389 research outputs found

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

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    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

    Scaling up HIV testing in resourceconstrained settings: Debates on the role of VCT and Routine ‘Opt-in or Opt-out\' HIV Testing

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    Scaling up of the numbers of people voluntarily undergoing HIV testing has become vital, especially in resource-constrained settings, where the need for knowledge of HIV status for both prevention and care is critical. The reality is that for most people in Africa, access to HIV testing and to voluntary counselling and testing (VCT) has been very limited, and this has human rights implications – missing the opportunity to be diagnosed with a disease that is now well understood, manageable and treatable means certain death. The key challenge in our current context is how scaling up of HIV testing should be done. In responding to this challenge, we are guided by Gruskin and Loff,1 who state that ‘A human rights approach mandates that any public strategy, whether or not rights are to be restricted, be informed by evidence and widely debated. This approach protects against unproved and potentially counterproductive strategies, even those motivated by the genuine despair in the face of overwhelming public health challenges.\' This article describes the arguments and discussion raised during a session on models for increasing access to HIV testing at the 2nd National Conference on HIV/AIDS held in Durban in June 2005. It describes the legal framework for HIV testing in South Africa, frames the issues at the heart of the debate, and describes and discusses the various models of HIV testing, routine HIV testing, VCT and mandatory or compulsory HIV testing, within the context of HIV prevention and care. It concludes with recommendations. Southern African Journal of HIV Medicine Vol. 6 (3) 2005: pp. 45-4

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

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    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

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    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

    Falling through the gaps: how should HIV programmes respond to families that persistently deny treatment to children?

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    INTRODUCTION: Children living with HIV rely on adult caregivers for access to HIV testing and care, including clinical monitoring and adherence to treatment. Yet, many caregivers confront barriers to ensuring children's care, including fear of disclosure of the child's or the parents' HIV status, competing family demands, fluctuating care arrangements and broader structural factors such as entrenched poverty or alternative beliefs about HIV's aetiology and treatment. Thus, many children are "falling through the gaps" because their access to testing and care is mediated by guardians who appear unable or unwilling to facilitate it. These children are likely to suffer treatment failure or death due to their caregivers' recalcitrance. DISCUSSION: This Commentary presents three cases from paediatric HIV services in Zimbabwe that highlight the complexities facing health care providers in providing HIV testing and care to children, and discusses the implications as a child's rights issue requiring both legal and programmatic responses. The cases provide examples of how disagreements between family members about appropriate care, conflicts between a child and caregiver and religious objections to medical treatment interrupt children's engagement with HIV services. In all three cases, no social or legal mechanisms were in place for health staff to intervene and prevent "loss to follow up." CONCLUSIONS: We suggest that conceptualizing this as a child's rights issue may be a useful way to raise the debate and move towards improved treatment access. Our cases reflect policy failure to facilitate access to children's HIV testing and treatment, and are likely to be similar across international settings. We propose sharing experiences and encouraging dialogue between health practitioners and global advocates for children's right to health to raise awareness that children are the bearers of rights even if they lack legal capacity, and that the failure of either the state or their caregiver to facilitate access to care is in fact a rights violation

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

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    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

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

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    The South African National Health Act (No. 61 of 2003) provides 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

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

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    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

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

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    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
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