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Abstract:
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These Guidelines are issued by the South African National Health Research Council (NHREC), under the auspices of the National Department of Health of the Republic of South Africa (NDoH), as mandated by Section 72 of the National Health Act 61 of 2003 (NHA). These Guidelines draw their authority from the NHA and associated regulations, and bind all health and health-related research involving human participants, and the use of animals in research for human health purposes, within South Africa (see also 1.7). The minimum norms and standards for South Africa, as contained in these Guidelines, are established by the NHREC, its application overseen by institutional research ethics committees (RECs) registered with the NHREC, and implemented by the researcher(s) in studies approved by the relevant REC(s). Importantly, the Guidelines are not intended to be a detailed instruction manual, but rather to explain principles and to provide binding normative1 and illustrative informative2 guidance on how to think about the principles in practical contexts. |