UKZN Research Office: Biomedical Research Ethics

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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

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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 Registration with SA Department of Health National Health Research Ethics Council UKZN BREC Registration Certificate 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.zn with Reciprocity specified in the subject line BREC Terms of Reference, Standard Operating Procedures: BREC Terms of Reference (2020) BREC Standard Operating Procedures (2020) BREC Meeting and Submission dates, Current membership and Review Fees 2023 BREC Meeting Dates Biomedical Research Ethics Committee 2023 BREC Levy Fees for Biomedical Ethics Review 2023 Relevant National and International Guidance Documents 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 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 BREC Application for Extended and Full Review BREC: Expedited Database Class Approval Form
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: Application for Exemption from Ethics Review 2014
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. Application Form: Protocol Amendment
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: Application Form: Biomedical Research Ethics Recertification
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: BREC Serious Adverse Event Form 2010 BREC Protocol Deviation Form
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 BREC Informed Consent Resource Template 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
KZN Provincial Department of Health: Health Research and Knowledge Management: website and application forms for KZN Provincial permission to contact research
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
Online Research Ethics Certificate:
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. 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
SARETI UKZN ARESA (Stellenbosch)

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