Cláudio Lorenzo

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.

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.

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.

Bioética global na perspectiva da bioética crítica

Since the 1990s bioethics has increasingly approached the discussions related to international health and life sciences, which led some authors to refer to the “global bioethics”. This article examines this concept as elaborated in the theoretical perspectives of three formulations of North American bioethics: Van Rensselaer Potter, the Tristram Engelhardt, and Beauchamp and Childress. By balancing the strengths and weaknesses of the approaches of these authors, it is proposed the “critical bioethics” as the best qualified alternative theoretical to address the global issues of bioethics from the historical perspective of the countries of the Global South.Global bioethics from the perspective of critical bioethics Since the 1990s bioethics has increasingly approached the discussions related to international health and life sciences, which led some authors to refer to the “global bioethics”. This article examines this concept as elaborated in the theoretical perspectives of three formulations of North American bioethics: Van Rensselaer Potter, the Tristram Engelhardt, and Beauchamp and Childress. By balancing the strengths and weaknesses of the approaches of these authors, it is proposed the “critical bioethics” as the best qualified alternative theoretical to address the global issues of bioethics from the historical perspective of the countries of the Global South.

Sistema suplementar de saúde e internação domiciliar de idosos na perspectiva da bioética crítica

Home Care (HC) is currently the main option in elderly dehospitalization, especially in the supplementary system. Varied ethical conflicts arise in the context of assistance along with varied familiar contexts. We per formed an explanatory study of two HC cases in health insurance providers, in which the ethical conflicts were delimited in two main Bioethics playing fields: the clinical bioethics, regarding to interpersonal relationships and decision-making on assistance; and the Bioethics applied to public health, regarding to challenges to the organization and provision of services. The conflicts were discussed based on the critical bioethics model. The study generated propositions for reducing some ethical conflicts on HC, and demonstrated the need of more extended studies in order to know in greater length and depth this problem in Brazil.En Brasil, actualmente, la hospitalizacion domiciliar (ID) es la principal opcion para disminuir la ocupacion de los ancianos en el sistema adicional de salud. Surgen varios conflictos eticos para la asistencia en medio a diversos contextos familiares. En este trabajo, realizamos un estudio exploratorio de dos casos de ID en las operadoras de seguros de salud, en la cual los conflictos eticos identificados fueron delimitados a dos campos principales de actividad de la bioetica: el de la bioetica clinica referente a las relaciones interpersonales y en las decisiones en torno a la asistencia, y el de la bioetica aplicada a la salud publica, respecto a los desafios para la organizacion y prestacion de los servicios. Los conflictos fueron discutidos en base en el modelo de bioetica critica. El estudio genero proposiciones para la reduccion de algunos conflictos eticos involucrados en la ID, y fue demostrado la necesidad de investigaciones mas amplias para conocer en mayor extension y profundidad este problema.

A interface entre bioética e fisioterapia nos artigos brasileiros indexados

INTRODUCTION: Although still incipient rapprochement between Physical Therapy and Bioethics in Brazil has been growing concern about its development due to the variety of ethical conflicts that may involve physiotherapists. This paper was a study on the themes and the theoretical foundation of the articles indexed wishing to discuss the interface between Physical Therapy and Bioethics. MATERIALS AND METHODS: This study was conducted by content analysis method Bardin in all papers published in refereed journals, found in the sources BIREME and SciELO between 2000 and 2011 using the keywords: physiotherapy and bioethics and its derivatives. RESULTS: We confirmed the primary level of development of bioethical reflection in physical therapy, showing conceptual deficiencies, distance of more modern theories and models developed in Brazil and lack of consideration of sociocultural and economic factors as influencing the generation of conflict. FINAL THOUGHTS: It was pointed out the need to develop training projects in bioethics for teachers and researchers in the field of physical therapy in order to develop content in undergraduate programs and graduate.

Global bioethics from the perspective of critical bioethics

Since the 1990s bioethics has increasingly approached the discussions related to international health and life sciences, which led some authors to refer to the “global bioethics”. This article examines this concept as elaborated in the theoretical perspectives of three formulations of North American bioethics: Van Rensselaer Potter, the Tristram Engelhardt, and Beauchamp and Childress. By balancing the strengths and weaknesses of the approaches of these authors, it is proposed the “critical bioethics” as the best qualified alternative theoretical to address the global issues of bioethics from the historical perspective of the countries of the Global South.Global bioethics from the perspective of critical bioethics Since the 1990s bioethics has increasingly approached the discussions related to international health and life sciences, which led some authors to refer to the “global bioethics”. This article examines this concept as elaborated in the theoretical perspectives of three formulations of North American bioethics: Van Rensselaer Potter, the Tristram Engelhardt, and Beauchamp and Childress. By balancing the strengths and weaknesses of the approaches of these authors, it is proposed the “critical bioethics” as the best qualified alternative theoretical to address the global issues of bioethics from the historical perspective of the countries of the Global South.

Debate on the paper by Feitosa et al.

, exempli-fies the contra-hegemonic bioethical models that have emerged in Brazil and elsewhere in Latin America. Epistemologically based on interdisci-plinary sharing of concepts and methods from distinct areas of knowledge, and philosophically structured not on principles, but on the norma-tive potentialities of language, the article offers an interesting channel for resolution of ethical conflicts related to life and generated in contexts of great moral pluralism and cultural diversity.The authors clearly express their perception that the possibility exists for constructing an

Influência de uma comissão de ética na proteção de animais

The creation of animal ethics committees in teaching and research establishes a new ethics in relations with non-human animals. The present article carried out a statistical study of data from 390 research protocols evaluated over eight years by a commission at one Brazilian university, to determine if its actions brought about a reduction in suffering and a proportional decrease in the practice of euthanasia. A statistical significance study was carried out using an extension of the Wilcoxon test, seeking to verify a long-term trend of protection procedures, such as lower predicted levels of stress and pain in protocols, more frequent use of anesthesia and sedatives and a reduction in euthanasia. The results were statistically significant for all three of these items, suggesting a concrete effect of animal protection. The method used is proposed as a form of evaluating the use of these procedures by commissions.The creation of animal ethics committees in teaching and research establishes a new ethics in relations with non-human animals. The present article carried out a statistical study of data from 390 research protocols evaluated over eight years by a commission at one Brazilian university, to determine if its actions brought about a reduction in suffering and a proportional decrease in the practice of euthanasia. A statistical significance study was carried out using an extension of the Wilcoxon test, seeking to verify a long-term trend of protection procedures, such as lower predicted levels of stress and pain in protocols, more frequent use of anesthesia and sedatives and a reduction in euthanasia. The results were statistically significant for all three of these items, suggesting a concrete effect of animal protection. The method used is proposed as a form of evaluating the use of these procedures by commissions.

A Cooperação Sul-Sul em saúde, segundo organismos internacionais, sob a perspectiva da bioética crítica

The South-South Cooperation in health is presented as an alternative to the welfare character and transfer of technologies that mark the old North-South model. The resulting actions that come from it have a clear ethical dimension, as they involve resources allocation, intercultural relations, biotechnology sharing and collective decision processes. In this current essay, it is presented the critical bioethics model from which are analyzed three important international documents containing guidelines for the South-South cooperation, in order to understand to which extent they favor the construction of structuring and emancipatory programs.