Research Committees at Ministry of Health, Fiji Islands

1. Research Committees at Ministry of Health, Fiji Islands Dr. Shareen Swastika Ali (BDS, PGDETT, MPH) Health Research Officer

2. Types of Research Committees • Divisional Research Committees • Cent – East Research Committee • Western Health Research Committee • National Health Research Committee (NHRC) • Fiji National Health Research Ethics Review Committee (FNRERC)

3. Where is the Office? • Divisional Health Research Committee • NHRC and FNRERC The Secretariat 2nd Floor Ministry of Health Headquarters 88 Amy Street Dinem House Suva Ph: 3321 424 Fax: 3318 227

4. Why do we have these committees? • Act as a regulatory body • Initiate and support health research • Enhance the quality of health research in Fiji • Foster training in health research • Collaborate with other research organisations

5. Divisional Research Committee – Membership • Chair • Members from Clinical Services • Members from Community Health • Members from other institutions • Members from the community

6. NHRC – Membership • Chair – DIPI • Secretary – HPO • Directors – DPHPT & DC • FSMed • NAFH • NCHP • NFNC • FNRERC – Chair • DNHS • FSN • NACA • MOE • Co – opted members from time to time

7. FNRERC – Membership • Chair – DIPI • Secretary – HPO • Directors • USP – Rep • FSMed – 4 • FSN • HRCP • Legal • MOE • Representatives of the community

8. Meetings of NHRC Every third week of the month on Tuesday afternoon @ 2pm @ MOH Conference Room

9. Meetings of FNRERC Two weeks after the NHRC sits First Tuesday of the month @ 2pm @ Ministry of Health Conference Room

10. Submission to Divisional Research Committees • Divisional Application form • Cover letter

11. Submission to NHRC and FNRERC • Cover letter to the Chair of NHRC • NHRC application form • FNRERC application form • CV of investigators • Research Permits for external investigators

12. Application for Funding • NHRC approves all funding • A maximum ofFJ $5000can be requested • Divisional committeesdo not processapplicationfor funding but can recommend to NHRC if such a request comes • NHRC has theauthority to revetthe proposal

13. Process of Vetting • 2 reviewersare selected • Request sent • Materials sent • Report written by reviewers • This is sent to investigators for clarification • Reply sent to reviewers • Presentation to committee • Decision on endorsement

14. Expedited Reviews • Takes minimum of two weeks Criteria • Research activities involving no risk or minimal risk • Collection of hair/ nail clipping • Extracted deciduous and permanent teeth • Collection of excreta and external secretion • Recording of data from subjects 21 years and older in a non invasive way. • Voice recording • Moderate exercise • Study of existing data • Research on individual or group behaviour of characteristics of individuals

15. FNRERC – Registration • Institutional Review Board (IRB) / Independent Ethics Committee ( IEC) • Federalwide Assurance (FWA) for the protection of Human Subjects for International (Non-U.S.) Institutions.

16. Requirements of Chair of FNRERC • Chair should have training in Bioethics • Resources are available on: http://bioethics.od.nih.gov/

17. Health Research Procedure in Fiji Internal Research External Research Divisional Level Verified & Vetted by the Divisional Research Committee External Researchers sent Ethical Application Form To Ethics Review Committee Advise applicant of approval. Advise applicant of no approval. Application outcome sent back to External Researchers Research Proposal sent back to Primary Investigator Not Approved Approved Inform NHRC of Outcome. Fiji National Health Research Ethics & Technical Review Committee (FNRERC) Research proposals with ethical & technical issues will need the approval of the Ethics Review Committee National Health Research Committee (NHRC) Review and Make Decisions on Research Proposals Vetted. Not Approved Approved Institution Level Verified & Vetted by the Institution Research Committee

18. Question Time