UKZN Brec



UKZN Brec, All health-related biomedical and social research at the University of KwaZulu-Natal requires prior ethical clearance by the Biomedical Research Ethics Committee (BREC).



BREC is registered with the SA Department of Health’s National Health Research Ethics Council (http://www.doh.gov.za/nhrec/) (NHREC REC 290408-009). BREC is also registered with the US Office for Human Research Protections (http://www.hhs.gov/ohrp/) (OHRP) and has Federal-Wide Assurance (FWA) Assurance number 678, Institution number IORG 0000923 and IRB number 00001293.
BREC Applications must be made on the appropriate form. See form below:
  • Application Form: Ethics Approval with Human Participants
 Expedited Review
Ethics applications may be considered for expedited approval. Please note that in the case of studies for degree purposes the application for expedited approval must be submitted to the Postgraduate Office to be reviewed and approved by the Postgraduate Higher Degrees and Research Committee in the first instance, before being sent for ethics review and approval by BREC.
If the application cannot be expedited, you will be advised that it is to be put onto the next BREC Agenda.
Below is the application form for expedited review:



  • Application Form: Expedited Biomedical Research Ethics Review
  • BREC: Expedited Database Class Approval Form
 Exemption Review
Certain research projects qualify for exemption from ethics review. To apply for exemption from ethics review, please read and complete the following form:



  • Application for Exemption from Ethics Review 2014
 Research Project Amendment
All protocol amendments must be applied for to the BREC, using the appropriate form below. Amendments may not be implemented without BREC approval unless patient safety is at stake and the issues have been discussed with the BREC Chair or Deputy chair in the absence of the Chair.
  • Application Form: Protocol Amendment
 Project Recertification
According to its Terms of Reference and Standard Operating Procedures and the South African Department of Health Research Ethics Guidelines, BREC must review all UKZN approved ongoing research projects at least annually. Researchers must submit three copies of this application at least two months before current BREC approval expires. If the required information is not received by the deadline date, the application may not be reviewed and recertified in time, leading to noncompliance with BREC Terms of Reference and suspension of the study until the protocol is recertified. The appropriate form below can be used to apply for recertification:
  • Application Form: Biomedical Research Ethics Recertification
 Terms of Reference
BREC approves as submitted, approves subject to specified conditions or rejects research proposals on the basis of the University’s Research Ethics Policy, BREC Terms of Reference, Standard Operating Procedures and applicable guidance. BREC may also withdraw or suspend approval of an ongoing research project due to serious concerns regarding its ethical aspects. BREC may also provide guidance and advice on ethical issues to those undertaking research. Below are the BREC Terms of Reference: