NATIONAL HEALTH RESEARCH NATIONAL HEALTH RESEARCH ETHICS COUNCIL STRUCTURE AND ETHICS COUNCIL STRUCTURE AND

MANDATEMANDATE

ByBy D. du Toit D. du Toit

NATIONAL HEALTH RESEARCH ETHICS COUNCIL

National Health Research Ethics National Health Research Ethics Council (NHREC) StructureCouncil (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

NHREC FunctionsNHREC 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

NHREC AchievementsNHREC 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

Advise to Minister of HealthAdvise 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

Section 71 of NHASection 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.

Thank You!