Work Package 7 Sarah Edwards – Professor of Bioethics, UCL

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Work Package 7 Sarah Edwards – Professor of Bioethics, UCL Ben Quayle – consultant research assistant 10th January 2019

Work Package 7 Work Package Title: “Engaging policy makers, global public health bodies and communities and ethical, administrative, regulatory and operational obstacles during outbreaks” Lead by: Prof. David Heymann - Royal Institute of International Affairs (Chatham House) Co-Leads: Dr. Osman Dar (Chatham House) Prof. S. Edwards Prof. A. Zumla (UCL) Prof. Francine Ntoumi-Congo Chatham House | The Royal Institute of International Affairs

WP7 – Overall Objectives Using a One Health approach analyse the role of health system governance structures, and networks in addressing challenges to build laboratory, public health and clinical trial capacity for the rapid investigation of EID outbreaks with epidemic potential To understand perceptions among key One Health stakeholders of EID risks and their level of support for specific interventions To identify multi-sectoral strategies and institutional capacities for building appropriate levels of preparedness and response to EID outbreaks To investigate the barriers that impede the rapid and effective responses to EID outbreaks and the uptake of capacity building mechanisms Develop evidence-based, contextually-appropriate policy options Set up ethical, regulatory and administrative systems ready to assess and approve rapid response protocols from the network within 48-72 hours Develop ethical and operational rules that regulators and ethics committees should use to inform the approval of a range of interventions from the network To identify operational ‘pressure points’ and streamline administrative practices in gaining research authorisation, to create system that is both flexible and durable Ensure regions have the capacity to respond efficiently to EID outbreaks Chatham House | The Royal Institute of International Affairs

Deliverables Deliverable Number Deliverable Name Lead Participant Organisation Month deliverable will be achieved 7.1 Stakeholder analysis report Chatham House Centre on Global Health Security 33.0 7.2 Roundtable event 1 9.0 7.3 Roundtable event 2 University College London (UCL) 21.0 7.4 Roundtable event 3 Fondation Congolaise pour la Recherche Médicale 36.0 7.5 Review of recommendation form Ebola Outbreak   University College London(UCL) 6.0 7.6 Workshops National Institute for Medical Research - Tanzania (NIMR) 24.0 7.7 Training programme University of Zambia (UNZA) 7.8 Pool of ethical expertise among rapid response teams 7.9 New training material 7.10 Consensus statement (consensus amongst regulators and ethics committees harmonising ethical principles and regulatory rules) 30.0 7.11 Training programme (seminars for research regulators and ethics committees) 7.12 Appointment of an external ethics advisor 3.0 7.13 Ethics Monitoring by the external ethics advisor Quarterly Chatham House | The Royal Institute of International Affairs

Milestones Milestone Number Milestone Name Means of Verification Month milestone will be attained 7.1 Roundtable 1 Published meeting summary 9.0 7.2 Roundtable 2 21.0 7.3 Roundtable 3 36.0 7.4 Stakeholder analysis study plan Approved protocol by advisory group 6.0 7.5 Literature review and policy actor mapping Peer-review  publication  and progress report on stakeholder analysis 18.0 7.6 In depth interviews and ranking exercise Recorded and transcribed interviews and progress report 24.0 7.7 Analysis and final report write-up Peer-reviewed publication 7.8 Review recommendations following Ebola Report 6 7.9 Workshops Attendance record and delegate feedback 24 7.10 Consensus statement Analysis and published outcome 30 7.11 Training programme 7.12 Worked analysis of ethics and regulation 12 7.13 Pool of ethical expertise among rapid response teams Portfolio of training records 36 7.14 Survey of operational systems completed New training material produced Traning material available publicly 7.15 Appointment of External independent Ethics Advisor External independent Ethics Advisor appointed 03 Chatham House | The Royal Institute of International Affairs

Work Undertaken Recruitment Consultant research assistant in place - Sept. 2018 Recruitment and initiation of Chatham House African Fellowship programme – July/Aug 2018 Organisation of launch/dissemination event – June 2018 – March 2019 To be held on the 15th MARCH 2019 at the African Union’s International Conference on (Re-)Emerging Infectious Diseases Stakeholder mapping performed for launch event More systematic process underway presently – ToC adding to this Review recommendations following Ebola Initiated at this meeting – individual interviews and online survey will be used to collate information. Chatham House | The Royal Institute of International Affairs

Future Work Chatham House African Fellowship Programme Will recruit a fellow for the next three iterations of the programme 2018 cohort - Dr Raji Tajudeen (Africa CDC) Media Training – with SciDev.net Syllabus currently being finalised – will arrange first half of 2019 Complete Stakeholder Mapping 15th MARCH 2019 – Int. Conference on (Re-)Emerging Infectious Diseases Chatham House | The Royal Institute of International Affairs

Prof. Zumla’s Requested Slide WP collaborations Working closely with WP 2 (WP5) African Fellowship Programme Covers new research & training New Research Applications Future work with Project ECHO WHO KOICA (training capacity for emergency response) Involved with: Africa CDC, Nigeria CDC, HORN, ILRI Chatham House | The Royal Institute of International Affairs

Chatham House | The Royal Institute of International Affairs