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
- 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
- HREC Application Form 2024 – to be used for applications through the Wits Health Consortium Ethics
Secretariat – [Doc 001]: (MSWord)
-
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
- Instructions to assist you with an Ethics Application are contained in Submission Requirement
document - PLEASE NOTE THE REVISED SUBMISSION REQUIREMENTS
- [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]:
(PDF)
- 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 (2024) for Wits Human Research Ethics Committee: (Medical) - [Doc 002]: (MSWord)
- Payment Instructions for ETHICS SUBMISSIONS - [Doc
155]: (MSWord)
- Price List - [Doc
150]: (MSExcel) 2023
- Protocol Review Application Form - [Doc 080]: (MSWord)
- Instructions 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. SAHPRA 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) Please note: The template has
been updated to include mandatory reporting requirements and a POPIA compliance paragraph
- Assent 7-11 years example – [Doc 111]: (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)
- 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.
- Click
here for the South African Good Clinical Guidelines
- Click here for the Ethics in
Health Research DOH 2015 Guidelines
- Click here for ICH GCP E6 R2
Step 4 (Nov 2016) Guidelines
- Click here to learn more on Storage of Blood and Genetic Testing
- Click
here to learn about Blood volumes from pediatric population for research purposes
- List of
Wits BEC Approved Biobanks
- Wits HREC (Medical) Guidance Document on Mandatory Reporting obligations in
research involving minors