Accurate documentation of patient consent is essential, as poor records can turn routine care into a costly clinical negligence claim.
Obtaining valid consent is a fundamental part of providing quality care and a key ethical and legal requirement in medicine. Issues around consent can, however, trip up even the most experienced medical professionals.
In the UK, consent was the dominant allegation in 1 in 5 of the highest value claims Medical Protection Society supported members within 2022. The following example from the MPS case files demonstrates how warning of all risks associated with a particular procedure — and good documenting of discussions around alternative treatment options — can help avoid medicolegal complications centred on consent.A 45-year-old woman presented to Mr A, a consultant general surgeon, with an incisional hernia following previous abdominal surgery, requesting repair. Following a thorough history and examination, Mr A suggested open hernia repair, and the patient was added to the elective list 3 months later. On the day of surgery, a consent form was signed by the patient, which listed the benefits and risks, including infection, bleeding,Unfortunately, the following day she was readmitted to hospital with abdominal pain and tachycardia. A CT scan of the abdomen demonstrated a pneumoperitoneum, and an urgent laparotomy was arranged. At laparotomy, a small bowel perforation was identified and repaired. 18 months later, Mr A was shocked to receive correspondence from the patient’s solicitors requesting a copy of the medical records and intimating a potential clinical negligence claim against him. This was followed by a formal letter of claim alleging inadequate consent and poor surgical technique. Mr A contacted MPS, and a medicolegal consultant and lawyer were assigned to his case, providing initial advice and reassurance. On review of the records and after consultation with an appropriate medicolegal expert, it became apparent that Mr A had failed to document any discussion of alternative treatment options or to warn of the risk of bowel injury. Combined with very brief documentation and failure to document any consent process prior to the day of surgery, this made the claim very difficult to defend. MPS went on to settle the claim on behalf of Mr A. Mr A acknowledged that he had discussed the risks of surgery prior to the day of surgery but had failed to document any of these discussions or the specific risk of bowel injury on the consent form. As a result, he said he would reconsider how he documented the consent process in the future.A doctor has a clinical, legal, and professional obligation to ensure that valid consent is obtained from a patient before a procedure takes place. In this specific case, the patient was providing explicit consent for the operation in a non-emergency situation. For the patient’s consent to be valid, they must:c) be free to make the decision voluntarily If there is concern regarding the patient’s capacity or whether they are under undue influence from someone else, caution is required during the consent process, and further advice or action may be needed as the consent may not be valid. However, this case highlights several key issues and pitfalls regarding the concept of ‘informed consent’ that may ultimately lead to a successful clinical negligence claim.Obtaining a patient’s consent on the day of a procedure in a non-emergency situation may be considered poor practice, as it provides the patient with little time to consider the risks and benefits to the procedure. There may be undue pressure to proceed without being given the option of not performing the procedure. Similarly, there may be pressure on those obtaining the consent to avoid delaying the surgical list. Consequently, the appropriate information that should be shared with the patient can be somewhat reduced.The consent process should be a dialogue between the clinician and the patient and should be a continuing process. During this dialogue, the patient should be informed about the planned procedure, the anticipated benefits, the risks, and — importantly — reasonable alternatives, which may include doing nothing. This enables the patient to be fully supported in their decision-making. The information provided must be provided in a language and format the patient can understand. This may require forward planning, such as booking an interpreter or someone proficient in sign language. The patient’s understanding of the information provided should be checked before the consent form is signed and treatment commences. Time restraints should not impact the information sharing process with a patient. Clinicians could consider involving other suitably skilled members of the healthcare team to assist with the process, if this would ensure the consenting process is not rushed. Even if the dialogue has taken place 3 months previously in the outpatient clinic, time should be taken to revisit the dialogue on the day of the procedure to establish if the patient has any new concerns.When seeking consent to treatment, the adequacy of the information provided is judged from the perspective of a reasonable person in the patient’s position. The ruling from Montgomery refined the earlier test for consent. Previously, clinicians could determine what information was given to a patient provided that it had the support of a responsible body of medical opinion. This was known as the Bolam test. Since Montgomery, a doctor must provide information about all material risks, as well as any risks an individual patient would likely attach significance to. However, a doctor is not expected to provide information about options that are not in line with their clinical judgement. Whilst it is not possible to list every single potential complication or side effect, the conversation should be tailored to the individual and guided by what matters to them. In the above case, had the patient been made aware of the potential risk of bowel perforation, they may have decided not to proceed with the hernia repair. The fact that this was either not discussed, or not documented as having been discussed, led to a successful claim.It is important to provide enough time to explain to the patient the risks and benefits of the proposed treatment, in a language that they understand, and to take time to find out what is important to them. What is materially important to one patient may be very different to another. Be sure to also include alternative options, including the option to do nothing. Clearly document in the patient records the discussions that have taken place. Whilst a consent form may not record all the potential complications of that treatment, a clear and concise note of the conversation should be entered into the records.In the above case, it is not clear who obtained the patient’s written consent on the day of the procedure. The list of complications detailed on the consent form may have been different to those discussed in the outpatient clinic by Mr A. However, without adequate documentation in the patient’s records, it is unclear what was previously discussed.The responsibility for ensuring valid consent has been obtained lies with the person carrying out the procedure. In some circumstances, taking consent may be delegated to a colleague, but only if that colleague has the necessary knowledge, skills, and experience. Whether delegation is appropriate depends on the complexity of the intervention, the level of uncertainty surrounding the outcome, the relationship to the patient, and any concerns the patient may have. When delegating responsibility for obtaining consent, it is important to ensure that the person undertaking the task has a full and comprehensive knowledge of the procedure and understands all the risks and benefits of the treatment. This case highlights that a signed consent form is not sufficient evidence to defend a claim. The absence of evidence that alternative treatment options were offered to the patient prior to surgery was a significant factor. The lack of documentation around the consent process contributed to the consent being deemed invalid, resulting in a successful claim. This case highlights the importance of incorporating good consent procedures into everyday practice, together with clear and sufficient documentation. It is important for all healthcare professionals to keep up to date with consent guidelines to help improve patient care. Understanding the challenges that can arise in this area can also protect you from a complaint or claim relating to consent. MPS’s Online Learning Hub hosts a wide range of interactive courses, webinars, and videos to help doctors reduce their risk, including excellent modules on consent. I would encourage all members to make use of it. It is a benefit of membership, counts towards continuing professional development requirements, and the resources can be accessed at any time.that aims to deliver medicolegal content to help healthcare professionals navigate the many challenges they face in their clinical practice. Dr Victoria Cox joined MPS as a Medicolegal Consultant in July 2024, after working for 26 years in the NHS as a Paediatric Emergency Medicine Consultant. She was the risk lead for the Emergency Department for over 8 years during which time she positioned the department at the forefront of the Trust’s initiatives to improve patient care and share learnings from patient safety incident investigations. Dr Cox was also a Medical Examiner for over 3 years. MPS membership provides the right to request access to expert advice and support on clinical negligence claims, complaints, GMC investigations, disciplinaries, inquests, and criminal charges such as gross negligence manslaughter. Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
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