RESUMO
BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.
Assuntos
Conscientização , Indústria Farmacêutica , Comitês de Ética em Pesquisa , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , Sujeitos da Pesquisa/educação , Adulto , Idoso , Estudos de Casos e Controles , Conflito de Interesses/legislação & jurisprudência , Indústria Farmacêutica/ética , Indústria Farmacêutica/legislação & jurisprudência , Revisão Ética , Feminino , Guias como Assunto , Experimentação Humana/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , México , Pessoa de Meia-Idade , Sujeitos da Pesquisa/psicologia , Adulto JovemRESUMO
As lesões musculoligamentares relacionadas ao trabalho, inicialmente, chamadas de LER (Lesões por Esforços Repetitivos) e, posteriormente, de DORT (Distúrbios Osteomusculares Relacionados ao Trabalho), são consideradas, talvez, a patologia ocupacional de maior controvérsia pelo modo de adoecer. Acometem principalmente a população jovem, no auge de sua produtividade e existência. No final da década de 80, começaram a surgir as epidemias de LER / DORT no Brasil e no mundo, tornando-se grave e preocupante problema de saúde pública, devido aos custos socioeconômicos elevadíssimos. Dentre os fatores causadores das LER / DORT, estão aspectos de administração, organização e ergonômicos do Trabalho. Esta dissertação tem como objetivo principal entender o que os trabalhadores da Trefilaria de São Paulo da Siderurgia Belgo Mineira pensam sobre as LER / DORT. Para tanto, aplicou-se a metodologia qualiquantitativa, utilizando-se o Discurso do Sujeito Coletivo, característica própria e indissociável do pensamento coletivo, considerado e preservado em todos os momentos da pesquisa, desde a elaboração das perguntas, coleta e processamento dos dados, até a apresentação dos resultados. Concluiu-se pela análise ter havido evolução do entendimento do que sejam as LER / DORT, bem como a forma de prevenção e tratamento quando comparadas às representações dos trabalhadores no final da década de 80. (AU)
Work-related injuries to muscle tissue and ligaments, initially denominated Injuries caused by Repetitive Strain Injury (RSI) and later on Work Related Musculoskeletal Disorders (WMSD), are probably the most controversial occupational pathology today, due to the way in which they are contracted. The victims are mostly young people at the peak of their productive professional existence. In Brazil and around the world RSI/WMSD began to reach epidemic proportions in the late eighties, becoming a serious public health problem due to its extremely high social and economic costs. Certain aspects of administration, organization, and ergonomics at the workplace, among others, are increasingly perceived as the reasons for the emergence of RSI/WMSD. The object of this dissertation was to find out and understand what the workers of Siderurgia Belgo-Mineiras Trefilaria de São Paulo think about RSI/WMSD. To this end was applied the method of quality and quantity evaluation by using Expressions of the Collective Subject. This, being an inseparable characteristic of collective thinking, has been the guideline throughout the research, from collecting and processing data to the final conclusion of this work. Analyzing the findings, the conclusion is that there has been significant advance, as far as the understanding of RSI/WMSD, its prevention and treatment are concerned, compared with workers perception of the problem in the late 80s. (AU)