Consent in Care: What CQC Regulation 11 Requires and How to Get It Right
Care can only be given with consent. Here is what valid consent means, how it works in practice, what to do when someone lacks capacity and how to evidence it.
Consent in care means a person agrees to their care or treatment, having been given information they can understand, without pressure. Regulation 11 says care and treatment must only be provided with the consent of the relevant person, and where a person aged 16 or over lacks capacity to consent, the provider must act in accordance with the Mental Capacity Act 2005. CQC can prosecute for a breach of this regulation without first serving a Warning Notice.
Consent underpins almost everything in care, from personal care to medicines to a move into a care home, yet it is often treated as a form to sign. This guide explains what valid consent looks like, how capacity changes the picture and how to record consent so it stands up to an inspector.
Key takeaways
- Care and treatment must only be provided with the consent of the relevant person.
- Consent must be informed: information about risks, complications and alternatives in a form the person can understand.
- Consent is a continuing process and can be withheld or withdrawn at any time.
- If a person lacks capacity, staff must act under the Mental Capacity Act 2005 and its code.
- Consent can be implied or non-verbal, but the record should show how it was established.
In this guide
What Regulation 11 Says
Regulation 11 requires that “care and treatment of service users must only be provided with the consent of the relevant person”. CQC says providers must obtain consent lawfully and make sure that the person obtaining it has the necessary knowledge and understanding of the care or treatment. If the person is 16 or over and lacks capacity, the provider must act in accordance with the Mental Capacity Act 2005, and if the Mental Health Act 1983 applies, in accordance with that Act (CQC: Regulation 11).
CQC can prosecute for a breach of this regulation, and can move directly to prosecution without first serving a Warning Notice. It is also one of the fundamental standards. See the fundamental standards.
What Makes Consent Valid
| Element | What CQC guidance says |
|---|---|
| Informed | Information about the proposed care and treatment must be provided in a way the person can understand, including risks, complications and alternatives |
| By someone who understands it | A person with the necessary knowledge should give the information and be able to answer questions |
| Communication needs met | Use different formats or languages, or involve speech and language therapists or independent advocates where needed |
| Voluntary | People must not be pressured into giving consent; plan ahead so there is time to answer questions |
| Ongoing | Consent is a process throughout care and can be withheld or withdrawn at any time; refusal or withdrawal must be respected |
| Can be implied | Non-verbal signs, such as rolling up a sleeve for a blood pressure check, can show consent |
CQC also notes that consent does not override safety: providers must not provide unsafe or inappropriate care just because someone has consented to it.
When a Person Lacks Capacity
The Mental Capacity Act 2005 starts from five principles: assume a person has capacity unless shown otherwise, take all practicable steps to help them decide, do not treat a decision as lacking capacity just because it seems unwise, make decisions in their best interests if they lack capacity, and choose the least restrictive option (Mental Capacity Act 2005, section 1). CQC guidance says staff who obtain consent must be familiar with the principles and codes of conduct associated with the Act and able to apply them.
- Capacity is decision-specific and time-specific: assess it for the particular decision, when it needs to be made.
- Record how capacity was assessed and the outcome.
- If the person lacks capacity, follow a best interests process, and consider whether a deprivation of liberty needs authorisation. See MCA and DoLS in practice and our DoLS tracker.
- Involve family, advocates and others who know the person.
How to Record Consent
- What was proposed, and the information given.
- Who gave it, when and how it was communicated.
- The person’s response, including refusal, and any support used.
- Capacity assessment where in doubt, with the outcome.
- Any best interests decision, who was consulted and why it was the least restrictive option.
- Review dates, because consent can change.
Policies and procedures must reflect current legislation and staff must follow them. See policies and procedures.
Checking Consent in Practice
Inspectors look at care records, but also ask staff how they gain consent and watch practice. Build consent into audits: sample records for signed or recorded consent, capacity assessments and best interests decisions, and observe how staff ask before helping. CQCLogic’s audit schedule includes a quarterly DoLS/MCA compliance audit linked to Regulation 11, and its DoLS/MCA tracker records authorisations with expiry alerts and a mental capacity log.
Keep consent and capacity evidence tracked
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Frequently Asked Questions
What is consent in care?
A person’s agreement to care or treatment, given after they have been given information they can understand and without pressure. Regulation 11 says care must only be provided with the consent of the relevant person.
What does CQC Regulation 11 require?
That care and treatment is only provided with consent, that consent is obtained lawfully by someone with the right knowledge, and that where a person lacks capacity the Mental Capacity Act 2005 is followed.
Does consent have to be written?
CQC guidance says consent can be implied, including non-verbal. What matters is that valid consent exists and you can show how it was established, which usually means recording it.
What if someone lacks capacity to consent?
Act under the Mental Capacity Act 2005: assess capacity for the specific decision, take steps to support the person and, if they still lack capacity, make a best interests decision using the least restrictive option.
Can a person withdraw consent?
Yes. CQC guidance says consent is a continuing process that can be withheld or withdrawn at any time, and refusal or withdrawal must be respected.
Can CQC prosecute for breaching Regulation 11?
Yes. CQC can prosecute for a breach of this regulation and can move directly to prosecution without first serving a Warning Notice.
Sources: CQC: Regulation 11, Need for consent · Mental Capacity Act 2005, section 1