Suchergebnisse

Active parental consent is a requirement that may threaten the validity of including minors in research. This study investigated possible sources of bias between the responses of children whose parents actively consented to their participation in a school-based survey and those of children whose parents were nonresponders. Due to a serious administrative error in a study to examine health-related quality of life (HRQoL), all 514 eligible schoolchildren were tested, although only 177 parents signed consent. After deliberation, the relevant human research ethics committee gave permission to include all results in the analysis. The HRQoL was not different between the groups. Male children returned significantly fewer consent forms (p=.026). More of the nonresponding group reported that their parents "Never had enough time for them" (p=.023). The high nonresponse rate and associations between response and parental interest and gender indicate that some bias may be introduced through the need for active consent, but overall there were no differences in responses to the quality of life questionnaire.

BACKGROUND:The National Health Act, No 61, 2003 in South Africa is the first effort made by the government to protect health-related research participants under law. Implemented on March 1, 2012, the law mandates active consent from a parent or legal guardian for all research conducted with research participants under the age of 18 years. This paper focuses on the Act's implications for school-based adolescent sexual and reproductive health research.DISCUSSION:Although well intentioned, the added legal protections in the National Health Act may have the unintended consequence of reducing participation rates in school-based adolescent sexual and reproductive health research, thereby excluding the most at-risk students. The Act may also compromise adolescents' right to dignity and privacy, especially considering the personal nature of research on sex and sexuality. Devolved, discretionary decision-making, which empowers local human research ethics committees to permit a wider range of protective measures, including passive consent, independent adolescent consent or community consultation ought to be considered. The continued and direct involvement of young people in their sexual and reproductive health and well-being is an important principle to uphold.SUMMARY:This paper calls for a re-examination of section 71's ethical guidelines relating to informed consent in the National Health Act, No 61, 2003 in South Africa in order to better serve the interests of South African adolescents in sexual and reproductive health research.