Obtaining valid patient consent is one of the most important responsibilities for surgeons before performing any surgery. In 2015, a significant development in UK case law, known as the Montgomery decision, led to a surge in claims against healthcare professionals related to the consent process.

To ensure good practice in obtaining consent and avoid unnecessary claims or regulatory proceedings, surgeons must understand the current legal landscape and the practical challenges involved. By keeping their processes updated and well-documented, surgeons can also better defend against any claims that may arise.

This guide is divided into four parts and aims to assist busy surgeons in addressing the issues related to Montgomery and informed consent. It includes:

1. A recap and refresher on the legal developments in recent years.
2. An in-depth exploration of the practical challenges that have emerged, along with suggestions for addressing them.
3. Recommendations to optimize existing standard or template forms used for consent-taking.
4. Real-life scenarios faced by specialist surgeons, illustrating potential pitfalls and ways to avoid them.

Even nearly four years after the Montgomery decision, we still encounter examples of surgeons misunderstanding their obligations. Some surgeons have omitted to warn or obtain consent for certain risks out of concern for the patient, or because they believed the risks were unlikely to occur. These cases have resulted in notifications to insurers, fee refunds, or compensation payments, as these surgeons relied on an outdated approach to consent that is no longer legally acceptable.

Letter of the Law

What is the current UK law?

In 2015, the UK Supreme Court established the principle of ‘informed consent,’ which remains the prevailing approach. As the Supreme Court is the highest authority in the UK, this key principle is unlikely to undergo significant changes in the foreseeable future. The case of Montgomery v Lanarkshire Health Board [2015] UKSC 11, commonly referred to as ‘Montgomery,’ clarified that healthcare professionals have a duty to discuss the ‘material risks’ associated with a proposed treatment and any alternative options with the patient.

The determination of ‘materiality’ depends on the patient’s individual circumstances. A risk is considered ‘material’ if a reasonable person in the patient’s position would attach significance to it, or if the doctor is aware or should be aware that the specific patient would find it significant. This requires a holistic approach that considers the patient as an individual.

There are situations where obtaining informed consent before treatment may not be possible. Examples include cases where the patient lacks capacity, emergency treatment is necessary, or disclosure of risks would severely harm the patient’s health. However, such situations are rare.

A limited amount of case law helps to elucidate the meaning of ‘materiality.’ For instance, in A v East Kent Hospitals University NHS Foundation Trust (2015), the judge ruled that a risk deemed ‘theoretical, negligible, or background’ did not need to be communicated to a patient. In that case, expert evidence estimated the particular risk under consideration to be 1 in 1000. Similarly, in Tasmin v Barts Health NHS Trust (2015), the judge emphasized that a risk with a 1 in 1000 probability is ‘too low to be material.’

While these cases provide some reassurance to surgeons that they won’t always need to provide extensive information about every remote risk, it’s crucial not to interpret them too rigidly. Surgeons should not assume that risks below a notional 1 in 1000 threshold never require mention.

The test, as established in Montgomery, always revolves around whether ‘a reasonable person in the patient’s position would attach significance to the risk’ or if ‘the doctor is or should reasonably be aware that the particular patient would find it significant.’ This means that certain patients, due to their unique circumstances, may be unwilling to accept even a 1 in 1,000,000 chance of a specific adverse outcome.

The practical challenge for busy surgeons is to remain vigilant in identifying ‘outlier’ patients who require counselling on extremely marginal risks, in addition to the more probable ones. In this guide, we offer suggestions to help surgeons identify instances where they need to provide more detailed information to patients regarding remote risks

What does this mean for surgeons?

The significance of a risk can vary from patient to patient, highlighting the inadequacy of a ‘one size fits all’ approach when advising patients. Surgeons must update their practices to ensure they obtain informed consent for every intervention or procedure.

Following the principles established in Montgomery, it is crucial to view consent as a process rather than a single event. This process can be approached in several broad stages, which are further discussed in the next section:

1. Gathering the patient’s medical and social history.
2. Securing consent for ancillary matters, such as clinical photographs.
3. Consulting with the patient, including providing information through patient leaflets.
4. Obtaining final consent to proceed with the intervention or treatment.

Ideally, particularly for elective surgery, there should be sufficient time between each stage for patients to consider the risks and have a realistic opportunity to withdraw from the surgery at any stage. The potential risks associated with patients feeling ‘committed’ to a procedure without fully understanding the implications are examined later in this guide.

We understand that, in certain situations, all stages of the consent process may need to occur within a single meeting between the patient and the healthcare professional. When a procedure is urgent or the clinic is busy, there might be limited time for discussion. However, by keeping these stages in mind, surgeons are more likely to obtain valid informed consent, even under significant time pressures. It is crucial to thoroughly document each stage of the process in the patient’s notes, as this will serve as vital evidence in defending against any potential claims.

Does it have to be in writing?

Obtaining oral consent, without written documentation, is technically valid, so conducting investigations or treatment based solely on oral consent does not constitute a criminal assault.

However, from a legal standpoint in defending against compensation claims, written records are irreplaceable. We have assisted surgeons who mistakenly believed that a clinic letter stating ‘all potential complications were discussed’ and their recollection of their past practices regarding explaining potential complications to patients would suffice. Unfortunately, that is not the case.

In a hypothetical trial, if there is no written record of a specific risk being discussed, the surgeon’s evidence would be, ‘I don’t have a specific record, but I believe I must have warned of this,’ while the patient’s evidence would be ‘no, he didn’t.’ In such a situation, the judge would typically favor the patient’s testimony. The prevailing wisdom is that the consultation is an exceptional or significant event for the patient, making their recollection of the details more reliable than that of the surgeon, for whom this meeting is similar to many routine encounters. Additionally, judges are often unwilling to give the surgeon the benefit of the doubt when it is the surgeon’s responsibility to document the meeting, not the patient’s.

Well-designed template forms can facilitate the consent process and help reduce the risk of costly complaints and claims from arising in the first place.

For instance, while adopting a ‘checklist mentality’ may not always be beneficial, a standardized document can serve as a useful reminder for busy surgeons, ensuring that all essential information is covered with each patient. These forms can be particularly helpful in highlighting newly discovered or unusual risks associated with a procedure. They also ensure comprehensive record-keeping by providing a convenient and consistent method for taking necessary notes, which is vital in defending against any ensuing claims.

Effective forms are those tailored or adapted to the surgeon’s specific practice. They should be regularly reviewed and updated to capture all essential information and reflect any changes in known risks associated with the procedure. Additionally, the forms should be written in clear and straightforward language.

When designing or adapting forms, surgeons should consider not only the content but also the layout and format. For instance, based on my experience, many surgeons fail to anticipate whether their standard forms provide sufficient space to record all necessary details. Poorly designed forms often lack ample room for answers, leading to important information being either omitted or becoming illegible.

What if surgery would have been deferred, not rejected?

We have spoken with surgeons who mistakenly believe that if a surgery is essential and certain to proceed, the consent process becomes less important because the patient has to accept the surgical risk. However, we believe this is a potentially risky misinterpretation of the legal position.

Even in cases where surgery is essential and certain, there can still be consent-related issues regarding the timing of the procedure (excluding emergency surgery, of course).

The difficulty arises due to a somewhat controversial case known as Chester v Afshar. This case established that when a patient has not been adequately consented, they only need to prove that they would have delayed the surgery. By doing so, they demonstrate the legal causation between the inadequate consent and the resulting injury, making them eligible for compensation. In other words, even if the patient would have taken an extra day to consider the risks, the court must legally assume that the injury was caused by the inadequate consent. While this may be a legal fiction, we are bound by this reality. The patient does not have to prove that the surgery would never have taken place in order to be entitled to compensation.

While some patients might argue that they would have taken additional time to think about the risks had they been warned more thoroughly, others may have practical reasons for delaying or deferring surgery. For instance, a parent with young children may prefer to wait until all the children are in school to better manage the recovery process and minimize the risk of delayed healing. A patient facing surgery with a significant risk of mortality may want to wait a few days to create a will. Similarly, a patient whose surgery could hinder their ability to drive may choose to postpone the procedure until they have transitioned to a job that doesn’t require driving.

The practical implication of this legal landscape for surgeons is that during the consent process, they need to encourage patients to consider not only whether they will have the surgery but also when they will have it. There can be numerous practical reasons why a patient might wish to delay or defer the surgery, be it for a short period or even several years, until they feel more prepared or capable of managing the material risks associated with the procedure.

Final thoughts on the legal landscape

Surgeons genuinely care about their patients. While there is a consensus on the importance of raising standards, some surgeons feel frustrated by the resulting emphasis on process-driven care, which can lead to a depersonalized approach. However, the Montgomery case should be seen as a reason for optimism, as it requires healthcare professionals to view each patient holistically and consider how a proposed procedure will personally impact them.

Nevertheless, this case has also introduced increased risk for surgeons, as it has become rare for claimants not to allege a failure to obtain informed consent. Documentation plays a crucial role, and following the aforementioned processes can help safeguard against such risks. If documentation is lacking or non-existent, it becomes impossible for your lawyer to effectively defend you against such allegations.

In Part 1 of this guide, we discussed the current UK law regarding consent. Based on these legal changes, it is recommended to approach the consent process in the following stages:

1. Taking the patient’s medical and social history.
2. Obtaining consent for ancillary matters, such as clinical photographs.
3. Consulting with the patient, including providing patient information leaflets.
4. Obtaining final consent to proceed with the intervention or treatment.

In this section, we will delve into the practical aspects of gathering the patient’s medical and social history.

Obtaining the patient’s medical and social history

Montgomery makes it clear that surgeons need to give advice about the risks material to that individual patient. It will be almost impossible to do that without a detailed medical and social history that allows the surgeon to gauge what is material to the particular patient. For example, if the surgeon does not know that the patient is a professional singer, they would not advise of any potential risk (however rare) of permanent damage to the vocal cords during surgery (perhaps due to the need to ventilate under general anaesthetic).

In turn, they could be sued in negligence if the patient’s voice is permanently damaged during the procedure and the patient contends that they would not have consented to the procedure had they known of that risk. Each healthcare professional needs to give careful thought to which medical or social factors could potentially make a difference to the advice about the consequences and risks of a procedure for that particular patient. While this is necessary for all types of surgery, even those where the only alternatives would inevitably lead to death or serious disability, the process is perhaps particularly important for the following types of surgery:

• Medically necessary, but not urgent and can be deferred for some time. In these cases the issue for the patient might not be so much whether to accept the risks of surgery, but when to go ahead so as to manage the potential complications best. For example, if a risk of surgery is slow healing leading to a long recovery period, a patient who is a parent of small children might find that risk easier to accept if the surgery is delayed until the children are all in school. Similarly, if a risk of the surgery is that the patient might not be able to drive for a time after surgery, and the patient’s job is dependent on them being able to drive, the patient may wish to defer the surgery until after retirement.
• Not strictly medically necessary, purely elective. The classic examples include aesthetic surgery and some types of eye surgery, but examples exist in most surgical specialisms. In these cases the consenting process can be especially difficult because the very factors that give the patient the desire for the surgery might make the inherent risks more ‘material’ for that patient. For example, a patient who is so concerned about his aesthetic appearance that he is willing to pay privately for aesthetic surgery is inherently less likely to be able to accept the risk that the surgery might in rare cases leave him with a worse aesthetic appearance. Similarly a patient whose job or hobbies mean that they would like to be able to dispense with spectacles might be least able to cope if rare complications manifest that adversely affect their vision.

After Montgomery surgeons simply must ensure that sufficient information is obtained from each patient to allow them and the patient to assess what risks are most ‘material’ to them in the particular context.

Surgeons must also document that information as part of the evidence on which their clinical judgement and advice was based. The medical and social history process is a key part of this process.

How to obtain and document the medical and social history

Often, the most convenient method for taking a patient’s medical and social history is to have a standard written questionnaire for the patient to fill in before or at the consultation. While a ‘checklist mentality’ is not necessarily helpful, well-designed forms can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient, to give the best possible chance that the surgeon identifies what risks will be particularly ‘material’ to that patient.

The following is certainly not a prescriptive statement of what a surgeon’s questionnaire should contain. Instead it is intended as guidance and ‘food for thought’ to help you review your current documentation and assess whether improvements can be made to help protect you from complaints and claims.

In addition to thinking about the content of your template documents for use in the medical and social history-taking process, you should also think about the layout and format. Even a form with a perfectly optimised set of questions could be rendered useless if there is so little space left for the answers that incomplete information is actually obtained or recorded.

Example outline medical and social history form

To ensure that surgeons can provide appropriate advice and care, it is crucial for patients to provide a complete and accurate medical and social history. Failing to do so can jeopardize their health and lead to undesirable consequences. Here are the important details that should be included:

1. Patient identification details: Full name, title, and any aliases.
2. Patient’s address: Consider the distance the patient has to travel, especially for follow-up appointments or to address urgent complications post-discharge.
3. Date of birth and age at the time of consultation.
4. Sex/gender description: It is important to have inclusive options beyond just “male” and “female.” Taking into account intersex conditions or gender-fluid individuals is crucial, as certain risks of the procedure may be particularly significant for them.
5. Social history:
   • Patient’s present or immediate past job/work/career details: Any potential changes in their job or career?
   • Hobbies/interests that are important to the patient.
   • Marital status or civil partnership, and relationship status.
   • Children: Number and age of children, and any plans for additional children.
   • Other caring responsibilities: This includes caring for parents, friends, neighbors, or even animals that rely on the patient.
   • Language/reading ability considerations: Assess the patient’s fluency in the consultation language and the language used in patient information leaflets. Determine if they have any difficulties in reading written material due to poor eyesight, dyslexia, or low literacy. It’s essential to ask these questions orally to ensure the patient’s understanding, as relying solely on written forms would defeat the purpose.
   • Future social factors: Identify any upcoming events that are important to the patient and could potentially be affected by the proposed procedure, either directly or due to potential complications. Examples include weddings, special social events, or pre-booked holidays.
6. Past medical and social history:
   • Children: Number and age of children, and any plans for additional children.
   • Set out questions to gather comprehensive information about the patient’s medical and social history, including current medication, past procedures, and previous health problems. Cover any factors that, based on your clinical knowledge, could potentially impact the risks associated with the specific procedure.
   • Include specific questions about the patient’s past mental health. Ensure that the patient has the necessary capacity to provide informed consent for the treatment.
   • Consider including questions about the patient’s personality type, such as their general level of optimism and resilience when faced with difficulties.
7. Future medical and social history:
   • Determine if the patient has any planned or anticipated medical procedures in the short or long term. Confirm if these procedures are already booked or paid for.

By collecting all this relevant information, surgeons can better assess the risks and tailor their advice and care to each patient’s unique circumstances.

Other steps in optimizing your template or standard forms

We hope that this guide contains helpful guidance about designing or optimising your template forms or documents for use in the process of taking a patient’s medical and social history.

If you would like additional assistance in updating your documents, you have various options. We understand that various companies offer consenting ‘systems’ that aim to ensure that healthcare professionals use compliant consenting documents and processes. By way of an example only (we do not endorse this or any other provider), here is the website of one such provider https://www.eidohealthcare.com/.

Consultations and Information Leaflets

In this section we focus on the practicalities of consultations with patients, providing patient information leaflets to support that process, and obtaining the final consent to go ahead.

Consulting with the patient and providing patient information leaflets

In this stage, the patient is informed about the nature, purpose, and potential risks of the proposed intervention or procedure. It is crucial that the discussion is led and documented by the surgeon who will perform the procedure whenever possible. Delegating parts of this process can have risks, as discussed in Part 4 of this guide.

A detailed discussion about potential alternative treatment options and their merits is essential. This includes alternatives that the surgeon may not consider the most appropriate, as well as the option of not proceeding with any treatment at all. Failure to advise patients of alternatives is a common allegation in consent claims. For instance, a patient who consented to surgery may claim that they were not adequately informed about the option of conservative treatment.

To obtain effective consent, it is important to provide all the necessary information to the patient in a format and manner that they can comprehend. Each surgeon should carefully consider the information needed for each procedure they offer and establish an effective process for providing that information and keeping records.

Therefore, template forms used for consultations should be individually tailored to address each type of procedure offered. These forms should also be flexible enough to be adapted to the specific circumstances of each patient.

While conveying all the potential material risks and discussing the pros and cons of alternatives is necessary for all types of surgery, it is particularly important for the following types:

1. Medically necessary procedures that are not urgent and can be deferred. In these cases, the issue for the patient may not be whether to accept the risks of surgery but rather when to proceed to manage potential complications effectively. For example, a patient who is a parent of young children may find it easier to accept the risk of slow healing and a long recovery period if the surgery is delayed until the children are in school. Similarly, if a patient’s job depends on their ability to drive and a surgery may temporarily restrict driving, they may choose to defer the procedure until after retirement.

2. Purely elective procedures that are not strictly medically necessary. Examples include aesthetic surgery and certain types of eye surgery, but similar situations exist across various surgical specialties. The consenting process can be challenging in these cases because the factors driving the patient’s desire for surgery may also make the inherent risks more significant for them. For instance, a patient who is deeply concerned about their aesthetic appearance and is willing to pay privately for aesthetic surgery may struggle to accept the risk of rare complications that could worsen their appearance. Similarly, a patient who wants to eliminate the need for glasses due to their job or hobbies may find it particularly difficult to cope with rare complications that adversely affect their vision.

Following the Montgomery ruling, surgeons must ensure that they provide sufficient information to allow patients to make fully informed decisions about whether to proceed. This includes considering risks that are particularly material to each patient personally.

Some surgeons may express concerns that providing all necessary information might dissuade patients from undergoing potentially beneficial surgery. It is true that if the consenting process is conducted properly, some patients may decide against the procedure or choose to postpone it. The surgeon may not agree with or fully understand the patient’s reasoning, and they may find the patient’s decision irrational. However, this is the outcome dictated by the Montgomery ruling. The paternalistic model no longer applies, and patients must be given all necessary information about the risks involved so that they can make their own subjective decision about which risks are acceptable to them.

Surgeons must also document the advice and information provided. This serves to assist in follow-up or future treatment and is necessary to defend the surgeon in the event of a complaint or claim.

Are patient information leaflets helpful?

Depending on the procedure, especially elective ones, it can be beneficial to provide patients with information leaflets that outline the proposed procedure.

Well-designed information sheets help surgeons present clear and concise generic procedure information to patients. They serve as valuable support and complement the advice given during consultations. Written information allows patients to reflect, often after the consultation, in a manner that face-to-face interactions may not allow.

When a claim is filed, it becomes challenging to prove whether an information sheet was provided to the patient and, if so, which specific sheet was given. Therefore, it is crucial to establish a robust method for documenting which information sheet each patient receives.

The usefulness of information leaflets relies on the quality of the information they contain. Outdated or incomplete information in a leaflet could potentially do more harm than good. Surgeons who incorporate information leaflets into the standard consenting process must recognize the need to invest time periodically in reviewing and updating these documents.

Some surgeons have transitioned from physical leaflets to directing patients to their websites, where regularly updated procedure information is available. Using a website saves the cost of printing physical leaflets and allows for quick and frequent updates accessible to all patients (and often the general public). However, it’s important to note that not all patients have internet access or may feel comfortable using online resources. Ensuring that patients have accessed and read the relevant website content can present challenges. In certain cases, surgeons may need to print out relevant web pages for patients who are unwilling or unable to access them independently.

During this stage, after providing all necessary information, the patient gives their final consent to proceed with the procedure, typically by signing a form referred to as “the consent form.” However, using this term can be misleading as it suggests that consent is solely an event involving form signature. In reality, obtaining consent is a process that culminates in form signing.

Templates and documents for the consultation stage

Outline consultation guide and records

• Patient identification details
• Proposed procedures.
• Space on form to record any updated medical/social history that the patient did not mention on their medical and social history questionnaire.
• Ask the patient why they want the procedure and record their answer in detail.
• Explanation of what the proposed procedure involves. This should be a step-by-step summary of:
  • What tests/investigations need to take place first (eg x-rays, blood tests).
  • Whether the patient will need to do any preparation (eg losing weight, stopping smoking/drinking, nil by mouth before surgery etc.).
  • Whether anaesthetic needed and if so what type (local/general).
  • What happens during the procedure
  • What happens after procedure and before discharge.
  • Any tests/checks that need to take place afterwards (eg blood pressure).
  • What happens after discharge, what the follow up will be, why attending follow up is necessary.
• Explanation of what the intended/hoped for benefits of the procedure are (eg reduction in pain).
• Explanation of the inevitable consequences or side-effects of the procedure. Explain that these are inevitable and will occur even if the treatment is carried out optimally, eg for an open surgery, there will almost inevitably be scarring from the surgical incision, pain to manage, a minimum recovery time before normal activities can resume. Ask the patient to think about how these will affect them and to plan how their other responsibilities (eg childcare) will be managed over that time.
• Explanation of the recognised potential risks or side effects of the procedure. Explain that these unwanted outcomes can occur even if the treatment is carried out optimally. Explain all the potential risks, from the common to the rare, eg for an open surgery, there is a risk of infection and around x% of cases will develop a post-surgery infection, and there is also a small risk of death which occurs in around every y% of cases. Also, explain that a potential risk is that the intended/hoped for benefit will not happen, such that the patient could experience disappointment with the outcome.
• Explain the potential alternatives to the proposed procedure, including having no treatment at all. Explain the pros and cons of the available alternatives. Ask the patient for their thoughts on those potential alternatives and record the response, especially if the patient gives reasons for not wanting to explore those alternatives further. The healthcare professional also needs to explain and record the potential risks of any procedures associated with the ‘main’ procedure, particularly of any anaesthetic that may be required.
• Ask the patient expressly whether they have any questions. Record their questions and the healthcare professional’s answers.
• Explain that the patient needs to read any patient information leaflets provided, and/or any other resource (such as a website) that is appropriate. If the patient intends to do his or her own further research, do not dissuade them, but caution the patient against using potentially unreliable sources, such as Wikipedia or public discussion forums. Record the exact information sheets/leaflets provided, including what date or version they are.
• – Explain that the patient needs to consider the information sheets/leaflets, reflect on the discussion, and consider whether they have any more questions, before deciding whether to go ahead. Give guidance on how much time they have to reflect – in cases where the patient is deteriorating quickly find a way to give them time to reflect without inadvertently putting pressure on them to rush a decision.
• If going ahead is not recommended, but the patient is insistent that they nevertheless want to go ahead, the healthcare professional should expressly record their advice and the reasons for it in narrative on the document. Also, record the patient’s reasons for nevertheless wanting to go ahead.
• For surgery under general anaesthetic the healthcare professional will need to discuss with the patient what should happen if during surgery it is found that further or alternative operative measures are found to be necessary or advisable. Does the patient want to consent to the surgeon using discretion to carry out those additional procedures to save them the need for a separate further surgery? Or would they prefer to wait until they have had the opportunity to consider whether to go ahead with any such other procedure?

Outline final consent form

• Patient identification details, space on form to record any updated medical/social history and further questions asked by the patient and the practitioner’s response.
• I provided a medical and social history on [date]. I have seen my signed record of that medical and social history dated [date]. It is and remains complete and accurate. I understand that giving a complete and accurate medical and social history is necessary to enable those treating me to give me the appropriate advice and care.
• I have attended consultation(s) with [name(s)] on the following date(s) [dates]. I have seen the consultation records dated and signed on [date]. I agree that the document(s) contain a complete record of advice I received about the nature of the procedure, its intended benefits, its inevitable consequences and sideeffects, and its potential risks and sideeffects. I agree that the document(s) contain a complete record of the advice I received about the potential alternatives open to me.
• I confirm that I received the patient information leaflets recorded in those document(s). I confirm that I have read those leaflets. I have also read the following additional information [list any websites/other resources considered].
• I agree that I have been given sufficient time to consider the advice and information received. I understand that I am not obliged to have this, or any, treatment or procedure. I have decided to go ahead with this procedure knowing of the alternatives explained to me.
• I understand that there can be no guarantee that the procedure will bring about the intended benefits. I consent to go ahead with this treatment/procedure in the knowledge that the intended benefits may not come about. I understand that inevitable consequences and sideeffects will occur, and that the potential risks and side effects could occur, even if the treatment is carried out perfectly and with no errors on the part of the medical staff. I consent to this treatment/procedure knowing the consequences, sideeffects and risks explained to me.
• [If applicable] [I acknowledge and accept that I have been advised against going ahead with this treatment and I have nevertheless decided to proceed and consent to this procedure knowing that it is not recommended for me.]
• Healthcare professional’s statement – I have fully explained the proposed procedure. I have provided the information recorded in the consultation records and on this consent form. I have taken the medical and social history provided by the patient into account and their explanation of what they want to achieve [space for the healthcare professional to sign].

Particular challenges in obtaining consent

In this final section of our guide to informed consent, we look at some particular practical situations where obtaining valid consent can present a challenge.

Consent for ancillary matters such as photographs

Clinical photographs of the patient may need to be taken. At an appropriate point in the consent process, the surgeon should explain the purpose of taking photographs and the fact that they will form part of the patient’s medical records. The patient’s consent to the photographs being taken should be recorded in writing, ideally by the patient signing a suitable form, before any photographs are taken.

In the vast majority of cases, getting consent to take clinical photographs of the patient is extremely straightforward as the vast majority of patients understand that they are a necessary part of clinical recordkeeping and will consent straight away.

Nevertheless, we know of surgeons who have been faced with practical difficulties even in this aspect of the process. For example, one surgeon had a patient who simply refused to allow clinical photographs to be taken of her lower body (where the surgery was to take place), on the basis that she found the idea of the photographs “intrusive” and was worried it would exacerbate her clinically diagnosed PTSD.

We gave guidance that without consent to the photographs they could simply not be taken. Without clinical photographs the surgery could not properly go ahead, given the importance of those records in complying with the duty to make and keep proper records. We recommended that the patient be referred to her existing mental health team to assist with ascertaining whether she could or would consent to the photographs with the necessary support and if not then it would be much safer for the surgeon to not go ahead with surgery for that patient.

While examples such as this are rare, they do highlight how important it is to avoid treating consent as a ‘rubber stamping’ exercise and be alert for patients that have unusual needs that give them problems with even routine aspects of their care.

Can the ‘patient pathway’ affect the validity of the consent?

In our view, yes it can.

We have dealt with a number of cases where a patient paid for the procedure upfront on a non-refundable basis after only a preliminary consultation (a cynic would say ‘sales pitch’) from an employee of a private healthcare provider company. Only then was the patient allocated to a self-employed surgeon to actually carry out the surgery. While more detailed consultations with the surgeon did follow before the actual surgery, the purported consent for surgery was very questionable because by then the patient had made a financial commitment. The particular examples we have seen have arisen in the context of elective eye surgery or aesthetic surgery, in relation to companies that specialise in marketing certain procedures to the general public, and contract with self-employed surgeons to carry out the actual surgery. In principle the problem could arise in any situation where the surgeon does not have control over the whole consenting process.

The General Medical Council and the law are clear that it is the surgeon who ultimately has the responsibility for obtaining valid consent. This is the case even if in practice the majority of the informing and consenting process is purportedly taken care of by other healthcare professionals. This is also the case even if the self-employed surgeon does not have any real control over when he or she sees the patient for the first time or how long he or she has with the patient to deal with consent before surgery. If a patient brings a claim for compensation alleging a lack of consent, the surgeon’s defence team will of course endeavour to ‘pass on’ some of the legal liability to the company that actually took conduct of the initial stages of the consenting process. Ultimately, the best outcome in that situation is sharing liability with another defendant, rather than being able to completely defend the claim.

While it is possible to ‘delegate’ the consent process, this should only be done if the treating surgeon is confident that i) the person obtaining consent is suitably trained and qualified, ii) the person obtaining consent has sufficient knowledge of the proposed investigation or treatment and understands the risks involved.

Therefore we would recommend that all self-employed surgeons should endeavour to find out exactly what the ‘patient pathway’ is for private patients in the organisations they work within, and particularly what information patients are provided with (if any) by others before they reach the surgeon. The surgeons should ideally review that material (which could include ‘sales scripts’, patient information leaflets or even patient information videos) and decide what else the patients need to be able to give valid consent. This is particularly important if the other healthcare provider makes it a contractual obligation to use patient information materials or consent forms produced by them.

The surgeon should also consider whether the financial arrangements between the patient and the other healthcare provider will make it difficult to ensure that valid consent is actually being obtained in each case. Based on that, the surgeon can make a better informed decision about whether it will be safe to provide self-employed surgical services through that organisation, or whether they will be at risk of taking the consequences of another organisation’s inadequate patient consenting process.

Consenting for anaesthetic risks

Other examples of how the ‘patient pathway’ can affect the quality of the consent process and the vulnerability of the surgeon comes from observations that surgeons have made about certain differences between the NHS consenting process and that in many private hospitals.

In the NHS the patients are often sent for an assessment appointment led by nurses and anaesthetists who will specifically assess the anaesthetic risks for the patient and advise them in preparation to be consented for surgery later on. By contrast, it is often the case in private hospitals that there is no equivalent process to deal with anaesthetic risks specifically. The surgeon has to take charge of consenting the patient for the anaesthetic risks and the patient may not even meet the anaesthetist until the day of surgery itself.

The upshot for surgeons in these situations is that they need to be sufficiently well informed to be able to ensure that the patient is warned of any material anaesthetic risks, as well as surgical ones, or risk being liable for a consent failure if an anaesthetic risk manifests.

Final thoughts

Surgeons care deeply about their patients. While most agree that driving up standards is essential, some feel frustrated that this has caused the growth in process-driven care that risks depersonalising patients. In this context, Montgomery should be considered a cause for optimism because it requires healthcare professionals to consider each patient from a holistic point of view and to understand how a proposed procedure will affect them personally. Nevertheless, this has created an increased risk for surgeons because it is now rare for a claimant’s pleaded case to not contain allegations about a failure to obtain informed consent. Documentation is key and following the above processes will help protect you. If the documentation is lacking or does not exist at all, it will be impossible for your lawyer to defend you against such allegations.