A new Australian study is raising questions about how informed consent is achieved in prenatal care, finding that forms used for non-invasive prenatal testing (NIPT) are often confusing, inconsistent and blur the lines between medical consent and commercial marketing.
About NIPT
NIPT is a common blood test that analyses fragments of foetal DNA circulating in a pregnant woman’s blood.
The test detects chromosomal conditions such as Down syndrome with higher accuracy than older prenatal screening tests.
While it’s widely used, NIPT in Australia isn’t publicly funded and can cost expectant parents up to $550 through private providers.
The study
Led by University of South Australia bioethicist Dr Hilary Bowman-Smart, the study – conducted with researchers from Monash University and the University of Melbourne – analysed NIPT request forms from 7 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,” 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 3.
“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 often 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 that 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,” says Dr Bowman-Smart.
“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.”
Clear, standardised documentation needed
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.”
