摘要：Objectives. We examined the process of obtaining “active,” written parental consent for a school-based HIV/AIDS prevention project in a South African high school by investigating (1) parental consent form return rates, (2) parents’ recall and knowledge of the research, and (3) the extent to which this consent procedure represented parents’ wishes about their child’s involvement in the research. Methods. This cross-sectional descriptive study comprised interviews with parents of children in grades eight and nine in a poor, periurban settlement in Cape Town. Results. Within 2 weeks, 94% of 258 parents responded to a letter requesting written consent and of those, 93% consented, but subsequent interviews showed that 65% remembered seeing the consent form. At the end of the interview, 99% consented to their child’s participation. Conclusions. These findings challenge many of the assumptions underlying active written parental consent. 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. More than 60% of the 39.4 million people living with HIV/AIDS live in sub-Saharan Africa. 1 In South Africa, 1500 new HIV infections occur daily, 60% of these in persons aged 15 to 25 years. 2 Adolescence, when sexual activity generally commences but behavior patterns are still malleable, is a critical time for HIV prevention. 3 , 4 Schools are particularly important for adolescent sexual behavior interventions, especially where health services are inaccessible. 4 Yet in sub-Saharan Africa, few school-based AIDS prevention programs exist, and even fewer have been evaluated using randomized, controlled designs. 4 Because adolescents may not legally consent to participate in research in South Africa, parental consent is needed. South African research ethics committees accept “passive” parental consent procedures. Parents/guardians are informed (usually by letter) about the nature of the research, their permission for their child’s participation is sought, they are alerted to their right to refuse this, and they are given directions for whom to contact if they should wish to do so. In the absence of such notification, it is assumed that consent has been given. In the United States, by contrast, “active” written parental consent for adolescents’ participation in research is required by the US Department of Health and Human Services, the US National Institutes of Health, and most ethics review boards. 5 The parents/guardians must be informed and must positively notify the school or researcher in writing that they permit their child to participate in the research, or else it is assumed that consent has been denied. In the United States and Canada, many parents fail to return consent forms, and so even though research shows that the overwhelming majority of “nonresponding” parents approved of their child’s participation, it is presumed that consent was denied. 6 – 8 Active consent procedures in school-based research on youths’ risk behaviors produce less representative samples and underrepresent minority and high-risk youths in the sample, in comparison with passive procedures. 9 , 10 The National Institutes of Health funds South African school-based HIV prevention research but requires active consent, so we have examined the process of obtaining active, written parental consent in the South African context. This research was undertaken in 2003 in a high school participating in a school-based HIV prevention controlled trial. We investigated (1) parental consent form return rates, (2) parents’ knowledge and recall of the research, and (3) the extent to which active, written parental consent represented parents’ wishes about their child’s involvement in the research.
