HSRC Integrated Annual Report 2018/2019

The mandate of the HSRC REC is to review all HSRC research proposals for compliance with national research ethics guidelines (NHREC, 2015). Data collection may not commence until full ethics approval has been granted. The REC may grant exemption from ethics review for research meeting certain criteria, for example, systematic reviews and secondary analysis of data that are freely available in the public domain. The REC may recognise the authority of other registered RECs at other institutions to avoid duplication of review(s). The HSRC REC also reviews external proposals submitted by researchers not employed by or contracted to the HSRC if they do not have access to the services of a more suitable or eligible REC in South Africa. The latter is done under specific conditions, including payment of a predetermined administrative fee. The HSRC REC is constituted and conducts its work in accordance with formal Terms of Reference (TOR) and Standard Operating Procedures (SOP) that reflect requirements set by the NHREC as well as international oversight bodies. Its members are drawn from within and outside the HSRC. External members are selected for their expertise in required areas of work, in accordance with the categories of membership required for FWA and NHREC compliance. Internal members are identified by executive directors of research programmes, to ensure that the committee has the capacity to review proposals across the areas of research specialisations in the HSRC. During 2018/19, external membership of the HSRC REC changed, due to the terms of office of some long-serving members expiring. An open call for applications led to the appointment of four new external members, with four external members who were eligible and willing to serve for another term, re-appointed. Up until 31 October 2018, the chairperson of the REC was Prof. Douglas Wassenaar of the University of KwaZulu-Natal, an independent external expert. He was supported by two deputy chairs — one (Prof. Anne Pope of the University of Cape Town) also external, and the other (Dr Mokhantšo Makoae) internal to the HSRC. As of 1 November 2018, the new external chairperson is Prof. Theresa Rossouw of the University of Pretoria. Dr Makoae is still serving as internal deputy chairperson, while a new deputy chair will be appointed from serving external members early in 2019/20. The external members of the REC, during 2018/19 were: Up to 31 October 2018: • Prof. DouglasWassenaar – University of KwaZulu- Natal (UKZN), REC Chairperson; • Prof. Anne Pope – University of Cape Town (UCT), Deputy Chairperson; • Prof. Peter Cleaton-Jones – Steve Biko Centre for Bioethics, University of the Witwatersrand; and • Prof. Jerome Singh – UKZN andUniversity of Toronto. From 1 November 2018: • Dr Munira Khan – UKZN; • Dr Bongile Mabilane – Anova Health Institute; • Prof. Shenuka Singh – UKZN; and • Prof. Peter Nyasulu – Stellenbosch University. For the entire reporting period: • Prof. Warren Freedman – UKZN; • Prof. Theresa Rossouw – Faculty of Health Sciences, University of Pretoria, REC Chairperson since 1 November 2018; • Prof. Anne Strode – UKZN; and • Ms Nothemba Vusani – Community Representative Member.  The REC provides oversight of the needs and concerns of potential participants and beneficiaries of research. REC members are trained to review research proposals to ensure that national and international ethical standards and guidelines are adhered to. The REC inter alia reviews each application with regard to the adequacy of: • Proposed community engagement plans; • Potential social value; • The validity of the scientific design; • Fair selection of participants; • Favourable risk/benefit ratio; • Informed consent plans and processes; • Plans to respect participants’ rights and interests during and after the proposed study; and • Proposed data management plans. In compliance with national guidelines (2015), ethics approval is only given for a one-year period – annual ethics approval must be applied for in relation to all ongoing projects, failing which, the ethics approval lapses. Approval letters explicitly inform all applicants of this requirement. The REC has a system in place to deal with complaints and adverse events, and the HSRC has a unique toll-free hotline for participants and other parties to register any ethical concerns about HSRC REC-approved research projects. PART C: GOVERNANCE 74 / HSRC INTEGRATED ANNUAL REPORT 2018/19