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Informed Consent for UK Clinic Owners: Moving Beyond the Signature for Better Governance

6 min read
informed consent UKhealthcare governanceMontgomery standard
Informed Consent for UK Clinic Owners: Moving Beyond the Signature for Better Governance

Running a successful healthcare clinic in the UK requires more than just clinical excellence. As clinic owners, we are also business leaders, which means we must navigate the complex world of governance, compliance, and risk management. In a recent episode of the Treat Your Business Podcast, I sat down with Sarah Tribe, the Co-Founder of Healthcare Professionals Governance (HCPG), to discuss one of the most misunderstood aspects of modern practice: informed consent.

For many physiotherapists, osteopaths, and podiatrists, informed consent is often viewed as a administrative hurdle or a simple tick-box exercise at the start of an initial assessment. However, as Sarah explains, if your approach to consent starts and ends with a signature on a generic form, your business could be at significant risk. This guide explores how to modernise your approach to informed consent to protect your patients, your staff, and your professional reputation.

The Great Misconception: A Signature is Not Consent

One of the most frequent mistakes made in private practice is the belief that a signed piece of paper equals informed consent. Sarah Tribe highlights that a signature is merely evidence that a process took place; it is not the process itself.

True informed consent is an ongoing dialogue between the clinician and the patient. It is about ensuring the individual sitting in front of you fully understands the nature of the treatment, the potential benefits, and, crucially, the risks involved. If a patient signs a generic form without a detailed discussion regarding their specific treatment plan, that consent may not hold up in a legal or regulatory setting.

To move beyond the signature, you must view consent as a fundamental part of your clinical communication. It is not something that is only done once: it should be revisited whenever a treatment plan changes or a new modality is introduced.

Understanding the Montgomery Standard

For years, the healthcare industry followed the Bolam standard, which essentially suggested that a professional was not negligent if they acted in accordance with a responsible body of medical opinion. However, the legal landscape shifted significantly with the landmark Montgomery case.

Under the Montgomery standard, the focus has moved from the clinician to the patient. Practitioners are now legally required to disclose any material risks that a reasonable person in the patient's position would want to know. This means you cannot simply decide which risks are worth mentioning based on your own clinical judgment. You must consider what matters to the individual patient.

While this shift can feel time-consuming, it is an essential part of providing transparent, patient-centric care. It requires clinicians to slow down and ensure that every patient has the information they need to make an autonomous decision about their health.

Actionable Steps: Patient Information Leaflets (PILs)

One of the most practical pieces of advice Sarah Tribe shares is the implementation of Patient Information Leaflets (PILs). In a busy clinic environment, it can be difficult to remember every single risk associated with every treatment modality.

By providing patients with a detailed PIL before their appointment, you achieve several things:

  1. Enhanced Understanding: Patients have the time to read through the information at their own pace, away from the pressure of the clinical room.
  2. Standardisation: You ensure that every patient receives the same high-quality information, regardless of which clinician they see.
  3. Protection: The leaflet acts as a reference point for the patient and serves as part of your portfolio of evidence that information was provided.

Your PILs should cover the common risks, the rare but serious risks, and the alternative options available, including the option to do nothing at all.

The Vital Role of Documentation

In the world of healthcare governance, if it is not documented, it did not happen. Having a robust informed consent policy is the first step, but your clinical notes must reflect that this policy was followed.

Sarah recommends that clinicians document the specific risks and benefits discussed during the session. Rather than writing 'informed consent obtained,' your notes should reflect the conversation. For example, you might note that the patient was informed of the risks of post-treatment soreness or the rare risk of a skin reaction to a specific tape, and that they indicated they understood and wished to proceed.

This level of detail creates a strong portfolio of evidence. Should a complaint or a claim ever arise, having a clear trail of documentation that shows a personalised consent process is your strongest defence.

Navigating Complex Consent: Minors and Capacity

Obtaining consent becomes even more nuanced when working with minors or individuals with fluctuating capacity. As clinic owners, you must ensure your team is trained to handle these scenarios with care and legal precision.

For adults who may lack the capacity to make a specific decision, Sarah points to the three-stage test for mental capacity. Clinicians must assess whether the patient can:

  1. Understand the information relevant to the decision.
  2. Retain that information long enough to make the decision.
  3. Use or weigh that information as part of the decision-making process.

If a patient lacks capacity, you must work within the legal frameworks to seek consent from appropriate legal representatives or act in the patient's best interests. Similarly, when treating minors, understanding 'Gillick competence' is vital for determining whether a child has the maturity to consent to their own treatment without parental involvement.

Building a Culture of Governance

Governance should not be something that clinic owners shy away from or view with dread. Instead, see it as the foundation of a safe and successful business. When you have clear policies, well-trained staff, and robust documentation, you create an environment where both your patients and your clinicians feel secure.

Sarah Tribe and the team at HCPG specialise in helping healthcare professionals navigate these complexities. If you feel that your current policies are outdated or that your team needs a refresher on the Montgomery standard, do not hesitate to seek expert support. Investing in your governance structures today will save you significant stress and potential legal complications in the future.

Conclusion

Informed consent is the cornerstone of professional healthcare practice. By moving away from the 'tick-box' mentality and embracing a process-driven approach, you elevate the standard of care in your clinic. Remember to prioritise clear communication, provide written information through leaflets, and maintain meticulous documentation.

Protecting your business starts with protecting your patients. Take the time to review your informed consent procedures this week and ensure they align with the modern standards of UK healthcare governance.

To hear the full conversation with Sarah Tribe and dive deeper into the world of healthcare governance, listen to the full episode of the Treat Your Business Podcast.

Listen to the full episode on the Treat Your Business podcast (https://Thrive-businesscoaching.com)

Frequently Asked Questions

What is the Montgomery standard for informed consent in UK clinics?

The Montgomery standard shifted the legal focus from the clinician to the patient. You must now disclose all material risks that a reasonable person in that specific patient's position would want to know. It is no longer enough to rely on what a body of medical professionals deems appropriate. Practitioners must ensure every individual has enough information to make an autonomous decision.

Is a signed consent form enough to protect my clinic legally?

No, a signature is merely evidence of a process rather than the process itself. For consent to be legally valid, it must be an ongoing dialogue. You must ensure the patient fully understands the nature of the treatment, potential benefits, and specific risks. Relying solely on a generic form without documenting a personalised discussion puts your clinic at significant regulatory and legal risk.

How should I document informed consent in my clinical notes?

Avoid simply writing informed consent obtained in your clinical notes. Instead, your documentation should reflect the actual conversation. Record the specific risks, benefits, and alternative options discussed with the patient. Note their understanding and any questions they asked. This creates a robust portfolio of evidence that demonstrates a personalised consent process took place, which is your strongest defence against future legal claims.

Why should I use Patient Information Leaflets in my healthcare practice?

Patient Information Leaflets (PILs) help standardise the information provided to every patient, regardless of which clinician they see. They allow patients to digest complex risk information at their own pace outside the clinical room. Using PILs also provides a clear reference point and forms part of your evidence that you have proactively shared necessary details about common and rare risks with the patient.

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