National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Research with Human Participants4. 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. |