At long last the Department of Health has issued new guidance on consent to treatment issues and revisions for consent forms following the implementation of the Mental Capacity Act 2005 (MCA).  

The guidance and revised consent forms can be found by clicking here.  

Background  

The guide serves as a useful reminder of the issues in English law involved when taking valid consent from patients. The summary has been revised to take into account the principles of assessing capacity laid out by the MCA and also sets out the obligations to instruct independent mental capacity advocates in certain circumstances, as well as reminding clinicians on how to deal with lasting powers of attorney, court-appointed deputies and applying to the Court of Protection.  

In our experience, clinical audit within many trusts suggests that healthcare professionals all too often fail to undertake the consent process properly. In addition there is still a lack of adequate note-taking and a failure to complete consent forms properly and retain them in the clinical notes. Our advice is that all those involved in clinical governance as well as healthcare professionals at all levels should study the new guidance and ensure compliance.  

Action  

Trusts are advised that the following action should be put in place immediately:  

  • Consent policies must be reviewed and updated in line with this new guidance and also to take account of recent developments in both statue and case law.
  • Trusts should revise, amend and update consent forms.  
  • Trusts should undertake a clinical audit to ensure compliance with policies and to ensure healthcare professionals are dealing with consent adequately and that forms are properly completed and retained.

Main points from the guidance  

The guidance sets out and deals with the following points:

  • The statutory test for assessing capacity.
  • Guidance on the information required to enable patients to make proper decisions.  
  • How patients should be helped to make informed judgments.  
  • The assistance required to help people, even in difficult situations, make their own decisions.  
  • To take account of decisions made in advance.  
  • Particular requirements for the retention and use of body parts, organs and tissue removed from dead patients.  
  • Living donations.  
  • The responsibility on the consultant for the consent process and the limits of delegation to junior healthcare staff.  
  • The use of verbal and non-verbal consent and the application for consent forms.  
  • The particular consent requirements for treatment which involves research or experimental processes.  
  • The use, applicability and validity of advance decisions
  • How to deal with the difficult issue of patients who self harm.  
  • Particular steps and actions to take under the MCA when a person lacks capacity including:
    • the best interests principle;  
    • the duty to consult;  
    • the importance of record keeping; and  
    • when to apply to the Court of Protection.  
  • The role, applicability and formalities of a lasting power of attorney.  
  • The role, applicability and formalities for court-appointed deputies.  
  • How to settle disputes with patients and family members over care and best interests.  
  • The role of the Independent Mental Capacity Advocate (IMCA) and the duty upon clinicians to instruct an IMCA.  
  • The role of the Court of Protection and when to seek a court order or guidance from the court.  
  • The problems of treating 16 and 17-year-olds, including:
    • their ability to consent; and  
    • steps to take and considerations when a young person refuses treatment.  
  • Treating children under 16 and “Gillick” competence.  
  • Involving family members in decisions in respect of children and young people.  
  • Steps to take when children lack capacity, particularly:
    • the welfare of the child;  
    • dealing with parental refusal;  
    • settling disputes and the role of the Court of Protection; and  
    • who has parental responsibility.  
  • Guidance on withdrawing/withholding life sustaining treatment including:
    • when to apply to the Court of Protection;  
    • applying the “best interests” principle; and  
    • avoiding deliberate action intending to cause death.  

Consent forms  

The guidance sets out advice on amending and revising consent forms. Consent forms and local policies need to take into account not only the guidance but also recent developments in the law and local issues and circumstances. There are significant changes required to Form 4 (Lack of Consent) to reflect the MCA and the role of the lasting power of attorney, the IMCA and court-appointed deputies.

When to seek legal advice and the guidance of the Court of Protection  

There are certain situations where the guidance reminds us that legal assistance is required and an application to the Court of Protection must be made:  

  • decisions to withhold or withdraw artificial nutrition and hydration from patients in a permanent vegetative state;
  • organ, bone marrow or peripheral blood stem cell donation by adults who lack capacity;  
  • cases of the non-therapeutic sterilisation of people who lack capacity (eg, for contraceptive purposes); and  
  • any time where there is doubt or dispute about whether a particular treatment is in a patient’s best interests.  

There are other situations where the guidance suggests it is wise to get legal help and an application to the court might be of assistance. These include cases involving:  

  • ethical dilemmas involving healthcare professionals and treatment (especially in untested or novel areas, eg, innovative treatments for variant CJD);
  • disputes with families and refusal of treatment involving young people (16 - 18);  
  • the applicability and the validity of advance decisions;  
  • difficult decisions where a patient’s capacity is unclear; and
  • irresolvable conflicts between healthcare staff, or between staff and family members.