Institutional Review Board
Standard Operating Procedures
Clinical Trial Submissions
WITS HEALTH CONSORTIUM WEBSITE – IMPORTANT NOTIFICATION:
It is the responsibility of the Sponsor and Principal Investigator to ensure, where required, that relevant approvals are in place and compliance with the following is adhered to before a trial may begin:
- If being conducted in Provincial Health Facilities: Approval from the Hospital CEO / Clinic Manager / District Research Committee (whichever is applicable) be obtained.
- The study is submitted onto The National Health Research Database (NHRD) for record purposes.
- The relevant approvals are uploaded onto the NHRD system: Ethics Approval, MCC Approval, Hospital CEO/Clinical Manager/District Research Committee Approval
Our expectation is that once these approvals have been uploaded onto the NHRD system and confirmation of submission has been received, a trial may begin.
For future trial submissions we request that the new ‘Protocol Review Application Form’ be completed in place of the historical ‘PRC Application Form’. This form includes the steps to be taken
following ethics approval. This form will be available on our website from December 2015.
Institutional Review Board
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The WHC Regulatory Secretariat Division acts as secretariat to the Universities 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 and Prof Ames Dhai.
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
Prof Feldman 011 488 3840
Prof Woodiwiss 011 717 2153
Prof Dhai 011 717 2718
Standard Operating Procedures (SOP’S)
Wits Human Research Ethics Committee – Medical
As the SOP’s are updated regularly please check this site for revisions.
- Policy regarding IEC approval of Clinical Trials – [POL-IEC-001] (PDF)
- Procedure for Research Approval - [SOP-IEC-001]: (PDF)
- Ongoing Review of Research – [SOP-IEC-002]: (PDF)
- Voting for the Wits IEC - [SOP-IEC-003]: (PDF)
- Policy regarding IEC Management of Queries etc -[SOP-IEC-004]: (PDF)
- Adverse Event Processing for Review -[SOP-IEC-005]: (PDF)
- Good Clinical Practice (GCP)[SOP-IEC-010]: (PDF)
- Transport and storage of blood specimens, tissue samples and genetic testing.[SOP-IEC-012]: (PDF)
- Blood Storage Amendment.[SOP-IEC-012v3]: (PDF)
- Human Research Ethics Committee Principles and Policy on Biobanks:This is dealt with by the Biobank Ethics Committee, a Subcommittee of the HREC (Medical). For
Application Forms for the approval of a Biobank/Storage/Retrieval/Transfer of HBM, please contact Zanele Ndlovu at 011 717 1252
- ABPI compensation guidelines 2014
The South African Good Clinical Practice Guidelines require adherence to the Association of the British Pharmaceutical Industry (ABPI) compensation guidelines. These guidelines have been revised
and the 2014 version is the one to be used. In Informed Consent documents ‘(2014 version)’ must appear after each mention of APBI compensation guidelines.
Clinical Trial Submissions - Ethics Applications
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)
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)
For Other Studies please contact the Research Office, University of the Witwatersrand – 011 717 1234
Ethics Clearance Procedure for Research in Faculty of Health Sciences
Instructions to assist you with an Ethics Application are contained in Submission Requirement document - [Doc 010]: (MSWord)
To avoid unnecessary delays please complete the checklist with your Ethics Application and please read the attached document before continuing - [Doc 000]: (MSWord)
IRB and FWA Assurance reference information please refer to the following document - [Doc 170]: (MSWord)
For Amendments please refer to the attached example - [Doc 120]: (MSWord)
Amendment Classification please refer to the attached guidelines - [Doc 121]: (MSWord)
Meeting and Submission Dates (2017) for Ethics Review Committee and Human Research Ethics Committee: (Medical) (Medical) - [Doc 002]: (MSWord)(APRIL MEETING WILL BE HELD ON 5 MAY 2017 DUE TO PUBLIC HOLIDAYS)
Price List - [Doc 150]: (MSExcel)
Payment Instructions for ETHICS SUBMISSIONS - [Doc 155]: (MSWord)
Financial Contract example - [Doc 130]:(MSWord)
Payment Instructions for FINANCIAL AGREEMENTS - [Doc 135]: (MSWord)
Financial Contract Checklist - [Doc 140]:(MSWord)
Protocol Review Application Form - [Doc 080]: (MSWord)
for completion of the Protocol Review Application Form - [Doc 090]: (MSWord)
Declaration by Principal Investigator - [Doc 060]: (MSWord) - it is important that this format of the declaration be completed. MCC Format is acceptable.
Declaration by Sub-Investigator - [Doc 070]: (MSWord)
CV Format for Investigators and Sub-Investigators -[Doc 050]: (MSWord)
List of Ethics Committee Members - [Doc 200]: (MSWord)
Informed Consent Checklist - [Doc 109]: (MSExcel) Informed Consent Form example - [Doc 110]: (MSWord)
- 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)
- Storage Amendment Application Form [Doc 180] : (MSWord)
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.
South African Good Clinical Guidelines
Storage of Blood and Genetic Testing
- Guidelines for use of Wits MTA Template version 3 dated 6 December 2016
- MTA – WITS HEALTH CONSORTIUM (WHC) Material Transfer Agreement & Data (Updated May 2017 – updated logo)
- MTA – WITS Material Transfer Agreement – Finalised May 2017
- MTA – WHC Covance FINAL MTA Template 2_12_16 (Updated Logo)
- MTA Basic terms and Conditions.2010
- Blood volumes from pediatric population for research purposes
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