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Registered providers and managers carrying on regulated activities in England. Different legal rules can apply to children, people lacking capacity and treatment under mental-health legislation.
What the law requires
- Provide care and treatment only with the consent of the relevant person, subject to the statutory exceptions.
- For a person aged 16 or over who lacks capacity for the relevant decision, act in accordance with the Mental Capacity Act 2005.
- Where Parts 4 or 4A of the Mental Health Act 1983 apply, act in accordance with those provisions. A relative’s involvement does not by itself establish legal authority to consent.
What CQC expects
- CQC guidance expects an understandable explanation of the proposed care, risks, benefits and alternatives, given by someone with appropriate knowledge.
- People should be able to ask questions, refuse or withdraw consent without pressure. Communication support and capacity assessment should relate to the particular decision.
Suggested checks for your review
- Sample decisions with different levels of complexity and trace how information, understanding and agreement were established before care.
- Where capacity was questioned, check the assessment, support offered, lawful decision-making route and review when circumstances changed.
- Check staff responses to refusal and whether any representative’s authority and its limits were verified.
Illustrative evidence
Choose evidence relevant to the actual service and risk. These examples are not a universal list of documents required by CQC.
- Decision-specific consent discussions and accessible information supplied to the person.
- Capacity assessments, best-interests records and verified authority where applicable.
- Records of refusals, alternatives considered and changes to the care plan.
Potential gaps to check
- A general admission form is relied on for later decisions without a fresh discussion.
- A diagnosis is treated as proof of incapacity, or a family relationship is treated as automatic authority.
- Consent records describe a procedure but omit material choices, communication support or the person’s questions.
Sources and review
- cqc.org.uk — Regulation 11 (opens in a new tab)
- legislation.gov.uk — Uksi · 2014 · 2936 · regulation · 11 (opens in a new tab)
- legislation.gov.uk — Ukpga · 2005 · 9 · contents (opens in a new tab)
Content version: 1 November 2026. Next planned review 1 December 2026. Check current primary sources before relying on a requirement.
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