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HSRC Annual Report 2016/17
On 1 November 2014, when a new term of office came into effect, the HSRC REC consisted of nine external and seven
internal members, with several alternate internal members, to ensure ongoing support and capacity development in
this important area of work. By 31 March 2017, there were eight external and nine internal members. The REC is always
chaired by an expert external to the HSRC to assure independence.
Internal members are senior researchers representing all the research programmes of the HSRC, and are appointed
by the executive directors concerned. 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. The Chairperson of the REC
is supported by two deputy chairs – one external, and the other internal to the HSRC.
Dr Mokhantšo Makoae of the HSD Research Programme serves as the internal (HSRC-based) deputy chairperson of
the REC, alongside a strong team of internal members, drawn from the different research programmes of the HSRC.
The external members of the REC, whose term expires at the end of October 2017, are:
•
Prof. Doug Wassenaar (Chairperson) – School of Applied Human Sciences, UKZN, Pietermaritzburg;
•
Prof. Anne Pope (Deputy Chairperson) – Department of Private Law, University of Cape Town;
•
Prof. Peter Cleaton-Jones – Steve Biko Centre for Bioethics, University of the Witwatersrand;
•
Ms Shirley Mabusela – community representative;
•
Dr Nicole Mamotte – South African Research Ethics Training Initiative (SARETI); Contract Lecturer, UKZN;
•
Prof. Theresa Rossouw – Faculty of Health Sciences, University of Pretoria;
•
Prof. Jerome Singh – Centre for the AIDS Programme of Research in South Africa, Doris Duke Medical Research
Centre, Nelson R Mandela School of Medicine, UKZN;
•
Prof. Ann Strode – School of Law, UKZN (until February 2017); and
•
Ms Nothemba Vusani – community representative.
The REC provides oversight over 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 the:
•
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.
During the reporting period, the REC met ten times via video- and teleconference, as scheduled. A total of 130 new
applications were considered, of which 74 were internal to the HSRC and 56 were external. Two new applications (both
internal) were formally granted exemption from full review. There were 76 requests for amendments, extensions, and
additions to approved studies. Such requests are mainly triggered by a change or extension in the scope of work and
coverage area. There were 34 applications for renewal of protocols. The rate of annual ethics renewal remains low and
the HSRC and the REC will continue to address this factor in the coming year.
PART C: Governance