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 link 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 link 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.

The Reference Guide should be read in conjunction with the Consent Policy.

Last updated: September 2, 2010