{"id":3758,"date":"2017-01-20T11:53:49","date_gmt":"2017-01-20T11:53:49","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Sousa.pdf"},"modified":"2017-01-20T11:53:49","modified_gmt":"2017-01-20T11:53:49","slug":"sousa-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/sousa-2\/","title":{"rendered":"Sousa"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Sousa<\/a><\/p>\n

WMA Satellite Meeting
\nThe future of the Declaration of Helsinki
\nThe new Declaration of Helsinki and the use ofThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remainsplacebo in clinical trials: controversy still remains
\nSOUSA, Maria-Sharmila Alina
\nFRANCO-GHIRALDINI, Mirian Aparecida
\nMACIEL, Rui Monteiro de Barros
\nPESTANA, Jos\u00e9-Osmar Medina
\nMASSUD-FILHO, Jo\u00e3o
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 Declaration of Helsinki \u2013 strengthen measures to protect
\nresearch subjects
\n\u2022 Letter from Brasilia (2000):
\n\u201cThe Declaration of Helsinki should be maintained as an overall set
\nof concise principles. Even though the Declaration of Helsinki is
\nthe responsibility of the World Medical Association, the
\ndocument should be considered the property of all humanity\u201d
\nHuman, Fluss, 2000
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 1964 Declaration of Helsinki \u2013 worldwide accepted document
\n1975 (Tokyo)
\n1983 (Venice)
\n1989 (Hong Kong)
\n1996 (Somerset West)
\n2000 (Edinburgh)
\n\u2026
\n2002 (Washington)
\n2004 (Tokyo)
\n\u2026
\n\u2022 2008 Declaration of Helsinki \u2013 controversy
\n(Seoul)
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 DoH (2008) – \u00a7 32: \u201cThe benefits, risks, burdens and effectiveness of
\na new intervention must be tested against those of the best current
\nproven intervention, except in the following circumstances:
\n1. The use of placebo, or no treatment, is acceptable in studies where no
\ncurrent proven intervention exists; or
\n1. Where for compelling and scientifically sound methodological reasons
\nthe use of placebo is necessary to determine the efficacy or safety of an
\nintervention and the patients who receive placebo or no treatment will
\nnot be subject to any risk of serious or irreversible harm. Extreme care
\nmust be taken to avoid abuse of this option\u201d.
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 National Committee of Research Ethics (CONEP) :
\nResolution 404 (Aug 1st, 2008)
\n\u2022 DoH (2000) : \u201cThe benefits, risks, burdens and effectiveness of a new
\nintervention must be tested against those of the best current proven
\nintervention. This does not exclude the use of placebo, or no treatment,
\nwhere no current proven intervention exists\u201d.
\nBRAZIL OFFICIAL BAN (2008 \u2026 )
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 What are the options for the PLACEBO use debate?
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 What are the options for the PLACEBO use debate?
\na) When Placebo IS Acceptable:
\nVitamin D Clinical Trial
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 What are the options for the PLACEBO use debate?
\na) When Placebo IS Acceptable:
\nVitamin D Clinical Trial
\nb) When Placebo is NOT Acceptable:
\nTuskeegee (1972)
\nHIV Transversal Contamination (1996)
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 What are the options for the PLACEBO use debate?
\na) When Placebo IS Acceptable:
\nVitamin D Clinical Trial
\nb) When Placebo is NOT Acceptable:
\nTuskeegee (1972)
\nHIV Transversal Contamination (1996)
\nc) When Placebo CHANGES Gold-Standard:
\nCAST (1986) \u2013 Cardiac Arrhythmia Suppression Trial
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 Controversy remains \u2013 radicalisms
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\nICH
\nInternational Conference of Harmonisation
\nVersus
\n\u2022 Controversy remains \u2013 radicalisms
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\nICH
\nInternational Conference of Harmonisation
\nVersus
\nCFM and CONEP \u2013 Brazil
\nCFM (Federal Council of Medicine)
\nCONEP (National Committee of Research Ethics)
\n\u2022 Controversy remains \u2013 radicalisms
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\nICH
\nInternational Conference of Harmonisation
\nVersus
\nCFM and CONEP \u2013 Brazil
\nCFM (Federal Council of Medicine)
\nCONEP (National Committee of Research Ethics)
\nDeclaration of HelsinkiDeclaration of Helsinki
\n\u2022 Controversy remains \u2013 radicalisms
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 Declaration of Helsinki \u2013 common ground
\n\u2022 Placebo use
\na) pragmatic
\nb) idealistic
\nNOT!
\nThe new Declaration of Helsinki and the use of
\nplacebo in clinical trials: controversy still remains
\n\u2022 Declaration of Helsinki \u2013 common ground
\n\u2022 Placebo use
\nc) case \u2013 by \u2013 case
\nThank You.<\/p>\n"},"caption":{"rendered":"

Sousa WMA Satellite Meeting The future of the Declaration of Helsinki The new Declaration of Helsinki and the use ofThe new Declaration of Helsinki and the use of placebo in clinical trials: controversy still remainsplacebo in clinical trials: controversy still remains SOUSA, Maria-Sharmila Alina FRANCO-GHIRALDINI, Mirian Aparecida MACIEL, Rui Monteiro de Barros PESTANA, Jos\u00e9-Osmar Medina […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Sousa.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3758"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3758"}]}}