Abstract
This article intends to evaluate the structure, functioning and performance of 17 Institutional Review Boards (IRB), from the viewpoint of their presidents, in relation to the instructions of Resolution 196/96 of the National Council of Health, Ministry of Health, Brazil. Presidents of 33 IRBs, that evaluated proposals for research on fertility control, were indicated by the professionals responsible for the area of gynecology in 46 Brazilian medical schools and by the directors of four research centers on human reproduction . A letter with a questionnaire were sent to the presidents, asking them to volunteer for the study. Seventeen presidents completed the questionnaire. Results disclosed a series of violations of Resolution 196/96. Three IRBs did not include representatives of the community among their members; four took over a month to release the Board's decision on proposals and 13 did not follow-up the studies. Composition and filing of the research proposals were in agreement with the Resolution. However, in eight IRBs time of mandate differed from that set forth in the Resolution. Almost all presidents (about 14 of the 17) thought that the composition and activities of their IRBs were adequate. Eleven considered the Resolution appropriate but difficult to comply with. These results suggest that an extensive debate on the operational viability of the Resolution would be timely. This endeavor could bring forth valuable suggestions for the improvement and applicability of the Resolution contributing to the improvement of the scientific and ethical quality of research.
Highlights
Results disclosed a series of violations of Resolution 196/96
Composition and filing of the research proposals were in agreement with the Resolution
A porcentagem de presidentes (52%) que preencheu o questionário foi relativamente elevada, considerando as dificuldades enfrentadas para se obter resposta a pesquisas feitas por correio
Summary
ELLEN HARDY*, SILVANA FERREIRA BENTO, MARIA JOSÉ DUARTE OSIS, ELIANA MARIA HEBLING Trabalho realizado no Departamento de Tocoginecologia da Faculdade de Ciências Médicas da Universidade Estadual de Campinas – UNICAMP e Centro de Pesquisas Materno-Infantis de Campinas – Cemicamp, Campinas, SP. Uma das determinações desta Resolução era que toda instituição de saúde que realizava pesquisas em seres humanos, credenciada pelo CNS, tivesse um Comitê de Ética. A identificação desses presidentes foi obtida a partir de: 1) informação proporcionada pelos 46 responsáveis pela área de ginecologia das universidades que possuíam o curso de medicina, de acordo com levantamento do Conselho Federal de Medicina (CFM)18; 2) pelos diretores dos quatro centros de pesquisa em regulação da fecundidade, segundo o Inventario Latinoamericano de Centros de Investigaciones, Enseñanza y Recursos Humanos en Reproducción Humana (PLACIRH)[19]. Todos os CEPs eram compostos por pessoas de ambos os sexos, de acordo com a Resolução, mas em quase a metade deles (8/17) não se cumpria o tempo de mandato dos membros de três anos, de acordo com a Resolução (Cap. VII, item 9).
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