{"id":3781,"date":"2017-01-20T12:25:21","date_gmt":"2017-01-20T12:25:21","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Cape_Town_2012-_Bou__sseau.pdf"},"modified":"2017-01-20T12:25:21","modified_gmt":"2017-01-20T12:25:21","slug":"doh_cape_town_2012-_bou__sseau-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_cape_town_2012-_bou__sseau-2\/","title":{"rendered":"DoH_Cape_Town_2012-_Bou__sseau"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH_Cape_Town_2012-_Bou__sseau<\/a><\/p>\n

Expert Conference on the Revision of the Declaration of Helsinki
\n5 \u2013 7 December 2012
\nCape Town, South Africa
\nDr Marie-Charlotte Bou\u00ebsseau
\nEthics and Health
\nStrengthening ethics review systems
\nOverview
\n\u2022 Normative framework
\n\u2013 Consultative Expert Working Group on Research and
\nDevelopment \u2013 Financing and coordination
\n\u2013 UNAIDS\/ WHO guidance document
\n\u2022 Vulnerable populations
\n\u2022 Availability of outcomes
\n\u2022 Strengthening ethics review systems
\n\u2013 Operational standards \/RECs \u2013 Oversight of RECs
\n\u2013 Improving transparency in research (ICTRP)
\ne.g. Pan African Clinical Trials Alliance
\n\u2022 Building global consensus
\ne.g. working group of NECs on Biobanking
\nConsultative Expert Working Group on Research
\nand Development \u2013 Financing and coordination
\non Research and Development \u2013 Financing and
\ncoordination
\n\u2022 To facilitate equitable access to the benefits of
\nresearch, suggestions are made to delink the
\ncosts of R&D and the prices of health products
\nUNAIDS\/WHO guidance document on Ethical
\nConsiderations in Biomedical HIV Prevention Trials
\n\u2022 Vulnerable populations (Guidance 8)
\n\u2013 Multiple vulnerabilities: cultural, social, economical,
\npolitical
\n\u2013 Multiple groups: women, children, adolescents, MSM,
\nPWID (IDU), sex workers, indigenous, poor, etc.
\nAsses determinant of vulnerability at an early stage
\nDesign of the protocol should consider incidental risks of
\nsocial harm and establish measures to prevent them.
\n\u00ab\u00a0If the risk of exploitation is severe, the research should
\nnot be conducted.\u00a0\u00bb
\nUNAIDS\/WHO guidance document on Ethical
\nConsiderations in Biomedical HIV Prevention Trials
\n\u2022 Availability of outcomes
\n\u00ab\u00a0Researchers should inform trial participants and their communities
\nof the trial results. During the initial stages of development of a
\nbiomedical HIV prevention trial, trial sponsors and countries should
\nagree on responsibilities and plans to make available as soon as
\npossible any biomedical HIV preventive intervention demonstrated
\nto be safe and effective, along with other knowledge and benefits
\nhelping to strengthen HIV prevention, to all participants in the trials
\nin which it was tested, as well as to other populations at higher risk
\nof HIV exposure in the country.\u00a0\u00bb
\nStrengthening ethics review systems
\nStandards and Operational Guidance
\nfor Ethics review of Health related
\nResearch with Human Participants
\nhttp:\/\/www.who.int\/ethics\/publications\/research_standards
\n_9789241502948\/en\/index.html
\nIndicators for the oversight of RECs at
\ncountry level
\nStrengthening ethics review systems
\n\u2022 Joint reviews of multicenter trials
\ne.g. DNDi proposal on African Trypanosomiasis Treatment
\nAfrican Vaccine Regulatory Forum (AVAREF)
\n\u2022 Recommendations for the implementation of
\nexisting guidance in specific cases
\ne.g. placebo controlled vaccine trials
\nInternational Clinical Trial Registry
\nPlatform (ICTRP)
\n\u2022 WHA 2006
\n\u00ab\u00a0A voluntary platform to link clinical trials registers in order to
\nensure a single point of access and the unambiguous
\nidentification of trials with a view to enhancing access to
\ninformation by patients, families, patient groups and others\u00a0\u00bb
\n\u2022 Network of 15 WHO data providers
\n\u2022 More than 220 000 registered
\nData providers
\nICTRP (cont.)
\nA shared responsibility aiming to
\n\u2022 improve transparency
\n\u2022 ensure greater accountability
\n\u2022 prevent unnecessary duplication
\n\u2022 identify gaps in research
\n\u2022 prevent publication bias and selective reporting
\n\u2022 improve trial design
\n\u2022 improve public trust
\nFuture perspectives\/ trial registration
\n\u2022 Include information on ethical approval:
\n\u2013 RECs
\n\u2013 Justification for the ethics approval
\n\u2022 Include information about results of the
\nresearch
\nWHO technical support to countries
\nPan African Clinical trial Alliance
\n\u2013 RECs and NRAs from 20 Sub Saharan African
\ncountries (AVAREF)
\n\u2013 Focus on coordination and harmonization of ethics
\nreview and approval including clinical trail
\nregistration
\n\u2013 Common procedural framework
\nConsensus building
\n\u2022 Global Summit of NECs, Working group of on
\nBiobanking
\n\u2013 Identification of questions to be addressed
\n\u2022 Consent
\n\u2022 Public engagement
\n\u2022 Role of RECs
\n\u2022 Harmonization of legal frameworks
\n\u2022 Governance
\n\u2022 Benefit sharing
\n\u2022 etc.
\n\u2013 Coordination with on going initiatives in other
\ninternational organizations
\nConclusion
\nStrengthening national ethics review systems
\n\u2013 Ethical norms based on universal principles
\n(e.g. DoH \u2013 CIOMS \u2013 UNAIDS\/WHO)
\n\u2013 Strong institutions (RECs)
\n\u2013 Harmonized procedures (including registration of CT
\npublication of results, etc.) to ensure good
\ngovernance: transparency, accountability, equitable
\naccess to information, participation of all
\nstakeholders
\nbouesseaum@who.int
\nhttp:\/\/www.who.int\/ethics\/en<\/p>\n"},"caption":{"rendered":"

DoH_Cape_Town_2012-_Bou__sseau Expert Conference on the Revision of the Declaration of Helsinki 5 \u2013 7 December 2012 Cape Town, South Africa Dr Marie-Charlotte Bou\u00ebsseau Ethics and Health Strengthening ethics review systems Overview \u2022 Normative framework \u2013 Consultative Expert Working Group on Research and Development \u2013 Financing and coordination \u2013 UNAIDS\/ WHO guidance document \u2022 Vulnerable populations […]<\/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\/DoH_Cape_Town_2012-_Bou__sseau.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3781"}],"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=3781"}]}}