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Animal Research Ethics Committee (AREC)
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?
- 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
- 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
Downloads:
- AREC Submission Dates 2024
- 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
- Section 20 of the Animal Diseases Act - 1984
- 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
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Biobanks Ethics Committee
Reviews all applications for the establishment of biobanks and to make recommendations to the HREC; and to review all research using tissue samples and / or associated data from approved biobanks and make recommendations to the HREC.
How to apply?
For enquiries regarding progress or outcome of ethics application contact the Research Administrator – Ms Zanele Ndlovu, Mr Rhulani Mkansi HREC-Medical.ResearchOffice@wits.ac.za – 011 717 1252/2700/1234/2656
Form:
- Coronavirus And Ethics Committee Work 2020
- For collection, storage or transfer of biological samples and data at an approved Biobank. NB parallel submission to BEC2 and HREC (Medical) ethics application allowed.
Guidelines and Policies
Downloads
- BEC Ethics Meeting and Submission Dates 2025
- BEC 1 Application Form 2025
- BEC 2 Application Form 2025
- BEC 1 Biobank Checklist 2025
- BEC 1 Checklist 2025
- BEC 2 Checklist 2025
- Approved Biobanks - Storage Facilities 2023
- External Applications Reviewer Fee
- Policy and Principles on Biobanks 2017
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Clinical Drug Trials
How to apply?
Application forms may be downloaded from http://www.witshealth.co.za by clicking on Ethics. In the latter case, a fee is payable.
Contact:
Admin Supervisor
Jennifer Bryce-Borthwick
Tel: (011) 274-9278
E Mail: jbryce@witshealth.co.za
Ethics Administrator
Augustina Hennessy
Tel: (011) 274-9279
E Mail: ahennessy@witshealth.co.za
Ethics Administrator
Eric Moso
Tel: (011) 274-9280
E Mail: emoso@witshealth.co.za -
Human Research Ethics Committee (Medical)
All research activities under the auspices of the University of the Witwatersrand require ethics clearance for research involving human participants. The rule of thumb is that any staff or students from the Faculty of Health Sciences (FHS) must submit an application for ethics clearance to the HREC (Medical) if the research involves any human participants. If the proposed research is done at a medical facility (hospital or clinic, etc.) with/out medical professionals then an application for ethics clearance must be submitted to the HREC (Medical).
APPLICATIONS TO HREC (MEDICAL)
There are different categories of application forms to the Wits HREC (Medical) for clearance of research. The information on the application form category, title and description and the forms are included below.
- Full Application Form:
The full application form to HREC (Medical) is for PhD, MSc, MPH, MBA, and other Higher Degrees, as well as Undergraduate Degrees, and Investigator Initiated Research, usually of a Prospective Nature involving health related research activities e.g. clinical procedures, questionnaires/survey, interviews, focus group discussions, etc. The full application form is not for Case Studies, Sub-Studies, Retrospective Record Reviews, De-Identified Human Material Studies, Study Amendments, and Waivers.
Submission process:
Full applications follow the online submission process through the Ethics Management System (EMS). Full ethics applications must be submitted online by following the link: https://www.witsethics.co.za/Login.aspx.
Click here to download the Full application form to be completed and submitted online including supporting documentation.
Click here to download HREC (Medical) checklist and guiding information for Full study applications
This category of application is subject to monthly committee meetings for review. Please see the submission and meeting dates document below.
Meeting and Submission Dates (Jan-Nov 2025)
- for Full study applications (that are not grant/commercially funded) processed by the Wits Research Office housed within the Phillip V Tobias Building (WRO) - Click here.
* for Grant / Commercially Funded study applications processed by the Secretariat housed within Wits Health Consortium (WHC) - Click here.
For more information regarding the submission process for the grant/commercially funded study applications follow this link: https://www.witshealth.co.za/Services/Research-Ethics/Application-Forms.
Please note the other categories of applications following the expedited review process listed below should be submitted through the office email HREC-Medical.ResearchOffice@wits.ac.za. Hard copies are not required.
Retrospective Record Review Application Form:
This application form is appropriate for studies based entirely on the review of data already collected, usually but not necessarily, on hospital patients. If the study includes any prospective data collection, by whatever means, a Full HREC (Medical) application is required.
To download the Retrospective Record Review application form, click here.
Note: The checklist/guideline document is attached to the application form.
- Sub-Study Application Form
It is appropriate in a case wherein the applicant is interpreting data already collected under an earlier ethics clearance. Evidence is required that the person who was awarded the earlier clearance has agreed to grant access to their data for the purposes of a sub-study. If the applicant is gathering new data, interviewing participants, examining new samples, etc., this does not meet the Wits HREC (Medical) definition of a sub-study, and a Full HREC (Medical) application is required.
To download the Sub-study application form, click here.
Note: The checklist/guideline document is attached to the application form.
- Case Study Application Form
This application form is appropriate for studies in which a patient has displayed an unusual condition, before or after treatment. One primary reason to write up such a report is to alert peers to situations in which the standard diagnosis and treatment may be inappropriate. Usually, a case report involves a single patient. When the number goes beyond three, the Wits HREC (Medical) Office should be consulted as to the appropriate type of ethics application.
To download the Case study application form, click here.
Note: The checklist/guideline document is attached to the application form.
- De-identified Human Material Study Application Form
It is appropriate for studies based on the use of human de-identified materials, such as surplus blood stocks, urine, liver samples, brain cells, saliva, teeth, etc., which would otherwise normally be discarded by medical facilities. Where the research is to be conducted on commercially available cell lines and other materials not directly derived from humans, a waiver may be applied for, using the appropriate form (not this one).
To download the De-identified Human Material Study application form, click here.
Note: The checklist/guideline document is attached to the application form.
- Waiver Application Form
It is appropriate for studies in which no active human participants are involved and no human materials (tissue, blood, hair, sputum, etc.) are to be used. These will only be given for reviews of data in the public domain, in vitro laboratory studies, environmental surveillance studies, and observational studies of people in public places. All such studies require the submission of the Waiver Application Form before starting the research.
To download the Waiver application form, click here.
Note: The checklist/guideline document is attached to the application form.
- Additional/New Investigator Application Form
This application form should be completed when a Principal Investigator, who already has a current ethics clearance, wishes to add an additional member to the investigating team. This would normally be in one of two circumstances: (a) the study remains unchanged and an “extra pair of hands” is added to the team, or (b) one or more facets of the study is/are taken on by a new team member, who would often, but would not necessarily have to be, a postgraduate student; this person would be gathering new data, which is what distinguishes this exercise from a “sub-study.” (There is a separate Application Form for a sub-study).
To download the Additional/new investigator application form, click here.
Note: The checklist/guideline document is attached to the application form.
- Amendment Application Form
It should be completed when the Principal Investigator is seeking approval for a minor change to a study which has ethics clearance and is already underway. It is not to be used when the intention is to add new investigators to the study team – there is a separate form for this purpose. Nor is it appropriate for renewal of a clearance when the previous version has expired – usually after 5 years.
To download the amendment application form, click here.
Note: The checklist/guideline document is attached to the application form.
PLEASE NOTE:
Application for renewals, annual recertifications, progress reports, protocol violations, urgent communicable diseases outbreaks, and reciprocal studies approved by other primary universities should also be submitted via the office email HREC-Medical.ResearchOffice@wits.ac.za. Hard copy submissions are not required.
CONTACT US:
- 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.
- Telephone numbers: 011717 2700/71234/71252/72656/72816.
For additional information and templates, please see downloads below.
Downloads
- HREC Template data breach (For organisations / Investigators that have experienced a data breach and need to report it to the University.)
- Timelines 2024
- HREC (Med) Terms of Reference (ToR)
- HREC (Med) SOP
- HREC (Med) Procedure Notes
- HREC Progress Report
- Information Sheet
- Risk Table (Medical)
- Generic Consent Form
- Interviews-Questionnaires-Focus Groups
- Minor Blood Volumes
- Distress Protocol
- Biobanks – please visit /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
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Human Research Ethics Committee (Non-Medical)
All research activities under the auspices of the University of the Witwatersrand requires ethics clearance from the HREC (non-medical) if it involves humans participants; and if the research includes social, educational and/or psychological behaviour or perceptions, personal data required by an institution.
How to apply?
- Coronavirus And Ethics Committee Work 2020
- 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 Shaun Schoeman, Shaun.Schoeman@wits.ac.za- 011717 1408 or Mmatshepo Taunyane, mmatshepo.taunyane@wits.ac.za - 011 717 1788 for queries.
Downloads
- HREC (NON-MED) Meeting Dates - 2025
- 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 Applications for Ethics Clearance to the HREC (Non-Medical)
- Guidelines for observations
- Distress Protocol
- 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
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Institutional Biosafety Committee (IBC)
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.
- Please contact Mmatshepo Taunyane at mmatshepo.taunyane@wits.ac.za or 011 717 1788 for queries.
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
Downloads
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Research Integrity - Wits Policy
The University of the Witwatersrand, Johannesburg (Wits, or the University), is a research intensive university that strives for excellence in research as part of the broader scope of scholarly endeavour. Research is understood to be the process of thorough investigation, systematic discovery and/or rigorous analysis that aims to uncover the truth, produce a deeper understanding and/or create new knowledge.
- Click here Wits Research Integrity Policy
- Click here: Wits Research Integrity Procedures
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Ethics in Health Research
Health research is vital for the advancement of health care services for the people of South Africa. Because of its excellent health care and research infrastructure, skills and expertise, South Africa provides a rich arena for health and health-related research.
Click here: Ethics in Health Research Principles, Processes and Structures