Regulations for service providers and managers

Page last updated: 7 August 2024

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Regulation 11: Need for consent

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 11

The intention of this regulation is 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. Providers must make sure that they obtain the consent lawfully and that the person who obtains the consent has the necessary knowledge and understanding of the care and/or treatment that they are asking consent for.

Consent is an important aspect of providing care and treatment, but in some cases, acting strictly in accordance with consent will mean that some of the other regulations cannot be met. For example, this might apply with regard to nutrition and person-centred care. However, providers must not provide unsafe or inappropriate care just because someone has consented to care or treatment that would be unsafe. See the glossary for the definition of 'relevant person' in relation to Regulation 11.

CQC can prosecute for a breach of this regulation or a breach of part of the regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action. See the offences section for more detail.

CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation.

The regulation in full

11.—

  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).

* Mental Capacity Act 2005

** Mental Health Act 1983

Guidance

This sets out the guidance providers must have regard to against the relevant component of the regulation.

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

11(2) Paragraph (1) is subject to paragraphs (3) and (4).

11(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.

11(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.

11(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).