Regulation 11: need for consent in care

The regulation: Regulation 11 in full

Regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, headed Need for consent, has five paragraphs:

1. “Care and treatment of service users must only be provided with the consent of the relevant person.”
2. “Paragraph (1) is subject to paragraphs (3) and (4).”
3. “If the service user is 16 or over and is unable to give such consent because they lack capacity to do so, the registered person must act in accordance with the 2005 Act.”
4. “But if Part 4 or 4A of the 1983 Act applies to a service user, the registered person must act in accordance with the provisions of that Act.”
5. “Nothing in this regulation affects the operation of section 5 of the 2005 Act, as read with section 6 of that Act (acts in connection with care or treatment).”

The 2005 Act is the Mental Capacity Act 2005; the 1983 Act is the Mental Health Act 1983, whose Parts 4 and 4A cover treatment of detained patients and community patients. The Mental Health Act 2025 will change how those Parts work when it is brought into force; on 8 October 2026 none of those changes had commenced, and Regulation 11(4) is unchanged.

The “relevant person” is defined in Regulation 2 as “the service user or, where the service user is under 16 and not competent to make a decision in relation to their care or treatment, a person lawfully acting on their behalf”. For every adult, the person whose consent Regulation 11 requires is the person receiving care.

CQC's guidance on Regulation 11 states the intention: “to make sure that all people using the service, and those lawfully acting on their behalf, have given consent before any care or treatment is provided”. Consent also limits person-centred care: Regulation 9(2) says the duty to meet needs and preferences “does not apply to the extent that the provision of care or treatment would result in a breach of regulation 11”. And consent does not license poor care: CQC adds that “providers must not provide unsafe or inappropriate care just because someone has consented to care or treatment that would be unsafe”.

What valid consent looks like in a care service

Valid consent has three elements: it is given voluntarily, by a person with capacity to make the decision, who has the information they need. The Department of Health's Reference guide to consent for examination or treatment (2009) calls them “the elements of voluntariness, appropriate information and capacity”. CQC's guidance on Regulation 11(1) turns them into practice:

• Information the person can understand. “When a person is asked for their consent, information about the proposed care and treatment must be provided in a way that they can understand. This should include information about the risks, complications and any alternatives.” The person obtaining consent must have “the necessary knowledge and understanding of the care and/or treatment that they are asking consent for”.
• Consent can be implied. “Consent may be implied and include non-verbal communication such as sign language or by someone rolling up their sleeve to have their blood pressure taken or offering their hand when asked if they would like help to move.”
• It continues, and can be withdrawn. “Consent must be treated as a process that continues throughout the duration of care and treatment, recognising that it may be withheld and/or withdrawn at any time.”
• No pressure. “Consent procedures must make sure that people are not pressured into giving consent and, where possible, plans must be made well in advance to allow time to respond to people's questions and provide adequate information.”
• Staff who know the Mental Capacity Act. Providers must make sure staff who obtain consent “are familiar with the principles and codes of conduct associated with the Mental Capacity Act 2005, and are able to apply those when appropriate”.

In a care home or home care service, consent is mostly everyday consent: asking before a wash and waiting for the answer, explaining a new tablet before offering it, and asking before fitting night-time sensors or a bed alarm. Taking photographs and sharing information with a GP or family raise questions of privacy and confidentiality too, but those fall under Regulation 10's duty to ensure privacy and under data protection law, not Regulation 11. Most of it is spoken or implied and none of it needs a form. What matters is that staff ask, notice the answer, and stop when the answer changes.

When the person says no

A refusal by a person with capacity is the end of the matter for that care at that time. CQC's guidance says: “When a person using a service or a person acting lawfully on their behalf refuses to give consent or withdraws it, all people providing care and treatment must respect this.” The Department of Health's guide adds that “A person with capacity is entitled to withdraw consent at any time, including during the performance of a procedure.”

An unwise choice is not evidence that the person lacks capacity. Section 1 of the Mental Capacity Act 2005 says “A person must be assumed to have capacity unless it is established that he lacks capacity”, and “A person is not to be treated as unable to make a decision merely because he makes an unwise decision.” A resident who refuses a shower for the third day running, or a home care client who will not take a prescribed tablet, is exercising a right, and the service's job is to understand why, explain the risks, offer alternatives and try again later, not to treat the refusal as a capacity problem.

Record a refusal as carefully as consent: what was offered, what the person said or did, the information and alternatives given, any risk explained, who was told (the nurse, the GP, the family where the person agrees), and when it will be offered again. Where a pattern of refusals puts the person at risk, that record is what shows the service respected their choice and still did its job.

When there is a genuine reason to doubt that the person can make the decision, the Mental Capacity Act's two-stage test applies, decision by decision. Our mental capacity assessment records guide covers the test, best interests decisions and what to write down.

Who can consent for someone else, and who cannot

Next of kin has no legal power to consent for an adult. The Department of Health's guide puts it plainly: “Under English law, no one is able to give consent to the examination or treatment of an adult who lacks the capacity to give consent for themself, unless they have been authorised to do so under a Lasting Power of Attorney or they have the authority to make treatment decisions as a court appointed deputy … Therefore, in most cases, parents, relatives or members of the healthcare team cannot consent on behalf of such an adult.” The two people who can are:

• An attorney under a health and welfare lasting power of attorney. A lasting power of attorney “is not created unless” it is made and registered (MCA section 9). Under section 11(7), a personal welfare attorney's authority “does not extend to making such decisions in circumstances other than those where P lacks, or the donee reasonably believes that P lacks, capacity”, is subject to any advance decision, and “extends to giving or refusing consent to the carrying out or continuation of a treatment”. Under section 11(8) it does not cover life-sustaining treatment “unless the instrument contains express provision to that effect”, and it “is subject to any conditions or restrictions in the instrument”. A property and financial affairs attorney has no authority over care decisions.
• A deputy appointed by the Court of Protection with authority over the decision. Under section 20, a deputy has no power to decide anything the person can decide for themselves, and can never refuse consent to life-sustaining treatment.

Both must act in the person's best interests. Before relying on either, check the document. The Office of the Public Guardian's guide for staff, Making decisions, says “It is important to read the LPA if it is available to understand the extent of the Attorney's power.” Under gov.uk's guidance on proving a lasting power of attorney, an attorney can show the original registered LPA, a certified copy, or (for an LPA registered on or after 1 January 2016) an online summary through an access code, which shows the donor's restrictions and conditions. Once an attorney or deputy has made a decision within their authority, section 6(6) means staff cannot override it under section 5, although section 6(7) still allows life-sustaining treatment, or anything reasonably believed necessary to prevent a serious deterioration, while a decision is sought from the court.

Where nobody holds that authority, decision-making falls to the provider, in the person's best interests under the Mental Capacity Act, consulting family, carers and an advocate where appropriate. The OPG guide says that, having complied with the Act, staff “can carry out many aspects of a person's personal care without their consent and have protection from liability in doing so”, and that “it is in your interests to keep a record of the steps taken and the factors considered”. Restraint is protected only where it is necessary to prevent harm and proportionate (section 6); arrangements that amount to a deprivation of liberty need an authorisation, which our DoLS record keeping guide covers.

An advance decision to refuse treatment, made by the person at 18 or over while they had capacity, binds staff if it is valid and applicable: under section 26(1) it “has effect as if he had made it, and had had capacity to make it” at the time. An advance decision refusing life-sustaining treatment must be in writing, signed and witnessed, with a statement that it applies “even if life is at risk” (section 25(5) and (6)). It is not valid if the person later made a health and welfare LPA giving the attorney authority over the same treatment, and the person can withdraw it at any time while they have capacity, without writing (section 24).

Consent records, and how CQC checks them

Regulation 17(2)(c) of the 2014 Regulations requires “an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided”. Consent and refusal are decisions in that sense. A signature is not the point: “The validity of consent does not depend on the form in which it is given. Written consent merely serves as evidence of consent”, as the Department of Health's guide puts it. A good consent entry in the care record shows:

• the decision: what care or treatment, and when
• the information given, including risks and alternatives, and how (spoken, easy read or other formats, an interpreter)
• how consent was given or refused: in words, by gesture, or by action
• who was present, and who obtained the consent
• any authority relied on: an LPA or deputyship checked, with the date and what it covers, or a best interests decision with its reference
• any advance decision and whether it applies
• when the decision will be reviewed, for anything ongoing

CQC assesses consent under the Consent to care and treatment quality statement, under the effective key question: “We tell people about their rights around consent and respect these when we deliver person-centred care and treatment.” Its related regulation is Regulation 11, with Regulations 9 and 10 to “also consider”, and its subtopics are consent, advocacy and support, and DNACPR. CQC has said it will replace quality statements with new supporting key lines of enquiry, and is piloting its new assessment approach between June and October 2026; pilot judgements “have no legal standing”, so until the new frameworks go live this statement still applies.

Regulation 11 is also an offence. Regulation 22(1)(a) makes it “an offence for a registered person to fail to comply with” Regulation 11, and CQC's guidance says it “can move directly to prosecution without first serving a Warning Notice”. A registered person includes the registered manager as well as the provider. Regulation 22(4) gives a defence where the registered person proves “they took all reasonable steps and exercised all due diligence to prevent the breach”, and that defence is argued from records: the consent policies and procedures, training, and the entries that show consent was sought, refused or decided lawfully.

Consent given and withdrawn in messages

Much of the consent a care service relies on never reaches the consent form. A daughter who holds a health and welfare LPA replies “yes, go ahead” to the manager's text about her mother's flu jab. A resident tells a carer she no longer wants checks during the night, and the carer mentions it in the shift group chat. An attorney withdraws agreement to bed rails for his father in a message to a nurse's own phone.

Each is a consent decision Regulation 11 turns on, and each is part of the record Regulation 17 requires. Held on personal phones, none of it is somewhere the provider can produce it when a family disputes what was agreed, when CQC asks how the service knew, or when the registered person needs to show due diligence.

ComplyChat gives those conversations, including with attorneys and families, a channel the provider holds. A mobile number verified by SMS is the identity, so relatives and bank staff without a work account can take part; everyone added to a channel is told it is on the record; and messages are recorded on the server as they are sent. On paid plans the lasting record files into the provider's own Microsoft 365 once its tenant is connected, under its own retention rules. It does not obtain or verify consent, check an LPA or update the care plan; the decision still has to reach the care record.

A question for the next leadership or governance meeting: when a family member agrees to something by message, how do staff check they had the authority to agree, and where would we find that message a year from now?

Questions people ask

What is regulation 11?

Regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 is CQC's fundamental standard on need for consent: “Care and treatment of service users must only be provided with the consent of the relevant person.” Where a person aged 16 or over lacks capacity to consent, the provider must act in accordance with the Mental Capacity Act 2005.

Does CQC regulation 11 require consent for care and treatment?

Yes: Regulation 11(1) requires consent before any care or treatment, and CQC's guidance says its intention is that people “have given consent before any care or treatment is provided”. The exceptions are a person of 16 or over who lacks capacity, where the Mental Capacity Act 2005 applies, and a person to whom Part 4 or 4A of the Mental Health Act 1983 applies.

What are the four conditions for valid consent?

The Department of Health's reference guide describes three elements, not four: consent must be voluntary, informed, and given by a person with capacity to make the decision. CQC's Regulation 11 guidance adds that consent is “a process that continues throughout the duration of care and treatment” and can be withdrawn at any time.

Can a family member give consent for a care home resident?

A family member cannot consent for an adult who lacks capacity unless they hold a registered health and welfare lasting power of attorney, or are a court-appointed deputy, covering that decision, and even then only while the person lacks capacity, within any restrictions in the LPA, and for life-sustaining treatment only if the LPA expressly allows it; a deputy can never refuse life-sustaining treatment. Without that authority the provider decides in the person's best interests under the Mental Capacity Act 2005, consulting the family.

Is breaching Regulation 11 a criminal offence?

Yes: failing to comply with Regulation 11 is an offence under Regulation 22(1)(a) of the 2014 Regulations, and CQC's guidance says it “can move directly to prosecution without first serving a Warning Notice”. Regulation 22(4) gives a defence where the registered person proves they took all reasonable steps and exercised all due diligence.

Does consent have to be in writing?

Consent to care does not have to be written: CQC's guidance says consent “may be implied and include non-verbal communication”, such as offering a hand when asked about help to move, and the Department of Health's guide says “Written consent merely serves as evidence of consent”. The exception is an advance decision refusing life-sustaining treatment, which the Mental Capacity Act requires to be written, signed and witnessed.

Official guidance and your next step

The primary sources are Regulation 11 on legislation.gov.uk; CQC's guidance on Regulation 11 and its Consent to care and treatment quality statement; the Mental Capacity Act 2005 and its Code of Practice; and the Office of the Public Guardian's guide for people who work in health and social care. The Department of Health's 2009 reference guide is useful on who can consent and on the form of consent, which are unchanged, but it was written for health professionals before the 2014 Regulations. Quotations are from those pages as published on 8 October 2026.

This guide is a summary for providers registered with CQC in England, not legal advice about a particular person's care. The Mental Capacity Act applies in England and Wales; Scotland has the Adults with Incapacity (Scotland) Act 2000, and Northern Ireland its own law.

Then do one thing: pick five people your service supports, and for each check whether the care record shows who can consent for them if they cannot, and, where an attorney or deputy is named, that someone has read the document and recorded what it covers.