CPD Short: Informed consent in ultrasound - legal context and clinical Practice

By Dr Alexandra Drought, consultant ultrasonographer, obstetrics and gynaecology ultrasound, Chelsea and Westminster Hospital NHS Foundation Trust

Informed consent is fundamental to patient safety and autonomy. However, the financial and legal implications of failings in this area are significant.

NHS negligence claims linked to the informed consent process totalled £80.4 million between 2021 and 2022.  

For sonographers, the critical importance of this process was underscored by the 2019 legal case, ‘Mordel v Royal Berkshire NHS Foundation Trust’.

The following six principles outline the standard for obtaining informed consent prior to an ultrasound examination: 

1. Prior information: Patients should receive written or digital information regarding their ultrasound examination, provided in advance whenever possible. This allows sufficient time for patients to process the information and formulate questions they may wish to ask. 
2. Effective communication: The informed consent process begins with a dialogue. Sonographers must provide relevant information to patients with capacity, which includes the benefits, material risks and alternatives (including the option of not having an ultrasound examination). Capacity is defined as the patient’s ability to understand, retain and weigh the information provided. 
3. Identifying ‘material risks': A ‘material risk’ is one to which a reasonable person in the patient’s position – or the specific patient themselves – would likely attach significance. For example, a patient morally opposed to the termination of pregnancy may view the risk of detecting unexpected ultrasound findings on the fetus differently from another patient. The sonographer must be sensitive to these individual values.  
4. Autonomy and voluntariness: A robust informed consent process provides patients the space to reach choices aligned with their personal values and beliefs. Informed consent must be given voluntarily by patients, free from any pressure or coercion from sonographers. 
5. Verifying understanding: The informed consent process should conclude with the sonographer assessing the patient’s comprehension. Utilising open-ended questions allows the patient to confirm their decision and provide a final opportunity for clarification. The patient should be given time to ask any further potential questions. 
6. A continuous process: Consent is not a one-time event, but an ongoing continuous dialogue that might be shared between several healthcare professionals, for instance, radiologists, sonographers and midwives. Patients retain the right to withdraw consent at any stage. For instance, a patient may consent to a transvaginal scan but withdraw that consent immediately prior to probe insertion. In such cases, the sonographer must stop the examination and respect the patient’s final decision.   

Reflection prompts

1. Assessing personal communication styles: Reflecting on your last ultrasound session, how often did you use open-ended questions (e.g. “What is your understanding of why you are having this scan today? ") versus closed questions (e.g. “Are you happy to proceed?”).  How might changing your questioning style impact the depth of the dialogue required for informed consent?
2. Material risk: A patient’s unique background (cultural, religious or personal) might make a ‘standard’ risk more significant to them. How would you tailor your pre-scan discussion to identify those individual values?
3. Managing time pressures: In a high-pressure clinical environment with back-to-back ultrasound appointments, what strategies would you use, or could you implement, to ensure a patient does not feel coerced or rushed into a decision, particularly for intimate examinations like a transvaginal scan?
4. Consent as a continuous process: Think of a time when a patient became hesitant during an ultrasound examination.  Did you interpret this as a potential withdrawal of consent? Reflect on how you balanced the clinical need to complete the scan with the patient’s right to stop immediately and how you documented that interaction.

Further reading

1. Ainsworth, N., Hussain, M.I., Houten, R., Martin, A.P., Toh, S. Rao, C., St. John, E.R. (2023)  Informed consent failures: National Health Service Resolution data, BJS, 110, (8), pp. 993-995.
2. General Medical Council (GMC) (2020) Decision making and consent. Manchester: General Medical Council. Available at: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf
3. Health and Care Professions Council (HCPC) (2023) Consent and Confidentiality. London: Health and Care Professions Council.  Available from: https://www.hcpc-uk.org/standards/meeting-our-standards/confidentiality/guidance-on-confidentiality/consent-and-confidentiality/
4. Montgomery v Lanarkshire Health Board (2015) UKSC 11, AC1430. Available from: https://www.bailii.org/cgi-bin/format.cgi?doc=/uk/cases/UKSC/2015/11.html&query=(Montgomery)+AND+(v)+AND+(lanarkshire)
5. Mordel v Royal Berkshire NHS Foundation Trust. (2019)  EWHC 2591 (QB). Available from https://www.bailii.org/cgi-bin/format.cgi?doc=/ew/cases/EWHC/QB/2019/2591.html&query=(Mordel)
6. NHS Choices (2022) Consent to Treatment, National Health Service, UK.  Available from: https://www.nhs.uk/conditions/consent-to-treatment/
7. NHS Fetal Anomaly Screening Programme (NHS FASP) (2011) Consent Standards and Guidance. Exeter: NHS FASP
8. SCoR (2020) Obtaining consent: a clinical guideline for the diagnostic imaging and radiotherapy workforce.  London: Society and College of Radiographers.  Available from: https://www.sor.org/learning-advice/professional-body-guidance-and-publications/documents-and-publications/policy-guidance-document-library/obtaining-consent-a-clinical-guideline-for-the-dia 
9. SoR (2020) Consent for radiographers and sonographers.  London: Society and College of Radiographers.  Available from: https://www.sor.org/news/scor/consent-for-radiographers-and-sonographers.