Patient consent

Published on 12/06/2015 by admin

Last modified 22/04/2025

Print this page

This article have been viewed 1472 times

Patient consent

Introduction

It is a legal requirement that consent be obtained from a patient before any medical care can be provided, with the exception of emergencies where consent cannot be obtained.

Consent can take two forms: implied or express. When patients attend for low-risk procedures consent is often implied and has been taken by the referring clinician prior to the patient arriving in the radiology department on behalf of the reporting clinician, for example a chest radiograph.

Express consent is required for more complex procedures. It may be appropriate for this to take the form of verbal consent; as long as the discussion and granting of consent are documented in the patient notes, for example a nephrostogram.

The General Medical Council (GMC) requires written consent to be obtained in the following circumstances (GMC 2008):¹

• The investigation or treatment is complex or involves significant risks

• There may be significant consequences for the patient’s employment, or social or personal life

• Providing clinical care is not the primary purpose of the investigation or treatment

• The treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.

The three components of consent are: voluntariness, information and capacity. For consent to be valid consent must be voluntarily given, the patient must have information regarding the treatment concerned and must be competent to do so.

Voluntariness

Consent should be given freely without undue influence to either accept or refuse treatment. It is the responsible clinician’s duty to ensure that the patient is not under pressure from relatives or carers to consent to medical treatment. Doctors should also guard against exerting pressure on patients, especially if the patient’s wishes do not agree with their own.

It is useful to create a suitable environment to facilitate voluntary consent taking. It is good practice to take consent prior to the patient entering the operating room, as this environment places the patient under pressure and may invalidate consent.² Suitable environments, which allow privacy and sufficient time for the patient to understand the information provided and to ask questions, include outpatient clinic and ward quiet rooms.

After taking consent the patient may change their mind and decline to confirm consent at the time of the procedure. The doctor should explore the patient’s decision without being coercive and provide any support or additional information that the patient requests. The withdrawal of consent and subsequent discussion should be clearly documented in the patient’s notes.

Patients may occasionally withdraw consent during a procedure. Should this occur, the doctor should immediately stop the procedure (even temporarily) and explore the patient’s concerns. Medication or pain may affect the patient’s capacity at this time. However, if the patient wishes the procedure to end and there is no possibility of immediate harm, the patient’s wishes should be accepted as a withdrawal of consent and the procedure halted.²

Patients who are detained by the Police, Criminal Justice systems and Immigration Authorities and those detained under Mental Health legislation may be particularly vulnerable to coercion. Doctors should ensure that patients understand their rights to refuse or withdraw consent. Patients who are detained under Mental Health legislation can be treated for their mental illness and not physical illness. Where mentally ill people also lack capacity to consent to interventions, the advice below should be followed.

Information

The GMC advises that doctors discuss these matters with patients, encourage them to ask questions, listen to their concerns and ask for and respect their views.

Importantly, when providing information about risks, doctors should include all significant risks, however unlikely. Furthermore, material information that the individual is likely to attach meaning to because of their unique circumstances should also be provided. For example, the risk of losing kidney function following renal artery stenting is of particular risk in a patient with a single kidney, however small that risk may be. Doctors who omit this information leave themselves vulnerable to ‘Failure to warn’ litigation charges.

Visual aids depicting risk are helpful in clarifying numerical data. These may be produced within departments or doctors may use smartphone applications.

Information literature should be clear and concise and designed for patients.² Many radiologists make use of patient information booklets compiled by professional societies such as the RCR, CIRSE and BSIR, which go some way to providing standardized complication rates for common procedures.

• http://www.cirse.org/index.php?pid=612,

• http://www.rcr.ac.uk/content.aspx?PageID=323

• http://www.bsir.org/content/PatientsHome.aspx

Capacity

The Mental Capacity Act 2005 of England is underpinned by five statutory principles:

• All persons are assumed to have capacity unless the contrary is demonstrated

• All practicable steps must be taken to assist the person in making a decision

• The person should not be considered to lack capacity if they choose to make an unwise decision

• Any decision made or act done under this Act on behalf of a person lacking capacity should be in that person’s best interests

• Any act done or decision made should be the least restrictive possible that would ensure a good outcome.

The Adults with Incapacity (Scotland) Act has similar requirements and includes an expectation that interested parties should be consulted and that incapacitated people are encouraged to use existing skills.

The legislation together with the GMC guidelines require doctors to assume that patients have the capacity to accept or decline a treatment or intervention, unless the doctor has demonstrated and documented that the person lacks capacity.

Assessment of capacity

It is important to remember that capacity is not generalized. Capacity assessments aim to establish whether the person in question has capacity to make a specific decision at a specific time. Someone may have the capacity to consent to have their nightclothes changed on the ward, but not to the siting of a PICC line, as the process of the latter is more complex and requires greater mental processing abilities to evaluate risks and benefits.

In order to undertake a capacity assessment, a two-stage test of capacity should occur.

1. Does the person have an impairment (of mind or brain) or is there a disturbance affecting the way their mind or brain works?

2. If so, does the impairment mean that the person is unable to make the decision at the time needed?

An assessment of capacity need only be undertaken if there is a doubt about the person’s mental functioning at the time.

In order to assess capacity, the following need to be evaluated (Mental Capacity Act 2005: Code of Practice):⁵

• Does the person have a general understanding of what decision they need to make and why they need to make it?

• Does the person have a general understanding of the likely consequences of making or not making this decision?

• Is the person able to understand, retain, use and weigh up the information relevant to this decision?

• Can the person communicate their decision (by talking, using sign language or other means)? Would the services of a professional (such as a speech and language therapist) be helpful?

• And in more complex or serious decisions: Is there a need for a more thorough assessment (perhaps by involving another professional expert)?

Patients are deemed to lack capacity if they cannot:

• Understand information about the decision to be made (the Act calls this ‘relevant information’)

• Retain that information in their mind

• Use or weigh that information as part of the decision-making process, or

• Communicate their decision (by talking, using sign language or any other means).

Only one of the above needs to be absent for the person to lack capacity, although more than one is often present.

Capacity to consent is best established by the clinician offering the proposed intervention, as they will have sufficient knowledge of the risks and benefits involved. For more complex procedures or where there is an underlying illness contributing to difficulties in reasoning (e.g. dementia) it may be of benefit to work in collaboration with expert colleagues (e.g. psychiatrists).

Supporting patients to make decisions

Before a patient can be deemed to lack capacity to consent to a procedure, all practicable steps should be taken to support the person to make the decision. Making use of images or visual aids, involving family members, interpreters or other professionals may be beneficial. Where a treatment can safely be delayed to allow the person to regain capacity, this should be done.

Doctors may encounter patients who choose not to undergo treatments or procedures offered to them even though this may result in significant morbidity or death. Patients have the right to make unwise decisions and doctors should guard against coercion.⁶

In these cases all discussions with the patient, a comprehensive and contemporaneous documentation of the capacity assessment and consent procedure should be entered into the patient’s medical notes. The RCR recommends that in these cases the notes are witnessed by a third party.² If this patient later loses the capacity to consent to a procedure, clinicians must not then perform the intervention in the patient’s best interests: under the Mental Capacity Act this would be considered a criminal offence of ill-treatment.

Acting for patients who lack capacity

When a person has been established to lack capacity to decide on treatment offered, the treating clinician may lawfully treat the patient in their best interests. Prior to proceeding, the clinician should take into consideration any previously expressed wishes. These may be formalized in Advance Statements or may be ascertained from other sources: family, carers or other professionals involved in providing care to the person previously.

Clinicians should establish if any proxy decision-makers have been appointed. Under English law a person may have designated a Lasting Power of Attorney (LPA) to make health and welfare decisions on their behalf once they no longer have mental capacity.

Note however:

• Within the health and welfare LPA agreement there is an explicit declaration made determining whether the attorney is empowered to give or refuse consent for treatments specifically deemed to be life-sustaining so clarification should be sought.

• Separate Lasting Power of Attorney arrangements can also be made for property and financial decisions but these alone do not confer any power for the attorney to make health-related decisions on behalf of the patient.

• Scottish law makes no distinction between differing powers of attorney.

When acting in a person’s best interests, clinicians should do so in the least restrictive manner possible. If less invasive alternatives exist to the preferred intervention, then these should be attempted first.

In an emergency situation where consent cannot be obtained, clinicians can act in the patient’s best interest to administer emergency treatment. Treatment should be immediate and necessary to prevent further deterioration. No further treatment may be given until a capacity and if necessary a best interest’s assessment has been undertaken.

Clinicians are directed to the MCA 2005 and Adults with Incapacity (Scotland) Act 2000 Codes of Practice for details on the roles of powers of attorney. These can be stored as PDF documents on computers or smart phones. Seeking legal advice from employment lawyers or protection societies is recommended if clinicians are unclear of how to proceed.

Documenting assessment of capacity

Most hospitals have standardized pre-printed consent forms for patients who lack capacity. In addition to completion of these forms, the authors recommend contemporaneous documentation of assessment of capacity in the patient’s notes or the relevant radiology report. Documentation should include the following information:

• Full patient details

• The details of the intended intervention

• The specific reason the patient has been deemed to lack capacity and how this judgement was reached (as above)

• Attempts that have been made to assist the patient to make his/her own decision and why these were unsuccessful

• The likelihood that the patient may regain capacity and the reason the intervention needs to be performed before this can occur

• The steps taken to establish the patient’s previously expressed wishes including the names of the family members consulted

• The names and designation of clinical colleagues consulted in deciding on the proposed intervention

• The name of the clinician responsible for performing the procedure