Institutional Review Board

Standard Operating Procedures

Clinical Trial Submissions
Ethics Applications

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The Wits Regulatory Secretariat Division chairs the Wits Protocol Review Committee and acts as secretariat to the University’s Human Research Ethics Committee – Medical (HREC), which meets every month to review research applications. Professor Peter Cleaton-Jones is the Chairperson of the Wits HREC assisted by Prof Charles Feldman, Prof Angela Woodiwiss, Prof Ames Dhai and Prof Merryll Vorster.

Professor Peter Cleaton-Jones is also a member of the Human Sciences Research Ethics Committee. Professor Ames Dhai is also a member of the National Health Research Ethics Council.

The Wits HREC was one of the first ethics committees to be established in the world in response to the 1966 seminal article ‘Ethics in Clinical Research” by Henry K Beecher. Importantly, the HREC has been continuously operational since inception.

The HREC operates according to latest ICH GCP guidelines, the guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa and the South African Medical Research Committee guidelines first applied in 1997.

Contact Details of the HREC Chair’s:

Prof Cleaton Jones 011 717 2301
(Monday-Wednesday-Friday mornings)

Prof Feldman 011 488 3840

Prof Woodiwiss 011 717 2153

Prof Dhai 011 717 2718

Prof Vorster 011 717 2099

Standard Operating Procedures (SOP’S)

Wits Human Research Ethics Committee – Medical

As the SOP’s are updated regularly please check this site for revisions.

1. Policy regarding IEC approval of Clinical Trials – [POL-IEC-001] (PDF)
2. Procedure for Research Approval - [SOP-IEC-001]: (PDF)
3. Ongoing Review of Research – [SOP-IEC-002]: (PDF)
4. Voting for the Wits IEC - [SOP-IEC-003]: (PDF)
5. Policy regarding IEC Management of Queries etc - [SOP-IEC-004]: (PDF)
6. Adverse Event Processing for Review - [SOP-IEC-005]: (PDF)
7. Good Clinical Practice (GCP) [SOP-IEC-010]: (PDF)
8. Transport and storage of blood specimens, tissue samples and genetic testing. [SOP-IEC-012]: (PDF) 

Clinical Trial Submissions - Ethics Applications

1. With effect from 1 January 2006 all Ethics Applications need to be captured on www.ethicsapp.co.za and the proof of capture attached to the pack submitted to Ethics Committees, as part of the process for the registration of local research on the South African National Research Register. For more information please refer to the following document – [Doc 300]: (MSWord)
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) - INSTRUCTIONS [Doc 001A]: (MSWord) 
3. For Other Studies use the following form – [Doc 040]: (MSWord)
4. Instructions to assist you with an Ethics Application are contained in Submission Requirement document - [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 for Ethics Review Committee and Human Research Ethics Committee (Medical) - [Doc 002]: (MSWord)
10. Price List - [Doc 150]: (MSExcel)
11. Payment Instructions for ETHICS SUBMISSIONS - [Doc 155]: (MSWord)
12. Financial Contract example - [Doc 130]:(MSWord)
13. Payment Instructions for FINANCIAL AGREEMENTS - [Doc 135]: (MSWord)
14. Financial Contract Checklist - [Doc 140]:(MSWord)
15. Protocol Review Committee – PRC Application Form - [Doc 080]: (MSWord)
16. Instructions for completion of the PRC Application Form - [Doc 090]: (MSWord)
17. Declaration by Principal Investigator - [Doc 060]: (MSWord) - it is important that this format of the declaration be completed. MCC Format is acceptable.
18. Declaration by Sub-Investigator - [Doc 070]: (MSWord)
19. CV Format for Investigators and Sub-Investigators - [Doc 050]: (MSWord)
20. List of Ethics Committee Members - [Doc 200]: (MSWord)
21. Informed Consent Checklist - [Doc 109]: (MSExcel) Informed Consent Form example - [Doc 110]: (MSWord)
22. Continuing Review of Clinical Trial Recertification Application Form. In accordance with the Internationally adopted continuing review requirement of the Federal Office for Human Research Protection (OHRP), with immediate effect (January 2004) all Ethics Applications emanating from Faculty of Health Sciences Department as well as Wits Health Consortium Syndicates must be submitted for reviews to the HREC Secretariat, housed within the Wits Health Consortium, Second Floor, 8 Blackwood Avenue, Parktown. (drug trial, vaccine trials, original donor / commercially funded research and original unfunded research) - [Doc 160]: (MSWord)
23. Declaration of Helsinki
24. South African Good Clinical Guidelines
25. Storage of Blood and Genetic Testing
26. Basic Conditions Used In A MTA
27. Materials Transfer Agreement - Draft

Senior Ethics Administrator
Jennifer Bryce-
Borthwick
Tel:(011) 274-9280
E Mail:
jbryce@witshealth.co.za

Ethics Administrator
Desiree Kopp
Tel:(011) 274-9279
E Mail:
dkopp@witshealth.co.za

Ethics Administrator
Eric Moso
Tel:(011) 274-9335
E Mail:
emoso@witshealth.co.za

FAX
(011) 274-9281

Street Address
8 Blackwood Avenue
Parktown
Johannesburg
2193

Map
Click here

Postal Address
Postnet Suite 189
Private Bag X2600
Houghton
Johannesburg
2041