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 efforts. Reciprocity can only be issued with the full written approvals of the relevant REC Chairs. Applicants are encouraged to upload their applications on to the RIG system.

• BREC Terms of Reference (2020)
• UKZN BREC Standard Operating Procedures (2023)

• 2026 BREC Meeting Dates
• 2025 BREC Meeting Dates
• 2024 BREC Meeting Dates
• Biomedical Research Ethics Committee 2025
• Biomedical Research Ethics Committee 2024
• BREC Levy Fees for Biomedical Ethics Review 2024

• South African Health Research Ethics Guidelines 2024
• SA Department of Health Research Ethics Guidelines (2015)
• SA NHREC 2022 Final Guideline for Research Ethics in a pandemic
• South African Good Clinical Practice Guidelines (2020)
• National Guidelines for Payment of Participants in Clinical Trials (2012)
• National Guidelines for Community Advisory Groups for Research (2012)
• National Regulations Relating to Research with Human Participants R719 of 2014
• UKZN Research Ethics Policy (Research Policy V)
• US Common Rule 45CFR46 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
• Singapore Statement on Research Integrity (Adopted by UKZN Senate): https://www.wcrif.org/downloads/main-website/singapore-statements/223-singpore-statement-a4size/file
• World Medical Association Declaration of Helsinki 2013
• CIOMS Guidelines (2013): https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
• UNAIDS 2011 Guidance on Good Participatory Practice in HIV Vaccine Trials https://www.unaids.org/en/resources/documents/2011/20110629_JC1853_GPP_Guidelines_2011%20OK
• UNAIDS 2021 Ethical Considerations in HIV Prevention Trials: https://www.unaids.org/sites/default/files/media_asset/ethical-considerations-hiv-prevention-trials_en.pdf
• SAGER Guidelines on sex and gender equity in research: https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0007-6/tables/1

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

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.  BREC does not accept manual applications. All submissions must be done online in the RIG system.

• BREC Application for Expedited and Full Review 
• BREC: Expedited Database Class Approval Form

The RIG Online Help Page provides access to comprehensive User Guide documents and training videos designed to help applicants getting familiar with the RIG System. Visit: https://ics.ukzn.ac.za/rig-online-help-1/

Protocol Amendments may not be implemented without prior BREC approval unless the 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, within the main application.

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.

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.

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

• BREC Informed Consent Resource Template 2024
• BREC Template Informed Consent for Tissue Storage

Materials Transfer Agreement Templates must be on RSA approved templates:

• Material Transfer Agreement of Human Biological Materials 2018 (MS Word)
• Material Transfer Agreement of Human Biological Materials 2018 (pdf)
• Alternate MTA Agreement

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.

Form A: For non-therapeutic research with Minors

• http://www.kznhealth.gov.za/hrkm.htm
• Research Application Process 2019
• Guidelines for submitting research proposals to the KwaZulu-Natal Department of Health for Approval
• Synopsis of Study Template 2019

• US NIH Responsible conduct of research
• US OHRP Research ethics training
• TRREE
• CITI
• FHI
• Global Health Training Centre
• Free online certificate-generating module on stakeholder engagement in clinical trials:           

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. 

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.

• SARETI UKZN
• ARESA (Stellenbosch)