Section 11(r) of the National Health Act of 2004 focuses specifically on research. Regulations in general and clinical trials registration in particular are being drafted. They will require:

(a) all research and clinical trials to receive ethics clearance from an accredited ethics committee and

(b) all health research will be required to be registered and receive a research register number prior to commencement of the trial.

www.ethicsapp.co.za                   SANCTR Fact Sheet             www.sanctr.gov.za

All clinical research studies should be registered/logged online with the National Health Research Ethics Committee (NHREC). A 'proof of capture' form will be generated, and should be included with the ethics application to the accredited local Health Research Ethics Committee. Clinical trials also have to register trial-specific information online with the South African National Clinical Trials Register (SANCTR) and feed back the trial number obtained to the NHREC.

REGISTERING FOR THE FIRST TIME

  • Step 1:  Applicants apply for their new NHREC Ethics Application account on-line at www.ethicsapp.co.za . 
  • Step 2:  Upon opening the website Applicants select the "Register" button in the top right-hand part of the site.
  • Step 3:  Applicants will then enter the data required in the Registration Form.
  • Step 4:  Under USERNAME please ensure to use a generic name relevant to the Company and/or University department to ensure that all studies/trials/research data are grouped under one USERNAME on the website.  (Please contact Portal Administrator for assistance).  Please use lower case and no spaces.  Example: uctmedicine (this would enable the Portal Administrator to group all research under the relevant Organisation / University)
  • Step 5:  The application for a new account will be processed and Applicants will be contacted to verify details after which the new account will be activated.   ONLY once verification by the portal administrator is obtained, will you be able to access the system and proceed with the registration of the application.
  • Step 6:  Trial information can only be captured once the new account is activated. Go to www.sanctr.gov.za and log in with this same username and password to capture trial-specific information (if applicable).