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 nature and complexity 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, as well as the nature, purpose, benefits and risks of the procedure. Drawings, interpreters, videos or other means may be used to help ensure that the patient understands the situation, 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 with regards to what the clinician 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 entered into the medical record.
- Where there is a significant risk to the patient, “Expressed Consent” is to be obtained in all cases
Expressed consent (written or verbal) will be obtained for any procedure which carries a risk that the patient is likely to consider substantial. A note will be made in the medical record detailing the discussion about the consent given and the risks of the procedure. A Consent Form (available in EMIS) may be used for the patient to express consent which should then be attached to the clinical record.
- Consent (Implied or Expressed) will be obtained prior to any procedure
- The clinician will ensure that the patient is competent to provide a consent (i.e. is 16 years old or over) or has “Gillick Competence” if under 16 years. Further information about Gillick Competence and obtaining consent for children is available within the Gillick and Fraser Guidance Policy
- 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, this would be extremely rare. 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’s consent 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 use a Consent Form where procedures carry a degree of risk and for all minor surgery or where, for other reasons, they consider it appropriate to do so (e.g. malicious patients)
- Other aspects which may be explained by the clinician include:
- Details of the diagnosis, prognosis, and implications if the condition is left untreated
- All 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 the need for further treatments
- The option of a second opinion
- No alterations can be made to a Consent Form once it has been signed by a patient or legal representative
- Clinicians will ensure that consents are freely given and not under duress (e.g. under pressure from other present family members etc.
- 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
- A GP Partner may sign for some procedures in the best interest of a patients lacking capacity, e.g. ‘Proxy Online Access for Care Home staff’ to enable the care home staff to order repeat medication
- Admin staff must routinely obtain consent prior to releasing or sending any medical information outside of Business as usual procedures*. All staff can refer to the Practice specific forms for consent, examples include: consent to use an email address for correspondence, consent to allow family members access to medical records. All forms are held within the Practice shared drive and / or EMIS system. All forms should be accompanied by proof of ID which should be photographic
- In the rare event that written consent cannot be obtained (e.g. patient is poorly and cannot attend) staff must always ensure that three security questions are asked with answers that we would reasonably expect only the patient would be able to answer. Questions such as the last GP they saw, the date of the appointment or a repeat medication / when it was last issued should be answered satisfactorily before obtaining verbal consent from the patient. Staff must always record every step taken within the EMIS record to evidence best interest intentions
- Any queries regarding the above should be directed to the patients GP or our Caldicott Guardian, Dr Sam Campbell
Informed consent must be obtained prior to giving an immunisation. There is no legal requirement for consent for immunisation to be in writing, and a signature on a consent form is not conclusive proof that consent has been given. Recording of verbal consent within EMIS serves to record the decision and discussions that have taken place with the patient, or the person giving consent on a child’s behalf. Only those with parental / legal guardianship may attend and consent for a child to have a vaccination. Grandparents or sibling may not bring children on behalf of parents without prior written and checked consent from the legal guardian
Consent for children
Everyone aged 16 or over 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 Gillick Competence), then he/she will be judged 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 they may like a parent to countersign as well. Further information about Gillick Competence and obtaining consent for children is available within the Gillick and Fraser Guidance Policy. For children under 16 (except for those who have Gillick Competence as noted above), someone with parental responsibility should give consent on the child’s behalf by signing accordingly on the Consent Form.
Concerns over consent for adults and vulnerable patients
Any concern regarding a patients competency to give consent should be raised with the patients regular GP or our Caldicott Guardian, Dr Sam Campbell. All clinicians should be adequately trained to deal with capacity / consent capabilities. Clinicians can seek further guidance by reviewing the NICE guidance for The Mental Capacity Act (MCA) and DoLS available on our intranet, GP Team Net.
Consent for medical forms / reports and SAR’s
When we receive requests for medical reports / letters / Subject Access Requests there must be an accompanying explicit consent form in line with GDPR May 2018. The Consent form should:
- Be clear and legible
- Include full name, date and signature
- Clearly express what exactly the patient is consenting to and whether they wish to see anything prepared before it is sent to a third party or solicitor etc
- Be appropriate for the request e.g. if a solicitors wants information relating to a RTA but the consent form gives access to the whole records from birth then this must be challenged and confirmed as necessary with the patient
- Staff will need to use our consent forms if the form received is not appropriate or legible before proceeding with the request
- If the competency of the patient is in question or a member of staff suspects coercion they can raise this with the Practice Caldicott guardian, Dr S Campbell or our SIRO, Dr A Larkin before proceeding with the request
- Parents cannot automatically make requests / sign consent for children over the age of 16 years or / and in line with the competency guidance above
Reviewed & updated 11.05.2022 MJ (V2) / Review due: 11.05.2024 or as needed