General Notices

• Important notice for re-imbursements based on SAHPRA’s T.I.E model for research/studies/projects involving Wits HREC (Medical) – click here
• General Notices from the HREC (Medical) – click here

HREC Applications/Submissions

1. The South African National Clinical Trials Register (SANCTR) provides the public with updated information on clinical trials on human participants being conducted in South Africa. In November 2005 the Department of Health issued a notice that as from the 1st December 2005 all new clinical trials to be conducted in the country must be registered in the South African National Clinical Trials Register, and the proof of capture must be attached to the pack submitted to Ethics Committees. For more information please refer to the following link: [Link] (SANCTR)
2. HREC Application Form 2025 (Version 5) – to be used for grant and/or commercially funded study applications  – [Doc 001]: (MSWord) 
3. Studies for degree and non-degree purposes submitted to the Research Office, University of the Witwatersrand - [Link] (Wits University)
4. Instructions to assist you with an Ethics Application are contained in Submission Requirement document - PLEASE NOTE THE REVISED SUBMISSION REQUIREMENTS  -  [Doc 010]: (PDF)
5. To avoid unnecessary delays please complete the checklist with your Ethics Application and please read the attached document before continuing - [Doc 000]: (PDF)
6. IRB and FWA Assurance reference information please refer to the following document - [Doc 170]: (PDF)
7. Application Form for Protocol Amendment to Approved Study (Version 4)[Doc 003]: (MSWord)
8. HREC Medical Meeting and Submission Dates (Jan-Nov 2025)
   * for Grant / Commercially Funded study applications processed by the Secretariat housed within Wits Health Consortium (WHC) [Doc 002a]: (PDF)
   * for Research Applications (that are not grant/commercially funded) processed by the Wits Research Office housed within the Phillip V Tobias Building (WRO),  please contact @HREC-Medical.ResearchOffice for meeting dates
9. Payment Instructions for ETHICS SUBMISSIONS -  [Doc 155]: (MSWord)
10. Price List -  [Doc 150]: (PDF) 2025
11. Protocol Review Application Form -  [Doc 080]: (MSWord)
12. Instructions for completion of the Protocol Review Application Form -  [Doc 090]: (MSWord)
13. Declaration by Principal Investigator -  [Doc 060]: (MSWord) - it is important that this format of the declaration be completed. SAHPRA Format is acceptable.
14. Declaration by Sub-Investigator -  [Doc 070]: (MSWord)
15. CV Format for Investigators and Sub-Investigators - [Doc 050]: (MSWord)
16. List of Ethics Committee Members -  [Doc 200]: (PDF)
17. Informed Consent Checklist -  [Doc 109]: (MSExcel) Informed Consent Form example -  [Doc 110]: (MSWord) Please note: The template has been updated to include a clause regarding parental/legal guardian consent
18. Assent 7-11 years example – [Doc 111]: (MSWord)
19. Recertification Application Form – Recertification of ongoing/current/approved research studies. PLEASE NOTE: INITIAL ETHICS APPROVAL IS VALID FOR FIVE YEARS. RECERTIFICATION APPLICATIONS ARE DUE WHERE THE INITIAL 5-YEAR APPROVAL IS SET TO EXPIRE, AND WILL BE VALID FOR AN ADDITIONAL FIVE YEARS (UNLESS MORE FREQUENT RECERTIFICATION IS RQUIRED BY THE SPONSOR/FUNDER).  -  [Doc 160]: (MSWord)
20. Follow link for the Declaration of Helsinki - [Link] (World Medical Association)
21. Follow link for the South African Good Clinical Guidelines - [Link]: (PDF)
22. ABPI compensation guidelines 2014 - [Link]: (PDF)
23. Follow link for the NDoH 2024 - South African Ethics in Health Research Guidelines: Principles, Processes and Structures, 2024, 3rd ed - [Link]: (PDF)
24. Follow link for ICH GCP E6(R3) Step 4 Final Guideline (06 January 2025) - [Link]: (PDF)
25. Follow link to learn more on Storage of Blood and Genetic Testing - [Link]: (PDF)
26. Follow link to learn about Blood volumes from pediatric population for research purposes - [Link]: (MSExcel)
27. List of Wits BEC Approved Biobanks - [Link]: (MSWord)
28. Wits HREC (Medical) Guidance Document on Mandatory Reporting obligations in research involving minors - [Link]: (PDF)
29. Memorandum of Agreement for External / Private Research Sites – MOA required for External/Private sites submitted to the Wits HREC (Medical) for approval - [Link]: (MSWord)
30. HREC Template data breach, V1 - For organisations / Investigators that have experienced a data breach and need to report it to the University of the Witwatersrand, Human Research Ethics Committee (Medical) - [Link]: (MSWord)
31. Four-Weekly Progress Report Template, V1 – For very high risks associated with Phase 1, especially First-in-Human studies - [Link]: (MSWord)
32. Three-Monthly Progress Report Template, V1 – For moderate to high-risk studies (especially clinical trials) - [Link]: (MSWord)
33. Six-Monthly Progress Report Template, V1 – For non-interventional studies - [Link]: (MSWord)
34. Protocol Deviation and Violation Template - [Doc 004]: (MSWord)

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