Forms for a common genetic screening test often blur the lines between commercial marketing and medical consent, a new study has found.
The authors are calling for clearer, standardised documentation and more emphasis on counselling that explores parents’ values and expectations.
The non-invasive prenatal testing (NIPT) is a blood test that analyses fragments of fetal DNA circulating in a pregnant woman’s blood.
It detects chromosomal conditions such as Down syndrome with higher accuracy than older prenatal screening tests.
But it is not publicly funded, requiring prospective parents to access the test through commercial providers and costing up to $550.
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 NIPT providers.
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,” Dr Bowman-Smart said.
“Some look like simple pathology request forms, and others resemble consent documents or even marketing brochures.
“Many combine elements of all three.”
She said that most forms used words like ‘informed consent’ but often failed “to provide the essential information that parents need to make a decision in a way that’s easy to understand.”
The study found the use of technical language – such as aneuploidy, microdeletions and karyotype – is common.
But 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,” Dr Bowman-Smart said.
“It’s also important for expectant parents to know that NIPT can sometimes return false-positive results.
“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.”
Dr Bowman-Smart said the NIPT forms appeared 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,” she said.
“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.”
Dr Bowman-Smart said written forms should support, not replace, conversations between clinicians and patients.
“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,” she said.
