Failing the vulnerable: Three new consent norms that will undermine health research with children

Abstract

a legal framework for the regulation of the health system across the country. Within the Act, section 71 introduces a number of legal norms relating to research or experimentation with human subjects, including research on HIV prevention and treatment. These norms have been criticised for the negative impact they will have on research involving children. This article describes three of the new consent requirements in section 71 of the Act. It shows, using a range of case studies, how important HIV-related research will be halted or undermined if the current provisions are implemented. The article argues that the new consent requirements are out of step with other statutory provisions and ethical guidelines, and as a result they will exclude a large population group -children in diverse settings -from much-needed evidence-based healthcare interventions. The article concludes with a clarion call for support of advocacy on this issue with the Minister of Health and the Health Portfolio Committee.

A critical review of health research ethical guidelines regarding caregiver consent for HIV research involving minors in South Africa: Ethical and legal issues

“…If research institutions are required to comply with the letter of these regulations, child research in SA will effectively grind to a halt, and this will ultimately harm the population it purports to benefit. [31] Our study joins a body of literature [14,25,[28][29][30][31][32] in advocating for greater inclusivity of caregivers in HIV research practices; to promote responsive research with children, while recognising that these child participants require extra protection. HIV testing is a complex issue with important implications and consequences to the child being tested.…”

Child research in South Africa: How do the new regulations help?

“…The latter consent strategy has been criticised elsewhere as overly restrictive because other consent approaches endorsed by ethical guidelines are excluded. [4,7] …”

“…[4–7] The regulations do little to resolve the tension between the law and ethical guidelines in this regard, stating only that research with human participants should be undertaken with ‘appropriate consent processes’. This leaves RECs with an unresolved dilemma between obligations to approve research that they find to be ethical, as set out in section 73 of the NHA, and ensuring that research complies with the legal standards set out in section 71.…”

Enrolling HIV-positive adolescents in mental health research: A case study reflecting on legal and ethical complexities

“…[49] Excluding adolescent children from health research infringes on their constitutional rights to both basic healthcare and access to healthcare services. [50] Recommendations for mental health research with adolescents arising from this study…”