South Africa: Written Parental Consent in School-Based HIV/AIDS Prevention Research

Adolescence is a critical time for HIV prevention, and schools are important venues for adolescent sexual behavior interventions, especially where health services are inaccessible, reported the authors. Yet in sub-Saharan Africa, few school-based HIV/AIDS prevention programs exist, and even fewer have been evaluated using randomized, controlled designs.

South Africa requires parental consent for adolescents to participate in research, but research ethics committees accept passive parental consent procedures. Passive consent involves sending parents/guardians a letter about the research, requesting permission for the child to participate, informing them of their right to refuse, and providing a contact if they wish to do so. In the absence of refusal notification, consent is assumed.

The United States, on the other hand, requires active written parental consent for adolescents' participation in research. Parents/guardians must be informed and must positively notify the school or researcher in writing that they permit the child to participate in the research. Otherwise, consent is assumed to be denied. Many parents fail to return consent forms, although research shows that a majority of non-responding parents approved of their child's participation. This leads to less representative samples and underrepresentation of minority and high-risk youths in comparison with passive procedures.

The National Institutes of Health funds South African school-based prevention research but requires active consent. In that context, the authors examined the process of obtaining active written parental consent for a school-based HIV/AIDS prevention program in a South African high school.

The research took place in 2003 in a high school participating in a school-based HIV prevention controlled trial. The authors investigated parental consent form return rates; parent's recall and knowledge of the research; and the extent to which active, written parental consent reflected parents' wishes about their child's involvement in the research.

The aim of the trial was to assess the impact of a story-telling and drama-based intervention for eighth- and ninth-grade students. The intervention took place in one school and another school served as a control. The parental consent investigation was confined to the intervention school. The intervention school was in a poor, periurban settlement in Southern Cape Peninsula, an area characterized by high unemployment rates, shack dwellings, and a high risk of HIV infection.

The cross-sectional descriptive study comprised interviews with 246 parents/guardians of the 258 children in grades eight and nine at the school. Within two weeks of all 258 students being given consent letters for their parents/guardians, students returned 243 (94 percent), of which 225 (93 percent) indicated parental consent and 18 (7 percent) parental refusal. Subsequent interviews showed that 65 percent remembered seeing the consent form. At the end of the interviews, 99 percent consented to their child's participation in the research.

"The current implicit gold standard of consent is active written consent by parents," the authors noted. "We believe that in South African school settings, this standard of consent, if widely applied, would artificially lower the proportion of parents who wish to have their child included in low-risk studies of educational and informational interventions. This applies to both non-responding and refusing parents: for both groups the vast majority of parents gave consent once fully informed."

"These findings challenge many of the assumptions underlying active written parental consent," the authors concluded. "However, they should not be used to deny adolescents at high risk of HIV infection the opportunity to participate in prevention trials. Rather, researchers together with the communities in which the research is undertaken need to decide on appropriate informed consent strategies."

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