About Pharma-Ethics


South African:

National Health Research Ethics Council Registration number:  REC-220508-008

FDA OHRP registration details: 

FWA No:  00012241
IRB no:  0001483

Pharma-Ethics Independent Research Ethics Committee is an independent Research Ethics Committee in South Africa. The committee reviews biomedical research and research proposals and has no affiliation with any research institution. The objective of Pharma-Ethics is to contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants and to ensure that the goals of research do not override the health, well-being and care of research participants.

The committee has a chairperson and a deputy chairperson and members who collectively have the qualifications and experience to review and evaluate the science, health aspects and ethics of the proposed research.

Pharma-Ethics operate according to written Standard Operating Procedures (SOP’s) which are updated regularly to comply with both national and international Good Clinical Practice and Ethics guidelines and regulations. 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- 2006 FDA Code of Federal Regulation Parts 50, 56 and 312, Ethics in Health Research: Principles, Structures and Processes – 2004]. 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.

Meetings are normally held every two 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 ten 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.