South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
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Historical Article
The research ethics evolution: from Nuremberg to Helsinki.
Health research sets out to acquire not only theoretical knowledge but also benefits for many people and often society as a whole, and is therefore justified. The quandary, though, is how such an important, shared purpose can be pursued with full protection of individuals and communities, in particular those with vulnerabilities. ⋯ When read together, the Nuremberg Code and the Universal Declaration of Human Rights can be interpreted as establishing a basis for underpinning the principles of free and informed consent and avoiding harms and exploitation in scientific experiments involving human participants. The Declaration of Helsinki has been recognised as one of the most authoritative statements on ethical standards for human research in the world.
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Worldwide, South Africa (SA) has the worst tuberculosis (TB) epidemic. In SA, there are > 6.1 million people living with HIV (PLWH) and the country now has the largest antiretroviral treatment programme with > 2 million people receiving combination therapy. While there has been a marked recent decline in HIV-associated deaths, > 50% of TB cases still continue to be diagnosed in PWLH. ⋯ SA has implemented the World Health Organization policy and IPT is now recommended for HIV-positive people for up to 36 months. Originally, there was only one SA study included in the evidence base supporting this policy, but subsequently four randomised controlled trials have been conducted in SA populations. These studies, together with local observational studies, are the subject of this local, evidence-based review.
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While clinical disease caused by drug-sensitive Mycobacterium tuberculosis (MTB) can usually be treated successfully, clinical disease caused by drug-insensitive MTB is associated with a poorer prognosis. In December 2012, a new drug, bedaquiline, was approved by the US Food and Drug Administration. This article documents the process whereby the National Department of Health, Right to Care and Médecins Sans Frontières obtained access to this medication for South Africans who might benefit from subsequent implementation of the Clinical Access to Bedaquiline Programme.
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Monitoring the prevention of mother-to-child transmission (PMTCT) programme to identify gaps for early intervention is essential as South Africa progresses from prevention to elimination of HIV infection in children. Early infant diagnosis (EID) by an HIV polymerase chain reaction (PCR) test is recommended at 6 weeks of age for all HIV-exposed infants. The National Health Laboratory Service (NHLS) performs the PCR tests for the public health sector and stores test data in a corporate data warehouse (CDW). ⋯ Laboratory data can provide real time, affordable monitoring of aspects of the PMTCT programme and assist in achieving virtual elimination of paediatric HIV infection in South Africa.
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The use of natural gas that is obtained from high-volume hydraulic fracturing (fracking) may reduce carbon emissions relative to the use of coal and have substantial economic benefits for South Africa. However, concerns have been raised regarding the health and environmental impacts. The drilling and fracking processes use hundreds of chemicals as well as silica sand. ⋯ These substances can enter the environment in various ways: through failures in the well casing; via alternative underground pathways; as wastewater, spills and leaks on the wellpad; through transportation accidents; and as air pollution. Although many of these chemicals and elements have known adverse health effects, there is little evidence available on the health impacts of fracking. These health concerns have not yet been fully addressed in policy making, and the authors recommend that the voice of health professionals should be part of the public debate on fracking and that a full health impact assessment be required before companies are given the go-ahead to drill.