ABSTRACT
O objetivo deste artigo é relatar a experiência do Comitê de Ética em Pesquisa da Secretaria de Estado de Saúde do Distrito Federal (CEP/SES/DF) Brasil, durante o período de 10 anos a partir de sua fundação. Trata-se de uma avaliação descritiva e documental, na modalidade estudo de caso, utilizando-se a totalidade de projetos protocolados no CEP/SES/DF (Nº 052/08) nesse período. As pendências mais freqüentes dos projetos foram: termo de consentimento livre e esclarecido (30 por cento), folha de rosto (25 por cento), metodologia (20 por cento), curriculum vitae (12 por cento), planilha de orçamento (9 por cento), outros (4 por cento). O relato das atividades do CEP/SES/DF no período de 10 anos revelou, através de sua produtividade, a legitimidade do processo de análise ética dos protocolos visando à proteção dos participantes da pesquisa.
El objetivo de este artículo es relatar la experiencia del Comité de Ética en Investigación de la Secretaría de Estado de Salud del Distrito Federal (CEP/SES/DF), Brasil, durante un período de 10 años (1997-2007) a partir de su fundación. Se trata de una evaluación descriptiva y documental, en la modalidad estudio de caso, utilizándose la totalidad de proyectos protocolizados en el CEP/SES/DF (Número 052/08) en ese período. Los conflictos más frecuentes fueron: término de consentimiento libre e informado (30 por ciento), protocolo de investigación (25 por ciento), metodología (20 por ciento), currículum vitae (12 por ciento), planilla de presupuesto (9 por ciento), otros (4 por ciento). El informe de las actividades del CEP/SES/DF en 10 años reveló, a través de su productividad, la legitimidad del proceso de análisis ético de los protocolos, confirmando la protección de los participantes en la investigación.
The objective of this article is to relate the experience of the Research Ethics Committee of the Secretary of Health, Federal District, Brazil (CEP/SES/DF) during 10 years (1997-2007) from its creation. It deals with a descriptive and documentary evaluation, in the form of case studies, utilizing all projects subject to protocol in CEP/SES/DF (Number 052/08) during that period. The most frequent conflicts were: terms of free and informed consent (30 percent), identification page (25 percent), methodology (20 percent), curriculum vitae (12 percent), budget (9 percent), others (4 percent). The activity report of CEP/SES/DF in 10 years revealed, as a result of its productivity, legitimacy in the process of ethical analysis of protocols which confirms the protection of research participants.
Subject(s)
Humans , Ethics Committees/history , Ethics, Research , Bioethics , BrazilABSTRACT
It has been suggested that the administration of certain nutrients may improve the immune response of patients with cancer. Experimental studies have shown that deficiencies in specific amino acids have a worse effect on humoral immunity than they do on cell-mediated immunity because they impair antibody synthesis. Here, arginine plays a particularly important role, and research with several experimental and human tumor models to determine the therapeutic utility of this amino acid is under way. In this paper, we review current literature on the use of arginine as pharmacologic nutritional support for cancer patients. Dietary supplementation with arginine has been shown to benefit these patients by reducing the growth of transplantable tumors, the incidence of metastases, and the tumor-producing potential of carcinogens. However, results observed in humans have given rise to controversy regarding the optimal dosage of arginine supplementation and the types of cancer best treated with amino acids. Further prospective and randomized studies will be necessary in order to determine the proper utilization and the therapeutic benefits of such dietary supplementation.