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) 
  9. Blood Storage Amendment. [SOP-IEC-012v3]: (PDF)
  10. 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 
  11. 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.