Consent Policy

General Consent

Before you examine, treat or care for competent adult patients, you must obtain their consent.

Adults are always assumed to be competent unless demonstrated otherwise. If you have doubts about their competence, the question to ask is: “Can this patient understand and weigh up the information needed to make this decision?” Unexpected decisions do not prove the patient is incompetent but may indicate a need for further information or explanation.

Patients may be competent to make some health care decisions, even if they are not competent to make others.

Giving and obtaining consent is usually a process, not a one-off event.

Patients can change their minds and withdraw consent at any time. If there is any doubt, you should always check that the patient still consents to your caring for or treating them.

To be valid, consent must be:

• Voluntary
• Informed
• Given by someone with capacity

Can Children Give Consent For Themselves?

Before examining, treating or caring for a child, you must also seek consent.

Young people aged 16 and 17 are presumed to have the competence to give consent for themselves.

Younger children who understand fully what is involved in the proposed procedure can also give consent (although their parents will ideally be involved). In other cases, some-one with parental responsibility must give consent on the child’s behalf, unless they cannot be reached in an emergency. If a competent child consents to treatment, a parent cannot over-ride that consent. Legally, a parent can consent if a competent child refuses, but it is likely that taking such a serious step will be rare.

Children under 16 can consent if they are Gillick competent. For contraception-related decisions, refer to Fraser Guidelines (1986).

Parental responsibility may be held by guardians or local authorities. Staff should record who holds parental responsibility in the child’s notes.

Who is the right person to seek consent?

It is always best for the person actually treating the patient to seek the patient’s consent. However, you may seek consent on behalf of colleagues if you are capable of performing the procedure in question, or if you have been specially trained to seek consent for that procedure.

The person seeking consent must be competent to explain the procedure and answer questions.

What information should be provided?

Patients need sufficient information before they can decide whether to give their consent: for example, information about the benefits and risks of the proposed treatment, and alternative treatments. If the patient is not offered as much information as they reasonably need to make their decision, and in a form, they can understand, their consent may not be valid.

Patients should also be told what will happen if they decline treatment.

Consent must be given voluntarily: not under any form of duress or undue influence from health professionals, family or friends.

Does It Matter How The Patient Gives Consent?

• No: consent can be written, oral or non-verbal. A signature on a consent form does not itself prove the consent is valid – the point of the form is to record the patient’s decision, and also increasingly the discussions that have taken place.
• Non-verbal consent is only valid if the patient understands what is being proposed.

Refusal of Treatment

• Competent adult patients are entitled to refuse treatment, even when it would clearly benefit their health. The only exception to this rule is where the treatment is for a mental disorder and the patient is detained under the Mental Health Act 2007 in which case the patient can receive care or treatment relating to his mental health disorder/illness without giving consent. However, in this situation the patient still retains the right to give or refuse consent for any other care or treatment should he/she be deemed competent to do so. A competent pregnant woman may refuse any treatment, even if this would be detrimental to the foetus.

Adults Who Are Not Competent To Give Consent

Consent cannot be given on behalf of an adult who lacks capacity, but treatment may proceed if it is in their best interests.

‘Best interests’ go wider than best medical interests, to include factors such as the wishes and beliefs of the patient when competent, their current wishes, their general well-being and their spiritual and religious welfare. People close to the patient may be able to give you information on some of these factors. Where the patient has never been competent, relatives, carers and friends may be best placed to advise on the patient’s needs and preferences.

If an incompetent patient has clearly indicated in the past, while competent, that they would refuse treatment in certain circumstances (an Advance Decision to Refuse Treatment - ADRT), and those circumstances arise, you must abide by that refusal. Any ADRT regarding life-sustaining treatment in a life-threatening situation must be witnessed and signed by the patient and the witness.

Types of Consent

Consent is often wrongly equated with a patient’s signature on a consent form. A signature on a form is evidence that the patient has given consent, but is not proof of valid consent. If a patient is rushed into signing a form, on the basis of too little information, the consent may not be valid, despite the signature. Patients may, if they wish, withdraw consent after they have signed a form: the signature is evidence of the process of consent-giving, not a binding contract.

If a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment.

Implied Consent

The majority of examinations provided by health professionals are carried out under implied consent This is no longer considered best practice as staff should not rely on a patient’s apparent compliance with a procedure as a form of consent i.e. the fact that a patient lies down on an examination couch does not in itself indicate that the patient has understood what is proposed and why. For consent to be legal, the professional must demonstrate through documentation that the patient understands the process, procedure, problems and outcome. If there is an alternative to this procedure, this must also be fully discussed.

Implied consent is still acceptable for sharing information for direct care, unless the patient objects.

Verbal Consent

Verbal consent should be sought before any procedure takes place. A clear explanation of what is to be done, any risks to consider and any alternative should be discussed with the patient. The discussion which takes place should be recorded in the case notes. Written evidence of consent should include how you tested that the patient understood what was going to be done to them; this will demonstrate that informed consent was given. As with all entries to case notes, the date and time must be recorded and the entry signed.

Written Consent

There are no legal requirements in terms of specific procedures that require written consent. However, as a matter of good practice, the General Medical Council guidance states that written consent should be obtained in cases where the treatment is complex or involves significant risks and/or side effects.

It is good practice to get written consent if any of the following circumstances apply:

• the treatment or procedure is complex, or involves significant risks
• the procedure involves general/regional anaesthesia or sedation
   
• providing clinical care is not the primary purpose of the procedure
  there may be significant consequences for the patient’s employment, social or personal life
   the treatment is part of a project or programme of research

Completed consent forms should be scanned onto the patient’s EMIS notes. Any changes to a consent form, made after the form has been signed by the patient, should be clearly documented.

It will not usually be necessary to document a patient’s consent to routine and low risk procedures, such as providing personal care or taking a blood sample.

However, if you have any reason to believe that the consent may be disputed later or if the procedure is of particular concern to the patient (for example if they have declined, or become very distressed about, similar care in the past) it would be helpful to do so.

Mental Capacity Act 2005

The Mental Capacity Act 2005 provides the legal framework for acting and making decisions on behalf of individuals who lack the mental capacity to make particular decisions for themselves. Everyone working with and/or caring for an adult who may lack capacity to make specific decisions must comply with this Act.

The two-stage test for assessing capacity is:

1. Is there an impairment of, or disturbance in, the functioning of the person’s mind or brain?
2. Does that impairment mean the person is unable to make a specific decision when required?

A person is unable to make a decision if they cannot:

• Understand the relevant information
• Retain it long enough to make the decision
• Use or weigh that information
• Communicate their decision (by any means)

Where an adult patient does not have the capacity to give or withhold consent to a significant intervention, this fact should be documented in form 4, along with the assessment of the patient’s capacity, why the health professional believes the treatment to be in the patient’s best interests, and the involvement of people close to the patient. The standard consent forms should never be used for adult patients unable to consent for themselves. For more minor interventions, this information should be entered in the patient’s notes.

The Act introduced a duty on NHS bodies to instruct an Independent Mental Capacity Advocate (IMCA) in serious medical treatment decisions when a person who lacks the capacity to make a decision has no one who can speak for them, other than paid staff. The Act allows people to plan ahead for a time when they may not have the capacity to make their own decisions: it allows them to appoint a personal welfare attorney or make an Advance Decision to Refuse Treatment (ADRT).

Apparent incapacity may stem from communication barriers rather than a true lack of capacity. Reasonable adjustments, such as using visual aids or involving speech and language therapists, should be made to support the person in making their own decision wherever possible.

Occasionally, there will not be a consensus on whether a particular treatment is in an incapacitated adult’s best interests. Where the consequences of having, or not having, the treatments are potentially serious, a court declaration may be sought.

Is The Consent Given Voluntarily?

To be valid, consent must be given voluntarily and freely, without pressure or undue influence being exerted on the person either to accept or refuse treatment. Such pressure can come from partners or family members, as well as health or care practitioners. Practitioners should be alert to this possibility and where appropriate should arrange to see the person on their own in order to establish that the decision is truly their own.

Practitioners should be especially vigilant in settings where power dynamics may affect voluntariness, such as care homes, psychiatric units, or custodial environments.

Treatment of Young Children

Parental responsibility: The mother of a child, and the child’s father (if he is married to the mother) automatically have parental responsibility. If the parents are not married, the father will have parental responsibility if he acted with the mother to have his name recorded in the registration of the child’s birth and the child’s birth was registered after 1 December 2003.

An unmarried father can also obtain parental responsibility by later marrying the mother, by making a parental responsibility agreement with her, or by getting a court order. Parental responsibility can also be granted to other people by the courts, such as a legally appointed guardian.

Members of Staff are advised to check carefully and record details of parental responsibility in the child’s records. Parents and those with parental responsibility can only provide or refuse consent if they are thought to be capable and can communicate their decision. Children who are under 16 years of age can also consent or refuse treatment if it is thought that they have sufficient intelligence, competence, and understanding to fully appreciate what is involved in their treatment. This was recognised in the House of Lords in the Fraser case of 1986 which resulted in the concept of ‘Fraser Competent’.

Teenagers and Consent & Confidentiality

Teenagers who are 16 or 17 years of age are entitled to consent to their own treatment. Their consent is treated as if they were adults under the Family Law Reform Act 1969. However, in rare cases, their refusal may be overridden by a court if it is in their best interests.

Who Is Responsible for Seeking Consent?

The health professional performing the procedure is legally responsible for ensuring that the patient has given valid, informed consent. This includes confirming that the patient understands the nature, purpose, benefits, and risks of the procedure.

IMCA Service in Somerset

Independent Mental Capacity Advocacy (IMCA) is a type of advocacy service introduced by the Mental Capacity Act 2005. The service came into effect in April 2007.

IMCAs support and represent people who lack capacity (possibly due to a learning disability, dementia, acquired brain injury or mental health condition) and who have no appropriate person to support them when major, potentially life-changing decisions are being made.

In Somerset, the IMCA service is provided by:

• Swan Advocacy
• Website
• Phone: 0844 800 1041