PLEASE NOTE: WITS HREC (MEDICAL) DIRECTIVE ON FUTURE BIOMEDICAL RESEARCH AND GENETIC TESTING

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: https://sanctr.samrc.ac.za
2. Ethics Application Form - Wits HREC Application Form to be used for application to the Wits HREC. For CLINICAL TRIALS use the following form –  [Doc 001]: (MSWord)  PLEASE SEE REVISED SECTION 8.3 REGARDING CONFIDENTIALITY –  001A. Instructions for completion of HREC Ethics Application [Doc 001A]: (MSWord) 
3. For Other Studies please contact the Research Office, University of the Witwatersrand – 011 717 1234  click here for the Ethics Clearance Procedure for Research in Faculty of Health Sciences
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]: (MSWord)
7. For Amendments please refer to the attached example -  [Doc 120]: (MSWord)
8. Amendment Classification please refer to the attached guidelines -  [Doc 121]: (MSWord)
9. Meeting and Submission Dates (2022) for Ethics Review Committee and Human Research Ethics Committee: (Medical) -  [Doc 002]: (MSWord)
10. Payment Instructions for ETHICS SUBMISSIONS -  [Doc 155]: (MSWord)
11. Price List -  [Doc 150]: (MSExcel) 2022
12. Protocol Review Application Form -  [Doc 080]: (MSWord)
13. Instructions for completion of the Protocol Review Application Form -  [Doc 090]: (MSWord)
14. Declaration by Principal Investigator -  [Doc 060]: (MSWord) - it is important that this format of the declaration be completed. SAHPRA Format is acceptable.
15. Declaration by Sub-Investigator -  [Doc 070]: (MSWord)
16. CV Format for Investigators and Sub-Investigators - [Doc 050]: (MSWord)
17. List of Ethics Committee Members -  [Doc 200]: (MSWord)
18. Informed Consent Checklist -  [Doc 109]: (MSExcel) Informed Consent Form example -  [Doc 110]: (MSWord)
19. Continuing Review of Clinical Trial Recertification Application Form. Certain sponsors, especially when US Federal funding is used, require annual recertification of studies. The responsibility of determining whether this is required rests with the Principal Investigator.  -  [Doc 160]: (MSWord)
20. Storage Amendment Application Form  [Doc 180] : (MSWord)
21. Click here for the Declaration of Helsinki   PLEASE NOTE: The World Medical Association (WMA) has adopted and published a revised version of the Declaration of Helsinki. This version of the Declaration of Helsinki updated October 2013, is supported by the Wits HREC (Medical). From 1 January 2014 all applications submitted for consideration must refer to the revised version.
22. Click here for the South African Good Clinical Guidelines
23. Click here for the Ethics in Health Research DOH 2015 Guidelines
24. Click here for ICH GCP E6 R2 Step 4 (Nov 2016) Guidelines
25. Click here to learn more on Storage of Blood and Genetic Testing
26. Click here to learn about Blood volumes from pediatric population for research purposes
27. List of Wits BEC Approved Biobanks