Child consent in South African law: Implications for researchers, service providers and policy-makers

Children under 18 are legal minors who, in South African law, are not fully capable of acting independently without assistance from parents/legal guardians. However, in recognition of the evolving capacity of children, there are exceptional circumstances where the law has granted minorsthe capacity to act independently. We describe legal norms for child consent to health-related interventions in South Africa, and argue that the South African Parliament has taken an inconsistent approach to: the capacity of children to consent; the persons able to consent when children do not have capacity; and restrictions on the autonomy of children or theirproxies to consent. In addition, the rationale for the differing age limitations, capacity requirements and public policy restrictions has not been specified. These inconsistencies make it difficult for stakeholders interacting with children to ensure that they act lawfully

Compensation for research-related injury in South Africa: A critique of the good clinical practice (GCP) guidelines

This article examines the current South African Department of Health Good Clinical Practice (2006) guideline recommendations regarding compensation for harm incurred in clinical trials. It applies the case of a phase IIb HIV vaccine trial in South Africa, for which enrolments and vaccinations were suspended early, based on data from an international companion study that indicated no evidence of efficacy and greater susceptibility to HIV infection in a subgroup of vaccinees. The case application indicates certain substantive and procedural limitations within the South African Department of Health Good Clinical Practice (2006) guideline recommendations on compensation for harm, which should be re-considered in order to improve protections for trial participants

Reporting underage consensual sex after the Teddy Bear case: A different perspective

Doctors and researchers face a complex dilemma regarding the mandatory reporting of consensual underage sex, because of contradictions between the Children’s Act and the Sexual Offences Act. When providing underage children with sexual and reproductive health services, they have had to decide whether to provide these confidentially, in terms of the Children’s Act, or thereafter report the consensual but illegal sexual behaviour to the police, in terms of the Sexual Offences Act. The recent Teddy Bear Clinic for Abused Children, and Resources Aimed at the Prevention of Child Abuse and Neglect (RAPCAN) v. Minister of Justice and Constitutional Development case addressed whether consensual underage sex ought to be a criminal offence and thus reported. The court held that aspects of sections 15 and 16 of the Sexual Offences Act infringed on the constitutional rights of adolescents (aged 12 - 15 years) by proscribing many consensual sexual activities. McQuoid-Mason has described this case in detail. He submits that following the judgement, doctors are no longer under a reporting obligation in relation to consensual underage sex. We respectfully disagree. This article critiques McQuoid-Mason’s approach, sets out our views on the mandatory reporting obligations after the Teddy Bear case and concludes with some comments on the judgement’s implications for researchers and medical practitioners

Identifying permethrin resistance loci in malaria vectors by genetic mapping

Identification of the major loci responsible for insecticide resistance in malaria vectors would aid the development andimplementation of effective resistance management strategies, which are urgently needed to tackle the growing threat posedby resistance to the limited insecticides available for malaria control. Genome-wide association studies in the major malariavector, Anopheles gambiae, have been hindered by the high degree of within-population structuring and very low levels oflinkage disequilibrium hence we revisited the use of quantitative trait loci (QTL) mapping to study resistance phenotypesin this vector species. Earlier work, identified two major QTL associated with pyrethroid resistance in A. gambiae s.s. fromEast Africa using genetic crossing of laboratory-colonized resistant and susceptible strains. In this study, we report theresults from genetic mapping of pyrethroid resistance in three isofemale pedigrees established from wild-caught femaleA. gambiae s.s. mosquitoes from Benin. We identified two QTL on chromosomes 2L and 3R in these field populations, insimilar genomic locations to theQTLidentified in laboratory strains. The relative merits of two alternative study designs arediscussed and suggestions made for future genetic mapping studies of insecticide resistance in mosquitoes

Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa

With millions of adolescents becoming infected with HIV globally, it is essential that barriers to much-needed interventions are reduced for at-risk adolescents. In this article we review the legal and policy framework in South Africa for adolescent access to male circumcision. We are of the view that the framework does confer protection for adolescent boys while enabling access to male circumcision; however, we identify ambiguities and tensions that exist between the Children’s Act, regulations and national guidelines. We recommend reform to further enable access by this vulnerable group to this prevention modality

Mandatory reporting obligations within the context of health research: Grappling with some of the ethical-legal complexities

Mandatory reporting of various forms of abuse, from violence to corruption, is an attempt by the state to intervene in circumstances where there is a public or a private interest that ought to be protected. This intrusion of the state into what is often a very personal space, such as the home, is largely justified on the basis of the need to provide protection to prevent further harm, and in services to vulnerable populations such as children, the disabled or the elderly. In some instances, researchers and other members of the study team may encounter reportable information requiring the consideration of mandatory reporting in the design, implementation and review of health research. This is not simple. There are complex and competing interests at play, particularly as there are differing approaches in law and ethical guidelines. This article aims to describe the mandatory reporting obligations in South African law, discussing the ways in which these provisions apply within the context of health research, and to propose some factors that could be used to determine whether it is ethical or not to report information

One step forward, two steps back – requiring ministerial approval for all ‘non-therapeutic\' health research involving minors

The new National Health Act has clarified that children may take part in ‘non-therapeutic\' research (NTR) and the age at which they may provide independent consent to such research, viz. at legal majority. However, the Act will require consent from the Minister of Health for all research classed as NTR and involving minors regardless of the level of risk. This requirement is overly broad. It will require that low-risk research without direct benefits, which might be adequately reviewed by an accredited research ethics committee (REC), must also be reviewed by the Minister. As it currently stands this requirement serves no plausible ethical purpose, will cause delays and discourage essential research on the needs of children, and may inspire researchers and RECs alike to ‘foil the system\'. We argue that in the long term there should be comprehensive law reform for child research. However, in the short term, amendments should be made to the Act to narrow the scope of this provision. The amendment should require ministerial consent for research that is currently not approvable by an REC in terms of national ethical guidelines, namely, research that does not hold out direct benefit but presents more than a minor increase over minimal risk. If our law reform recommendations are rejected, we favour the delegation of this task to RECs because, if they receive appropriate training, they should be competent to conduct it. We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.South African Medical Journal Vol. 97 (2) 2007: pp.200-202

Obtaining informed consent for a sterilisation in the light of recent case law

The need to obtain informed consent prior to any sterilisation is a very well-established ethical and legal obligation. South African law, however, does not specifically state who is responsible for obtaining informed consent before performing a sterilisation. This has implications for the liability of a surgeon or gynaecologist in circumstances where the informed consent is defective. Due to the vagueness of the applicable law, a surgeon or gynaecologist might be held liable, even in situations where he/she did not obtain the consent and relied on a nurse or assistant to procure the relevant informed consent. This article explores the relevant statutory law and canvasses two legal cases that came before the court regarding defective informed consent and the resultant liability for damages. We also make recommendations for proposed amendments to the current law to provide further clarity