RESUMO
This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze - as an example - the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries.
Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Países Desenvolvidos , Países em Desenvolvimento , Ética em Pesquisa , Regulamentação Governamental , Experimentação Humana/ética , Internacionalidade , Pesquisa Biomédica/normas , Pesquisa Biomédica/tendências , Comportamento Cooperativo , Comitês de Ética em Pesquisa , Europa (Continente) , Governo Federal , Órgãos Governamentais , Guias como Assunto , Declaração de Helsinki , Humanos , Japão , Sujeitos da Pesquisa/legislação & jurisprudência , Estados Unidos , United States Food and Drug Administration , Universidades , Venezuela , Organização Mundial da SaúdeRESUMO
OBJECTIVE: To characterize parental perception of clinical research, particularly in emergency settings. To identify specific aspects of clinical research that concern parents and to discuss how these concerns can be addressed. STUDY DESIGN: Quantitative and qualitative survey in tertiary care children's hospital and affiliated clinics. RESULTS: Family caregivers (n = 136) participated in this study; 81% of study participants agreed or strongly agreed that physicians should do research involving children, with 5% disagreeing. However, 18% felt that researchers care more about the research than about the patient, and 13% believed that when a child is in a research study, physicians must follow the research protocol even if it is not in the best interest of the child. Participants were significantly less likely to endorse the conduct of research in an emergency setting than in a nonspecified setting (P < .001). Parents' foremost concern about emergency research was that it could delay therapy or distract physicians' attention from the child's needs. CONCLUSION: Parents largely support pediatric clinical research, but they have specific concerns that should be addressed in research planning and in communicating with parents about clinical research.