Overview
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 Education Committee in the first instance, before being sent for ethics review and approval by BREC.
In the case of studies for non-degree purposes (only those studies from Departments at the Medical School) applications for expedited approval are to be submitted to the Medical Research Committee in the first instance to be reviewed and approved before being sent for ethics review and approval by BREC. There are no set dates for submission of expedited review applications. These can be submitted at any time.
However, this does not apply to applications from CAPRISA, Africa Centre, Aurum Health, MRC etc.
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
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:
BREC Terms of Reference (2010)
NOTE: Other important BREC documents below:
BREC Informed Consent Resource Template
BREC Template Informed Consent For Tissue Storage
BREC Template for Materials Transfer Agreement (MTA)
BREC Serious Adverse Event Form 2010
SA Department of Health Ethics Guidelines (2004)
South African Good Clinical Practice Guidelines (2006)
National Guidelines for Payment of Participants in Clinical Trials (2012)
National Guidelines for Community Advisory Groups for Research (2012)
BREC Fees for Biomedical Ethics Review 2013
BREC Meeting Dates 2013
Biomedical Research Ethics Committee 2013
Online Research Ethics Certificate:
US NIH
TRREE
CITI
FHI
USNSF
Face to face postgraduate training in Research Ethics:
Singapore Statement on Research Integrity
Map and Inventory of African Research Ethics Committees:
Contact Us
Anusha Marimuthu
Senior Administrative Officer
Tel: (031) 260 4769
Fax: (031) 260 4609
Patricia Ngwenya
Assistant Administrative Officer
Tel: (031) 260 1074
Fax: (031) 260 4609
Kim Laing
Administrative Assistant
Tel: (031) 260 4769
Fax: (031) 260 4609