12 November 2025

pregnant woman and doctorA new Australian study has found that forms used for one of the most common genetic screening tests in pregnancy – costing prospective parents up to $550 – are often confusing and inconsistent, blurring the lines between medical consent and commercial marketing.

Non-invasive prenatal testing (NIPT) is a blood test that analyses fragments of fetal DNA circulating in a pregnant woman’s blood, detecting chromosomal conditions such as Down syndrome with higher accuracy than older prenatal screening tests.

However, in Australia it is not publicly funded, requiring prospective parents to access the test through commercial providers.

University of South Australia bioethicist Dr Hilary Bowman-Smart has led a study with researchers from Monash University and the University of Melbourne, analysing forms from seven major providers of NIPT.

The researchers found “significant variation” in how the forms are signed, worded and designed, raising questions about how informed consent is achieved in prenatal care, particularly when testing is provided on a user-pays basis.

“These forms are far from standardised,” says Dr Bowman-Smart.

“Some look like simple pathology request forms and others resemble consent documents or even marketing brochures. Many combine elements of all three.

“While most of the forms we analysed use words like ‘consent’ or ‘informed consent,’ they often fail to provide the essential information that parents need to make a decision in a way that’s easy to understand.”

The use of technical language, such as aneuploidy, microdeletions and karyotype is common, and key facts – including the possibility of false positives, test limitations, or incidental findings – are missing from many forms.

“Only half of the forms explained the difference between a screening test and a diagnostic test. It’s also important for expectant parents to know that NIPT can sometimes return false-positive results,” says Dr Bowman-Smart.

“That’s a major gap, given this information is critical to helping expectant parents understand what the test can and can’t tell them. This information might be conveyed verbally by clinicians, but it’s missing from these forms.”

The study found that patient and clinician signatures were often required, but the accompanying text explaining what was being signed for was frequently in tiny print.

Dr Bowman-Smart says the NIPT forms appear to serve multiple, sometimes conflicting functions – as medical records, administrative tools, and commercial contracts.

“Many forms include branded colours and logos, and some request credit card details or online payment confirmation, positioning the test as a consumer purchase rather than a medical procedure,”

“This commercial framing can shift the dynamic between clinician and patient. When a genetic test is marketed like a product, it risks making a deeply personal medical decision feel like a transaction.”

The authors are calling for clearer, standardised documentation and more emphasis on counselling that explores parents’ values and expectations.

“Written forms should support, not replace, conversations between clinicians and patients,” says Dr Bowman-Smart.

“As genetic testing becomes more complex, the human element – and the time and resources to allow clinicians and prospective parents to have meaningful conversations about their prenatal testing options – is more important than ever.”

‘The Function of Non-Invasive Prenatal Testing (NIPT) Request Forms in the Australian Context’ is published in Healthcare Analysis. DOI: 10.1007/s10728-025-00543-0

 

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Media contact: Candy Gibson M: +61 434 605 142 E: candy.gibson@unisa.edu.au
Researcher contact: Dr Hilary Bowman-Smart E: hilary.bowman-smart@unisa.edu.au

 

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