All research and teaching activities involving animals under the auspices of the University of the Witwatersrand, Johannesburg requires ethics clearance from the AREC.

How to Apply?

• Use the new online Ethics system, Infonetica to submit applications. Find out how here.
• Applicants can self-register, save, download, and submit their online ethic applications for approval to the various ethics committees
• It is very important that you first read the Guidelines for completion of applications to Animal Research Ethics Committee
• Applicants seeking information on the Animal Research Ethics can email to Dept-Secretary-AREC@wits.ac.za or Shaun.Schoeman@wits.ac.za - 011 717 1408 or mmatshepo.taunyane@wits.ac.za - 011 717 1788
  

• AREC Meeting and Submission Dates 2026
• Application for approval to undertake a sugical training course using animals
• Application For Adaptations Or Modifications And Extensions To Experiments
• Planning studies or teaching activities
• Guidelines for studies at more than one institution
• SA National Standard on the Care and Use of Animals for Scientific Purposes
• Guidelines for Section 20 Applicants
• Section 20 Application Form
• Amendment Request Form for Section 20 Permit
• Section 20 of the Animal Diseases Act - 1984
• Vet vs Non-Vet Procedures
• SAVC GUIDELINE FOR AUTHORISATION
• SAVC_Employee Employer Supervision Agreement
• SAVC - Table of Approved Protocols
• FR-SL.I004_study log index
• 1 FR-SL.FC001_study log front cover
• 2 SOP-G.FR001_guidelines for filling form records
• 3 FR-SL.SR002_study record
• 4 FR-SL.WR003_weight recordsheet
• 5 FR-SL.WM002B_welfare monitoring CatB group
• 5 FR-SL.WM003C_welfare monitoring CatC group
• 5 FR-SL.WS008_welfare scoresheet
• 6 FR-SL.SS007_study summary
• 7 R-VR.SP002 sedation and preparation
• 8 R-VR.DL004_drug list
• 9 R-VR.PA003_procedure and anaesthetic
• 12 FR-SL.RS006 record of signatures
• 13 R-VR.TL006 treatment record
• 14 R-VR.HN001_history and necropsy
• 15 FR-SL.TR010_training compitence register
• 2a AREC Classification of Severity Categories in Animal Research
• 3a Annexure A AREC Incident Report
• 3a Annexure B AREC Incident Investigation_Annexure B V2
• 3a Annexure C AREC Formal Inquiry_Annexure C V2
• 3a AREC Policy Incident_Adverse event_Non-compliance
• SAVC 2021 APR 21_Updated Veterinary VS Non-Veterinary Procedures Table_FINAL
• SAVC Application Form_Authorisation_Veterinarians and Para-vets_Editable
• SAVC Supervision Agreement_Editable
• 1a AREC AECC ToR
• 1a AREC SOP
• 1a Code of Conduct
• EIT Workshop Application to undertake surgical training course using animals

Reviews all applications for the establishment of biobanks and to make recommendations to the HREC (Medical); and to review all research using tissue samples and / or associated data from approved biobanks and make recommendations to the HREC (Medical). 

How to apply?

For enquiries regarding progress or outcome of ethics application contact the Research Administrator – Mrs Tanya Coetzee or Mr Rhulani Mkansi via email: HREC-Medical.BEC@wits.ac.za  or Tel: 011 717 2816/1234

Application Forms:

• BEC 1 Application: Application for registration of a Biobank/ Biorepository /Databank. BEC 1 applications must be submitted in hard copy (1 x copy of an application form and all the required/supporting documents) at our offices and via e-mail: HREC-Medical.BEC@wits.ac.za *BEC 1 applications are subject to the published monthly closing dates.
• BEC 2 Application: Application for, storage, retrieval or transfer of biological samples and data at an approved Biobank. Study Ethics Clearance Certificate by the Medical Ethics Committee is required (no BEC 2 applications should be submitted without an Ethics Clearance Certificate and finalised supporting documents). BEC 2 applications must be submitted in hard copy (1 x copy of an application form and all the final required/supporting documents) at our offices and via e-mail: HREC-Medical.BEC@wits.ac.za at any time, i.e. BEC 2 applications are not subject to the published monthly closing dates.

• 2026 Finalised Wits MTA
• ABPI Compensation Guidelines 2014

• BEC Ethics Meeting and Submission Dates 2026
• Approved Biobanks – Storage Facilities 2025
• BEC 1 Application Form 2026
• BEC 2 Application Form 2026
• BEC 1 Biobank Checklist 2026
• BEC 1 Checklist 2026
• BEC 2 Checklist 2026

The Human Research Ethics Committee (HREC) (Medical) is an independent committee which provides ethics approval and oversight for all research at the University with a medical nature involving human beings/data. HREC (Medical) comprises of two secretariats with differing roles, one for university-based research for degree and non-degree purposes, based in the PV Tobias Building, and one for complex grant-funded and commercial research, based at the Wits Health Consortium (WHC). Both secretariats form part of HREC (Medical) and are not two separate HRECs (Medical).

Application forms for degree and non-degree HREC (Medical) applications

The nine (9) categories of application forms listed below include a description of their purpose and submission requirements. Please refer to the appendix of each form for the relevant checklist and guidance notes.

How to apply?

1. Full HREC (Medical) Application Form: Application for studies of a prospective nature (not for case reports, sub-studies, retrospective record reviews, secondary data analyses, de-identified human biospecimen studies, waivers and amendments).

• To download the Full HREC (Med) application form, click here
• To download the HREC (Med) Checklist and guiding information 2026 for Full HREC (Med) applications, click here.
• Applicant must submit the completed Full HREC (Med) application and required documents online via the Ethics Management System (EMS) https://www.witsethics.co.za/Login.aspx.
• Applicant can self-register, save, download, and submit their online ethic applications for review to HREC (Medical). The Ethics user guide is available on the link.

Please note: The online submission method through the EMS is strictly for Full HREC (Med)                       application forms and PhD studies.

2. Retrospective Record Reviews (RRR) Application Form: Application for studies solely focused on existing data (no new data).

• To download the Retrospective Record Review application form, click here.
• Applicant must submit completed RRR application form and required documents via office email:HREC-Medical.ResearchOffice@wits.ac.za.

3. Sub-study / Secondary Data Analysis Application Form: Application for studies solely focused on interpreting data already collected under an earlier ethics clearance.

• To download the Sub-study / secondary data analysis application form, click here.
• Applicant must submit completed Sub-study / Secondary Data Analysis application form and required documents via office email:HREC-Medical.ResearchOffice@wits.ac.za.

4. De-identified Human Biospecimens Application Form: Application for studies solely based on the use of left-over stored human biospecimens.

• To download the De-identified Human Biospecimens Study application form, click here.
• Applicant must submit completed De-identified Human Biospecimens application form and required documents via office email:HREC-Medical.ResearchOffice@wits.ac.za.

5. Case Report(s) Application Form: Application for a case report involving 3 or less participants.

• To download the Case report(s) application form, click here.
• Applicant must submit completed Case report application form and required documents via office email:HREC-Medical.ResearchOffice@wits.ac.za.

6. Waiver Application Form: Application for studies involving review of data in public domain, in vitro laboratory, environmental surveillance and observational studies of people in public places.

• To download the Waiver application form, click here.
• Applicant must submit completed Waiver application form and required documents via office email: HREC-Medical.ResearchOffice@wits.ac.za.

7. Amendment(s) and New Investigator(s) Application Form: Application for amendment(s) or addition of investigator(s) to a study which has ethics clearance and is already underway.

• To download the amendment and the new investigator(s) application form, click here.
• Applicant must submit completed Amendment(s) and New Investigator(s) application form and required documents via office email: HREC-Medical.ResearchOffice@wits.ac.za.

8. Renewal / Recertification Application Form:

• Renewal of approved studies: Applicants must submit a renewal application when the initial clearance or 5-year approval period is nearing its expiry, and the investigator wishes to continue with the study. A renewal application should be submitted before the expiry date.
• Recertification of approved studies: Applicants may need to submit an annual recertification as required by the sponsor/funder throughout the 5-year period. It does not change the original 5-year expiry date as above.

• To download the Renewal / Recertification application form, click here.
• Applicant must submit completed Renewal / Recertification application form and required documents via office email:HREC-Medical.ResearchOffice@wits.ac.za.

9. Annual Progress Report Form: Annual progress reports must be submitted each year until the study ends or after 5 years. Failure to submit may result in suspension of ethics approval.

• To download the Annual progress report form, click here.
• Applicant must submit completed Annual progress report form and required document(s) via office email: HREC-Medical.ResearchOffice@wits.ac.za.

Submission Deadlines

The submission deadline for Full Applications is 5pm on the Monday following the HREC (Medical) meeting held on the last Friday of the month (except December – deadline is the last Friday at 5pm before 16th December).

Click here to download the submission and meeting dates document. Wits HREC (Medical) monthly meeting takes place over two days:

1. First meeting is for commercially funded and grant funded (>R500,000) studies
2. Second meeting is for university-based research (degree and non-degree)

Please note: There are no submission deadlines for Retrospective Record Review, Sub-study/Secondary analyses, Case reports, De-identified human biospecimen studies, Waivers, and New investigator and Amendment applications, except for PhDs, which must be submitted by 5pm on the last Monday of the month before the meeting.

PhD Studies

Please note that all HREC applications for PhDs must be reviewed by two members of the HREC and discussed at the monthly meeting regardless of whether they are full applications, retrospective record reviews, waivers, sub-studies or secondary data analyses. We will however provide waivers outside of the committee for the initial literature/scoping review component of the PhD. A Full HREC (Med) application will however be required for the rest of the PhD. Forms for retrospective record review, sub-studies/secondary analyses or de-identified human biospecimen studies may be used for a PhD application if applicable but will still need to be seen by the full HREC (Medical) following review by two members.

Other Submissions

Submissions such as protocol deviations, Serious Adverse Events (SAEs), urgent communicable diseases outbreaks etc. should be submitted via office email HREC-Medical.ResearchOffice@wits.ac.za. Please consult HREC (Medical) Office for submission requirements.

• General notices from the Wits HREC (Medical)
• HREC Ethics Training Requirements
• List of HREC (Medical) Members
• HREC Template data breach (For organisations / Investigators that have experienced a data breach and need to report it to the University.)
• HREC (Med) SOP
• HREC Progress Report
• Information Sheet 
• Risk Table (Medical)
• Generic Consent Form
• Interviews-Questionnaires-Focus Groups
• Minor Blood Volumes
• Distress Protocol
• Biobanks – please visit https://www.wits.ac.za/research/researcher-support/research-ethics/ethics-committees/ and select Biobanks Ethics Committee
• Wits Research Integrity Policy
• Wits Research Integrity Procedures
• DoH Ethics in Health Research Guidelines
• 2026 Finalised Wits MTA

General Notices

For enquiries regarding the progress or outcome of ethics application contact the Ethics Officers using this central email address: HREC Medical.ResearchOffice@wits.ac.za.

Office address: Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Corner York Road, and 29 Princess of Wales Terrace, Parktown, 2193.

HREC (Medical) Secretariat for Degree and Non-degree HREC applications:

All non-medical research involving human participants conducted under the auspices of the University of the Witwatersrand, Johannesburg requires ethics clearance from the Human Research Ethics Committee: Non-Medical (Wits HREC-NM). This includes, but is not limited to, studies involving social, behavioural, economic, and educational research. It may also include health-related research where the well-being of humans is studied outside of clinical settings.

The HREC-NM is formally registered with the South African National Health Research Ethics Council (NHREC) (registration 101114-044). This national registration is a legal requirement and enables the Wits HREC-NM to review all research involving human participants, including studies involving health-related topics and studies with minors.

The Wits HREC-NM helps protect and safeguard the rights, dignity, and safety of everyone involved in research, from the research participants and communities to the researchers themselves. It also actively supports and empowers researchers to uphold the highest ethical standards, advancing knowledge and innovation that promotes responsible research for good.

How to apply?

• A new online Ethics Management System (EMS) with Ethics User Guide is available on link: https://www.witsethics.co.za/Login.aspx
• Applicants can self-register, save, download, and submit their online ethic applications for approval to the various ethics committees.

Please contact Mokgaetsi Madubanya, mokgaetsi.madubanya@wits.ac.za - 011 717 1408, Shaun Schoeman shaun.schoeman@wits.ac.za - 011 717 1408 or Mmatshepo Taunyane, mmatshepo.taunyane@wits.ac.za - 011 717 1788  for queries.

• HREC (NON-MED) Meeting Dates - 2026
• Terms of Reference
• Standard Operating Procedures SOP of the Human Research Ethics Committee
• Appeals form
• Ethics complaint structure
• Ethics complaints form
• Example of a Consent Form
• Example of a Participant Information Sheet
• Example of letter requesting permission
• Example of Consent Form for 1 child’s parent or guardian
• Ethics handling of Honours and MCWRR projects by Schools
• Guidance on the use of Permission letters
• Guidelines for amendments
• Risk Table
• Wits Research Integrity Guidelines & Procedures
• Wits Research Integrity Policy
• HREC Progress Report Form
• Signature page when making a Non Medical ethics application
• FORM A Request from Hons, Masters & PhD students or staff to conduct research
• FORM B Request to conduct research (Non Wits staff and students)
• Guidelines for completion of applications to Human Ethics (Non-Medical) Committe
• Guidelines for observations
• Distress Protocol
• Ethics training guidelines Ethics training guidelines
• Transparency in Ethical Research
• Guidelines for the Reporting and Management of Serious Adverse Events
• Serious Adverse Event (SAE) Reporting Form
• Guidelines to conduct research in GDE institutions
• GDE - Research Request Form
• Statement on Retrospective Applications

Biosafety is concerned with the containment methods required when managing parasites, infectious agents and infected or potentially infected animals, tissues or other materials. The purpose is to reduce exposure of laboratory workers, other persons and the outside environment, to potentially hazardous agents.

Four principles of biomedical ethics are generally recognised:

• autonomy (respect for the person - a notion of human dignity
• beneficence (benefit to the research participant)
• non-maleficence (absence of harm to the participant)
• justice (notably distributive justice - equal distribution of risks and benefits between communities

Worker and public safety is of paramount concern. Workers must be adequately trained and provided with a working environment in which the necessary facilities and equipment are available. If this is done and the guidelines below are observed, risk to the public will be minimised.

When considering research protocols, the Biosafety Committee is involved in various processes, including risk assessment, which would include, but not be limited to:

• concentration and quantity of organisms
• stability and viability of organism
• potential for transmission, by contact or aerosol
• nature of the work
• specific risks associated with genetically-modified organisms (GMO s)
• risk of harmful bi-products
• risk of unknown contaminants

Please contact Mmatshepo Taunyane at mmatshepo.taunyane@wits.ac.za  or 011 717 1788 for queries.

NIH Update on Public Disclosure of IBC Meeting Minutes

On March 28, 2025, the National Institutes of Health (NIH) issued a memorandum titled “Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.” In alignment with this update, NIH now requires that approved minutes from all Institutional Biosafety Committee (IBC) meetings held on or after June 1, 2025, be made publicly accessible on an institutional website immediately following IBC approval.

• IBC Minutes - 30 June 2025

• General Information
•  IBC Meeting and Submission Dates 2026
• Application Form for Research Project
• Checklist for Research Project
• Checklist for Lab Application
• Application for Laboratory Certification
• SOP for Handling of Biohazardous Material