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National Health Act, 2003 (Act No. 61 of 2003)


Regulations relating to Research with Human Participants

7. Ministerial consent for non-therapeutic research with minors


Protocols for human participants' research that propose non-therapeutic research with minors must have ministerial consent in terms of Section 71(3)(a)(ii) of the Act or, where appropriate, consent from a delegated authority in terms of Section 92(a) of the Act.

(a) Applications for ministerial consent must be made on Form A;
(b) the application should be considered by the Minister or the delegated authority after the protocol is reviewed by a registered health research ethics committee to assess whether it meets the required norms and standards of the health research ethics committee;
(c) in granting ministerial consent, relevant bodies or experts may be consulted;
(d) the researcher must be notified of the outcome in writing within 60 days; and
(e) the researcher may appeal the outcome including by approaching the National Health Research Ethics Council in terms of Section 72(6)(d) of the Act.