General Consent
When Do Health Professionals Need Consent From Patients?
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.
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.
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.
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.
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.
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
- No-one can give consent on behalf of an incompetent adult. However, you may still treat such a patient if the treatment would be 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 refusal’), and those circumstances arise, you must abide by that refusal. Any ‘advance refusal’ 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.
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 (the term ‘risk’ is used throughout to refer to any adverse outcome, including those which some health professionals would describe as ‘side-effects’ or complications’)
The guidance on best practice applies especially to:
- Minor surgery performed under local anaesthesia.
- the provision of clinical care is not the primary purpose of the investigation or examination eg videoing of consultation for education and training
- there may be significant consequences for the patient’s employment, social or personal life.
- the treatment is part of research programme
Mental Capacity Act 2006
The Mental Capacity Act 2005 (the Act) provides the legal framework for acting and making decisions on behalf of individuals who lack the mental capacity to make particular decisions for them. Everyone working with and/or caring for an adult who may lack capacity to make specific decisions must comply with this Act when making decisions or acting for that person, when the person lacks the capacity to make a particular decision for themselves. The same rules apply whether the decisions are life-changing events or everyday matters.
For mental capacity principles, assessments, best interests, restraint & deprivation of liberty information please refer to Policy for Mental Capacity Procedures to follow when patients lack capacity to give or withhold consent
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 (form for adults who are unable to consent to investigation or treatment), 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 Mental Capacity 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 to make health and social care decisions, including medical treatment, on their behalf or to make an advance decision to refuse medical treatment. Further guidance is available in the Mental Capacity Act (2005) Code of Practice.
An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than genuine incapacity. You should involve appropriate colleagues in making such assessments of incapacity, such as specialist learning disability teams and speech and language therapists, unless the urgency of the patient’s situation prevents this. If at all possible, the patient should be assisted to make and communicate their own decision, for example by providing information in non-verbal ways where appropriate.
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.
When people are seen and treated in environments where involuntary detention may be an issue, such as prisons and mental hospitals, there is a potential for treatment offers to be perceived coercively, whether or not this is the case. Coercion invalidates consent, and care must be taken to ensure that the person makes decisions freely. Coercion should be distinguished from providing the person with appropriate reassurance concerning their treatment, or pointing out the potential benefits of treatment for the person’s health. However, threats such as withdrawal of any privileges, loss of remission of sentence for refusing consent or using such matters to induce consent may well invalidate the consent given, and are not acceptable.
Written 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. Similarly, if a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment. 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.
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 term ‘risk’ is used throughout to refer to any adverse outcome, including those which some health professionals would describe as ‘side-effects’ or ‘complications’)
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.
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’ :-Refer to Fraser Guidelines (1986)
Teenagers and Consent & Confidentiality
Teenagers who are 16 or 17 years of age are entitled to consent to their own treatment.
Who Is Responsible For Seeking Consent?
The health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done: it is they who will be held responsible in law if this is challenged later.
Where oral or non-verbal consent is being sought at the point the procedure will be carried out, this must be done by the health professional responsible.
IMCA Service In Salford
Independent Mental Capacity Advocacy (IMCA) is a new type of advocacy service introduced by the Mental Capacity Act 2005. They can be accessed through Mind in Salford
