Consent
Consent is a fundamental ethical and legal requirement in healthcare, requiring that patients are provided with sufficient information to make voluntary, informed decisions about their treatment, rooted in the principle of autonomy and upheld by the Montgomery ruling.
Key Facts
Valid consent requires three elements: the patient must be informed, have capacity, and consent must be given voluntarily Montgomery v Lanarkshire (2015): landmark Supreme Court ruling establishing duty to inform patients of material risks — risks a reasonable patient would attach significance to Implied consent (e.g. rolling up sleeve for blood test) is acceptable for minor procedures; explicit consent (verbal or written) required for significant interventions Written consent is a record of the process, not consent itself; the discussion is what constitutes consent Consent is a process, not a one-off event; can be withdrawn at any time Children: Gillick competence (Fraser guidelines) allows children <16 to consent if they demonstrate sufficient understanding Adults lacking capacity: treat in their best interests under the Mental Capacity Act 2005 GMC guidance: Good Medical Practice and Consent: patients and doctors making decisions together
Overview
Key Facts
Consent is both an ethical obligation (respect for autonomy) and a legal requirement. Treating a competent patient without valid consent constitutes battery (trespass to the person) in law. The standard of disclosure shifted from doctor-centred (Bolam) to patient-centred (Montgomery) with the 2015 Supreme Court ruling.
Legal Framework
- Common law: consent is required for any touching; absence constitutes battery
- Montgomery v Lanarkshire (2015): doctors must inform patients of material risks that a reasonable person in the patient's position would want to know
- Bolam test (1957): historically, disclosure judged by what a responsible body of doctors would disclose — now largely superseded by Montgomery for consent
- Mental Capacity Act 2005: framework for decision-making for adults lacking capacity
- Children Act 1989: parental responsibility and children's rights
Ethical Principles
- Autonomy: respect for the patient's right to make their own decisions
- Beneficence: acting in the patient's best interest
- Non-maleficence: avoiding harm
- Justice: fair distribution of resources
- Consent operationalises the principle of autonomy
Types of Consent
- Implied: patient's actions indicate agreement (e.g. presenting arm for venepuncture)
- Verbal (express): spoken agreement; appropriate for many treatments
- Written: documented agreement; standard for surgical/invasive procedures; evidence of consent process
- Advance consent: consent given in advance for future treatment
- Broad consent: consent for a category of interventions (e.g. research biobank)
Clinical Presentation
Elements of Valid Consent
- Information: nature and purpose of treatment, material risks and benefits, alternatives (including no treatment), expected outcomes
- Capacity: patient can understand, retain, weigh information, and communicate decision
- Voluntariness: free from coercion, undue influence, or pressure
Montgomery Standard of Disclosure
- Disclose material risks: risks that a reasonable person in the patient's position would attach significance to
- Also disclose risks that this particular patient would consider significant (subjective element)
- Discuss reasonable alternative treatments
- Ensure patient understands information (not just that information was provided)
Special Situations
- Emergency: can treat without consent if patient lacks capacity and treatment is immediately necessary to preserve life (doctrine of necessity)
- Children <16: can consent if Gillick competent; parental consent also valid; if child refuses, parental consent may override for life-saving treatment
- 16-17 year olds: presumed to have capacity (Family Law Reform Act 1969); refusal can potentially be overridden by court or parental consent
- Adults lacking capacity: treat in best interests per MCA 2005
Red Flags
- Patient signing form without understanding — consent is not valid
- Coercion by family or healthcare professionals — invalidates consent
- Obtaining consent immediately before anaesthesia — poor practice; insufficient time for decision-making
- Consent by wrong person — should be obtained by the treating clinician or someone capable of performing the procedure
Differential Diagnosis
| Scenario | Consent Type | Legal Basis |
|---|---|---|
| Routine blood test | Implied | Common law |
| Prescription medication | Verbal | Common law |
| Surgical procedure | Written | Common law + GMC guidance |
| Unconscious patient in A&E | None (emergency) | Doctrine of necessity |
| Adult lacking capacity | Best interests | Mental Capacity Act 2005 |
| Competent child <16 | Child's consent if Gillick competent | Gillick v West Norfolk (1985) |
| Research participation | Written informed consent | Declaration of Helsinki, GCP |
Diagnosis / Investigation
Assessment of Consent Process
- Was the patient given sufficient information (Montgomery standard)?
- Was the information presented in an understandable way?
- Was there adequate time for decision-making?
- Was capacity assessed appropriately?
- Was the decision voluntary?
- Was the consent documented?
- Was the consenting clinician appropriately qualified?
Documentation
- Consent form (NHS standard forms: Form 1-4)
- Documented discussion in medical records
- Record of risks discussed, questions asked, and answers given
- Patient information leaflets provided
- Interpreter used if language barrier
- Record of who obtained consent
Management
Best Practice for Consent
- Treat consent as an ongoing process, not a single event
- Provide information in advance where possible (pre-procedure leaflets, clinic consultations)
- Use teach-back technique: ask patient to explain what they understand
- Document the discussion, not just the form signature
- Ensure the person obtaining consent can perform or supervise the procedure
- Respect refusal: a competent adult can refuse treatment even if the refusal leads to death
- Avoid jargon; use visual aids and written materials
- Offer time to think and discuss with family/friends
- Second opinion available if requested
When Consent Cannot Be Obtained
- Emergency treatment: provide immediately necessary treatment in patient's best interests
- Lacking capacity (non-emergency): follow MCA 2005; consult family/friends, IMCA if needed; best interests decision
- Advance Decision to Refuse Treatment (ADRT): valid and applicable ADRT must be respected
- Court declaration: can be sought for complex cases (e.g. treatment withdrawal, disputed cases)
Referral Criteria
- Ethics committee advice for complex cases
- Legal advice if consent is disputed
- Court of Protection for adults lacking capacity (complex/contested decisions)
- Advocate or IMCA appointment if patient has no family/friends
Prognosis
- Valid consent protects both patients and healthcare professionals
- Montgomery ruling has significantly increased emphasis on shared decision-making
- Failure to obtain valid consent can result in claims of battery (no consent) or negligence (inadequate information)
- Consent processes are regularly audited as part of clinical governance
- Well-conducted consent conversations improve patient satisfaction and reduce complaints
Other Relevant Information
NHS Consent Forms
| Form | Use |
|---|---|
| Form 1 | Patient agreement to investigation or treatment (competent adult) |
| Form 2 | Parental agreement for child or young person |
| Form 3 | Patient agreement (no consciousness required — e.g. local anaesthesia) |
| Form 4 | Adults lacking capacity |
Key Legal Cases in Consent
| Case | Year | Significance |
|---|---|---|
| Bolam v Friern Hospital | 1957 | Standard of care judged by responsible body of opinion |
| Sidaway v Bethlem Royal Hospital | 1985 | Bolam applied to consent (doctor-centred) |
| Montgomery v Lanarkshire | 2015 | Patient-centred disclosure; material risks test |
| Gillick v West Norfolk | 1985 | Children <16 can consent if competent |
| Chester v Afshar | 2004 | Failure to warn of risk sufficient for causation |