This document updates that issued in 2001 and provides a guide to the legal framework that all health professionals need to take account of in obtaining valid consent for any examination, treatment or care that they propose to undertake.
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. The department has been considering the future role of its guidance and has been 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 Department of Health guidance and forms.
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.
As part of our review, we will evaluate the impact on practice of the Department of Health 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. These documents include 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.