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008 160915s2014 gw | s |||| 0|eng d
020 _a9783319013633
_9978-3-319-01363-3
024 7 _a10.1007/978-3-319-01363-3
_2doi
035 _ato000542037
040 _aSpringer
_cSpringer
_dRU-ToGU
050 4 _aQH332
050 4 _aR724-726.2
072 7 _aPSAD
_2bicssc
072 7 _aMB
_2bicssc
072 7 _aMED050000
_2bisacsh
082 0 4 _a610.1
_223
082 0 4 _a174.2
_223
245 1 0 _aClinical Trials in Latin America: Where Ethics and Business Clash
_helectronic resource
_cedited by Nuria Homedes, Antonio Ugalde.
260 _aCham :
_bSpringer International Publishing :
_bImprint: Springer,
_c2014.
300 _aXVI, 291 p. 9 illus.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
490 1 _aResearch Ethics Forum,
_x2212-9529 ;
_v2
505 0 _aIntroduction; Núria Homedes and Antonio Ugalde -- A Review and Critique of International Ethical Principles;Núria Homedes and Antonio Ugalde -- Globalization and Clinical Research in Latin America; Núria Homedes and Antonio Ugalde -- The Regulatory Framework and Case Studies from Argentina; Antonio Ugalde and Núria Homedes -- Politics and Clinical Trials in the Province of Cordoba; Antonio Ugalde and Núria Homedes --  Brazil:  The System for the Protection of Voluntary Participants in Research; Corina Bontempo D de Freitas, William Saad Hossne and Susie Dutra -- Progress and Challenges of Clinical Research with New Medications in Brazil;Corina Bontempo D de Freitas and Bruno Schlemper Junior -- A Small Country for Big Pharma: Costa Rica; Antonio Ugalde and Núria Homedes.- Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica; Núria Homedes and Antonio Ugalde -- Ethical Guidelines for Clinical Trials in Mexico:  Theory and Practice; Emma Verástegui and Edith Valdés-Martínez -- Who Decides? Informed Consent among Cancer Patients in México; Alonso Cerdán, Alejandro González and Emma Verástegui -- A View from Inside: Regulation and Ethical Conflicts in Peru; Gabriela Minaya Martínez, Susi Olave Quispe and Duilio Fuentes Delgado -- Conclusion; Antonio Ugalde and Núria Homedes.
520 _aThe outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.       .
650 0 _amedicine.
_9566220
650 0 _aEthics.
_9293107
650 0 _aMedical ethics.
_9309749
650 1 4 _aMedicine & Public Health.
_9566221
650 2 4 _aTheory of Medicine/Bioethics.
_9309753
650 2 4 _aHealth Economics.
_9414392
650 2 4 _aHealth Promotion and Disease Prevention.
_9303017
650 2 4 _aEthics.
_9293107
700 1 _aHomedes, Nuria.
_eeditor.
_9448067
700 1 _aUgalde, Antonio.
_eeditor.
_9448068
710 2 _aSpringerLink (Online service)
_9143950
773 0 _tSpringer eBooks
830 0 _aResearch Ethics Forum,
_9448069
856 4 0 _uhttp://dx.doi.org/10.1007/978-3-319-01363-3
912 _aZDB-2-SHU
999 _c399947