GPs can leave themselves vulnerable to criticism if they fail to take proper consent, or fail to properly record the consent process. In order to properly consent to treatment, patients must be given enough information to make an informed choice, so the explanation given to and understood by the patient is crucial.
Here we address some of the common questions GPs ask about obtaining valid consent, providing information about risks and getting consent from patients who lack capacity.
How can I ensure consent is valid?
The GMC makes it clear in its publication Consent: doctors and patients making decisions together (2008) that it is the responsibility of the doctor undertaking the investigation or providing the treatment to discuss it with the patient. This means explaining to patients in non-technical language the nature, purpose and risks of the proposed procedure. If the treatment is difficult to understand, it may be helpful for you to use drawings, diagrams and models. If necessary, an interpreter should be there to make sure the explanation is given in a language the patient understands.
You may ask patients to sign a consent form for certain procedures such as minor surgery, but this is of secondary importance to the consent discussion, although it may be useful evidence if a complaint or claim arises.
Do I have to get consent for every procedure?
For many contacts between GPs and patient, it may be safe to assume consent is implied – for example, to a blood pressure check when a patient rolls up his/her sleeve. It is however, good practice to explain to the patient what you propose to do and why. It may seem obvious to you, but it may not be to the patient.
You should get the patient’s express (oral or written) consent for any procedure that carries significant risk, such as a joint injection. It is usually better to get written consent for procedures undertaken in general practice such as vasectomies. It is important to note down the key points of the consent discussion in the clinical records.
At what point should I get consent?
You should get the patient’s consent before undertaking a procedure. The specific timing of taking consent is not set, but it can be helpful to discuss plans in advance of the procedure itself. In minor surgery, for example, you might discuss the intended procedure during the clinic consultation and you might provide the patient with an explanatory leaflet to take away with them.
In that way you allow the patient a reasonable interval (a ‘cooling-off’ period) between getting consent and the procedure itself. Failure to give a patient enough time or information to make a decision about a procedure could mean the patient has not given consent.
You should confirm consent with the patient before beginning any treatment or procedure.
Who can obtain consent?
The person who discusses the procedure with the patient should, whenever possible, be the person who carries out the procedure. If that is not possible, then consent should be obtained by someone who is appropriately qualified and familiar with all the details and risks of the procedure, and any alternatives. If you have not taken consent yourself it is good practice to confirm the consent before proceeding.
What is the medico-legal definition of duress?
Consent must be freely given, and it may not be valid if given under any form of duress – for example, if the patient is subjected to undue influence from parents or other relatives. Particular care needs to be taken in seeking the consent of prisoners, or those under arrest or police investigation, to ensure that this is freely given.
What risks do you need to warn the patient about?
You will normally want to discuss any side effects, complications and other risks with patients to enable them to make informed decisions. The amount of information you discuss with the individual patient will depend upon their condition, general health and other circumstances, but will range from common but minor side effects to rare but serious adverse outcomes. You should tell patients about side effects that are particularly relevant to their case – for example, an increased chance of infection when removing a skin lesion in a patient with poorly controlled diabetes.
You should share information in a way that the patient can understand and whenever possible in a place and at a time when they are best able to understand and retain it.1
How can I help patients to make a decision? Should a GP try to make it easier for patients to make decisions for their care, eg by using simple language?
The ability of a patient to make a decision about whether to consent to a particular treatment can depend on various things such as capacity, the nature of the condition or the complexity of the decision. It is important to try and maximise their decision-making ability by providing information in various ways. A patient may not understand or retain all the necessary information at one consultation. Discussion with other healthcare professionals and family members may aid the patient’s understanding.
How can I assess whether the patient has capacity?
In England and Wales the law in relation to adults who lack capacity to make decisions on their own is laid down in the Mental Capacity Act 2005 (MCA). One of the five legal principles that underpin the MCA is the presumption that every adult patient has the capacity to make decisions about their care, unless it is established that he or she lacks capacity.
A patient can be found to lack capacity to consent if he or she is unable to:
· Understand the information relevant to the decision, including information about the reasonably foreseeable consequences of deciding one way or another, or failing to make a decision
· Retain that information
· Use or weigh the information as part of the process of making a decision
· Communicate his or her decision
Assessment of the patient’s capacity must be decision-specific, based on whether the patient has capacity to make a particular decision about a particular treatment at a particular time.
If you aren’t sure whether the patient has capacity to consent, it may be helpful to seek a second opinion, such as from a senior colleague or psychiatric team. Ultimately, you may need to seek legal advice if a decision cannot be reached and your medical defence organisation can advise you.
If the patient lacks capacity, how will this affect decisions about their care?
If the patient lacks capacity, you will need to find out if anyone has been legally appointed to act on their behalf. In England and Wales, this could be a lasting power of attorney related to health and welfare or a court appointed deputy.
The MCA sets out how such decisions must be approached but the underlying principle is that all decisions should be made in their best interests. Best interests are not defined in the MCA or the accompanying Code of Practice but are taken to be wider than just medical best interests. It is important to consider the views of others who have information about the patient’s wishes, feelings and values, such as family members or carers.
What if I disagree with the relatives about best interests?
Sometimes you may not share relatives’ views about the best interests of your patient. When there is a difference of opinion it is important to carefully explore the reasons underlying the relatives’ views and to sensitively explain your position.
Involve others who care for the patient where appropriate e.g. nursing home staff. It can often be helpful to obtain a second opinion from a colleague at your practice or a relevant specialist. Ultimately you cannot be compelled to provide treatment you consider to contravene a patient’s best interests but it is usually better for all concerned if agreement can be reached.
How can care plans improve the quality and outcomes of care for patients who lack capacity to consent?
If you are treating a patient who is likely to lose capacity it is important to discuss with them options regarding their future care. Patients need to know that they can plan their future care and formalise their wishes in an advance decision or by nominating someone to make decisions for them.
If the patient lacks capacity, you should check whether there are already any existing arrangements in place, such as an advance decision or lasting power of attorney.
Advance decisions only allow for patients to refuse future treatments. There is no corresponding legal right to demand specific treatments; however, it is important to consider a patient’s positive statement requesting treatment when assessing the patient’s best interests. It is helpful to record any advance care plan discussions and decisions made. The GMC advises this should be shared with the patient and others involved in their care (provided the patient agrees). 2
How much information should I record?
Records can provide crucial evidence if there is a dispute about consent. Keeping clear, detailed contemporaneous notes of conversations that you have with your patients about the consent process can help in the event of a complaint or claim. It is especially important to be able to demonstrate that a particular complication or risk was clearly explained to the patient.
GMC guidance states that the medical record or consent form ‘should include information discussed, any specific requests by the patient, any written, visual or audio information given to the patient and details of any decisions that were made’.3
What if a relative/carer complains about the treatment of a patient lacking capacity?
Ordinarily if you receive a complaint from someone other than your patient, you should get the patient’s consent to respond to the other party. It is important to remember that capacity is time and decision specific so whilst your patient may not have capacity to make decisions about complex medical treatment they may have capacity to consent to a relative or carer dealing with a complaint on their behalf. If, however, the patient lacks capacity you should proceed in their best interests.
Provided your patient has not previously expressed a wish that you do not communicate with their relative or carer, it will usually be appropriate to respond to the concerns.
Dr Caroline Fryar is a medico-legal adviser for the Medical Defence Union.
1 GMC. Consent: Patients and doctors making decisions together, paragraph 18. 2008
2 GMC. Treatment and care towards the end of life, paragraph 61. 2010
3 GMC. Consent guidance, paragraph 51.