Matches in SemOpenAlex for { <https://semopenalex.org/work/W37269138> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W37269138 abstract "Argentina is a middle income country that started implementing clinical trials in the 1960s. There is no national law guiding research involving humans and the responsibility for clinical trials rests in the provinces. Nevertheless the federal Ministry of Health and the regulatory agency (ANMAT) have a number of regulations and the country can be characterized as having an uneven but evolving legal infrastructure. This chapter describes the regulatory framework, the number and type of clinical trials that have been conducted in the country since 2005, the results of clinical trial inspections, and the growing concern about the role and performance of private for-profit research ethics committees (which currently approve about 80 % of all research protocols). Using case studies of clinical trials that have been questioned by researchers, the legal system, the ombudsman, regulatory authorities and informed journalists, this chapter describes cases where researchers failed to obtain informed consent, duplicated patient records, and violated inclusion and exclusion criteria. The studies that have generated controversy were financed by multinational companies and involved treatments for infections, cancer, heart and psychiatric problems, and pneumococcal vaccines. The underlying factors that facilitated the violation of scientific and ethical research principles include: conflicts of interests in the research ethics committees, research centers, public hospitals and possibly the regulatory agencies, and the pressure of the groups who benefit from the implementation of clinical trials, including the pharmaceutical industry, researchers, and the Argentinean government." @default.
- W37269138 created "2016-06-24" @default.
- W37269138 creator A5068014458 @default.
- W37269138 creator A5082816013 @default.
- W37269138 date "2013-10-18" @default.
- W37269138 modified "2023-10-07" @default.
- W37269138 title "The Regulatory Framework and Case Studies from Argentina" @default.
- W37269138 cites W2008122742 @default.
- W37269138 doi "https://doi.org/10.1007/978-3-319-01363-3_4" @default.
- W37269138 hasPublicationYear "2013" @default.
- W37269138 type Work @default.
- W37269138 sameAs 37269138 @default.
- W37269138 citedByCount "1" @default.
- W37269138 countsByYear W372691382014 @default.
- W37269138 crossrefType "book-chapter" @default.
- W37269138 hasAuthorship W37269138A5068014458 @default.
- W37269138 hasAuthorship W37269138A5082816013 @default.
- W37269138 hasConcept C108170787 @default.
- W37269138 hasConcept C118552586 @default.
- W37269138 hasConcept C138885662 @default.
- W37269138 hasConcept C142724271 @default.
- W37269138 hasConcept C144024400 @default.
- W37269138 hasConcept C144133560 @default.
- W37269138 hasConcept C153997805 @default.
- W37269138 hasConcept C158016649 @default.
- W37269138 hasConcept C17744445 @default.
- W37269138 hasConcept C199539241 @default.
- W37269138 hasConcept C204787440 @default.
- W37269138 hasConcept C2778137410 @default.
- W37269138 hasConcept C2778150722 @default.
- W37269138 hasConcept C3116431 @default.
- W37269138 hasConcept C36289849 @default.
- W37269138 hasConcept C39549134 @default.
- W37269138 hasConcept C41895202 @default.
- W37269138 hasConcept C535046627 @default.
- W37269138 hasConcept C68122502 @default.
- W37269138 hasConcept C71924100 @default.
- W37269138 hasConceptScore W37269138C108170787 @default.
- W37269138 hasConceptScore W37269138C118552586 @default.
- W37269138 hasConceptScore W37269138C138885662 @default.
- W37269138 hasConceptScore W37269138C142724271 @default.
- W37269138 hasConceptScore W37269138C144024400 @default.
- W37269138 hasConceptScore W37269138C144133560 @default.
- W37269138 hasConceptScore W37269138C153997805 @default.
- W37269138 hasConceptScore W37269138C158016649 @default.
- W37269138 hasConceptScore W37269138C17744445 @default.
- W37269138 hasConceptScore W37269138C199539241 @default.
- W37269138 hasConceptScore W37269138C204787440 @default.
- W37269138 hasConceptScore W37269138C2778137410 @default.
- W37269138 hasConceptScore W37269138C2778150722 @default.
- W37269138 hasConceptScore W37269138C3116431 @default.
- W37269138 hasConceptScore W37269138C36289849 @default.
- W37269138 hasConceptScore W37269138C39549134 @default.
- W37269138 hasConceptScore W37269138C41895202 @default.
- W37269138 hasConceptScore W37269138C535046627 @default.
- W37269138 hasConceptScore W37269138C68122502 @default.
- W37269138 hasConceptScore W37269138C71924100 @default.
- W37269138 hasLocation W372691381 @default.
- W37269138 hasOpenAccess W37269138 @default.
- W37269138 hasPrimaryLocation W372691381 @default.
- W37269138 hasRelatedWork W1030635930 @default.
- W37269138 hasRelatedWork W1047566280 @default.
- W37269138 hasRelatedWork W1555047025 @default.
- W37269138 hasRelatedWork W2027487739 @default.
- W37269138 hasRelatedWork W2040920273 @default.
- W37269138 hasRelatedWork W2067056285 @default.
- W37269138 hasRelatedWork W2078924677 @default.
- W37269138 hasRelatedWork W2115095948 @default.
- W37269138 hasRelatedWork W2148887867 @default.
- W37269138 hasRelatedWork W2213978906 @default.
- W37269138 hasRelatedWork W2277586826 @default.
- W37269138 hasRelatedWork W2396076827 @default.
- W37269138 hasRelatedWork W2415118569 @default.
- W37269138 hasRelatedWork W2470508948 @default.
- W37269138 hasRelatedWork W2579448445 @default.
- W37269138 hasRelatedWork W2612634357 @default.
- W37269138 hasRelatedWork W2952238823 @default.
- W37269138 hasRelatedWork W2981033676 @default.
- W37269138 hasRelatedWork W1872624159 @default.
- W37269138 hasRelatedWork W2167717147 @default.
- W37269138 isParatext "false" @default.
- W37269138 isRetracted "false" @default.
- W37269138 magId "37269138" @default.
- W37269138 workType "book-chapter" @default.