A proposta de regulamentação ética da pesquisa clínica apresentada ao Senado Brasileiro não interessa aos participantes de pesquisa

Bibliographic Data

ID5170156
AuthorsMarisa Palácios (0000-0001-6507-4199, Universidade Federal do Rio de Janeiro), Sergio Rego (0000-0002-0584-3707, Fundação Oswaldo Cruz)
Year2015
Volume31
Issue8
Pages1583-1585
Publication date2015-08-01
Open AccessYes
TypeARTICLE
VenueCadernos de Saude Publica (JOURNAL)
Journal identifiersISSN: 0102-311X • E-ISSN: 1678-4464
PublisherFapUNIFESP (SciELO) (PUBLISHER)
DOI10.1590/0102-311xpe010815
PMID26375638
OpenAlexW2185856092
SciELOS0102-311X2015000801583
LanguagePT
Citations received10

PERSPECTIVES 1The system for ethical review of scientific re-search in Brazil is currently under threat. A bill of law submitted to the National Congress aims to regulate the conduction of clinical trials in the country. The bill only refers to the current system under the CEP-CONEP (Ethics Research Committee-National Council for Research Eth-ics) when it attempts to justify dismantling the system, based on two arguments: (1) a purported legislative gap on the matter, claiming that the existing guidelines are “non-statutory provi-sions”; (2) that the ethical review process for re-search currently in force is “inefficient, anach-ronistic, and laced with serious distortions”

Engineering ethics · Legislative process · Legislature · Political science · Research ethics · Statutory law · Biomedical Ethics and Regulation · Engineering · Ethics in Clinical Research · Ethics in medical practice · Law · Public Administration

Tools

Open DOIOpen Access