Research Ethics Committee
Most HSRC research involves human participants. The bulk of the information and data gathered is likely to be of a personal nature. Researchers and the research leadership in the HSRC are fully aware of ethical considerations related to research with human participants, and these concerns are built into planning and review processes of all research proposals.
The performance, execution and completion of research projects are also carefully monitored to make sure that HSRC researchers and all project collaborators adhere to the highest ethical standards.
The HSRC drew up a Research Code in 1987, which was amended in 1993, further revised in 1997 and published as a Code of Research Ethics. In 2006 the Code of Research Ethics replaced the 1998 Code of Business Ethics. In the Code of Ethics the HSRC Board members and employees commit themselves to a code of ethical behaviour that accords with the HSRC's status, values, principles and obligations.
A HSRC Research Ethics Committee (REC) was established on 27 November 2002. The HSRC REC is registered with the South African National Health Research Ethics Council of the SA National Department of Health (NHREC No 290808-015) and also has US OHRP Federal-wide Assurance (FWA) accreditation (FWA 00006347, IRB No. 00003962).
From 2003 all HSRC researchers are required to submit all research applications for REC approval before commencement of research. Ethics approval is given to project proposals for a period of a year, after which the PI must apply for a renewal/recertification. Exemptions from ethics review must be applied for in advance if studies meet the criteria for exemption, for example reviews and analyses of data or materials that are freely available in the public domain, and conference commissions (except where they involve primary research).
Provided there is no more suitable or eligible REC in South Africa, and subject to terms and conditions including an administration fee, the HSRC REC may conduct ethics review of research proposals submitted by researchers not employed by or contracted to the HSRC.
Although it is mandatory that all research with human participants be ethically approved before data collection commences, the REC has processes in place to expedite the approval of certain types of research if justified by the applicant. Research which constitutes an extension of a study already approved by the REC, may qualify for a class approval under certain conditions. All amendments and changes to approved protocols must be approved by the REC before they are implemented.
Some interventional studies that are ethically reviewed by the HSRC REC may be regarded as clinical trials. All South African clinical trials must be registered with the South African National Clinical Trials Register (SANCTR). The definition of clinical trials is quite broad, and can be found at http://www.sanctr.gov.za/InvestigatorbrnbspInformation/Whatistoberegistered/tabid/195/Default.aspx
Given the HSRC REC’s registration with the NHREC, investigators responsible for clinical trials reviewed and approved by the REC are required to to register such trials with the SANCTR, as outlined at http://www.sanctr.gov.za/InvestigatorbrnbspInformation/Howtoregister/tabid/180/Default.aspx , or in the attached “Terms of Reference” of the HSRC REC.
The overarching ethics guidance for the HSRC is the SA NHREC Department of Health’s (2015) Ethics in Health Research: Principles, Processes and Structures. For clinical trials, the National Department of Health (2006) South African Good Clinical Practice Guidelines apply. Where relevant, the SA MRC Guidelines and major international guidance documents such as the CIOMS guidelines, the most recent version of the Declaration of Helsinki and the UNESCO guidelines might apply.
The Committee meets once a month and functions according to its Terms of Reference and a standard Operating Procedure.