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Consent
The creation of the Care Quality Commission, the publication of High Quality Care for All, the establishment of the NHS Constitution and publication of new guidance from professional bodies , all now set a new context for healthcare providers to consider their consent policy and processes.
Since 2001, the Department of Health guidance on consent has required NHS Trusts to adopt a model consent policy, model forms and information leaflets with the aim of ensuring that good practice in seeking consent was put in place throughout the NHS. Consent is an essential element in all aspects of care and treatment, and ensuring high standards of practice remains a key aim. In this respect, the Department has been considering the future role of its guidance in the new arrangements for the regulation of healthcare providers and promoting quality.
The Department is, therefore, currently undertaking a review of consent in the NHS which will not only identify and evaluate the NHS approach to, and practice on, gaining consent but which will also evaluate the impact on practice of existing DH guidance and forms. Importantly, the review will also be exploring how quality for consent can best be developed, enhanced and embedded across the NHS.
Interim Position
We are aware of the importance to Trusts of having up to date guidance available to them to ensure they continue to have in place effective and legal consent processes. This is especially so at a time when the Care Quality Commission is developing its regulatory framework (and associated guidance) and that there is a continuing need for Trusts to meet the risk management standards required by the NHS Litigation Authority.
Thus, as an interim measure whilst we carry out our review, we have updated the Reference Guide to Consent for Examination or Treatment, to reflect legal developments since the guide was issued, including the Human Tissue Act 2004, the Mental Capacity Act 2005 and relevant judgements made in the High Court of Justice. The revised guide is available via the DH weblink below.
As part of our review, we will evaluate the impact on practice of the DH consent forms and consider the best approach to promoting quality consent processes (including documentation) in the future. In the interim, Trusts are free to develop their own documentation, including their consent forms (using the DH model form if they so wish), to reflect the current legal position and reflect local practice as appropriate. The DH weblink below includes some advice on how legal terminology has evolved since the forms were produced, which may help in this regard.
Although the revised reference guide reflects the current legal position Trusts are advised to ensure that ALL relevant information and guidance is taken account of when establishing, reviewing or putting into practice consent policy and processes. Where Trust staff have any doubts about how the law applies to an individual case, they should seek appropriate legal advice.
NHS Litigation Authority (NHSLA)
We know that in the past Trusts have been required by the NHS Litigation Authority (NHSLA) to adhere strictly to DH model policy and forms to meet the compliance requirements of the Clinical Negligence Scheme for Trusts (CNST). Whilst still applying very strict requirements in respect of managing the risks associated with obtaining valid consent, the NHSLA now operates a more flexible approach to compliance which allows Trusts to demonstrate policy and practice on consent in a less prescriptive way. The NHSLA now requires Trusts to provide approved documentation which describes the process for managing the risks associated with consent. Approved documentation is that which has been ratified by the relevant body within the organisation as set out in its policy on procedural documents. Trusts are advised to contact their NHSLA assessor before assessment if they wish to discuss the suitability of their documentation.
The Mental Capacity Act 2005
The Mental Capacity Act (MCA) will be fully implemented on 1 October 2007. It is a wide-ranging piece of legislation and some of its provisions are relevent to consent. More details about the Act can be found on the Mental Capacity Act page. The Department of Health will amend its consent guidance and the model policy and consent forms to reflect the provisions of the MCA and details of these amendments will be available on this page.
Guidance on nominating a consultee for research involving adults who lack capacity to consent
Published: 22/02/2008
This guidance sets out how to identify an appropriate consultee for the purposes of section 32 of the Mental Capacity Act. The Act requires the researcher to take reasonable steps to identify a person who, as a result of an existing relationship with the person who lacks capacity, can advise the researcher about that person’s participation in the project. Where no such person can be identified, the Act requires another person who can provide this advice to be appointed in accordance with guidance.
Mental Capacity Act 2005: information about the transitional provisions for existing advance decisions to refuse life-sustaining treatment
Published: 22/10/2007 10:00
Information on Article 5 of the Mental Capacity Act 2005 (Transitional and Consequential Provisions) Order 2007. This relates to advance decisions to refuse life-sustaining treatment, which may have been valid under common law, but which will not comply with the new requirements in the Act that apply to life-sustaining treatment.
People who have existing advance decisions
Anyone who has already made an advance decision should check that it meets the new rules particularly if it deals with life-sustaining treatment.
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