1. Retha Britz Copyright 2013 All rights reserved for this presentation 1 Establishment and functioning of a REC Retha Britz

2. Requirement for RECs: Act No. 61 of 2003 National Health Act Section 73 (1) “Every institution, health agency and health establishment at which health research is conducted, must establish or have access to a health research ethics committee registered with the National Health Research Ethics Council (NHREC).” 2

3. Requirement for RECs: (continue) Act No. 61 of 2003 National Health Act Section 73 (2) “A health research ethics committee must - ” (a) Review research proposals and protocols (b) “Grant approval for research by the relevant institution, agency or establishment in instances where research proposals and protocol meet the ethical standards of that health research ethics committee” 3

4. Requirement for RECs: (continue) SA GCP section 8: “Ethics are as important as scientific considerations when reviewing a research project. An independent SA based research ethics committee must review the ethical and scientific rigour of all clinical trials to be conducted in SA. Institutions/organisations that undertake research involving human pts should ensure that there are adequate resources to establish and maintain a REC” 4

5. RECs as per SA GCP (see pages 58 to 63) 1. Responsibilities 2. Ethics and legislation 3. Composition (also see ICH GCP 3.2) 4. Appointment of members 5. Procedures 6. Advocacy role and interpreters 7. Expedited reviews for maximal public benefit 8. Records 5

6. RECs as per SA GCP (continue) 9. Monitoring 10. Complaints 11. Suspension or discontinuation of research 12. Disclosure of potential conflicts of interest 6

7. RECs as per the “Blue Book”  “An established REC must review and approve all research proposals involving human participants” REC function (p. 15):  Protect the rights and welfare of research pts  Ensure adequate resources to establish and maintain a REC  Terms of reference set out re the scope of responsibilities, relationship to non-affiliate researchers, accountability, mechanisms for reporting and remuneration for members (if any) 7

8. RECs as per the “Blue Book” (continue) 8 REC function (p. 15):  The institution/organisation must accept legal responsibility for decisions and advice received from the REC and indemnify REC members  Researchers without affiliation to an institution/organisation with a REC must ensure their projects are approved by an established EC

9. “Blue Book” and SA GCP has the same requirements in terms of:  Composition  Appointment of members  Procedures  Advocacy Role  Interpreters  Expedited Reviews for maximal public benefit  Monitoring  Complaints  Suspension/Discontinuation of research 9

10. What is different in the “Blue Book”?  Recording of Decisions  Compliance Reports to the NHREC 10

11. Recording of Decisions REC to maintain record of all research protocols received and reviewed including:  Name of responsible institution/organisation  Project identification number  PI  Title of the project  Date of ethical approval or non-approval  Approval/non-approval of changes to the protocol 11

12. Recording of Decisions (continue) REC to maintain record of all research protocols received and reviewed including:  Approval/non-approval of changes to PIL and ICFs  Approval/non-approval of changes to advertising materials, letters and notices  Complaints from researchers whose protocols were not approved  Ts & Cs of approval of any protocol 12

13. Recording of Decisions (continue) REC to maintain record of all research protocols received and reviewed including:  Whether approval was by expedited review  Whether the opinion of another EC was considered  Action taken by the EC to monitor the conduct of the research 13

14. Recording of Decisions (continue) For multi-centred research proposals, the EC shall also record:  Details of other centres involved  The approval status of the study at each centre  Details of any amendments required at other centres 14

15. Recording of Decisions (continue) On file should be:  Copy of the research protocol  Application submitted  Information sheets, ICFs  Relevant correspondence (in the form that it was approved)  A list of committee members present during the discussion of the applications and final decision making 15

16. Compliance Reports to the NHREC  All REC to be registered with the NHREC  NHREC auditing activities of RECs to ensure compliance with Blue Book requirements  Required information for audit purposes:  Membership and membership changes  Number of meetings held  Confirmation of participation by required categories of members  Nr of protocols presented, approved and rejected  Monitoring and related problems  Complaints procedures and nr of complaints received and handled 16

17. Other considerations  Secretariat (one full time administrative officer) and physical office  Standard Operating Procedures (SOPs) (See p 16 of Blue Book for required SOPs)  Website  Application Form  New research study  Amendment to already approved research protocol  Annual review / progress report 17

18. Other considerations (continue)  Informed Consent Templates  Main study Information Leaflet and Consent Form  Sub-study Information Leaflet and Consent Form  Helpful tools  Checklist of required/submitted documents  Schedule of submission dates and REC meeting dates  Guidelines for researchers 18

19. Other considerations (continue)  Training and Continuous Education of Members  Blue Book & SA GCP requires all members to have initial and continued education in research ethics, GCP and science  Chairperson and at least one other member to have in- depth training in research ethics  Proof of training to be available (e.g. certificates)  Sign and submit FWA in case of reviewing clinical research legal agreement between REC & US government that REC will comply with Office for Human Research Protection regulations and standards 19

20. References  SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research Coordination and Epidemiology. 2004. Ethics in health research: principles, structures and processes. Research ethics guidelines. Pretoria: Government Printer. 67 p.  SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research Coordination and Epidemiology. 2006. South African good clinical practice guidelines. 2 nd ed. Pretoria: Government Printer. 96 p.  SOUTH AFRICA. 2005b. National Health Act no. 61 of 2003. Government gazette, 469:1- 94, 23 July 2004. (Regulation gazette no. 26595.)