Informed Consent

Informed consent builds on the basic consent framework by emphasising that patients must receive and understand adequate information about proposed treatments, risks, benefits, and alternatives to make a genuinely autonomous decision, as mandated by the Montgomery ruling.

Key Facts

Informed consent requires disclosure of material risks, benefits, alternatives, and expected outcomes in language the patient can understand The Montgomery test (2015): a risk is material if a reasonable person in the patient's position would attach significance to it, or the doctor should reasonably be aware that this patient would Shared decision-making is the model: dialogue between clinician's expertise and patient's values/preferences Patients do NOT need to understand every medical detail — but must understand enough to make an informed choice Right NOT to know: patients can decline information, but this should be documented Clinicians should discuss: what the procedure involves, why it is recommended, what happens without treatment, material risks/complications, alternative treatments Consent for research has additional requirements: voluntary, right to withdraw, no impact on standard care (Declaration of Helsinki, GCP) Language barriers: professional interpreter must be used; family members should NOT routinely interpret for consent

Overview

Key Facts

Informed consent goes beyond simple agreement to treatment. It requires a genuine exchange of information enabling the patient to make an autonomous choice. The Montgomery ruling transformed UK consent law from a paternalistic model to a patient-centred approach.

Pre-Montgomery vs Post-Montgomery

  • Pre-Montgomery (Bolam/Sidaway): doctors disclosed what a reasonable body of doctors would disclose (doctor-centred)
  • Post-Montgomery (2015): doctors must disclose what a reasonable patient would want to know (patient-centred)
  • The patient's perspective is now central to determining adequacy of disclosure

Information to Disclose

  • Nature and purpose of the proposed treatment/investigation
  • Material risks and benefits
  • Alternative treatments (including no treatment)
  • Expected outcome and recovery
  • What the patient can expect during and after the procedure
  • Answer the patient's questions honestly and fully

Barriers to Informed Consent

  • Health literacy: approximately 43% of UK adults cannot fully understand health information
  • Language barriers
  • Cognitive impairment
  • Emotional distress at time of consent
  • Power imbalance between doctor and patient
  • Time pressures in clinical practice
  • Complexity of medical information

Clinical Presentation

Practical Approach to Informed Consent

  1. Check patient's understanding and prior knowledge
  2. Explain diagnosis and proposed treatment in plain language
  3. Discuss material risks using absolute numbers where possible
  4. Discuss benefits and expected outcomes
  5. Explain alternatives (including doing nothing)
  6. Invite questions
  7. Ensure understanding (teach-back method)
  8. Allow time for reflection
  9. Document the discussion
  10. Patient signs consent form (if applicable)

Communicating Risk

  • Use absolute risk rather than relative risk
  • Use consistent framing (e.g. '2 in 100' rather than '2%' or '1 in 50')
  • Visual aids (icon arrays, risk charts) improve understanding
  • Avoid minimising language ('small risk', 'rarely happens')
  • Context: compare to familiar risks where helpful
  • Patient decision aids can support the process

Special Considerations

  • Elective procedures: more time available; expect comprehensive discussion
  • Emergency procedures: abbreviated but essential consent; document constraints
  • Procedures under anaesthesia: consent must be obtained well in advance
  • Procedures with trainee involvement: disclose if trainee will perform part of procedure
  • Innovative/experimental treatments: higher standard of disclosure

Differential Diagnosis

StandardTestImplications
Bolam (1957)What a reasonable body of doctors would doPaternalistic; largely superseded
Sidaway (1985)Doctor decides what to disclose (with therapeutic privilege)Doctor-centred
Montgomery (2015)What a reasonable patient would want to knowPatient-centred; current standard
Canterbury v Spence (1972, US)Material risk = would affect patient's decisionInfluential US precedent

Diagnosis / Investigation

Quality Assessment of Consent

  • Was information provided in advance (not just at time of procedure)?
  • Was information in the patient's language and at appropriate health literacy level?
  • Were decision aids or written materials used?
  • Was there opportunity for questions?
  • Was the patient's understanding verified (teach-back)?
  • Was the consent discussion documented (not just the form signed)?
  • Were patient's specific concerns addressed?
  • Was the consent obtained by an appropriately qualified clinician?

Management

Improving Informed Consent in Practice

  • Decision aids: condition-specific tools helping patients weigh options (available via NHS, NICE, specialty societies)
  • Written information: pre-procedure leaflets sent in advance
  • Teach-back method: 'Can you tell me in your own words what we discussed?'
  • Cooling-off period: time between information provision and procedure
  • Professional interpreters: mandatory for non-English speakers; telephone interpreting services available 24/7
  • Easy Read materials: for patients with learning disabilities
  • Audio/visual aids: videos explaining procedures

When Informed Consent is Particularly Important

  • Procedures with significant risk of complications
  • Treatment with uncertain benefit (e.g. some cancer treatments)
  • Procedures with cosmetic implications
  • Irreversible procedures (e.g. sterilisation, amputation)
  • Research participation
  • Screening (informed choice about participation)

Therapeutic Privilege

  • The Montgomery ruling acknowledged a very narrow 'therapeutic exception' — withholding information if disclosure would cause serious harm to the patient
  • This exception is extremely narrow and rarely justified
  • Does NOT include withholding information because the doctor thinks the patient would refuse treatment

Prognosis

  • Good informed consent practice improves patient satisfaction, reduces complaints, and reduces litigation risk
  • The Montgomery ruling has led to significant changes in consent practice across the NHS
  • Ongoing challenges: time pressures, health literacy, cultural differences
  • Digital consent platforms and decision aids are improving the process
  • Training in communication skills and shared decision-making is now embedded in medical education

Other Relevant Information

Montgomery v Lanarkshire: Key Facts

ElementDetail
Year2015
CourtUK Supreme Court
FactsDiabetic mother not informed of risk of shoulder dystocia with vaginal delivery
RulingDoctors must inform patients of material risks
TestRisk is material if reasonable person in patient's position would attach significance to it
ImpactShifted UK law from Bolam (doctor-centred) to patient-centred disclosure

Communicating Risk — Recommended Format

Risk LevelNatural FrequencyDescriptor
Very common>1 in 10'More than 1 in 10 people are affected'
Common1 in 10 to 1 in 100'Between 1 and 10 in every 100'
Uncommon1 in 100 to 1 in 1,000'Between 1 and 10 in every 1,000'
Rare1 in 1,000 to 1 in 10,000'Between 1 and 10 in every 10,000'
Very rare<1 in 10,000'Fewer than 1 in 10,000'