Application Forms

General notice for re-imbursements based on sahpra's T.I.E model for research/studies/projects involving WITS HREC (Medical)

Please see attached Notice regarding the re-imbursements based on SAHPRA's T.I.E model for research/studies/projects involving WITS HREC (Medical).

 

Important notice regarding recertification due dates for 2024

Please see attached Notice regarding the recertification due dates for 2024.

 

NOTICE: HREC INITIAL APPROVAL EXPIRY DATE

Please see attached File Note regarding the initial ethics approval expiry dates for Wits HREC (Medical).

 

NOTICE: NEW CHAIRPERSON DETAILS

Please see attached File Note regarding the details of the new chairperson, Prof Paul Ruff.

 

Clinical Trial Submissions - Ethics Applications

  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 2024 – to be used for applications through the Wits Health Consortium Ethics Secretariat  – [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]: (MSWord)
  5. To avoid unnecessary delays please complete the checklist with your Ethics Application and please read the attached document before continuing -  [Doc 000]: (MSWord)
  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 - Please note: this application form may be used from now but will be a requirement for protocol amendment submissions from 1st June 2024.[Doc 003]: (MSWord)
  8. Meeting and Submission Dates (2024) for Wits Human Research Ethics Committee: (Medical) -   [Doc 002]: (MSWord)
  9. Payment Instructions for ETHICS SUBMISSIONS -  [Doc 155]: (MSWord)
  10. Price List -  [Doc 150]: (MSExcel) 2024
  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]: (MSWord)
  17. Informed Consent Checklist -  [Doc 109]: (MSExcel) Informed Consent Form example -  [Doc 110]: (MSWord) Please note: The template has been updated to include mandatory reporting requirements and a POPIA compliance paragraph
  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. Storage Amendment Application Form  [Doc 180] : (MSWord)
  21. Follow link for the Declaration of Helsinki - [Link] (World Medical Association)
  22. Follow link for the South African Good Clinical Guidelines - [Link]: (PDF)
  23. Follow link for the Ethics in Health Research DOH 2015 Guidelines - [Link]: (PDF)
  24. Follow link for ICH GCP E6 R2 Step 4 (Nov 2016) Guidelines - [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)