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Ethical issues associated with using human biological material in collaborative research with developed countries: a case studySathar, Mahomed Aslam January 2011 (has links)
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.
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Amartya Sen, ethics, and economics in the health care sector.Histed, Wendy 23 November 2011 (has links)
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.
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The role of law in combating global warmingNdung'u, Nugi James 15 October 2009 (has links)
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.
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Ethical and legal considerations in the relationship between medical scheme and memberSnoyman, Howard 09 January 2012 (has links)
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.
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Aspectos éticos e psicológicos do abortamento no casalCanário, Ana Catarina Miranda 26 February 2010 (has links)
Mestrado em Bioética / Master Degree Course in Bioethics
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"Implicações éticas das taxas moderadoras face à escassez de recursos em saúde".Barbosa, Ana Patrícia da Rocha 22 June 2009 (has links)
Mestrado em Bioética / Master Degree Course in Bioethics
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O consentimento informado na prática do cuidar em enfermagemAlmeida, Olga Maria de Oliveira 18 February 2008 (has links)
Mestrado em Bioética / Master Degree Course in Bioethics
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A boa morte: ética no fim da vidaGonçalves, José António Saraiva Ferraz 13 June 2007 (has links)
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.
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Decidir,informado. Um estudo em hemodiáliseRebelo, Maria do Rosário Amaral 09 July 2007 (has links)
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.
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Como pensa quem pensa? Um ensaio antropológica sobre o espíritoRegadas, Susana Carla Ribeiro de Sousa 14 December 2007 (has links)
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!
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