Ethical and legal challenges in enrolling adolescents in medical research in South Africa: implications for HIV vaccine trials

Strode, A.; Slack, C.; Grant, C.; Mushariwa, M.
May 2005
South African Journal of Science;May/Jun2005, Vol. 101 Issue 5/6, preceding p225
Academic Journal
IN THIS PAPER WE REVIEW LEGAL AND ETHICAL challenges to the enrolment of children in HIV vaccine trials, and discuss two main questions: 'When can children participate in research, such as HIV vaccine trials?' and 'Who can consent to child participation in such trials?' In examining the first question, we discuss the constitutional framework for research with children, and in particular the meaning of section 12(2)(c) of the South African Constitution. We submit that while there are no laws specifically prohibiting the enrolment of adolescents (provided that the research protects a child's constitutional rights and 'best interests', and is not against 'public policy'), there are challenges related to the absence of an objective standard in law for acceptable research-related risk for adolescents. We outline some ethical challenges to enrolment; namely, that ethical guidelines regarding what parents may consent to their children participating in are inconsistent, and that some guidelines take a restrictive stance, effectively precluding HIV vaccine trials with children. With regard to who can consent to child participation in such trials, we discuss current law, as well the new National Health Act. We explore possible inconsistencies between the Act and principles found in other children's law, as well as inconsistencies in current ethical guidelines, and the implications this may have for HIV vaccine research. Finally, we make recommendations for future work.


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