South African National Health Act (No. 61 of 2003) vs. Emmanuel framework for ethical research (2004): implications for children research.
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The South African government promulgated the National Health Act (NHA) (Act No. 61 of 2003) in 2004, where Section 71 (promulgated in March 2012) regulates research involving human participants, including minors. This study evaluated potential implications of compliance of paediatric research with the NHA, as well as with the framework for ethical research proposed by Emanuel et al. (2004), through the review of 55 published journal articles involving children as research participants, published by researchers from the Department of Paediatrics and Child Health at Stellenbosch University from 1 March 2012 – 31 March 2013, after the promulgation of Section 71. The majority (89%) of the studies could be defined as non-therapeutic research, with no prospect of direct benefit for the individual child. Nearly all (90%) of the non-therapeutic studies involved minimal risk, while therapeutic studies, on the other hand, mostly involved more than minimal risk but presented the prospect of direct benefit to the individual participants in 66%. All therapeutic studies (100%) presented the potential for direct benefits to the research participants. While the majority (42/49; 86%) of non-therapeutic studies did not offer direct benefit to the participants, 4% of non-therapeutic studies did offer direct benefits to the child participants. Benefits could not be determined in 10% of non-therapeutic studies. Overall, the reported studies presented a favourable risk-benefit ratio. The majority reported ethics approval (73%), with therapeutic studies more likely to mention it than non-therapeutic studies. As the majority (65%) of studies were retrospective, waiver of consent for parent/guardian was obtained in 51% of the studies, while waiver of child assent was obtained in 76% of the studies reported. This study established that the NHA places more stringent review standards for lower risk non-therapeutic research, but not for therapeutic research that is likely to involve more than minimal risk. Also, the NHA assumes that non-therapeutic studies present no direct benefits to child participants; however, this study found out that some non-therapeutic studies did present some direct benefits. The framework for ethical research proposed by Emmanuel et al. (2004) is proven a valuable framework in this study to determine if paediatric research is ethically acceptable. In situations where national regulations have been recently enacted, as in the case of the SA NHA (No. 61 of 2003) Section 71, it is very important to assess the implications to ensure that essential paediatric research can be conducted.