O sistema de avaliação da ética em pesquisa no Brasil: estudo dos conhecimentos e práticas de lideranças de Comitês de Ética em Pesquisa / Research ethics evaluation system in Brazil: knowledge and practices of leaders of research ethics institutional review boards.

AUTOR(ES)
DATA DE PUBLICAÇÃO

2007

RESUMO

The objective of the study was to analyze the profile of the persons indicated by the research ethics institutional review boards to become members of the National Commission of Research Ethics (Comissão Nacional de Ética em Pesquisa/CONEP), considered as leaders in the research ethics evaluation system in Brazil, as to their social group representation, professional experience, experience in research ethics, views about current practices in the system and relations to formal regulations. Questionnaires were sent by mail and electronically to the 188 members of IRBs indicated as candidates in 2003 for nomination as member of CONEP, with 94 answers, representing 80% of the IRB universe at that time. The questionnaire was composed of 4 parts, with part 1 dedicated to personal characterization. The results indicated equal gender proportions, high academic qualification, and frequent participation in short courses about research and bioethics. About 50% occupied institutional positions, 18% directly related to research, and only 4% were representatives of the patients. About 90% had involvement with research in the last 10 years, a third with clinical research. Part II was dedicated to their self-evaluation as members of IRBs, revealing feelings of satisfaction and gratification with their work, and valorization of attributes such as responsibility, compromise, team work capabilities, and 89% and 85% considered themselves prepared and competent for their functions, although with differing perceptions regarding representation and political understandings about their work. Some areas present more difficulties in the analysis of the projects and meetings, seminars and case discussions were mentioned as preferential mechanisms for development. Part III identified perceptions about the functioning of the national research ethics evaluation system, and the utilization of official regulations in project analysis. A more effective participation of the patient representatives and the monitoring of projects are major problems. Areas of necessary investment: how to deal with social sciences research projects, pre-requisites and preparation of IRB members and improved communication of IRBs with each other and the National Commission. Part IV consisted of case studies dedicated to frequent ethical dilemmas in research and the majority had convergent positions as to how to deal with them. The profile of these members as leaders in their IRBs reflects also very strong institutional cultures.

ASSUNTO(S)

committee members membro de comitê responsabilidade social. bioética Ética em pesquisa comitês de ética em pesquisa community participation health council bioethics research ethics committees participação comunitária research ethics ethical review social responsibility. revisão ética conselhos de saúde (sus)

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