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Objective: To survey the opinion of researchers, women -- subjects of research-- and of advocates of women's rights about the meaning of "research" and "guinea pigs"., Methods: Researchers (11), women (18) and advocates (10) were interviewed. The study was qualitative and a thematic analysis was carried out., Results: Participants experienced difficulty to explain what research meant and some were unable to do so. For the researchers and most of the women, subjects are not guinea pigs, because they have freedom of choice. Most of the advocates, however, said that subjects are guinea pigs, even when they consent to participate in a study., Conclusions: The difficulty experienced by researchers when explaining the meaning of research was surprising. The different opinions about "guinea pig" reflect the controversy about its meaning in research. Certainly the expression "guinea pig" does not apply to all studies however the different meanings identified should make researchers cautious about the ethical issues involved in their studies.

Background: In Brazil, all studies involving human beings must be evaluated by an institutional review board (IRB) registered with the National Commission for Ethics in Research (CONEP), the entity responsible for coordinating all IRBs in the country. Methods: In 2007, a broad quantitative evaluation of Brazilian IRBs was carried out, followed by a qualitative component conducted using a semistructured interview technique during the last three months of 2008. Twenty IRBs situated in five geographical regions of the country and located within different social and institutional contexts were selected. Eighty interviews were conducted. Results: In general, the functioning of all the IRBs was similar. Problems were found related to the infrastructure provided for their work and noncompliance with the Resolution 196/96 recommendation that IRB members be given time off from their normal duties for their work with the IRB. The research protocols were usually evaluated by only one or two members. It was mentioned that investigators tended to be resistant to sending their projects for evaluation and to challenging the reports issued. In general, the IRBs did not follow up on the studies that they approved because they lacked the means to be able to do so. Conclusions: Although a large network of IRBs has been created in Brazil, many of these IRBs confront serious difficulties in attempting to comply with the regulations established by the National Health Council (NHC), which may affect the ability of some IRBs to fulfill their role. [ABSTRACT FROM PUBLISHER]

In Brazil, Resolution 196/96 on research involving human subjects created the National Council of Ethics in Research (CONEP) with a mandate to stimulate the creation of institutional review boards (IRBs) throughout the country, provide guidelines, and regulate their structure and operation. A descriptive study was carried out in 2007. The coordinators of all 508 IRBs registered in CONEP in 2006 were invited to participate; 502 accepted (response rate = 99%) and responded to a structured questionnaire conducted via telephone. Prior to the publication of Resolution 196/96, IRBs were created at an average rate of 1.7 per year. In contrast, an average of 47.3 IRBs per year were created between 1997 and 2006. The percentage of IRBs with their own physical space and telecommunication equipment was higher among older IRBs compared to more recently established IRBs. A significantly greater proportion of IRBs created prior to the year 2000 provided services for other institutions, offered courses, and produced texts on bioethics compared to the more recently established IRBs. Thus, in a period of only 12 years, Brazil progressed from having a small number of functioning IRBs to the current number of 508, reflecting the capacity of the federal government to mobilize teaching and research institutions and investigators. Nevertheless, while research institutions are adhering to the requirement for the social control of ethics in research, they are not yet willing to provide the resources these committees need to function properly. Despite these limitations, the colossal effort to promote implementation of appropriate ethical standards in research studies involving human subjects in Brazil has been successful. [ABSTRACT FROM AUTHOR]