Legal changes to informed consent and application to clinical practice in surgery

Abstract

For consent to be fully informed, it must be tailored to each patient, who must be appraised of alternative treatments (including that of no treatment) and informed of the material risks which an individual would wish to know and consider significant. This also includes Covid-19 related risks. Whilst surgeons had at times to offer sub-optimal treatments due to pressures caused by the pandemic, patients should still be given the choice to delay their treatment. Consent obtained remotely via digital technology must comply with the same requirements as in a face-to-face setting.

Where we stand

Informed consent is an ethical and legal requirement which is one of the several key principles within the Good Medical Practice (Table 1) ¹ Every patient has the right to be involved in the decision-making process about their care and the doctor has to explain in clear terms all the information the patient needs to reach an informed decision. This includes: (a) diagnosis and prognosis of a pathology; (b) the proposed procedure, what it would involve and its desired outcome; (c) its risks and benefits, including the adverse effects; (d) alternative investigations and treatments; and (e) potential outcomes of taking no action.

Table 1.

The seven principles of decision-making and consent (GMC guidance – 2020). ¹

Principle 1	All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able.
Principle 2	Decision making is an ongoing process focused on meaningful dialogue: the exchange of relevant information specific to the individual patient.
Principle 3	All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.
Principle 4	Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.
Principle 5	Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements.
Principle 6	The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them.
Principle 7	Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.

Prior to 2015, the standard for disclosure of information was defined by the Bolam test, where the doctor was not considered to be negligent, if a reasonable (majority or minority) body of responsible doctors considered their practice appropriate.

The 2015 Montgomery v Lanarkshire Health Board Supreme Court ruling ² requires a doctor to take into account an individual patient’s wishes and enable them to decide which treatment to undertake after they have been informed of all material risks, namely, the risks which a reasonable patient would consider significant.

This shift to a patient-centred approach set by the Montgomery case was already the standard of care set by the General Medical Council (GMC) in 1998 and consolidated in 2008 and many years before the legal requirements set by the Supreme Court in 2015.

What Covid-19 has changed

The outbreak of the Coronavirus Disease 2019 (Covid-19) pandemic created an unprecedented strain on healthcare resources in the UK and elsewhere and resulted in doctors offering some patients sub-optimal treatments when first-line treatments were not available.

Despite the concept of “therapeutic exception” whereby doctors can withhold information that they consider may be detrimental to a patient’s health, it is still perfectly reasonable to inform patients about all treatment options, so they are able to make an informed decision whether to undergo a treatment, or to wait until a specific one they would prefer becomes available.

Table 2 highlights the material risks and complications associated with Covid-19 which the patient should know when consenting to treatment. ³

Table 2.

Considerations on consent to treatment during the Covid-19 pandemic (RCS guidance – 2020). ³

Discussion about options for treatment	Patient’s diagnosis and prognosis Treatment options, which include:   – Non-operative care   – Second-best treatment due to scarcity of resources in a given time (e.g. local or regional anaesthetic instead of general anaesthetic, inability to offer surgical procedures due to lack of ICU beds)   – Having no treatment or delaying treatment Advice on lifestyle and preparing for surgery which may modify disease process, recovery from surgery, and reduce risk of complications (e.g. need to quarantine in the pre- and post-operative period) Purpose and benefit of treatment Nature of treatment and what it involves Likelihood of success The names of the clinicians who will be involved in the treatment Potential follow-up treatment The material risks associated with the chosen procedure and alternative options (including the choice of having no treatment or delaying it) Cost of treatment and potential future costs in the event of complications (for private patients)
Unique considerations during the Covid-19 pandemic	The risk of contracting Covid-19 whilst in hospital: The risk of operation for patients who have tested positive for Covid-19:   – Elective patients who develop hospital-acquired Covid-19 have a post-operative 30-day mortality of 16.2%   – Two-thirds of these elective patients develop post-operative pneumonia, of which one-third of them develop Acute Respiratory Distress Syndrome (ARDS) (increased mortality at 23.8%)   – Increased length of hospital stay due to complications Changes in patient pathways and coordination of care, and possible resource scarcity:   – Need to undergo testing for Covid-19 as close to the day of surgery as possible (and no later than 72 hours from the day of surgery)   – Pre-operative period of self-isolation   – No visitors allowed when admitted in hospital   – Unavailability of ICU bed with potential negative consequences on post-operative care   – If there is a high Covid-19 prevalence in a specific area, self-isolation after hospital discharge of 4 weeks may be required The importance of advanced care planning:   – Patients and carers should be encouraged to put advanced care plans in place should the need arise
Timeframe of the consent process	Patients must have sufficient time to weigh up all relevant information before making an informed decision   – Discussion of treatment may need to take place over more than one session For virtual consultations, the consent can be sent to the patient either electronically or posted, after discussion has taken place At the time of admission, the surgeon should check if anything has changed during the consent process   – Especially in case of considerable delay from the original signing

During the pandemic, the healthcare system had to adapt itself to guarantee service provision. Remote consultations with visual and audio technology, referred to as “telemedicine”, developed considerably. The Royal College of Surgeons (RCS) states that, when obtaining consent, the principles set by the GMC applied whether the conversation was face-to-face or virtual. ⁴

Table 3 summarises the GMC guidelines for visual and audio recordings of patients, which can be used by clinicians to aid the process of obtaining informed consent. ⁵

Table 3.

Guidelines for making and using visual and audio recordings of patients (GMC guidance – 2011).^4,5

Recording for treatment and secondary purposes (research, teaching and training)	Inform patients of the purpose of the recording:   – What form the recording will take (photograph, audio, video)   – How long the recording will be kept   – How the recording will be stored Have the consent from the patient to record   – It is good practice to obtain written consent   – Written consent if the recording will be used in public media   – Consent to record should be stored with recording Telephone calls may be recorded for medico-legal purposes, staff training and audit, provided that all reasonable steps have been taken to inform patients that the call may be recorded Stop the recording if the patient withdraws their consent, objects to the recording verbally or shows distress about the recording Anonymise or code the recording Have arrangements to store the recordings safely Consent to record the following images is implicit: images of internal organs, pathology slides, laparoscopic and endoscopic images, recordings of organ functions, ultrasound images and X-rays
Disclosure and use of the recordings	Consent must be obtained if the patient is identifiable Disclosure without consent may be obtained if the material is anonymised or coded for its use in research It is good practice to still seek patient’s consent for anonymised recording which will be used in the public media Disclosure of identifiable material without consent may be justified in the public interest Following patient’s death, if a recording was made with the patient’s consent for a specific purpose (e.g. research, training, broadcast in a documentary), the recording can be used in accordance with the patient’s consent, where there is no reason to believe that consent was withdrawn before the patient’s death
Adults who lack capacity	All appropriate steps should be taken to enable patients who may lack capacity to make decisions for themselves. Some patients may still be able to decide whether they can be recorded Consent to recording needs to be obtained from someone who has legal authority to make a decision on the patient’s behalf   – If no one with legal authority has been appointed, the clinician can decide whether the recording can be used
Children and young people under the age of 16	They may consent for themselves if they have the capacity to do so For children and young adults who are not able to consent, someone who has parental responsibility must consent on their behalf When the child or young person has developed the maturity to make decisions about recording, they should be offered the opportunity to re-discuss the consent previously given by the person with parental responsibility (if the child or young adult is identifiable) Clinicians must not make recordings of children or young adults who lack capacity, even if the person with parental responsibility has given consent
Storing of recordings	Recordings are part of the patient’s medical health record; therefore they must be treated in the same way. Recordings have to be stored for:   – 3 years after death (Scotland)

Conclusions

The principle of informed consent has undoubtedly been revolutionised in the last decade and clinicians must adapt their procedures to fulfil their obligations to patients and avoid litigation.