The purpose of this protocol is to set out the practice’s approach to consent and the way in which the principles of consent will be put into practise. It is not a detailed legal or procedural resource due to the complexity and nature of the issues surrounding consent.
Where possible, a clinician must be satisfied that a patient understands and consents to a proposed treatment, immunisation or investigation. This will include the nature, purpose, and risks of the procedure, if necessary by the use of drawings, interpreters, videos or other means to ensure that the patient understands, and has enough information to give ‘Informed Consent’.
Implied consent will be assumed for many routine physical contacts with patients. Where implied consent is to be assumed by the clinician, in all cases, the following will apply:
- An explanation will be given to the patient what he / she is about to do, and why.
- The explanation will be sufficient for the patient to understand the procedure.
- In all cases where the patient is under 18 years of age a verbal confirmation of consent will be obtained and briefly entered into the medical record.
- Where there is a significant risk to the patient an “Expressed Consent” will be obtained in all cases (see below).
Expressed consent (written or verbal) will be obtained for any procedure which carries a risk that the patient is likely to consider as being substantial. A note will be made in the medical record detailing the discussion about the consent and the risks. A consent form will be used for the patient to express consent for minor surgery.
- Consent (Implied or Expressed) will be obtained prior to the procedure, and prior to any form of sedation.
- The clinician will ensure that the patient is competent to provide a consent (16 years or over) or has “Fraser Competence” if under 16 years. Further information about Fraser Competence and obtaining consent for children is set out below.
- Consent will include the provision of all information relevant to the treatment.
- Questions posed by the patient will be answered honestly, and information necessary for the informed decision will not be withheld unless there is a specific reason to withhold. In all cases where information is withheld then the decision will be recorded in the clinical record.
- The person who obtains the consent will be the person who carries out the procedure (i.e. a nurse carrying out a procedure will not rely on a consent obtained by a doctor unless the nurse was present at the time of the consent).
- The person obtaining consent will be fully qualified and will be knowledgeable about the procedure and the associated risks.
- The scope of the authority provided by the patient will not be exceeded unless in an emergency.
- The practice acknowledges the right of the patient to refuse consent, delay the consent, seek further information, limit the consent, or ask for a chaperone.
- Clinicians will ensure that consents are freely given and not under duress (e.g. under pressure from other present family members etc.)
- No alterations will be made to a Consent Form once it has been signed by a patient.
- If a patient is mentally competent to give consent but is physically unable to sign the Consent Form, the clinician should complete the Form as usual, and ask an independent witness to confirm that the patient has given consent orally or non-verbally.
Other aspects which may be explained by the clinician include:
- Details of the diagnosis, prognosis, and implications if the condition is left untreated.
- Options for treatment, including the option not to treat.
- Details of any subsidiary treatments (e.g. pain relief).
- Patient experiences during and after the treatment, including common or potential side effects and the recovery process.
- Probability of success and the possibility of further treatments.
- The option of a second opinion.
Informed consent must be obtained prior to giving an immunisation. There is no legal requirement for consent to immunisation to be in writing and a signature on a consent form is not conclusive proof that consent has been given, but serves to record the decision and discussions that have taken place with the patient, or the person giving consent on a child’s behalf.
Consent for Children
Everyone aged 16 or more is presumed to be competent to give consent for themselves, unless the opposite is demonstrated. If a child under the age of 16 has “sufficient understanding and intelligence to enable him/her to understand fully what is proposed” (known as Fraser Competence), then he/she will be competent to give consent for him/herself. Young people aged 16 and 17, and legally ‘competent’ younger children, may therefore sign a Consent Form for themselves, but may like a parent to countersign as well.
For children under 16 (except for those who have Fraser Competence as noted above), someone with parental responsibility should give consent on the child’s behalf.