range of benefits, but certain exclusions apply across the board in respect of all schemes operated by a medical aid. In this research report, I investigate the rationale and necessity, as well as some of the ethical and legal implications of numerous notable exclusions. I further make relevant recommendations with respect to their application within the legal and ethical framework of the South Africa’s Consumer Protection Act, No. 68 of 2010.

Mestrado em Bioética / Master Degree Course in Bioethics

Mestrado em Bioética / Master Degree Course in Bioethics

Mestrado em Bioética / Master Degree Course in Bioethics

Mestrado em Bioética / Master Degree Course in Bioethics / A morte ocorre inexoravelmente e é comum a todos os seres vivos. Os seres humanos que se crê terem dela uma consciência particular, em geral, não a desejam. Porém, o sofrimento provocado por certas doenças físicas e psicológicas leva algumas pessoas a desejar e a procurar a morte. O suicídio é uma das formas que algumas pessoas encontram para acabar com o seu sofrimento. Quando muito debilitadas para o poderem fazer pelos seus próprios meios, por vezes, procuram que profissionais de saúde, geralmente médicos, as ajudem a morrer. É hoje consensual que as pessoas podem, quando na posse das suas faculdades mentais, recusar quaisquer tratamentos ainda que estes lhe pudessem salvar a vida. Mesmo quando estão cognitivamente incompetentes, podem ainda manifestar-se se tiverem deixado instruções sobre a sua vontade. No entanto, quando a vontade do doente não é conhecida, outros problemas de decisão se colocam, devendo pugnar-se sempre por o que for entendido como os melhores interesses do doente. Uma resposta positiva ao sofrimento são os cuidados paliativos, cujo desenvolvimento é imperioso mas que se tem arrastado demais. O que os médicos portugueses pensam sobre este assunto não é conhecido. Por isso, foi feito um inquérito por via postal a oncologistas portugueses, incritos na Sociedade Portuguesa de Oncologia e outros. Observou-se que a maioria dos oncologistas é contra a prática da eutanásia e do suicídio assistido, mas mais de 30% são a favor da sua legalização. Só um médico admitiu ter praticado eutanásia num caso, mas nenhum prestou assistência ao suicídio de um doente. O factor mais importante associado a ser-se a favor ou contra as práticas da morte assistida foi o ser-se católico praticante ou não praticante, sendo estes últimos favoráveis a essas práticas numa percentagem maior. A maioria dos oncologistas é a favor da suspensão de medidas de suporte da vida a pedido do doente, embora só 41% estivesse disposto a suspender a alimentação e a hidratação. Mais de 95% dos médicos administraria um fármaco para aliviar o sofrimento de um doente, ainda que com isso pudesse encurtar-lhe a vida. Cerca de 80% considera que os cuidados paliativos poderiam evitar pelo menos muitos dos pedidos de morte assistida. Os resultados obtidos devem ser considerados com cautela, visto que só cerca de 33% dos médicos inquiridos responderam. A ideia de que os cuidados paliativos poderiam ser a resposta mais apropriada para os problemas dos doentes, na parte final da sua vida, reflecte um grande consenso e é uma das mais importantes conclusões do estudo. / Death occurs inexorably and is common to all living beings. Human beings, who are thought to have a particular consciousness about it, usually do not desire it. However, suffering due to some physical and psychological diseases makes some people desire and seek death. Suicide is one of the ways that some people find to terminate their suffering. When very frail to make it by their own means, sometimes, they try that health professionals, in general doctors, help them to die. Nowadays, there is a consensus that people can, when owning their mental capacities, refuse any treatments even when they could save their life. Even when cognitively incompetent, patients can express their will if they had left instructions about it. However, when the patient will is unknown, there are other decisional problems, but doctors should strive always for what they see as the patient s best interest. A positive response to suffering is palliative care, whose development is pressing but is being too slow. What most Portuguese doctors think about this topic is not known. Therefore, it was done a postal survey to Portuguese oncologists, belonging to the Portuguese Society of Oncology and others. It was observed that most oncologists are against the practice of euthanasia and of assisted suicide, but more than 30% are for their legalization. Only one doctor admitted having practiced euthanasia in one case, but no one assisted any patient in suicide. The most important factor associated with being for or against the practices of assisted death was to be catholic practising or not, with these being for those practices in a bigger percentage. Most oncologists are for the withdrawal of life support measures at the patient s request, although only 41% would accept the withdrawal of feeding and hydration. More than 95% of the doctors would give a drug in order to relieve the suffering of a patient, even if that could shorten his or her life. About 80% think that palliative care could avoid at least many of the requests to assisted death. The results obtained should be cautiously considered, because only 33% of the surveyed doctors replied. The idea that palliative care could be the most appropriated answer to the problems of patients at the final part of their lives reflects a large consensus and is one of the most important conclusions of this study.

Mestrado em Bioética / Master Degree Course in Bioethics / Introdução O prolongamento da existência, não deve ser critério decisivo para legitimar uma determinada terapia. Devem ser apreciadas as condições em que a vida se vai prolongar, vistas antes de mais, na perspectiva do doente e na medida do possível por ele próprio. Esta atribuição ao paciente do estatuto de verdadeiro sujeito, que não mero objecto, da actuação médica, exige ao médico um novo papel: o de facultar ao paciente os elementos imprescindíveis para que este conheça e compreenda, no essencial, os dados do problema e possa assim exercer conscienciosamente o seu poder de decisão. Objectivo Tendo a sensação que nem sempre os doentes em tratamento de hemodiálise, são informados devidamente, quis perceber junto deles, que importância atribuem ao direito à informação e de que forma esta contribuiu para a decisão de iniciar hemodiálise, bem como para a adaptação ao tratamento. Material e Métodos Foi realizado um estudo qualitativo seguindo as linhas de orientação de Van Manen, onde esta questão foi abordada a doentes que se encontram em programa de hemodiálise, através de uma entrevista não estruturada. Resultados e Conclusões Após a análise das entrevistas, conclui-se que em contexto de hemodiálise, a necessidade de tratamento e o sofrimento, leva a que os doentes coloquem no momento da decisão, a informação em segundo plano, pois todos foram unânimes que a situação de mal-estar em que se encontravam, e a falta de alternativas, levava a que não houvesse hesitações perante a proposta de iniciar tratamento. No que se refere há falta de informação, ela surgiu no estudo inserida no contexto de toda uma preparação que tem que existir para a adaptação ao tratamento e não tanto no que respeita à tomada de decisão. Valorizam deste modo a necessidade de elaboração de todo um processo informativo, salientando que este deve envolver não só a compreensão pelo doente mas também pela família, do significado da doença, e dos seus reflexos no quotidiano. Salientam a necessidade de existir um vínculo orientador entre eles e a equipe de saúde, onde atribuem uma importância fundamental ao facto da informação chegar através do apoio de várias especialidades e não só por parte de o médico que os assiste. Por fim, uma das características centrais desta vivência é a determinação que os participantes apresentam para mobilizar as suas forças no sentido de continuar o tratamento. Aqui mostraram que buscam ajuda na informação que receberam de que a hemodiálise poderá ser um tratamento provisório, e renovam a cada dia as suas esperanças de que a qualquer momento possam ser submetidos ao transplante renal. / Introduction The prolongation of the existence does not have to be decisive criterion to legitimize one definitive therapy. The conditions must be appreciated where the life if goes to draw out, seen before more, in the perspective of the sick person and the possible measure do for proper it. This attribution to the patient of the statute of true citizen, that not mere object, demands to the doctor a new paper: to authorize to the patient the essential elements so that this knows and understands, in the essential, the data of the problem and can thus exert conscientiously its power of decision. Objectives Having the sensation that nor always the sick people are informed duly, it wanted to perceive next to them, how much important attribute to the right to the information and of that it forms this contributed for the decision to initiate haemodialysis, as well as for the adaptation to the treatment. Material and Methods A qualitative study was carried through following the lines of orientation of Van Manen, where this question was boarded the sick people who if find in program of haemodialysis, through an interview not structuralized. Results and Conclusions After the analysis of the interviews, concludes that in context of haemodialysis, the necessity of treatment and the suffering, take the one that the sick people place at the moment of the decision, the information in second plain, therefore all had been unanimous that the malaise situation where if they found, and the lack of alternatives, took the one that did not have hesitations before the proposal of initiating treatment. In what it is mentioned has information lack, it appeared in the inserted study in the context of all a preparation that has that to exist not in such a way for the adaptation to the treatment and in what it respects to the decision taking. They in this way value the necessity of elaboration of all an informative process, pointing out that this must not only involve the understanding for the sick person but also for the family, of the meaning of the illness, and its consequences in the day by day. They point out the necessity to exist a orienting bond between them and the team of health, where they attribute a basic importance to the fact of the information to not only arrive through the support of some specialties and on the part of the doctor who attends them. Finally, one of the characteristics central offices of this experience is the determination that the participants present to mobilize its forces in the direction to continue the treatment. Here they had shown that they search aid in the information that had received from that haemodialysis could be a provisory treatment, and renews to each day its hopes of that at any time they can be submitted to the renal transplant.

Mestrado em Bioética / Master Degree Course in Bioethics / Esta tese, ancorada na forma de um "ensaio antropológico", expõe ideias, críticas e reflexões, realçando a questão antropológica sobre a natureza do homem, ou seja sobre tudo o que faz com que o homem seja e pense o que realmente é; e a Ética enquanto espaço de, e em, debate...um esforço de uma compreensão entre vários. Enfim, traduz um esforço para perspectivar pontos de concordância, linhas de fractura e enfatização de espaços! Retém-se sobre um dos desafios do ser humano, enquanto ser com uma autoconsciência, capaz não só de pensar no que vai fazer, mas como o irá realizar e quais os mecanismos mentais envolvidos neste processo, bem como na inserção biológica da consciência, transportada por um corpo fáctico e portanto nunca podendo ser pensada fora dele e da sua inserção no mundo. É nesta perspectiva de entrelaçamento entre corpo, consciência e mundo que uma reflexão fenomenológica sobre o pensamento crítico e o processo de tomada de decisão se me apresentou como fundamental. Não nos basta permanecer numa atitude reflexiva, num exercício, a que podemos chamar de metacognitivo temos também de reflectir sobre a própria reflexão, perceber quais os seus efeitos, para que o saber ético seja, verdadeiramente, saber absoluto. Assim, a necessidade da reflexão teórica como fundamentação da acção pode surgir, neste contexto, de certa forma cada vez mais creditada. Ora, a Bioética surge, assim, como uma aproximação à prática a fim de reflectir sobre ela e, desta forma, importante, no sentido em que ao se encontrarem as razões das nossas acções e dos nossos comportamentos, voltamos à prática de um modo mais enriquecido e consciente, porque reflectido, instaurando uma correlação entre áxis e práxis tendo em vista um agir cada vez melhor, um verdadeiro círculo hermenêutico, de um saber nunca acabado, sempre procurado. A opacidade deste ser real, que é o Homem dotado de inteligência reflexiva e simbolizadora e, por esta capacidade única, criador de uma cultura exterior simbólica, ser aberto ao mundo e incompleto, exprime-se pela finitude da sua experiência e do seu pensamento. Mas, ao mesmo tempo que o pensamento ético se dirige para a resposta às questões colocadas por uma sociedade num determinado contexto económico, político, cultural, ou outro, ele tem por obrigatoriedade a procura de fundamentos que dirijam a acção dos homens inseridos nessa mesma situação. A ética refere-se ao agir humano e sendo assim algo que respeita à interioridade de cada um, estando presente em todos os momentos da nossa vida e em tudo aquilo que fazemos. É inquestionável a existência de questões inéditas que se colocam em virtude da evolução da ciência e da técnica que obrigam a uma nova reflexão ética que oriente a acção, assim como o desenvolvimento de uma sabedoria prática da existência humana enraizada na sua compreensão teórica. A coerência entre temáticas aparentemente tão díspares dá-se pelo objectivo hermenêutico que permeia a abordagem de todas elas: a compreensão de compreensões diferentes. Através do pensamento reflexivo, desta capacidade de problematização, o sujeito humano eleva-se de coisas particulares e concretas, às explicações universais e necessárias, ultrapassa o momento presente, recordando o passado e abrindo-se ao possível e à ausência. A correlação que se estabelece entre esta tríade: Pensamento Crítico, Tomada de Decisão e Bioética, é uma conjugação que penso ser extremamente necessária, pertinente e útil para que, o Homem tal como os outros animais, que se encontram sujeitos ao fatal flaw , possam através do saber (saber, saber-ser, saber-estar e saber transformar-se) e do aprender a aprender do Homem, melhorar as suas vidas e, em última instância, permitir a sobrevivência da nossa e das outras espécies! / This thesis, anchored in the form of an anthropological essay, sets forth a set of ideas, critiques and reflections, emphasising the anthropological question of the human being s nature, this is, about everything that makes Man be and think about what he really is; it s Ethics in the means of space and in debate an effort of trying to understand among others. All in all, it shows an effort to put in perspective points of agreement, lines of fracture and emphasising spaces! It s all about one of the challenges of the human being, as a being that possesses auto-consciousness, allowing him not only to think on what he s going to do, but also on how he is going to achieve it and which mental mechanisms are involved in the process, as well as in the biological placement of the conscience, transported by a factic body and therefore never being thought of outside of it and of it s place in the world. In this perspective of a connection between body, mind and world, it came to me as crucial and important to reflect phenomenologically upon the critical judgement and the process of decision-making. It s not enough for us to have a reflexive attitude, in an exercise we call as metacognitive we also have to reflect upon reflection itself, understand what it s effects can be, so that the ethical knowledge may truly be an absolute knowledge. So, the need for a theoretical reflection as the basis of action may, in this context and in a certain way, appear as being more and more credible. In this way, Bioethics appears as a nearing to practise in order to reflect upon it, in a way that as we importantly find the reasons for our actions and our behaviour, we go back to reflect upon them and so, as we importantly find the reasons for our actions and our behaviour, we go back to practice in a more enriched and conscious way, reflecting, finding a correlation between áxis and praxis taking into account an improved way of acting, a true hermeneutical circle, of a never ending knowledge, always searched for. The opacity of this real being, which is Man gifted with reflexive and symbolising intelligence and for this unique capacity, creator of this exterior symbolic culture, open to the world and incomplete, expresses itself by it s endless experience and thought. However, at the same as the ethical thought steers itself to the answers to the questions made by a society in a determined economic, political, cultural and other contexts, it obligatorily looks for the causes that make human beings a part of that same situation. Ethics refers to the human action and consequently this has to do with the inside of each person, taking an active part in all the important moments of our lives and in everything we do. The existence of brand new questions that are placed in virtue of scientific and technical evolution are unquestionable and they oblige to a new ethical reflection that can lead action, as well as to the development of a practical knowledge of human existence embedded in it s theoretical understanding. The coherence between themes that apparently seem opposite is due to the hermeneutic objective that allows a contact between all: the understanding of different understandings . Through reflexive thinking, of this capability of putting everything into doubt, the human being raises himself from particular and specific things, to universal and necessary explanations, goes beyond the present moment, keeping the past in mind and opening itself to the possible and absent things. The correlation that is established in this triad: Critical Judgement, Decision-making and Bioethics, is a connection that I believe is extremely necessary and useful so that Man just as all other living animals that are subject to the fatal flaw , may eventually improve their lives through knowledge (knowledge, know how to be and how to transform) and learn how to learn and at a final stage, allow our survival and all other living creature species survival, too!