In granting its approval, the committee must be satisfied that the proposals conform to these guidelines and regulations [Declaration of Helsinki, ICH Harmonised Tripartite Guidelines E6: Note for the Guidance in Good Clinical Practice (CPMP/ICH/135/95), Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa, FDA Code of Federal Regulation Parts 50, 56 and 312, South African Ethics in Health Research: Principles, Structures and Processes. . Pharma-Ethics is registered with the National Health Research Ethics Council (NHREC) of South Africa (REC-220508-008), established in terms of the National Health Act (Act No. 61 of 2003). The committee is also registered with the Office for Human Research Protections (OHRP) in the United States of America (IRB00001483) and has a Federal Wide Assurance (FWA00012241) number.
Applications for New Trials, Major Amendments and Re-Approvals are done via electronic submission.
Meetings are normally held every two to three weeks and applications must be submitted no later than ten working days before the meeting. The committee’s decision will be known to the applicant within 15 working days after the meeting.
Continuing review of each approved research is conducted on an annual basis and if satisfied with the progress of the research, the committee will provide written annual re-approval for an additional year.
Where indicated, additional mechanisms for monitoring, including random inspection of research sites, data and signed consent forms will be put in place.
All study related applications, correspondence and Serious Adverse Events (SAE’s) are captured on an electronic database from which reply correspondence is generated. New applications are furnished with a reference number which will be used for the duration of the trial.
All local SAE’s are entered onto the database and reviewed by a designated member of the committee, who will generate queries where needed. All reported SAE’s are acknowledged in writing after review.