Consent and shared decision-making policy (independent specialist doctor)

1. What the regulation says

Care and treatment of service users must only be provided with the consent of the relevant person. (Reg 11(1): the headline duty)

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/11. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

You can only provide care or treatment with the consent of the relevant person. If the service user is 16 or over and lacks capacity, follow the Mental Capacity Act 2005. If Parts 4 or 4A of the Mental Health Act 1983 apply, follow that instead. Section 5 of the MCA (acts done in connection with care or treatment) still applies underneath.

3. Purpose

A single-handed independent specialist makes decisions with patients who are often paying privately and who may feel a procedure is expected once they have come this far. Good consent means a genuine, shared decision based on the patient's own goals, with the material risks and the alternatives, including doing nothing, set out honestly, and free from any pressure created by the doctor's financial interest in proceeding. This policy sets out how the practice takes consent and shares decisions.

The practice must verify this policy against current GMC consent guidance and the Montgomery standard of material risk before adoption.

4. Sources to verify before adoption

• GMC, Decision making and consent: https://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/decision-making-and-consent
• GMC, Good medical practice (including managing conflicts of interest and financial interests): https://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/good-medical-practice
• Montgomery v Lanarkshire Health Board [2015] UKSC 11; GMC Decision making and consent guidance
• Mental Capacity Act 2005: https://www.legislation.gov.uk/ukpga/2005/9/contents
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 11 (consent): https://www.legislation.gov.uk/uksi/2014/2936/regulation/11

5. Scope

This policy applies to:

• every treatment, procedure and investigation the practice offers
• the doctor and any staff who support the consent process
• adults with capacity, adults who may lack capacity, and (where in scope) young people

6. Roles and responsibilities

• Doctor / Registered Manager: owns the consent system, confirms which procedures need written consent, makes sure consent information is accurate, and reviews consent records, complaints and incidents.
• Doctor obtaining consent: leads the shared-decision conversation, checks capacity for the specific decision, explains options, risks, benefits, alternatives and the option of no treatment, and records the discussion.
• Clinical or administrative support staff: give approved patient information, book reflection periods where required, record cancellation or withdrawal of consent, and escalate concerns that a patient may feel pressured.
• Governance lead or nominated reviewer: audits consent records and tracks improvement actions after complaints, incidents, adverse outcomes or record-quality findings.

7. Consent and shared-decision procedure

The practice follows this procedure for each treatment, procedure or investigation:

1. Confirm the decision being made. Identify the exact treatment, procedure, test or course of action, and whether it is urgent, elective, cosmetic, diagnostic, invasive or repeat care.
2. Check capacity and communication needs. Start from the presumption that the adult patient has capacity, then check whether they need support, reasonable adjustments, an interpreter, accessible information, more time, an advocate or a best-interests process.
3. Find out what matters to the patient. Ask about the patient's goals, concerns, lifestyle, work, caring responsibilities, previous experience, cost concerns and the outcomes they would find unacceptable.
4. Explain options honestly. Explain the recommended option, reasonable alternatives, the likely result of each, and the option of doing nothing or waiting.
5. Discuss material risks. Cover risks a reasonable person in the patient's position would want to know, and risks that matter to this individual patient.
6. Check understanding. Give time for questions, use plain language, and check that the patient has understood the main benefits, risks, alternatives and uncertainties.
7. Manage pressure and conflicts. Make costs clear before treatment, avoid same-day pressure for elective irreversible procedures unless clinically justified, and make clear that the patient can decline or change their mind.
8. Record the decision. Record the conversation, the patient's questions, the information given, the options declined, capacity findings where relevant, and the decision reached.
9. Review consent when things change. Revisit consent if the plan, risk profile, patient's wishes, capacity, price, clinician, setting or timing changes.
10. Escalate concerns. If the patient may lack capacity, appears coerced, raises safeguarding concerns, has a serious adverse outcome, or complains about consent, pause where safe and escalate through the relevant safeguarding, incident, complaints or governance route.

8. A shared decision

Consent is a conversation, not a form. For each decision the doctor:

• finds out what matters to the patient: their goals, concerns and the things that would affect their choice
• explains the condition, the options (including doing nothing), and the likely outcome of each
• sets out the material risks, meaning those a reasonable patient in this person's position would want to know, and any that matter to this particular patient
• gives the patient time and space to ask questions and to decide

9. Honesty about benefit and alternatives

• the doctor is honest about how likely the treatment is to help, and does not overstate it
• the realistic alternatives, including more conservative options and doing nothing, are offered fairly
• the patient is never given the impression that a procedure is the only option when it is not

10. Financial interest and no pressure

Because the practice has a financial interest in providing treatment, the practice is careful that this never influences the advice:

• the doctor's financial interest in proceeding is recognised, and the patient is not pressured toward a paid procedure
• fees are explained clearly and in advance, so cost is not a surprise
• where the patient would be as well or better served by a less costly option, or by care the practice does not provide, the doctor says so

11. Time to decide for elective treatment

For elective treatment the patient is given time between the discussion and the procedure to reflect, is told they can change their mind at any point, and is not booked for an irreversible elective procedure on the same day as the first consultation unless there is a clinical reason.

12. Capacity

Where a patient may lack the capacity to make a decision, the practice follows the Mental Capacity Act: capacity is assessed for that decision, the patient is given all practicable help to decide, and where they cannot, a best-interests decision is made and recorded, involving those close to the patient and an advocate where the patient has no one to represent them.

13. Recording

The consent discussion, the options and risks covered, the patient's questions, the fee information given, and the patient's decision are recorded. The signed form is part of the record, not the whole of it.

14. Records and register links

The consent record should include:

• decision being made and whether it was urgent, elective, cosmetic, diagnostic, invasive or repeat care
• information given about benefits, risks, uncertainties, alternatives and no treatment
• what mattered to the patient and how that affected the advice
• questions asked by the patient and answers given
• fee information, cooling-off or reflection period, and any same-day treatment rationale
• capacity assessment, communication support, interpreter or advocate involvement where relevant
• consent form, if used, linked to the clinical note
• withdrawal of consent, refusal of treatment or change of plan
• complaints, incidents, safeguarding concerns or improvement actions linked to the consent process

Consent concerns raised through complaints are tracked in the complaints register. Consent-related harm, near misses or missing records are reviewed through the incident register. Repeated gaps are added to the risk register or improvement-actions register and reviewed at the governance meeting.

15. Training and competence

The doctor must remain up to date with GMC consent guidance, Mental Capacity Act duties, material-risk case law, communication adjustments and the procedures offered by the practice. Support staff who give patient information or arrange procedures must understand that they cannot obtain clinical consent unless competent and authorised to do so.

Training records are held in the training matrix. Consent themes from complaints, incidents, record audits and patient feedback are used for continuing professional development and peer review.

16. Audit cadence

The practice checks, on a stated cadence, that:

• consent records show a real, person-specific discussion of options, risks and alternatives, not a generic form
• elective procedures had time to reflect and were free from pressure
• fees were explained in advance and conflicts of interest managed
• capacity assessments and best-interests records are present where needed

The doctor and the Registered Manager review the results and record the improvement actions that follow.

17. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 11: Need for consent
• Mental Capacity Act 2005
• MCA Code of Practice (2007, update in consultation)
• GMC, Decision making and consent
• GMC, Good medical practice (including managing conflicts of interest and financial interests)
• Montgomery v Lanarkshire Health Board [2015] UKSC 11; GMC Decision making and consent guidance
• Independent specialist doctor: scope, indemnity and continuity (GMC Good medical practice; GMC remote prescribing/consent; medical indemnity provider guidance; CQC Reg 12/17)
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/11)

18. Related reading

• Related policy: Consent to Intimate Examinations and Procedures Policy
• Related policy: Mental Capacity Act Policy
• Related policy: Scope of practice, indemnity and continuity policy
• Regulation explainer: Mental capacity and DoLS recording

19. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

20. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.