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The University Research Office is based at the Govan Mbeki building on Westville campus

The University of KwaZulu-Natal currently has more than 250 post-doctoral fellows

Funds requests must be directed through the Colleges at the office of the College Dean of Research

You can upload your own publications on IRMA and ResearchSpace

ResearchSpace is the institutional repository of UKZN. It is a collection of full text theses and also includes research publications produced by UKZN academics.
Biomedical Research Ethics

 UKZN BIOMEDICAL RESEARCH ETHICS COMMITTEE
Special Urgent BREC Notices
No special urgent notices at present
           
 BREC Overview: Initial Applications for Ethics Review and Approval
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://nhrec.health.gov.za) (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 either approves as submitted, approves subject to specified conditions or rejects research proposals based on the current UKZN 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 failure to recertify or serious concerns regarding its ethical aspects. BREC may also provide guidance and advice on ethical issues to those undertaking research.

Reciprocity Applications

Current South African DoH Research Ethics Guidance permits REC chairs to consider and grant reciprocal recognition of ethics approvals from another registered South African Research Ethics Committee to avoid duplication of PI and REC effort. Reciprocity can only be issued with the full written approvals of the relevant REC Chairs. Applicants are encouraged to discuss such applications with the BREC chair by email through BREC@ukzn.ac.za with Reciprocity specified in the subject line

BREC Terms of Reference, Standard Operating Procedures:

BREC Meeting and Submission dates, Current membership and Review Fees

Relevant National and International Guidance Documents


RIG (RESEARCH INFORMATION GATEWAY)

All BREC applications must be made on the UKZN Research Information Gateway (RIG) portal https://rig.ukzn.ac.za/converis/secure/client/login

The login URL for external users is slightly different from the URL for UKZN Staff and Students. 

External applicant should login via the link below: https://rig.ukzn.ac.za/converis/secure/login

Copies of certain forms may also be downloaded below, but these do not replace completing all the required sections on RIG
RIG BREC APPLICATION TEMPLATES

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                 
 Exemption Ethics Review

Certain research projects qualify for exemption from ethics review – e.g. studies on information/data that is already fully in the public domain. To apply for BREC exemption from ethics review, please read the following form and submit it via RIG:
 Protocol Amendment

Protocol Amendments may not be implemented without prior BREC approval unless participant or other stakeholders’ safety is at stake and the issues have been discussed with the BREC Chair or Deputy chair in the absence of the Chair.  All protocol amendments must be applied for on RIG, using the appropriate format below.
 Protocol Recertification / Renewal

According to its Terms of Reference and Standard Operating Procedures and South African Department of Health Research Ethics Guidelines, BREC must review all BREC approved ongoing research projects at least annually. Researchers must submit a recertification/renewal application on RIG 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 possible suspension of the study until the protocol is recertified. The appropriate form below can be used to supplement the RIG recertification application:
 Serious Adverse Events, Protocol Violations, Protocol Deviations

All Serious Adverse Events, Adverse Events, Protocol Violations, Protocol Deviations must be reported to BREC within specified time frames, usually 7 to 14 days of the lead investigator’s awareness of occurrence, on RIG. Information required is consistent with the forms below:
 Other Important BREC Documents

Informed Consent Resources – should be used on all applications requiring participant informed consent and edited for specific purpose without deleting legally required sections

Materials Transfer Agreement Templates must be on RSA approved templates:

If minimal risk research with children is planned and a waiver of parental consent is requested, the form below must be completed and submitted on RIG with the initial application.
KZN Provincial Department of Health: Health Research and Knowledge Management: website and application forms for KZN Provincial permission to contact research
 Online Research Ethics Certificate:
Requirements for BREC Application is as follows:

Online TRREE Module 1 (Introduction) and then the South Africa specific TRREE module certificates are required. There is no need to do TRREE modules 2-4 unless you choose to do them as relevant to your study design or sample, or for educational  purposes. 

outh African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate.

South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate
South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate
South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate

South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate

South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate
outh African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate.
outh African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate

South African Current Good Clinical Practice (GCP) certification is required for clinical trials and interventional studies. BREC reserves the right to request a GCP certificate for interventional studies that are not formal clinical trials. The NIH online module may be compulsory for PIs who are funded by US Federal Agencies (e.g. NIH, NIMH, DAIDS, etc) – this is a funder requirement. 

 All Research Ethics Training and GCP certificates expire after 3 years unless otherwise stated by the issuer of the certificate

 Face to face postgraduate training in Research Ethics

 Contact Us
First Name Last Name Position Telephone Email
Anusha Marimuthu Senior Admin Officer (031) 260 4769

marimuthu@ukzn.ac.za
Nompumelelo Zulu  Assistant Admin Officer (031) 260 1074

ZuluN4@ukzn.ac.za
Pravini Pillay Assistant Admin Officer (031) 260 8323

Pillayp20@ukzn.ac.za
Nondumiso Mngadi Senior Admin Assistant (031) 260 2486

MngadiS2@ukzn.ac.za

 GENERAL BREC ENQUIRIES : BREC@ukzn.ac.za

  


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