Teses
URI Permanente desta comunidade
Navegar
Navegando Teses por Autor "Barbosa, Ricardo de Abreu"
Agora exibindo 1 - 1 de 1
Resultados por página
Opções de Ordenação
- TeseClinical trial regulation: processuality and performativityBarbosa, Ricardo de Abreu (2022-02-10)
Centro de Ciências Sociais e Aplicadas (CCSA)
This thesis aims to understand, under a procedural and performative approach, how regulation is constructed and developed. I adopted a procedural, relational and sociomaterial ontological perspective, using the actor-network theory, in its seminal version, developed by Bruno Latour, Michel Callon and John Law, to describe the activity raised by human and non-human actants (objects, quasi-objects and hybrid artifacts) generators of controversies that, in networks, relationally, promote the fluid character of reality. This procedural activity also has its moments of reifications, stabilizations or provisional punctuations, in addition to generating displacements called translations that give a dynamic character to realities through the closure of controversies, which in the actor-network theory we call black box closures. The research takes place through the monitoring of a process of reconstruction of the regulatory apparatus affecting the business segment of Brazilian clinical research, arising from the productive chain of research and development in the pharmaceutical sector, taken as a whole as a meta-organizational reality. The study encompasses activities that took place during the current legislative process in the Brazilian legislative power, which seeks to establish a legal framework for clinical research, in which a new regulatory system would be erected to replace the current regulatory model. ANT, which is known for revisiting the modern and substantive concept of groups, organizations and society itself, is also adopted here for the reconstruction of the very notion of regulation, of a stabilizing and controlling bias, but which is presented in the thesis as an artifact relational and procedural socio-technical, whose dynamics is explained by its performative character. The performativity of regulation is verified bidirectionally, in the infra-relational aspect, involving the associations of actants that participate in its reassembly, in the activities of the legislative process observed during the work carried out under the Bill of the Brazilian Federal Senate (PLS 200/2015, converted into the Bill of the Chamber of Deputies, PL 7082/2017) as well as in the normative revisions that took place within the scope of the National Health Council (CNS) that instituted and maintains the CEP-CONEP system that regulates the current ethical instance of Brazilian clinical research. Performativity is also observed in the inter-relational aspect, from the interactions that the regulatory artifact maintains with other elements that integrate the relationships of other macro-actors in the network, such as research sponsors, the scientific community, research participants and patients, and their representative groups. The methodological path followed an abductive approach using the technique of cartography of controversies. As a result of the work, it is possible to understand that regulation, unlike understandings focused on the centrality of human will and a substantive ontology, when studied in procedural and performative terms, is better recognized as a relational aggregate of heterogeneous elements rhizomatically fragmented that dislocate spatiotemporally by actors-networks.