title: One step forward, two steps back--requiring ministerial approval for all "non-therapeutic" health research involving minors.
abstract: The new National Health Act has clarified that children may take part in "non-therapeutic" research (NTR) and the age at which they may provide independent consent to such research, viz. at legal majority. However, the Act will require consent from the Minister of Health for all research classed as NTR and involving minors regardless of the level of risk. This requirement is overly broad. It will require that low-risk research without direct benefits, which might be adequately reviewed by an accredited research ethics committee (REC), must also be reviewed by the Minister. As it currently stands this requirement serves no plausible ethical purpose, will cause delays and discourage essential research on the needs of children, and may inspire researchers and RECs alike to "foil the system". We argue that in the long term there should be comprehensive law reform for child research. However, in the short term, amendments should be made to the Act to narrow the scope of this provision. The amendment should require ministerial consent for research that is currently not approvable by an REC in terms of national ethical guidelines, namely, research that does not hold out direct benefit but presents more than a minor increase over minimal risk. If our law reform recommendations are rejected, we favour the delegation of this task to RECs because, if they receive appropriate training, they should be competent to conduct it. We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.
authors: HIV AIDS Vaccines Ethics Group (HAVEG), School of Law, University of Kwa-Zulu-Natal, Pietermaritzburg, South Africa. strodea@ukzn.ac.za
authors: Ann E
authors: AE
authors: Strode
authors: Catherine M
authors: CM
authors: Slack
authors: Douglas R
authors: DR
authors: Wassenaar
authors: Jerome A
authors: JA
authors: Singh
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D002669:Child Welfare; D002675:Child, Preschool; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D013019:South Africa; D035862:Vulnerable Populations