Volnei Garrafa

Between the needy and the greedy: the quest for a just and fair ethics of clinical research

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise.

O médico frente ao diagnóstico e prognóstico do câncer avançado

Biotechnological scientific progress has brought about some misunderstanding between advances and ethical decisions. The relationship physician-patient when facing seriously ill patients has been altered. OBJECTIVE: To evaluate the physicians attitude when facing disclosure to patient, family or both of cancer diagnosis and prognosis including also a bioethical analysis about the conflicts between beneficence, respect for patient autonomy and paternalism. METHODS: Thirty-eight physicians responsible for neoplasic patients in a tertiary hospital were interviewed. The questionnaire was structured in two different parts. The first, with general information about the physicians and the second, with specific questions about diagnosis and prognosis disclosure to the patient, evaluating also the physicians comprehension of beneficence. RESULTS: Although most physicians (97.4%) inform the diagnosis to their patients in cases of fatal diseases, 50.0% rely on the family for support. In cases of fatal prognosis,63.1% tell only the families while 31.6% prefer to tell only the patients. The study showed that physicians misunderstand beneficence and paternalism. CONCLUSION: Physicians normally disclose diagnosis to their patients. When they run out of therapeutic resources, their attitudes become conflicting in relation to the principles of beneficence and autonomy. The number of physicians who believe in paternalism as a form of beneficence is still significant. The paternalistic attitude arises especially when therapeutic resources no longer seem to really solve the problem.

Hidden risks associated with clinical trials in developing countries

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.

Por uma vida não colonizada: diálogo entre bioética de intervenção e colonialidade

O objetivo deste trabalho e discutir algumas nocoes desenvolvidas pelos estudos sobre colonialidade originadas por um conjunto de pensadores(as) da America Latina acerca do modo como a Modernidade surgiu estruturada como uma maneira de arranjar o poder, o saber e o ser de modo que uma hierarquia entre centro e periferia, instalados em uma perspectiva colonial, organize nossa maneira de lidar com a politica, com as ciencias e - esse e o ponto principal que o trabalho sustentara - com a propria vida. A Bioetica de Intervencao (BI), que tem como proposta politizar de modo etico e aplicado o modo de lidar com os conflitos biotecnocientificos, sanitarios, sociais e ambientais a partir da realidade latino-americana, desenvolve uma linha de pesquisa que pode acolher as criticas e contribuicoes advindas dos estudos sobre a colonialidade, sobretudo no que diz respeito as bases conceituais relacionadas com as teorias eticas e epistemologicas que a sustentam. Entre estas, especificamente, o estudo discute as relacoes existentes entre o utilitarismo aceito pela BI por meio de um consequencialismo solidario e suas inter-relacoes com a ideia de colonialidade.

Bioethics in Brazil

In this article, the authors briefly sketch the nature of Brazilian bioethics. Bioethics emerged in Brazil later than in other Western countries and the 1990s were the most important period for the spread of the discipline in the country. It is in this period that some structural elements of bioethics were established, such as research groups, regulation of Local Research Ethics Committees (Comites Locais de Etica em Pesquisa - CEP), the creation of the National Commission of Ethics in Research with Human Beings (Comissao Nacional de Etica em Pesquisa com Seres Humanos - CONEP) and the Brazilian Bioethics Society (Sociedade Brasileira de Bioetica - SBB). With regard to theoretical work, Brazilian bioethics is clearly an importer of theories from countries central to the studies of bioethics, or, in another words, countries where bioethics first emerged and was established. The most commonly used theory among Brazilian researchers is principlism.

Helsinque 2008: redução de proteção e maximização de interesses privados

Trabalho realizado na Catedra Unesco e Programa de Pos-Graduacao (Mestrado e Doutorado) em Bioetica da Universidade de Brasilia e Faculdade de Medicina da Universidade Federal da Bahia, Salvador, BA.

Radiografía Bioética de Brasil

En marzo de 1997, el entonces presidente de la International Association of Bioethics (IAB) Alastair Campbell, visito Brasil por invitacion de la Sociedad Brasilena de Bioetica. Inicialmente se presento en el II Congreso Brasileno de Bioetica, celebrado en Brasilia, “capital arquitecturalmente proyectada y pieza representativa del diseno artistico”, segun sus palabras. En seguida conocio Sao Paulo, donde participo en un Seminario Internacional de Bioetica Clinica, desarrollado en el Hospital Publico de Heliopolis, la principal villa miseria del mayor centro poblacional e industrial de America del Sur. Al volver a Gran Bretana, escribio un emocionado editorial en el IAB News relatando lo que habia visto y sentido en el viaje. Uno de los parrafos decia lo siguiente: “When I left Brazil after a too short visit, it was with a sense of gratitude to my hosts, not just for their friendship and outstanding hospitality, but for the realisation of how so differently I now perceived the nature of Bioethics. I had glimpsed what it must be like to sustain a public health service with minimal resources and massive problems of poverty. I had seen something of the environmental challenges of massive urbanization without adequate infrastructure to sustain it. In the midst of this I met people determined to find a Bioethics that makes a RADIOGRAFIA BIOETICA DE BRASIL

Cooperação em saúde na perspectiva bioética

This study considers the scenario of international relations in the transition to the twenty-first century as a backdrop for reflection on the bioethical perspective of international cooperation in health. It presents an exploratory analysis of the interdisciplinary scientific production in bioethics and public health in the international context, revealing that the focus and confluence of both issues has scant coverage in terms of diplomatic relations. It describes the methodology used to select publications cataloged in this interdisciplinary area from two bibliographic sources available on the web (93 articles in BVS/BIREME and 161 in PubMed), pointing to difficulties in locating this literature. The potential of the epistemological approach that flourished in Latin America under the guise of the Bioethics of Intervention in addressing the challenges that confront the international cooperation system, identified as the benchmark for analysis of South-South cooperation in health, is recommended. It concludes by proposing systematization and broadening of knowledge at the intersection of bioethics, public health and diplomacy, whose projection in the political and institutional field can contribute to reducing inequalities in health conditions among nations.

Bioética e biossegurança: uso de biomateriais na prática odontológica

OBJETIVO: Analisar o uso de biomateriais em odontologia por cirurgioes dentistas especialistas sob os aspectos da Teoria Bioetica do Princiapialismo e da Etica da Responsabilidade individual e Coletiva. METODOS: Foram aplicados questionarios a 95 cirurgioes dentistas registrados no Conselho Regional de Odontologia do Distrito Federal, 2002. sobre o uso de biomateriais em sua pratica. Dados relativos ao controle sanitario foram obtidos por meio das respostas desses cirurgioes dentistas e de pesquisa nos orgaos competentes. RESULTADOS: Os profissionais entrevistados utilizavam rotineiramente biomateriais, sendo que 45% relataram acreditar nao haver riscos para os pacientes; 48% nao consideram biomaterial como medicamento e 70% se sentiam seguros com relacao a origem, apesar de membranas e osso serem os itens mais adquiridos por meio de vendedores autonomos. Apesar disso, 96% dos entrevistados afirmaram que deveria haver maior controle das autoridades sanitarias. Mais da metade dos entrevistados (51%) referiu pouca ou nenhuma participacao do paciente no processo de escolha terapeutica. O termo de consentimento informado foi anexado por 12% dos cirurgioes dentistas pesquisados. CONCLUSOES: Os resultados mostraram que os profissionais utilizam biomateriais desconhecendo riscos e efeitos adversos, distanciando-se do principio da beneficencia. A etica da responsabilidade publica nao e observada pelos organismos publicos responsaveis e orgaos de categoria profissional. O consentimento informado ainda nao esta incorporado a pratica profissional, permanecendo a relacao profissional-paciente em odontologia excessivamente vertical.

Estudo bioético dos transplantes renais com doadores vivos não-parentes no Brasil: a ineficácia da legislação no impedimento do comércio de órgãos

OBJECTIVE: This study aimed to know the opinion of five different social segments (public prosecutors, judges, general population, recipients of the awaiting list for kidney transplants and the crew involved in the organ transplantation process of a hospital in Brasilia - Hospital de Base) about the present organ transplant legislation, with an emphasis on the donation of kidney by unrelated living donors, and the new determination given by Law # 10.211, in March 23rd, 2001, specifically in its article 9, that enlarges the criteria for donation of organs between unrelated living people. METHODS: A questionnaire with six objective questions was used in order to know the opinion of five groups of people of the Federal District about the present organ transplant legislation in Brazil. RESULTS: For 80% of the people interviewed, when Brazilian legislation allows donation of organs between unrelated living people, it makes possible the existence of rewarded donation and 81% of them consider that the requirement for judicial authorization is not an effective instrument to prevent organ commercialism. CONCLUSIONS: The present research indicates that Brazilian legislation fails concerning the utilization of kidneys for transplantation from unrelated living donors, making possible the commerce of organs in the country. Considering that poor people are the most vulnerable ones in this context, the authors suggest changes in the legislation in force, aiming to protect them and, therefore, attain more justice.