Direito versus bioética em tempos de pandemia. Que desafios? / Law versus bioethics in pandemic times. What challenges?

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Bioética em investigação clínica no âmbito da Covid-19: disrupções, adaptações e lições / Bioethics in clinical research in Covid-19 context: disruptions, adaptations and lessons

A investigação clínica deve obedecer a regras éticas e metodológicas bem estabelecidas por várias instituições e organizações que visam proteger o participante, respeitando os 3 princípios fundamentais da bioética: o respeito pelas pessoas, beneficência e justiça. A pandemia da Covid-19 constitui uma emergência de saúde pública que necessita de respostas rápidas para obtenção de novos medicamentos, esquemas terapêuticos, vacinas e testes de diagnóstico que permitam diminuir o impacto da infeção por Sars-CoV-2. A pandemia constituiu um desafio para a realização de estudos clínicos, incluindo ensaios clínicos, que respeitassem os princípios estabelecidos internacionalmente de valor, ética e qualidade. As medidas de restrição à mobilidade das pessoas, que aumentaram as dificuldades de acesso, em particular dos grupos vulneráveis, bem como a necessidade de divulgação rápida dos resultados dos estudos, vieram trazer disrupções importantes na investigação clínica. Vários mecanismos adaptativos, baseados na experiência adquirida em surtos epidémicos anteriores (Sars, H1N1, VIH/SIDA e doença por vírus Ébola) foram accionados, incluindo a disponibilização de vias rápidas para a realização de estudos clínicos, implicando modificações no modo de funcionamento dos Comités de Ética na Investigação, bem como a verificação rigorosa da validade dos resultados antes da sua publicação e divulgação. As lições a retirar das disrupções e adaptações durante a pandemia mostram que o respeito dos valores éticos fundamentais na experimentação em seres humanos em contexto de emergência de Saúde Pública pode contribuir para uma melhor preparação na resposta face a surtos de doenças infeciosas e para a credibilidade da investigação biomédica

Clinical research must follow ethical and methodological rules well established by various institutions and organizations that aim to protect the participant, respecting the 3 fundamental principles of bioethics: respect for persons, beneficence and justice. The Covid-19 pandemic is a public health emergency that requires rapid responses to obtain new drugs, therapeutic regimens, vaccines and diagnostic tests to lessen the impact of the Sars-CoV-2 infection. The pandemic has challenged the conduct of clinical studies, including clinical trials, that respect internationally established principles of value, ethics and quality. The measures restricting mobility of people, which increased the difficulties of access, particularly for vulnerable groups, as well as the need for rapid dissemination of study results, brought major disruptions to clinical research. Several adaptive mechanisms, based on the experience gained from previous epidemic outbreaks (Sars, H1N1, HIV/AIDS and Ebola virus disease) have been triggered, including the provision of fast-track routes for conducting clinical trials, implying changes in the way Research Ethics Committees operate, as well as rigorous verification of the validity of results before publication and dissemination. Lessons from the disruptions and adaptations during the pandemic show that respect for fundamental ethical values in human experimentation in the context of a Public Health emergency can contribute to better preparedness in the response to outbreaks of infectious diseases and to the credibility of biomedical research.

Experiência do Comité Nacional de Bioética para a Saúdede Moçambique após Covid-19 / Experience of the National Bioethics Committee for Health of Mozambique after Covid-19

O Comité Nacional de Bioética para a Saúde em Moçambique (CNBS) tem como missão principal fazer a revisão, para aprovação ética, de todas as propostas de pesquisa em saúde, que envolvam seres humanos, realizadas em todo o território nacional, submetidas pelos investigadores, sejam estes nacionais ou estrangeiros. É apresentado, de forma sucinta, os objectivos do Comité Nacional de Bioética para a Saúde de Moçambique e da sua redede Comités Institucionais de Bioética paraa Saúde (CIBS ́s) e o modo do seu funcionamento para garantir o cumprimento dos procedimentos éticos na investigação para protecção do agente de pesquisa e do próprio investigador, bem como desenvolver a formação em bioética para a pesquisa, melhorando e agilizando a comunicação entre os investigadores, promotores ou financiadores destas pesquisas. Com o aparecimento da pandemia deCovid-19,e havendo necessidade destes comités, mais do que nunca, manterem-se em funcionamento, introduziram-se algumas alterações à sua actividade, nomeadamente a passagem para um regime de teletrabalho, a obrigatoriedade dos protocolos de estudo conterem um capítulo (se pertinente) sobre comoenfrentaria no terreno, a situação da Covid-19 e a avaliação expedita, entre outras. Conclui-se com o relato dos resultados desta experiência vivida num período de um ano (Janeiro a Dezembro de 2020).

The main mission of the National Bioethics Committee for Health in Mozambique (CNBS) is to review for ethical approval all health research proposals involving human subjects conducted throughout the national territory submitted by national or foreign researchers. The objectives of the National Bioethics Committee for Health in Mozambique and its network of Institutional Bioethics Committees for Health (CIBS's) are briefly presented, as well as how they function to ensure compliance with ethicalprocedures in research for the protection of the research agent and the researcher himself, as well as to develop training in bioethics for research, improving and streamlining communication between researchers, promoters or funders of such research. Withthe appearance of the Covid-19 pandemic and the need for these Committees, more than ever, to remain functional, some changes were introduced to their activity, namely the change to a teleworking regime, the obligation for study protocols to contain a chapter (if relevant) on how they would deal with the Covid-19 situation in the field and the expedite evaluation, among others. We conclude with the report of the results of this experience lived in a period of one year (January to December 2020)

Importância dos Conselhos Consultivos Nacionais de Bioética em tempos de Covid-19: realidade e perspectivas de Angola / Importance of National Bioethics Advisory Councils in Covid-19 times: Angola's reality and perspectives

A Covid-19 trouxe ao mundo uma nova dinâmica de vida, obrigando que os Conselhos Consultivos Nacionais de Bioética de muitos países, principalmente os africanos (Togo, Argélia) e alguns europeus (França e Portugal), se reinventassem para se adequarem ao contexto. Dentro da sua linha de actuação os conselhos apenas opinam, sugerem, analisam e recomendam algumas medidas que poderiam ser tomadas diante de conflitos morais. O objectivodeste trabalho é apresentar o papel dos Conselhos Consultivos Nacionais de Bioética no enfrentamento dapandemia daCovid-19. O texto sustenta-se metodologicamente em um estudo documental e bibliográfico com abordagem qualitativa e de carácter exploratório. Nos resultados, foram encontradas informações sobre Conselhos Consultivo Nacionais de Bioética em África, bem como outros denominados por Comité Nacional de Bioética. Entretanto, constatou-se que de algum modo eles ajudam na manutenção dos conhecimentos sobre como lidar com a Covid-19, embora em alguns países africanos sejainexpressivo. É essencial ressaltar que um Conselho Consultivo Nacional de Bioética tem missão diferente de um Comité de Ética em Pesquisa, uma vez que o Conselho vela por questões de maior magnitude, como projectosque serão convertidos em políticas de Estado. Por fim,vale ressaltar que no caso africano, existe uma ausência de órgãos governamentais atinentes à bioética. E é de suma importância para os países africanos a implementação de órgão dessa dimensão (Conselho Nacional de Bioética) para permitir o diálogo de temas de bioética de complexa resolução como é o caso da Covid-19.

Covid-19 brought a new dynamic to the world, thus forcing the National Bioethics Advisory Councils of many countries, mainly African (Togo, Algeria) and some European (France and Portugal) to reinvent themselves to fit the context. Within their line of action, the councils only give opinions, suggest, analyse and recommend some measures that could be taken in the face of moral conflicts. The aim of this paper is to present the role of National Bioethics Advisory Councils in confronting the pandemic of Covid-19. The text is methodologically sustained in a documental and bibliographical study with a qualitative approach and of exploratory character. In the results, information was found on National Bioethics Advisory Councils in Africa, as well as others called National Bioethics Committee. However, it was found that some how they help in maintaining knowledge on how to deal with Covid-19, although in some African countries it is inexpressive. It is essential to emphasise that a National Bioethics Advisory Council has a different mission from a Research Ethics Committee, since the Council watches over issues of greater magnitude, such as projects that will be converted into State policies. Finally, it is worth noting that in the African case, there is an absence of governmental bodies pertaining to bioethics. And it is of utmost importance for African countries to implement such a body (National Bioethics Council) to enable dialogue on bioethical issues of complex resolution as is the case of Covid19.

Desafios bioéticos na sociedade tecnológica / Bioethical challenges in the technological society

Há 50 anos atrás, Van Rensselaer Potter, considerado pai da Bioética, publicou Bioética: ponte para o futuro. Mesmo sendo uma disciplina relativamente recente, e ainda enfrentando o desafio de consolidar-se, a Bioética deve dar respostas à questões antigas e novas, conforme evidenciado napandemia deCovid-19. Na primeira parte deste trabalho, apresentam-se alguns dilemas actuais, que são possíveis pela tecnologia disponível. Utilizam-se casos dos últimos cinco anos, para ilustrar como o uso das novas biotecnologias exigem uma reflexão bioética, necessária tanto para os sujeitos envolvidos directamente, como para a sociedade em geral. Consideramos que o progresso, para que seja verdadeiro, deve ser um avanço na direcção correcta. Ou seja, a tecnologia por si só não basta para o progresso dahumanidade, é necessário que o seu uso favoreça a pessoa humana e a sociedade, sempre respeitando os direitos e considerando os deveres. A segunda parte concentra-sena origem, actualidade e horizonteda na Bioética. Revisam-se alguns dos acontecimentos mais importantes no seu desenvolvimento, desde a primeira vez que a palavra foi usada em 1927, até os desafios que se preveem nas próximas décadas. Conclui-se com a necessidade de uma Bioética verdadeiramente global, com métodose princípios consolidados, e capaz de dar respostas aos dilemas actuais. Portanto, os três desafios principais possivelmentesão: ampliar a visão, contar com um fundamento antropológico, e ser capaz de ser pró-activa

Fifty years ago, Van Rensselaer Potter, considered the father of bioethics, published Bioethics: Bridge to the Future. Even as a relatively recent discipline, and still facing the challenge of consolidating itself, bioethics must provide answers to old and new questions, as evidenced in the present pandemic of Covid-19. In the first part of this paper, some current dilemmas, which are made possible by the technology available today, are presented. Cases from the last five years are used to illustrate how the use of new biotechnologies requires a bioethical reflection, necessary both for the subjects directly involved and for society in general. We consider that progress, in order to be true, must be an advance in the right direction. In other words,technology alone is not enough for the progress of humanity, it is necessary that its use favours the human person and society, always respecting rights and considering duties. The second part focuses on bioethics, its origin, current affairs and horizon.Some of the most important events in the development of bioethics are reviewed, from the first time the word was used in 1927 to the challenges that are foreseen in the coming decades. It concludes with the need for a truly global Bioethics, with consolidated methods and principles, and capable of providing answers to current dilemmas. Therefore, the three main challenges are possibly: broadening the vision, having an anthropological foundation, and being able to be proactive.

Respect for Vulnerability is a Human Right: Article 8 of the UNESCO Declaration on Bioethics and Human Rights; and Senior Citizens in South Africa

It is untrue that the elderly in South Africa (SA) are probably discriminated against in healthcare as the result of inadequate legislation that does not conform to international standards. The National Health Act recognises vulnerability and gives expression to it. Respect for vulnerability has not yet been introduced to fundamental political and bioethical frames of reference in SA and that is probably the reason why the concept and right have not become part of the ethical awareness in healthcare. The appeal of this article is that respect for vulnerability must be brought to conform to the Universal Declaration on Bioethics and Human Rights by declaring the ethical principle as an independent human right

Universal Healthcare : Through the Eyes of a Medical Student

Regardless of which Bioethical Theory one consults - be it; for example; Utilitarianism; which states that one must do the most good for the greatest number of people 'An action is morally right if the consequences of that action are on balance more positive than negative for the greatest number' [1]; or perhaps Deontology; which is Duty Theory 'there are certain actions which we have a duty to perform or to refrain from performing' [1] - one will likely come to the conclusion that Universal Healthcare is an ideal which; if at all possible; should be achieved by mankind. It is a question of human rights; and respect for ones' fellow man; or perhaps; more fundamentally treating those around us with the care we would expect for ourselves; or family members.In this paper; I shall attempt to unravel Universal Healthcare as an ideal. To bring it down to fundamentals and perhaps make suggestions towards how such an ideal may be realised. I will look at relevant Healthcare systems which have been implemented overseas; and compare them to what government hopes to implement in South Africa - a National Health Insurance. Most importantly; I will analyse Universal Healthcare in the context of South Africa; and establish whether this ideal is attainable. Universal healthcare is the gem of healthcare in the 21st century. It is what all health care professionals would love to achieve within their life-times; but to achieve a goal as immense as this; one needs to build from the foundations upwards. As such; I shall discuss and suggest ways in which healthcare students can contribute to this ultimate ideal

Protection of Children by Substitute Consent: A Universal Principle and Right

In 2005; the world community and the United Nations Educational; Scientific and Cultural Organization (UNESCO); comprising 191 member nations; unanimously accepted the Universal Declaration on Bioethics and Human Rights (UDBHR). This declaration is the first and only bioethical text to which the entire world has committed itself and helps put bioethics on the agenda of states. However; it appears to have had little or no impact in South Africa (SA). This article aims to join UNESCO's mission and to form part of the social responsibility initiative of teaching the universal right and the ethical principle of proxy consent in the context of medical intervention to promote the UDBHR in SA. We compare the UDBHR and SA Children's Act No. 38 of 2005. It is clear that the world community sees surrogate consent as the right and duty of all communities

Current State of Public Cemeteries in River State; Nigeria

Cemeteries or 'sleeping places' are where bodies or cremated remains are buried. Dead bodies are essentially 'wastes' and their improper disposal in the form of burial may come with health implications. This is particularly apt in Nigeria and indeed Rivers State where unsupervised burials are carried out in homes (houses); compounds and community-based cemeteries. A walk through survey of five functional public cemeteries in Rivers State appraised their current state and their possible health implications. This on-the-spot site visit revealed infrastructural; operational and maintenance challenges which have further stressed the need for better managed public cemeteries and more objective studies on the subject