The principles of informed consent

Every clinical interaction involving a patient who has capacity rests upon a foundation of consent. Ms Diane Baylis, Clinical Risk Educator at Medical Protection, explores the principles of consent and provides advice on how to obtain valid consent from patients

With a proliferation of litigation in clinical negligence there has been a paradigm shift in the relationship between patients and practitioners from one of paternalism to a more equal one of shared responsibility. In the current healthcare climate, patients are generally much more involved in making decisions about their treatment, have a higher degree of autonomy and work in partnership with their doctor.

The practice of seeking informed consent has evolved from simply asking the patient for permission to carry out a procedure, to a complex engagement between doctor and patient.

A failure to obtain adequate consent could result in a clinical negligence claim, a complaint to the Medical Council or even civil or criminal proceedings for assault.

The Medical Council reinforces the importance of gaining consent stating: “You must make sure that patients have given their consent before you provide any medical investigation, examination or treatment.”

Conversely it is also important to remember that every adult with capacity is entitled to refuse medical treatment. Clinicians should respect a patient’s decision to refuse treatment, even if they disagree with that decision.
A signed consent form is not a legal requirement (with rare exceptions, for example, some treatments under the Mental Health Act 2001).

The presence of a signed consent form does not in itself prove that valid consent for a treatment was obtained. It simply documents that some discussion about the procedure or investigation has taken place. Consent forms are evidence of a process, not the process itself.

Informing patients and recognising their capacity

Firstly, for consent to be valid the patient must have the capacity to make the decision in hand. The patient must have sufficient knowledge and information on which to base a decision. Provision of information is key to obtaining valid consent.

Unless patients have sufficient information, they are not in a position to decide what is best for them. Discussion of all the issues surrounding a proposed investigation or treatment, and possible alternatives, is an integral part of the patient’s clinical care. These discussions may take place over several consultations, all forming part of the consent process.

The quality and clarity of the information given is the paramount consideration. The information provided should include:

• Aim of procedure/ treatment.
• Risks and benefits.
• Alternatives – which could include doing nothing, if appropriate.
• What the procedure entails.

There should be no coercion; in other words, consent must be voluntary. Patients should, wherever possible, be given time to consider their options and an opportunity to ask any questions before deciding to proceed with a proposed treatment.

With consent, the issue of capacity should be considered. The Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Professionals states:

“Adults who are considered not to have the capacity to make a decision are entitled to the same respect for their dignity and personal integrity as anyone with full capacity. You should seek and listen to their views, and involve them in decisions about their healthcare to the extent that they are willing and able to be involved.

Provision of information is key to obtaining valid consent. Unless patients have sufficient information, they are not in a position to decide what is best for them

“A lack of capacity may arise from a long-term or permanent condition or disability, or from short-term illness or infirmity. A person lacks capacity to make a decision if they are unable to understand, retain, use or weigh up the information needed to make the decision, or if they are unable to communicate their decision, even if helped.” In assessing patients’ capacity, you should consider:

• Their level of understanding and ability to retain the information they have been given;
• Their ability to apply the information to themselves and come to a decision; and
• Their ability to communicate their decision, with help or support, where needed.

In Medical Protection’s experience, a significant proportion of clinical negligence claims include allegations of failure to obtain valid consent. Consent rarely forms a whole claim, but it is often a significant part. In the context of a claim, the information and advice provided to the patient would be thoroughly analysed to ensure that the patient was given all the information in order to make an informed decision.

It is therefore critical that all information provided and discussed with the patient in relation to the consent process is clearly documented on the patient’s medical record as evidence that these discussions took place.
Very often we consider consent for treatment as consent for a specific procedure, for example a surgical operation or an invasive test.

It is important to highlight that consent for treatment would also include pharmacological and other therapies such as initiating a new medication. When prescribing a new medication, issues relating to the consent process such as risk and benefits of the medication, should be highlighted to the patient as well as documented in the patient’s record.

In particular, when prescribing high-risk medications such as methotrexate, lithium or warfarin, it is important to document the discussions held around the consent process including advice and agreement regarding blood monitoring and follow-up appointments. Many clinicians also highlight this important information as a footnote in the ‘special instructions’ section of the prescription.

Written consent

You should consider developing procedure-specific consent forms for the procedures that you regularly undertake, such as minor surgery and childhood immunisations at general practices for instance, which should incorporate the advice outlined above.

Medical Protection would strongly advise obtaining written consent in certain circumstances, such as:

• Where there are significant risks or side effects associated with the proposed treatment or procedure.
• Where the patient’s lifestyle, employment or personal relationships could be adversely affected by the outcome of the treatment or procedure.
• Where the treatment or procedure is being undertaken as part of a research programme.
• And where the main purpose of the proposed treatment or procedure is not the patient’s clinical care, for example cosmetic surgery.

Parental/guardian consent

A landmark legislation has increased the rights of unmarried fathers. Since 2016, an unmarried father would automatically be a guardian if he has lived with the child’s mother for 12 consecutive months, including at least three months with the mother and child after the child’s birth.

Doctors should be aware of such legislative changes and the implications for obtaining parental consent. Where parents are married, the child’s mother and father are automatically the legal guardians.

An unmarried father can become a joint guardian if both parents sign a statutory declaration agreeing to this, or he can apply to the court to be made a joint guardian. In this case the decision of whether to make the father a joint guardian is made in the best interests of the child.

Images and texting

Patient images may be shared more frequently via electronic means, more so during the current pandemic, as many doctors are undertaking remote consultations. Therefore, issues regarding consent can arise here too. It is important that the patient is made aware that you will be saving the image in their records and the possibility that it may be shared with colleagues for discussion purposes. You should obtain consent for this, and clearly document that appropriate consent has been obtained.

Text messaging is frequently used in general practice and is a cost effective and convenient way to communicate with patients. However, it is important not to assume that just because the practice holds the patient’s mobile number on the patient’s record, that they have provided consent for text messages to be sent.

Practices should only send text messages to patients when specific consent has been recorded. Patients who have consented should be advised of the importance of informing the surgery of any changes to their contact details.
In general, text messages should not be sent to children under the age of 16 as there is the added possibility of breaching patient confidentiality as text messages could be inadvertently sent to their parent’s number.

A useful document on texting, which outlines the risks and necessary safeguarding procedures, has been produced by the Irish College of General Practitioners’ quality-in-practice committee.

Conclusion

Issues regarding consent can be complex, and generate some of the most difficult issues for doctors and often form a large part of a clinical negligence claim.

For further expert advice, contact Medical Protection, or your medical defence organisation. Medical Protection members can find more information on this topic by visiting our online learning platform www.prism.medical.org.