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

Regulations

Regulations relating to Research with Human Participants

4. Research with human participants who are vulnerable

 

4. Research with vulnerable persons must—
(a) involve vulnerable persons only when non-vulnerable persons are not appropriate for inclusion;
(b) not systematically avoid inclusion of vulnerable participants because to do so is unfairly discriminatory and vulnerable persons are potential beneficiaries of relevant research;
(c) be responsive to the health needs and the priorities of vulnerable persons; and
(d) receive special attention in ethical review to ensure that research-related risks are assessed and minimized and that appropriate consent procedures are followed.

 

4.1 Research with minors should only take place when—
(a) adults are not appropriate participants for the research;
(b) the research poses no more than a minimal risk to the minor; or
(c) the research poses more than a minimal risk, but holds out the prospect of direct benefit to the minor; or
(d) the research poses a minor increase over minimal risk, and holds out no prospect of direct benefit to the minor, but is anticipated to yield generalizable knowledge about the condition under study.

 

4.2 Research with adults with decision-making incapacity is appropriate when—
(a) the research cannot be conducted with adults who have decision-making capacity;
(b) the research poses no more than a minimal risk; or
(c) the research poses more than a minimal risk, but holds out the prospect of direct benefit to the participant; or
(d) the research poses a minor increase over minimal risk, and holds out no prospect of direct benefit but is anticipated to yield generalizable knowledge about the condition under study.

 

4.3 Research with prisoners is appropriate when—
(a) the risk of harm posed by the research is commensurate with risks that would be accepted by non-prisoner volunteers;
(b) the rights of prisoners, including but not limited to the rights to dignity, privacy, bodily integrity and equality, will be protected;  and
(c) the procedures and guidelines issued by the Department of Correctional Services will be followed.

 

4.4 Research with persons in dependent or hierarchical relationships—
(a) includes but is not limited to research with users and their health-care workers; persons with life-threatening diseases and their care-givers, wards of the state and their guardians or care-givers, employees and their employers, prisoners and the relevant prison authorities and members of the national defence force and their superiors; and
(b) is appropriate when research-related risks of harm are minimized, and appropriate consent procedures have been followed.