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Developing a simple test to identify swiftly neonates with sepsis who carry the genetic variant which means that one dose of the recommended antibiotic, gentamicin, will cause the child to become profoundly deaf looks like an admirable objective. The baby needs antibiotics and needs them within 1 hour of admission to the neonatal intensive care unit (NICU). Conventional genetic tests take much longer to yield results. The test being trialled produces results in 25 min; a baby who carries the variant can be treated with a different antibiotic. All the test requires is a gentle swab of the baby’s inner cheek. Babies can be treated for potentially fatal sepsis without the risk that the drugs designed to save their lives will cost them their hearing. Parents and healthcare staff are relieved of worry—a great idea?
PALOH is not a trial of the safety or efficacy of the test, only to assess how feasible it will be to carry out this test in a busy NICU, without disrupting the care of the baby. A tiny painless ‘scrape’ will take a sample of DNA—what’s the fuss about? Several other invasive and painful procedures will be carried out without a fuss.1 The problem is DNA. Genetic information must be safeguarded from falling into the wrong hands. In section 45 of Human Tissue Act 2004 (HTA), Parliament legislated to prohibit non-consensual DNA testing.1 It fits uncomfortably in a statute designed to regulate retention and uses of human material, after revelations that organs and tissue from the …
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
↵Section 45 is one of only two sections of the Act extending to Scotland.
↵Human Tissue Act 2004 (ethical approval, exceptions from licensing and supply of information about transplants) Regulations 2006: para 2.