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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?

Downloads:

Biobanks Ethics Committee

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.

Guidelines and Policies

Downloads

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.

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

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?

  • 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 

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.

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

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. 

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

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