Legal Aspects of Consent Alison Perry, Legal Officer Basildon and Thurrock University Hospitals NHS Foundation Trust | Nethermayne | Essex | SS16 5NL

Background The concept of consent for medical treatment necessitates a medical professional ensuring they have obtained agreement from a patient before undertaking any form of medical examination, investigation or operative treatment.1 Whatever the context in which medical decisions are made, you must work in partnership with your patients to ensure good care.2 In so doing, you must: listen to patients and respect their views about their health discuss with patients what their diagnosis, prognosis, treatment and care involve share with patients the information they want or need in order to make decisions maximise patients’ opportunities, and their ability, to make decisions for themselves respect patients’ decisions Respect and honesty must be at the core of a patient-centred healthcare system3 NB: All adult patients are presumed as having capacity to make a valid decision unless it is deemed under the Mental Capacity Act 2005 that the patient lacks capacity. 1 Department of Health, Reference Guide to Consent for Examination or Treatment, 2009 2 GMC “Good practice in making decisions” 3 Kennedy Report, 2001

Legal Implications Failure to obtain valid consent before undertaking treatment can result in allegations of: Battery or assault - leading to a criminal prosecution Breach of duty of care - leading to clinical negligence claim under civil law It is agreed in law that in the case of a medical emergency, treatment may be given without consent in the best interests of a patient.

Professional Implications Poor compliance with the codes of a professional body can contribute to; Complaints Inquests Professional conduct hearings – with the danger of losing a licence to practice Revalidation procedures It is essential to follow best practice in consent, the professional guidelines highlight a documented relationship with the patient. Only take consent for procedures you have undertaken yourself or have observed. (ref to GMC/ trust policy)

The Changing Medical Landscape of Consent #1 In recent years there have been significant rulings that have reflected a patient’s entitlement to be fully informed of the risks and benefits of treatment. ‘Montgomery v Lanarkshire Health Board’ [2015] Birth injury claim in which a diabetic patient, who had been advised her baby was expected to be larger than normal, had not been appropriately informed of the risks of shoulder dystocia. Consultant confirmed she had not advised the patient of the risks of shoulder dystocia, despite the patient voicing anxiety about the size of the baby. Consultant confirmed this was her usual practice. Her reasoning being that more women would request a LSCS, which may not have always been in the patient’s best interest and also would have had potential financial implications for the Trust.

The Changing Medical Landscape of Consent #2 Judgement was in the claimant’s favour and reflected that a doctor should not prevent their patient from making an informed decision. Rather it is their duty to explain why one option is medically preferable to the other, having taken care to ensure awareness of the considerations for and against each of them. This case profoundly influenced case law relating to the doctor/patient relationship. However it was not out of step with the professional standards set by the GMC over several decades promoting patient autonomy. Most importantly Montgomery imposed a further duty upon medical professionals to “tailor their disclosures according to the individual patient’s priorities and concerns”. Consideration must be given to the risks that will be of significance to that particular patient and discussed in detail.

The Courts response to Montgomery and beyond As anticipated further consideration and direction to this ruling has been explored by the Courts: ‘Webster v Burton Hospital’ [2017] Brain damaged baby case taken to the Court of Appeal in light of the Montgomery case. The test applied to the consent issues by the Court of Appeal were those tests of Montgomery: had the patient had the material risks explained that an objective reasonable person would attach significance to; and the particular patient would attach significance to. Consideration was taken of the evidence that the patient had been willing to take responsibility for her pregnancy and her education, which included a degree in nursing. The Judge concluded that she would have attached significance to the risks of delaying labour and would have requested an earlier delivery. During the consenting process, the relationship of a doctor and their patient needs to include a thorough understanding of a patient’s specific lifestyle, intellect and conduct.

‘Thefaut v Johnson’ [2017] Things to consider One aspect of this claim alleged the patient had not been properly advised of the risks of the surgery and that there was a failure to provide any pre-surgery advice on the option of not having any treatment. Judgement concluded that had the patient been properly advised of the risks she would have rejected the option of surgery or at least deferred to seek a second opinion. No longer accepted by courts in general terms that patients would have proceeded in any event. Things to consider A patient must be made aware of any alternative treatments, no treatment is an alternative and valid option.

Useful Guidance in Approaching Consent A signature on a consent form proves nothing, only that the patient can write their signature. Presenting or reading a pre-drafted or standard wording is not sufficient, genuine dialogue should be evidenced in the healthcare records. ‘If it isn’t written down, it didn’t happen’ Duty of disclosure: The objective test, what would a reasonable patient need and want to know Consider particular individual characteristics, age, intellect, job, family life, social issues The subjective test, modify disclosure to address the personal characteristics in this specific situation – consider a specific risk Discuss realistic and reasonable alternative treatments, risks and benefits Include an explanation involving the right to refuse all/any treatments and risk Use simple language, avoid jargon and check there is a real understanding Document the discussion James Badenoch QC, Bristol Patient Safety Conference 2017

Learning for Practitioners Do’s Always document discussions regarding consent, especially if a patient has advised they do not wish to be told about risks etc. Consider is there a compelling need to disclose a risk? Is it reasonable to delegate the task to a junior doctor or nurse. Ensure you are sufficiently informed and adequately trained. Treat each patient as an individual. Document, sign (stamp) and date. You are unlikely to recall 6+ weeks (complaint), 6+ months (inquest) or 3+ years (litigation) why you did something. Definite Do Not's Don’t use a lack of time as a reason for unsatisfactory dialogue. It must be overcome. It is a patient’s most basic and fundamental right to decide their treatment. Don’t exert undue pressure. If asked directly what your choice would be, ensure you use clinical reasoning. Don’t underestimate the importance of good communication. Ensure you equip yourself with the necessary skills to communicate effectively. Don’t shy away from open and frank disclosure in advance, including addressing any uncertainty of a successful outcome. It may prevent a patient’s anger, complaint or litigation when things do not turn out well if they understand the outcome may be a recognised complication.