Informed Consent in Healthcare: How to Get It Right and Avoid a Complaint

What Is Informed Consent in Healthcare?

Informed consent is the process by which a patient gives voluntary agreement to a proposed treatment or procedure after receiving all the information they need to make a decision. It is not simply a form to be signed. It is an ongoing dialogue between the practitioner and the patient in which information is shared, questions are answered, and the patient's autonomous decision is respected.

For consent to be valid, three conditions must be met:

• Capacity — the patient must have the mental capacity to understand, retain, weigh up, and communicate a decision about the proposed treatment
• Information — the patient must have been given sufficient information about the treatment, its material risks, the expected benefits, any reasonable alternatives, and the option to do nothing
• Voluntariness — the consent must be given freely, without pressure, coercion, or undue influence from anyone

If any of these elements is missing, the consent is not valid. Proceeding with treatment without valid consent may constitute assault or battery in criminal law, negligence in civil law, and a breach of professional standards that can lead to regulatory action by your regulator.

The Montgomery Ruling: A Turning Point for Informed Consent

The Supreme Court's decision in Montgomery v Lanarkshire Health Board (2015) fundamentally changed the law on informed consent in the UK. Before Montgomery, the legal standard was based on what a reasonable body of medical opinion would consider appropriate to disclose — the so-called Bolam test. This meant doctors effectively decided what patients needed to know.

Montgomery replaced this with the "reasonable patient" standard. A risk is now considered material — and must be disclosed — if a reasonable person in the patient's position would be likely to attach significance to it, or if the doctor is or should reasonably be aware that this particular patient would consider it significant.

In practical terms, this means:

• You must disclose all material risks — not just the ones you think are important, but those the patient would consider important
• You must discuss reasonable alternatives — including the option of no treatment
• You must tailor the conversation to the individual patient — what matters to one patient may not matter to another
• You must ask questions — to find out what the patient cares about and what might influence their decision

The GMC's Seven Principles of Consent

In 2020, the GMC published updated guidance on Decision Making and Consent, setting out seven principles that all doctors must follow. While these are GMC principles, the NMC Code, GDC Standards, and HCPC Standards contain equivalent requirements. These principles apply to every regulated healthcare professional.

All patients have the right to be involved in decisions about their treatment and care, and to be supported to make informed decisions if they are able to do so.

Consent is not a one-off event. It is a continuing process of dialogue that should happen at every stage of the patient's care. Patients can change their minds at any time.

You must share all relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.

You must try to find out what matters to the individual patient so you can tailor the information you share and support them in making a decision that reflects their values and preferences.

Doctors and patients should work together to make decisions. The doctor brings clinical expertise; the patient brings knowledge of their own values, preferences, and circumstances.

Patients can ask for a second opinion, and doctors should support this request where possible.

Patients with capacity have the right to accept or refuse any proposed treatment, even if refusal may result in harm or death. This right must be respected.

Consent, Capacity, and the Mental Capacity Act

Assessing capacity is a fundamental part of the consent process. The Mental Capacity Act 2005 (applicable in England and Wales, with equivalent legislation in Scotland and Northern Ireland) provides the legal framework. The Act establishes five key principles:

1. Presumption of capacity — every adult is presumed to have capacity unless it is established otherwise
2. Support to make decisions — a person must be given all practicable help to make a decision before being treated as unable to do so
3. Unwise decisions do not mean lack of capacity — a person is not to be treated as lacking capacity merely because they make a decision that others consider unwise
4. Best interests — any decision made on behalf of a person who lacks capacity must be in their best interests
5. Least restrictive option — any intervention should be the least restrictive of the person's rights and freedoms

A person lacks capacity if they are unable to understand the information relevant to the decision, retain that information, use or weigh that information as part of the decision-making process, or communicate their decision. Capacity is decision-specific and time-specific — a person may have capacity for one decision but not another, and capacity can fluctuate.

Documentation: Protecting Yourself and Your Patients

Thorough documentation of the consent process is essential. In the event of a complaint, a claim, or fitness to practise proceedings, your medical records are your primary evidence that consent was properly obtained. Your documentation should include:

• What information was provided — including the diagnosis, proposed treatment, material risks, benefits, and alternatives
• How the information was tailored — noting any specific concerns or preferences the patient raised
• That the patient had capacity — and, if capacity was assessed, how the assessment was conducted
• That consent was voluntary — the patient was not under pressure from anyone
• Questions and answers — any questions the patient asked and how they were addressed
• Written materials provided — if you gave the patient leaflets, links, or other resources
• The form of consent — whether consent was written, verbal, or implied

Remember that a signed consent form alone does not prove that valid informed consent was obtained. The form is evidence that a process occurred, but the quality of the conversation that preceded the signature is what truly matters.

If it is not documented, it did not happen. That is the standard by which regulators and courts assess consent. The five minutes you spend documenting a consent conversation can save your career if a complaint is made years later.

Common Consent Failures That Lead to Complaints

Understanding where consent goes wrong helps you avoid the most common pitfalls. The following consent failures frequently appear in fitness to practise proceedings and negligence claims:

• Failure to disclose material risks — particularly risks the patient would have considered significant in their individual circumstances
• Rushing the consent process — obtaining consent immediately before a procedure without giving the patient time to consider the information
• Using jargon — failing to explain risks and options in language the patient can understand
• Not documenting the discussion — relying on the consent form alone without recording the substance of the conversation in the clinical notes
• Not checking understanding — assuming the patient has understood without asking them to confirm
• Not offering alternatives — failing to discuss reasonable alternative treatments, including doing nothing
• Not using a chaperone — failing to offer a chaperone during intimate examinations, leading to boundary-related complaints
• Proceeding without reassessing consent — when circumstances change during a procedure or treatment plan

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