title: Harmonizing regulations for biomedical research: a critical analysis of the US and Venezuelan systems.
abstract: 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.
authors.affiliation: Center for Bioethics, Columbia University, New York, NY 10032USA. dbd2102@columbia.edu
authors.forename: Dannie
authors.initials: D
authors.lastname: Di Tillio-Gonzalez
authors.forename: Ruth L
authors.initials: RL
authors.lastname: Fischbach
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000592:standards / Q000639:trends; D003299:Cooperative Behavior; D019049:Developed Countries; D003906:Developing Countries; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005060:Europe; D035082:Federal Government; D006077:Government Agencies; D033161:Government Regulation; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D038622:Internationality; D007564:Japan; D035842:Research Subjects / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration; D014495:Universities; D014687:Venezuela; D014944:World Health Organization