1. NATIONAL HEALTH RESEARCH ETHICS COUNCIL STRUCTURE AND MANDATE By D. du Toit D. du Toit NATIONAL HEALTH RESEARCH ETHICS COUNCIL

2. National Health Research Ethics Council (NHREC) Structure Sec. 72(1) of the NHA establishes NHREC 15 members & meets 4 times per annum, NHREC Working Group EXCO Registration & Auditing Human Subjects in Research Vulnerable Populations Training Complaints & Disciplinary Animal Health Material Transfer Agreement

3. NHREC Functions Determine guidelines for the functioning of RECs Register and audit RECs Set norms and stands for conducting research Advise DOH on research ethics matters

4. NHREC Achievements Finalised Regulations Setup REC registration system Developed REC guidelines Developed working tools Compiled & submitted Ministerial investigative reports Developed working relations with other research regulatory bodies

5. Advise to Minister of Health A need to amend sec. 71 (3)(a) (ii) of NHA DOH to fund REC for research monitoring & capacity building Create links with gov. depts on health research matters

6. Section 71 of NHA A need to amend sec. 71 (3)(a) (ii) of NHA Sec. 71 effective from March 2012 Requirements for Health Research : Mandatory Written Consent Child Research – Mandatory parental consent and ministerial consent for non therapeutic research.

7. Thank You!