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Type: Artigo de periódico
Title: Institutional Review Boards: Compliance With Resolution 196/96 [comitês De Etica Em Pesquisa: Adequação à Resolução 196/96.]
Author: Hardy E.
Bento S.F.
Osis M.J.
Hebling E.M.
Abstract: PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Rights: fechado
Identifier DOI: 
Date Issue: 2004
Appears in Collections:Unicamp - Artigos e Outros Documentos

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