References

Airedale NHS Trust v Bland. 1993;

Chatterton v Gerson. 1981;

Ciarlariello v Schacter. 1993;

Care Quality Commission. University Hospitals Birmingham NHS Foundation Trust pays fixed penalties of £8,000 for failures around consent. 2022. https//tinyurl.com/y2kthrjb (accessed 25 June 2024)

McCulloch v Forth Valley Health Board. 2023;

NHS Resolution. Consent claims. Freedom of information request details. FOI_4829. November 2020. 2021. https//resolution.nhs.uk/foi-disclosure-log/consent-claims (accessed 25 June 2024)

Nursing and Midwifery Council. The code: professional standards of practice and behaviour for nurses, midwives and nursing associates. 2018. https//tinyurl.com/gozgmtm (accessed 25 June 2024)

Nursing and Midwifery Council. Substantive Order review hearing. 2023. https//tinyurl.com/52zf6rdj (accessed 25 June 2024)

Re MB (Caesarean Section). 1997;

Re T (Adult: Refusal of Treatment). 1992;

Re U. 2002;

Williamson v East London & City HA. 1998;

Key requirements for obtaining valid informed consent to treatment

04 July 2024
Volume 33 · Issue 13

Abstract

Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment

Some 2240 claims for compensation relating to improper or inadequate consent were made between 2015 and 2021 (NHS Resolution, 2022). These claims resulted in approximately £189 million in compensation and costs.

Nurses recognise that consent is fundamental to person-centred nursing and is an essential legal and professional requirement.

The law has long recognised that adults have the right to determine what will be done to their bodies (Re MB (Caesarean Section) [1997]). Touching a person without consent constitutes trespass or even criminal assault. Autonomy and respect for bodily integrity are highly valued by the law, and any unlawful touching is actionable, regardless of the intentions.

‘The right to determine what shall be done with one's own body is a fundamental right in our society. The concepts inherent in this right are the bedrock upon which the principles of self-determination and individual autonomy are based. Free individual choice in matters affecting this right should, in my opinion, be accorded very high priority.’

Re MB (Caesarean Section) [1997]

Extent of the right to determine

In Airedale NHS Trust v Bland [1993], the House of Lords examined the extent of autonomous decision-making in health care. They concluded that a conscious, sound-minded adult patient has the right to accept or refuse treatment. Lord Keith stressed:

‘… it is unlawful, so as to constitute both the tort and crime of battery, to administer treatment to an adult, who is conscious and of sound mind, without his consent … Such a person is completely at liberty to decline to undergo treatment, even if the result of his doing so will be that he will die.’

Airedale NHS Trust v Bland [1993]

This fundamental common law right is now codified in the Mental Capacity Act 2005, section 1(4), which prevents a person from being considered incapable of making a decision merely because they make an unwise decision.

Consent as an element of professionalism

Standard 4 of the Nursing and Midwifery Council (NMC) Code (2018) requires nurses to act in the best interests of patients at all times. To achieve this, nurses must obtain and document properly informed consent before any action.

In the case of one nurse, her fitness to practise was found to be impaired and she was made subject to a ‘conditions of practice’ order for 18 months by the NMC when she failed to obtain informed consent before administering a depot contraceptive injection, travel immunisation and a whooping cough injection (NMC, 2023).

Obtaining consent is a regulated activity

Consent to care and treatment is a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 11 requires that suitable arrangements are in place for obtaining and acting in accordance with the consent of service users in relation to the care and the treatment provided.

The CQC's guidance on meeting the requirements of regulation 11 emphasises:

  • When a person is asked for 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
  • A person with the necessary knowledge and understanding of the care and treatment should provide this information, so they can answer questions about it to help the person to provide consent
  • Discussions about consent must be held in a way that meets people's communication needs. This may include the use of different formats or languages, and may involve others such as a speech and language therapist or independent advocate
  • 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
  • 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
  • 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
  • Where a person lacks mental capacity to make an informed decision or give consent, staff must act in accordance with the requirements of the Mental Capacity Act 2005 and associated code of practice
  • Consent procedures must make sure that patients 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
  • Policies and procedures for obtaining consent to care and treatment must reflect current legislation and guidance, and staff must follow them at all times.
  • An NHS Foundation Trust was issued with two fixed penalty notices by the CQC when nurses failed to meet the requirements of regulation 11, when it was assumed that a man who was deaf and had a diagnosis of autism was unable to make, or communicate about, decisions about his treatment. The man used British Sign Language and lip reading to communicate (Care Quality Commission, 2022).

    It is essential that nursing services are able to meet the requirements of regulation 11 and nurses must obtain a valid consent from patients before providing care and treatment.

    Elements of a valid consent

    To be a valid defence to a claim of trespass consent needs to be full, free and reasonably informed.

    Full consent

    When obtaining consent, a patient must agree to all the treatment being proposed. In Williamson v East London & City HA [1998] a surgeon was held to have committed a trespass when he failed to obtain further consent for a subcutaneous mastectomy of lumps that he had discovered in a pre-operative examination of a woman who was consenting to cosmetic surgery.

    Nurses must therefore take care to explain all the treatment or touching that will occur when obtaining consent from a patient, and ensure that any additional treatment or touching is subject to further consent.

    Free consent

    Consent is an expression of autonomy and must be the free choice of the individual. It cannot be obtained by undue influence (Re T (Adult: Refusal of Treatment) [1992]). This does not mean that a nurse cannot influence a patient's decision. Indeed, part of the nurse's role is to explain the benefits of treatment to patients in order to obtain consent.

    In law, undue influence must erode the free will of the patient (Re U [2002]) to make the consent invalid. It must be so forceful that the patient excludes all other considerations when making their choice. An example would be where a threat of force or harm forces a patient to accept treatment that they may otherwise have not.

    Reasonably informed

    To make a free choice a person needs to have sufficient information to inform that choice. For consent to be real nurses are required to explain in general terms what the procedure entails. If a patient can show that the procedure was not explained in broad terms, then the consent would be vitiated and liability in trespass result (Chatterton v Gerson [1981]).

    As well as a general explanation of the procedure, there is a duty to explain the risks inherent in a procedure. The Supreme Court in McCulloch v Forth Valley Health Board [2023] held that the need to provide information about the benefits and risk of treatment, and the availability of other reasonable treatment, was part of a nurse's advisory duty.

    This person-centred approach requires a meaningful dialogue with the patient about the treatment, so that the patient is in a position to make an informed choice about having it.

    Obtaining consent

    Nurses may lawfully obtain consent in two ways. A patient may express their consent by making known their willingness to be touched.

    Express consent can be written or oral. Written consent is usually obtained where a procedure is invasive or perceived to carry a material risk. A consent form provides a degree of evidential certainty that the patient agreed to treatment. It should not be relied on too heavily, however. Lord Donaldson in Re T (Adult: Refusal of Treatment) [1992] pointed out that a consent form was only as useful as the understanding of the person signing it. When obtaining consent, whether in writing or orally, it is essential it be recorded in the patient's file to corroborate the patient's agreement.

    The second form of consent is an implied consent. This is permission implied through the actions of the patient, which follow a request to give treatment. It does not mean that agreeing to come to hospital or allowing a nurse into their home implies that a patient agrees to treatment. Every episode of care or treatment must be subject to a valid consent.

    Consent is a continuous process and may be withdrawn at any time. A withdrawal of consent is as indistinguishable as an initial refusal to consent (Ciarlariello v Schacter [1993]). If a patient changes their mind and refuses to continue with treatment, then it must cease, or trespass to the person will occur.

    Conclusion

    Nurses must base their practice on consensual treatment, as consent legally expresses the moral principle of self-determination and promotes autonomy. The NMC requires that nurses always obtain and record the patient's informed consent before providing care or treatment.

    In England, the requirements of the common law duty of consent and the requirements of the NMC Code (2018) are supplemented by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 that require the guidance for obtaining and acting on consent set out by the CQC are adhered to as well. Failing to meet those standards can result in censure, fines or even closure of the service.

    KEY POINTS

  • Nurses must obtain and record a valid consent before commencing care or treatment
  • Valid consent must be full, freely given and reasonably informed
  • Consent to care and treatment is a regulated activity in England and must meet the fundamental standards for quality and safety set out by the Care Quality Commission