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. |
Copyright Act, 1978
