AEGiS-15IAC: The participation of children in HIV preventive vaccine trials in South Africa.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

The participation of children in HIV preventive vaccine trials in South Africa.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrC1249)

Slack CM, Strode A, Lindegger G, Milford C, Stobie M, Manegold J; University of KwaZulu-Natal, South African AIDS Vaccine Initiative, Pietermaritzburg, South Africa

ISSUES: The participation of children in HIV preventive vaccine trials poses complex ethical and legal challenges.

DESCRIPTION: In South Africa, HIV vaccine trials are currently focusing on adults who can give independent consent for participation. However the enrollment of children must be considered because of the need to develop safe and effective preventive vaccines to combat a burgeoning epidemic in this group. An ethics research and training group, the HIV AIDS Vaccines Ethics Group, was funded by the South African AIDS Vaccine Initiative to undertake consensus-building and research activities on the complex issue of child participation in trials.

LESSONS LEARNED: This paper presents outcomes of a consultative stakeholder meeting held in August 2003, to raise awareness of constraining and enabling aspects of the ethical-legal framework and to debate ethical complexities. Outcomes included the need to amend certain ethical guidelines, increase communication between investigators and regulators, and begin socio-behavioural research. It also presents results of conceptual research into the current ethical-legal framework, including a critique of the current restrictive stance of Medical Research Council general ethical guidelines regarding the scope of research for which parents may give consent (currently restricted to "observation research" of "negligible risk"). It also presents an audit into laws that may impact on investigator duties in the event of child disclosures of high-risk sexual activity and HIV status during HIV vaccine trials.

RECOMMENDATIONS: It is recommended that Medical Research Guidelines for HIV vaccine trials in South Africa, currently under development, are drafted to reflect a balance between protecting children from research-related risks and promoting critical research. Continued consensus-building activities are necessary among relevant stakeholders (including representatives of participating communities) to document their ongoing concerns, and anticipate rigorous methods to protect the welfare of child participants.

Keywords: AEGIS, HIV, Acquired Immunodeficiency Syndrome, HIV Seropositivity, AIDS Vaccines, HIV Infections, Evaluation Studies, Research Subjects, Research, Clinical Trials, HIV Seronegativity, HIV Seroprevalence, South Africa, Child, Humans, Adult, Ethics, immunology, organization & administration, methods

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