When should consent be taken?
For many elective procedures, consent is taken in the outpatient department weeks or sometimes months prior to admission for surgery.
There is no specific time limit on consent taken in advance, but further questions may occur to patients, or doubts about the wisdom of their decision may creep in during the interim. Patients’ conditions may also change during the intervening period, or new information about the procedure may have become available.
It is good practice, therefore, to confirm consent prior to the procedure, using this as an opportunity to find out if there have been any material changes since consent was first taken, and to ask the patient if there are any further questions. The fact that consent has been confirmed should be documented, either in the patient’s medical record or as a (signed and dated) supplementary note on the original consent form.
The fact that consent has been confirmed should be documented, either in the patient’s medical record or as a (signed and dated) supplementary note on the original consent form
As a general principle of good practice, if the treatment is not urgent, patients should be given plenty of time to think about their options before they consent to treatment and be encouraged to ask further questions. The commentary delivered by Mr Justice Kearns in a Supreme Court case18
confirms this view (see Appendix 1
, Fitzpatrick V White
 IESC 51).
Implied and express consent
Consent is often implied by the patient’s compliance
Patients undergoing invasive procedures will normally give express consent – either by signing a consent form or stating that they agree to go ahead with treatment. Written consent should always be taken where:
- There are significant risks or side effects associated with the proposed treatment or procedure.
- The patient’s lifestyle, employment or personal relationships could be adversely affected by the outcome of the treatment or procedure.
- The treatment or procedure is being undertaken as part of a research programme.
- The main purpose of the proposed treatment or procedure is not the patient’s clinical care.
However, consent is often implied by the patient’s compliance, an obvious example being when a patient rolls up a sleeve so that a blood sample can be taken. Nevertheless, patients should be told about the nature and purpose of any examination, investigation or procedure beforehand.
Any discussions with patients about the risks and benefits of a proposed procedure or treatment should be documented in the medical record.
Patient information leaflets
Numerous studies have shown that patients retain comparatively little information given to them during a consultation, particularly if they are anxious or in pain. Many patients find it helpful if they are given written information as a reminder of the key points discussed. However, written information is not a substitute for detailed discussion with patients and must be seen as an adjunct to, not a replacement for, that discussion. If information leaflets are used to augment discussion with a patient, this should be documented in the patient’s notes.
Mr S attends the A & E department of his local hospital with a severe allergic reaction thought to be from an insect bite. In addition to topical applications, he is given antihistamines. The following day he is involved in a road traffic accident, having failed to stop at a road junction. He claims that he was not informed that the medication could cause drowsiness and that it would be inadvisable for him to drive.
But the doctor at the hospital is adamant that appropriate warnings were given. However, these were not recorded in the notes. Mr Sykes subsequently makes a claim and the hospital’s solicitors advise settlement as they would be unable to prove that appropriate warnings were given.
Recording consent and consent forms
Apart from certain treatments carried out under the Mental Health Act 2001, there is no legal requirement to obtain written consent, but it is generally considered good practice to make some record of the consenting process.
Most health organisations, including public hospitals, independent hospitals, clinics and general practices, have policies stipulating when written consent should be obtained. Employees are expected to be familiar with these and adhere to them.
The presence of a signed consent form does not in itself prove valid consent to treatment
The presence of a signed consent form does not in itself prove valid consent to treatment – the important factors will always be the quality, extent and accuracy of the information given beforehand. Being able to demonstrate this afterwards depends on contemporaneous notes recording the key points discussed and relevant warnings given to the patient.
“Every adult with capacity is entitled to refuse medical treatment. You must respect a patient’s decision to refuse treatment, even if you disagree with that decision. In these circumstances, you should clearly explain to the patient the possible consequences of refusing treatment and offer the patient the opportunity to receive a second medical opinion if necessary.”19
Doctors cannot override a patient’s refusal of treatment simply because they think it is a foolish or illogical decision
Consent law would be completely pointless if it did not protect a patient’s right to refuse treatment. Doctors cannot override a patient’s refusal of treatment simply because they think it is a foolish or illogical decision. But neither can clinicians disregard patients who choose not to take their advice.
If the patient is not giving clear reasons for refusing the proposed treatment, it may be worth probing a little further to find out whether he/she is harbouring hidden fears and anxieties that could be assuaged with further information and discussion. Any such discussion, however, must be conducted sensitively and respectfully, otherwise it could be construed as coercion.
Occasionally, it may be appropriate to assess the patient’s capacity, but the patient’s refusal should never, in itself, be taken as evidence of lack of capacity. If the patient is capable, he/she should be given all material information to ensure that the refusal is truly informed. Available alternatives should then be offered, with a reminder that the patient can change his/her mind.
Mrs D is 42 and has recently discovered a lump in her breast. She is told that malignancy cannot be excluded and an urgent referral to a specialist is required. She asks the GP to defer the referral, however, explaining that her daughter is currently preparing for important exams in five weeks’ time and she does not want to cause her any anxiety.
Dr F, her GP, cannot understand how she can take such a risk but it is clear on talking to her that she fully understands the implications of her decision. Dr F records his findings along with Mrs D’s reasons for not agreeing to an immediate referral.