Informed consent for Down’s syndrome screening: asking patients the right question
An NHS antenatal screening facility in England has been found liable in negligence for failing to carry out screening for Down’s syndrome which, if taken, would have led to a termination of the plaintiff’s pregnancy.
- Whether the sonographer discharged her duty to the plaintiff in terms of obtaining the plaintiff’s informed consent?
The plaintiff had immigrated to England from Poland in 2008. In 2014, she was pregnant with her first child, and attended her community midwife, who informed the plaintiff of the Down’s syndrome screening process available under the NHS. The plaintiff booked into all six of the standard first trimester screening tests. On 22 July 2014, the plaintiff attended the Royal Berkshire Hospital. The Court found that the sequence of events was as follows:
- The sonographer, having introduced herself, asked “Do you want the screening for Down’s syndrome?”
- The plaintiff said “No”.
- The sonographer said, “So we are not doing the screening then, we are just doing the dating scan and I will be checking the baby and making sure that the dates are correct.”
- The plaintiff did not respond.
- The plaintiff was asked to lie down on the table.
- The sonographer then clicked on the drop down box on the clinic’s system and selected “Down’s screening declined.”
In January 2015, the plaintiff’s son was born with Down’s syndrome.
The decision at trial
The plaintiff’s competence in the English language was a significant factor. It was held that “care needs to be taken in not assuming that because a person appears to be reasonably fluent in the English language that [their] comprehension will be at the same level.”
The trial judge held that it was the sonographer’s duty to satisfy herself that the plaintiff was consenting to the procedure, before it was undertaken on the basis of proper information, and that the plaintiff’s consent was informed. This required:
- Checking that there has been a discussion between the plaintiff and the midwife regarding the nature and extent of the testing;
- Checking that the patient had been supplied with the NHS information booklet on the offered testing; and
- Ascertaining by brief questioning that the plaintiff understood the essential elements and purposes of scanning for Down’s syndrome.
In finding the clinic negligent, the sonographer’s simple question “Do you want the screening for Down’s syndrome?” was held to be inadequate in all the circumstances because there remained an unacceptable risk that a patient perplexed by the question would not be properly informed. The trial judge found that the plaintiff had failed to understand the question and that her unreflective response was to say “no”. Further, when she received no response from the plaintiff, the sonographer should have queried whether the plaintiff understood the question and its implications.
Implications for you
This decision is a timely reminder that establishing informed consent requires open-ended questions to avoid the risk that consent is not properly informed.
For example, rather than asking “Do you want the screening for Down’s syndrome?” the Court’s preferred wording was:
“I understand you have come today for me to measure the thickness on the back of the baby’s neck to enable me to alter your age-related risk for Down’s syndrome: is that correct?”
The decision highlights the importance of health care providers ensuring that their system takes into account that patients will naturally vary in terms of their ability, knowledge and capacity to understand, and that clinicians must be wary of their patient’s limitations in establishing informed consent.