2. By Caroline Kithinji KEMRI/Ethics Review Committee February, 2014 MOI IREC Annual Committee Members Workshop Kisumu Hotel KEMRI Research Review Process

3. KEMRI Background A state corporation established in 1979, under the Science and Technology (amendment) act of that year. A state corporation established in 1979, under the Science and Technology (amendment) act of that year. Mandated to carry out research in human health Mandated to carry out research in human health Generate Research Generate Research results to be applied in improvement of health in Kenya, Africa and the World

4. VISION To be a leading Centre of excellence in human health research MISSION MISSION To improve human health and quality of life through research, capacity building and service delivery

5. DIRECTOR/CHIEF EXECUTIVE Administration and Finance Research and Training Research and Training Finance & Marketing Procuremen t Human Resource Managemen t TrainingCommunicationCorporate Relations Research Development Engineering & Maintenance Collaborations Audit CBRD CCR CGHR CGMRC CIPDR CMRCPHR CTMDR CRDR CTMDR CVR ESACIPAC GRADUATE SCHOOL Monitoring & Evaluation KEMRI ORGANIZATION STRUCTURE

6. June 7, 2016June 7, 2016June 7, 20165 In Search of Better Health

7. The KEMRI Review Process Three Level Review Process: Peer Review Scientific Steering Review Ethics Review

8. Review Process Center Scientific Review Scientific Steering Animal Care & Use Ethics Review Committee Reviews for Scientific Merit Evaluates for Relevance Recommends Action Initiates Research Idea Conducts Research Final Approval Submits Application CenterInvestigator Evaluates for animal use

9. Centre Scientific Committee Model I Proposal submitted to the CSC Secretary Proposal submitted to the CSC Secretary Secretary allocates to three reviewers Secretary allocates to three reviewers Reviewers send comments to PI and Secretary Reviewers send comments to PI and Secretary PI receives comments PI receives comments PI presents at meeting PI presents at meeting Proposal is discussed Proposal is discussed PI submits final copy PI submits final copy 4 copies forwarded to SSC 4 copies forwarded to SSC

10. Centre Scientific Committee Model II Proposal submitted to the CSC Secretary Proposal submitted to the CSC Secretary Proposal is distributed to all members of the centre Proposal is distributed to all members of the centre PI presents at the meeting PI presents at the meeting Proposal is discussed Proposal is discussed PI submits final copy PI submits final copy 4 copies forwarded to SSC 4 copies forwarded to SSC

11. Centre Scientific Committee Model III Proposal submitted to the CSC Secretary Proposal submitted to the CSC Secretary Proposal is distributed to all members of the centre Proposal is distributed to all members of the centre Proposal is reviewed Proposal is reviewed Comments made on the proposal Comments made on the proposal PI receives revised proposal makes changes PI receives revised proposal makes changes PI submits final copy PI submits final copy 4 copies forwarded to SSC 4 copies forwarded to SSC NO MEETING NO MEETING

12. Scientific Steering Committee Proposal is distributed to 2 Centre Directors for review Proposal is distributed to 2 Centre Directors for review Proposal is evaluated for relevance Proposal is evaluated for relevance Agenda discussed at a meeting Agenda discussed at a meeting PI advised in writing about PI advised in writing about any required revisions PI makes changes PI makes changes 4 copies submitted to the 4 copies submitted to the Ethics Review Committee Ethics Review Committee

13. Ethics Review Committee

14. Agenda closed 2 weeks before the meeting Agenda closed 2 weeks before the meeting Protocols assigned to 3 reviewers each Protocols assigned to 3 reviewers each Packets distributed Packets distributed Annual renewals distributed Annual renewals distributed to Secretariat Meeting held Meeting held Comments collated by Comments collated bysecretariat PI communicated to in writing PI communicated to in writing

15. How Long Does It Take to Get Approval? Average time for proposal approval at CSC level is 2 months Average time for proposal review from SSC to ERC is 4.9-5.6 months

16. Workload at KEMRI ERC between 2004- 2013

17. ADILI BIOETHICS UNIT After the PEER review at centre level After the PEER review at centre level One stop shop for both Science and Ethics One stop shop for both Science and Ethics Will undertake training Will undertake training Will undertake monitoring Will undertake monitoring Save time Save time Increase efficiency Increase efficiency Adili (Swahili) justjust, fairfair

18. SHUKRANI ……….! DIRECTOR KEMRI P. O. Box 54840 Nairobi 00200 Tel: 254(020)-2722541/2713349 Fax: 254(020)-2720030 E-mail: director@kemri.org director@kemri.org Website: www.kemri.org