Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Construction of ethics in clinical research - Clinical trials registration

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

O poder e as injustiças nas pesquisas em seres humanos

Após considerações gerais sobre a ética na pesquisa envolvendo seres humanos, focaliza-se a possibilidade de ocorrências de injustiças, sob a égide de diversas formas de poder. Exemplificam-se situações concretas. Enfatiza-se a análise das possíveis injustiças à luz da Bioética, com destaque para multi e transdisciplinaridade. O autor se posiciona quanto às características atuais da Bioética, cuja ótica levou à elaboração das Diretrizes éticas para a pesquisa envolvendo seres humanos, no Brasil (Resolução 196/96 e complementares do Conselho Nacional de Saúde). Descreve-se a sistemática das atividades do Grupo Executivo de Trabalho - GET, designado pelo Conselho Nacional de Saúde (órgão de controle social na área da saúde), para elaborar as Diretrizes. É dado destaque à participação dos diversos segmentos da sociedade, evidenciando multi e transdiciplinaridade, sob a coordenação do GET, do qual o autor foi Presidente. Comentam-se os principais tópicos das Diretrizes brasileiras, enfocando-se a sua relação com o tema de poder e injustiça. Salienta-se o papel dos Comitês de Ética em Pesquisa - CEP e da Comissão Nacional de Ética em Pesquisa - CONEP.

Influência da expectativa do consumidor sobre a aceitação de suco tropical e de cachaça

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Análise do sistema de distribuição de medicamentos em hospital oncológico do Estado de São Paulo

Pós-graduação em Ciências Farmacêuticas - FCFAR

Proposta de um protocolo de terapia celular para o tratamento da doença pulmonar obstrutiva crônica

The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200 mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252). (c) 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier Espana, S.L. All rights reserved.

Condições de trabalho e transtornos mentais comuns em professores da rede básica municipal de encino de Bauru-SP

Pós-graduação em Saúde Coletiva - FMB

Condições de trabalho e transtornos mentais comuns em professores do ensino fundamental de Avaré – SP

Pós-graduação em Saúde Coletiva - FMB

Educação continuada e gerência participativa: indicadores de qualidade da gestão de recursos humanos em enfermagem

With the purpose to contribute to the construction of quality indicators in human resources management, this study aimed at identifying, from the perspective of nurse managers, essential elements in the composition of indicators for evaluating human resources management in nursing. To that end, phenomenology was adopted as the theoretical methodological framework for this qualitative investigation, in which ten nurses performing in teaching or care provision at a university hospital participated. Following approval by the Committee of Ethics in Research and the subjects’ consent, interviews were performed from September 2005 to July 2006. The analysis enabled the recovery of the following topics “Professional education”, “Training multiprofessional nursing teams” and “Institutional training conditions” in the Permanent Education category and topics “Actions that favor participant management” and “Team work” in the Participant Management category. In its conclusion, the study considers the findings to allow identify elements constituting quality indicators in human resources management.

Ensaio clínico randomizado duplo-cego do perfil inflamatório e do nível de estresse oxidativo em indivíduos com diagnóstico polissonográfico de SAOS antes e após o uso de CPAP

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Análise dos atendimentos obstétricos realizados pelo SAMU de Botucatu, SP

Pós-graduação em Enfermagem (mestrado profissional) - FMB

EVALUATION OF THE PERCEPTION TOWARDS RESEARCH INVOLVING HUMAN BEINGS IN BRASILEAN POST DEGREE STUDENTS

In Brazil, research involving human beings must obey to ethical norms foresaw by the 196/96 National Health Council Resolution of the Ministry of Health. This paper gives account of a knowledge evaluation about some concepts and rules established by the resolution by Dental post degree students. It is concluded that in spite of the spreading and importance of the resolution most students do not know about it. In the same situation are those who work in research.

Male Homosexuality in Brazilian Indexing Languages: Some Ethical Questions

Studies on ethics in information organization have deeply contributed to the recognition of the social dimension of Information Science. The subject approach to information is linked to an ethical dimension because one of its major concerns is related to its reliability and usefulness in a specific discursive community or knowledge domain. In this direction, we propose, through an exploratory research design with qualitative and inductive characteristics, to identify the specific terminology that Brazilian indexing languages allow for terms relating to male homosexuality. We also analyzed the terms assigned to papers published in the Journal of Homosexuality, Sexualities and Journal of Gay & Lesbian Mental Health between the years 2005 to 2009. From this analysis of terms and the Brazilian indexing languages, we see (1) the Brazilian context, (2) imprecision in the terminology, (3) indications of prejudices disseminated by political correctness, (4) biased representation of the subject matter, (5) and the presence of figures of speech.