Following a recent medicolegal case, Mordel v Royal Berkshire NHS Foundation Trust, and questions raised by SCoR members and members of the public, it would be an opportune time to review some of the guidance on consent for medical imaging procedures and treatment.
This summary provides a basic overview of consent for medical imaging and therapy and links to some relevant resources. It should be read in conjunction with the SCoR (2018) guidelines, Obtaining consent: a clinical guideline for the diagnostic imaging and radiotherapy workforce.
What is consent?
Consent is when a patient gives their permission to receive treatment or an imaging investigation or test.
Why is consent important?
As registered health care professionals, radiographers should ensure that they meet the Health and Care Professions Council (HCPC) standards of conduct, performance and ethics by making sure that they “have consent from service users or other appropriate authority before you provide care, treatment or other services” and “must give service users and carers the information they want or need, in a way they can understand.”
Performing an investigation, treatment, or even touching a patient without valid consent, could lead to the health care professional being subjected to a complaint or even potentially accused of negligence or assault and reported to the regulatory body.
In addition to the professional duty, consent is important to enable patient autonomy in the decision making process and promotes values-based practice. Radiographers should support patients during the consent process, working in partnership to “empower them to make decisions about their care and treatment”.
A medico-legal case in 2019 highlighted that “reasonable steps” should be taken to ensure valid, informed consent and the person undertaking the examination has a “duty to satisfy herself that the patient is consenting to the procedure”. Current best practice evidence should be used when discussing the various options with patients.
How do you gain valid informed consent?
SCoR guidelines state that “for a patient to give valid informed consent, they should be in possession of all the information they require to make a decision and should be able to do so voluntarily, without pressure from
external influences”. The RCN (2017) suggest that for consent to be valid it should be given “by an appropriately informed person who has the capacity to consent to the intervention in question”.
Patients must be provided with enough information to make an informed decision about their care, Montgomery (Appellant) v Lanarkshire Health Board (Respondent). This should be provided in advance of the investigation, treatment or test,where possible, and time should be available for the patient to ask questions or clarify any concerns they may have.
Information should be clear and presented in a way that can be understood. It should include the following information:
Sufficient information will vary for each patient and depend on their needs and level of understanding. Information should be tailored to the individual.
It is also important to remember that consent is not a one-off event; it is an on-going process. The consent process should continue throughout the test or treatment period and patients can withdraw consent at
any time. It is good practice to ensure that patients are happy with their decision and have opportunities to ask for further information, if required, to make informed judgements.
What does ‘capacity to consent’ mean?
Capacity means the person has the ability to understand the information being given, ie the details of the procedure, the risks, benefits, and implications of not having the procedure or test.
If someone can understand the information, they can elect to have or to refuse a test or treatment, and that wish should be respected by the health care professionals. For adults with capacity to consent, no one else can make the decision for them, unless there is ‘special legal provision’. Capacity can also fluctuate, particularly in some conditions which affect the ability to retain information, such as dementia. If someone lacks capacity to consent, you will need to ensure that you follow local processes for making decisions in the best interests of the patient. These will be linked to current legislation. A health care professional should not undertake an examination without consent, unless the appropriate processes have been followed, and this should be documented in the imaging report or patient notes. Children can consent to treatment or investigations if they have the capacity to consent, also known as ‘Gillick competence’, and the treatment is in their bestinterests.
If the child’s decision was to refuse treatment that would otherwise be in their best interest, their guardian or a court can overrule this in some situations. If a child lacks capacity to consent, a person with parental responsibility or the court can make decisions relating to their treatment, if it is in the best interests of the child. Further guidance can be found in the SCoR (2018) document Obtaining consent: a clinical guideline for the diagnostic imaging and radiotherapy workforce.
What needs to be included in consent for screening tests?
The health care professional undertaking the screening test should ensure that the patient has been provided with information about the screening test, understands what the screening test is for, and the nature of a screening test.
Screening is only ever going to provide patients with a chance of having the screened condition, eg breast cancer, a fetus with trisomy. Understanding risk can be difficult for patients. There will always be false positives and false negatives and the healthcare professional undertaking the examination needs to ensure that patients are aware of this, along with the interpretation of chance, to help their decision making.
In obstetric screening, some women will decline first trimester screening for trisomies. Their decision should be respected, however it is important to ensure fhey fully understand what they are consenting to if they attend for the second trimester fetal anomaly screening scan, because this can also detect signs that might link to trisomy and offers of further investigations.
Valid, informed consent is at the heart of any examination or treatment within the healthcare setting. “Seeking and giving of consent is usually a process, rather than a one-off event”.
Information should be provided in advance wherever possible, allowing patients time to assimilate the information and ask questions.
When the examination is due to take place, the person performing the examination should check patient understanding and ask if they have further questions before the examination commences.
There are a number of relevant documents and guidelines relating to consent for treatment, which. can be read in association with the. SCoR (2018) document.These include, but are not limited to the
• Department of Health (2009) Reference guide to consent for examination or treatment Second edition
• General Medical Council (2008) Consent: patients and doctors making decisions together
• Health and Care Professions Council (2016) Standards of conduct, performance and ethics.
• NHS (2019) Consent to treatment
• Royal College of Radiologists (2012) Standards for patient consent particular to radiology, Second edition.
• Royal College of Surgeons(2018) Consent: Supported Decision-Making.