Changes to the law on consent in South Africa: implications for school-based adolescent sexual and reproductive health research

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

Deformation analysis of a metropolis from C- to X-band PSI: proof-of-concept with Cosmo-Skymed over Rome, Italy

Stability of monuments and subsidence of residential quarters in Rome (Italy) are depicted based on geospatial analysis of more than 310,000 Persistent Scatterers (PS) obtained from Stanford Method for Persistent Scatterers (StaMPS) processing of 32 COSMO-SkyMed 3m-resolution HH StripMap ascending mode scenes acquired between 21 March 2011 and 10 June 2013. COSMO-SkyMed PS densities and associated displacement velocities are compared with almost 20 years of historical C-band ERS- 1/2, ENVISAT and RADARSAT-1/2 imagery. Accounting for differences in image processing algorithms and satellite acquisition geometries, we assess the feasibility of ground motion monitoring in big cities and metropolitan areas by coupling newly acquired and legacy SAR in full time series. Limitations and operational benefits of the transition from medium resolution C-band to high resolution X-band PS data are discussed, alongside the potential impact on the management of expanding urban environments

Assessing children's competence to consent in research by a standardized tool: a validity study

Contains fulltext : 109814.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children's competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents.Methods/designIn this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130--190 subjects, providing a minimum of 10--15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. DISCUSSION: A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children's competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies