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

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances

HIV vaccine research - South Africa\'s ethical-legal framework and its ability to promote the welfare of trial participants

No abstract. South African Medical Journal Vol. 95 (8) 2005: 598-60

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

A letter providing updated information on an orginal article published in 2010

Walking the tightrope : creating an ethical-legal framework for health research with children : balancing child protection and participation with the facilitation of appropriate health research.

Ph. D.  University of KwaZulu-Natal, Pietermaritzburg  2013.Abstract not available

How well does South Africa's National Health A.ct regulate research involving children?

Currently there are no laws in South Africa regulating the rights of research participants. The National  Health Act is the first attempt by the legislature to use the law to protect research participants, including children. This article describes the strengths and limitations of the provisions, implications for  researchers and research ethics committees, and makes recommendations. Strengths of the Section include that it enables the Minister of Health to issue regulations detailing protections for research participants, it supplements existing law on consent, it introduces the concept of the 'best interests' of the child and it creates procedural safeguards. Limitations of the Section include that it does not set an independent age for consent to research, it focuses on informed consent and not other protections, it is inconsistent with existing or draft legislation and ethical guidelines, and it retains the contested  distinction between 'therapeutic' and 'non-therapeutic' research. Poor drafting and inconsistencies also impede interpretation. The implications for researchers are that it facilitates socalled 'non-therapeutic' research on children. However, procedural burdens for obtaining consent are created. Research Ethics Committees (RECs) will have to work with the 'therapeutic' and 'non-therapeutic' distinction as well as new concepts such as 'best interests' of the child, and ensure that consent procedures comply with the Act. We conclude that while the Act is an important development in the law, it is flawed in places. We recommend that amendments be made and that capacity development be provided to stakeholders

Implications of the ethical-legal framework for adolescent HIV vaccine trials – report of a consultative forum

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants

Sex, lies and disclosures: Researchers and the reporting of under-age sex

Children are a vulnerable group and require legal protection due to their youth and inexperience. Resultantly, various provisions in the law ensure the care and protection of children through mechanisms such as the mandatory reporting of abuse. A recent change in the law has broadened the mandatory reporting obligations by requiring any person who is aware of a sexual offence having been committed against a child to report this to the police. Given that it is a sexual offence to have sex below the age of 16 researchers involved in research with teenagers in which they may become aware that that they are engaging in sex or sexual activity but are under the age4 of 16 will be obliged to inform the police of this fact. The issue of reporting under-age sex is very complex as in our view there are various categories of under-age sex. We argue that researchers should not comply with the mandatory reporting obligations for underage consensual, non-exploitative sexual activity but in all other cases there should be reporting. We argue that because the mandatory reporting of underage sex/ activity (even consensual and non-exploitative activity) may alienate children from services and “punish” them by reporting their conduct to the police, advocacy is needed for a change to the Sexual Offences Act to ensure consistency with the approach taken in the Children’s Act which enables such children to access sexual and reproductive services.

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

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