The significance of clinical trials, in forging ground-breaking treatments and therapies, is often undervalued. For healthcare professionals in the UK, who navigate the nuances of clinical trials, the quest for progress is intrinsically linked to the responsibility of ensuring patient safety while minimising risks.
Liability insurance serves as a vital protective measure, specifically crafted to shield those involved from potential liabilities, risks, and legal complexities they may encounter.
We can provide our members with a specific, clinical trial liability quote. Please contact one of our team for more information.
The safety and well-being of participants is paramount in any trial. Even with rigorous planning, unanticipated adverse events can occur. Clinical trials liability insurance is designed to provide coverage for claims arising out of participant injuries.
Legal proceedings and compensation claims can be financially crippling, potentially jeopardising your personal assets and professional standing. The right insurance offers financial protection by covering legal expenses, settlements and damages that may arise from related claims.
Regulatory bodies such as the MHRA set stringent standards for clinical trials which include insurance coverage requirements. Adherence to these regulatory requirements is essential in ensuring that the trials remain fully compliant with local legislation.
While medical indemnity covers traditional medical activities, it may not fully address the unique risks posed. Our insurance is tailored to the specific challenges you face as a healthcare professional involved in experimental research, offering coverage that bridges the gaps left by standard policies.
As a respected member of the medical community, your reputation is built on trust and ethical conduct. In the event of a clinical trial-related incident, this reputation could be at stake. Specific liability insurance helps to provide a structured response when addressing claims and can therefore reduce any potential negative perceptions that may arise as a result.
Clinical trials continue to play a major role in transformative medical breakthroughs, at the same time presenting complex challenges that can impact both patients and healthcare professionals. Clinical Trials Liability Insurance provides you with added protection, empowering you to focus on innovation, secure in the knowledge that you are protecting your practice, your reputation, and your future.
Consent, and ensuring that there is evidence of good consenting practice, is important to fulfil ethical obligations of autonomy as well as legal requirement. It can minimise the risk of a successful claim being brought forward, for failing to obtain informed consent from a patient.
This article considers developments in the law, the nuances of consent in plastic surgery and practical considerations to minimise the risk of litigation.
The Law Pre-Montgomery
For many years the legal test for consent was no different to the general test applied for treatment, this being the Bolam test; i.e a doctor had to discuss options/warn of risks in line with the practice of a responsible body of medical opinion in that same speciality. This was an objective clinician focussed view, rather than a subjective patient centred test, and did not necessarily take account of the specific needs of an individual patient. The case of Sidaway v Board of Governors of the Bethlem Royal Hospital  confirmed the applicability of the Bolam test in relation to consent.
Despite a number of small shifts in the law, through various cases, it was the decision in Montgomery in 2013 when change finally came.
Montgomery v Lanarkshire Health Board 
Montgomery moved the focus of consent away from the professional Judgment of a clinician, into a more patient-centric approach. The case related to a child born with shoulder dystocia. There was failure from the obstetrician to warn about the increased risks of a vaginal delivery of a large child, particularly given the small stature and diabetes status of the mother, Nadine Montgomery, which increased the risk associated with a large baby and shoulder dystocia in particular. The obstetrician’s view was that the risk of shoulder dystocia did not require specific discussion with diabetic patients, as the risk was very small and this would be supported by a body of obstetricians. The Supreme Court considered that the appropriate approach was a subjective one and the obstetrician should have provided information about all material risks, disclosing any risk to which a reasonable person in the patient's position would attach significance, and reasonable alternative options: see Capsticks Insight: Montgomery – the law of informed consent.
A number of cases have clarified the position in certain scenarios following Montgomery.
Therefore, whilst the patient may have the final say as to what treatment to choose, the decision as to the ‘menu’ of options given to the Claimant is a matter of professional Judgment for the clinician. This decision of the Supreme Court reaffirms the approach in Duce i.e. that to some extent professional opinion does still matter and Bolam continues to play a role in the consent process.
Consent in Plastic Surgery
Patients undergoing plastic surgery may, in some circumstances, be vulnerable or have both an unrealistic view of their current situation and expectations as to outcomes. Furthermore, these are often purely elective treatments where there is absolutely no medical need but at the same time, significant and invasive surgical procedures with all the inherent risks attached. Appropriate consent is therefore vital as the following examples show:
Practical tips on good consenting
Those undertaking cosmetic work should be familiar with the Royal College of Surgeons’ Professional Standards in Cosmetic Surgery Guidelines. These refer to the GMC’s own guidance and adds a specialist element for cosmetic work. There are a number of pages dedicated to the “Partnership with Patients”. This covers what needs to be discussed, but also issues such as the reflection time to give to patients.
Litigation based around allegations of consent is still all too common. Good consenting, with clear evidence of this, not only ensures that ethical and legal obligations are discharged but also that the risk of litigation is minimised.
Incision Indemnity work with Capsticks, to advise health professionals and institutions on all aspects of medical malpractice claims, including consent. Alongside this, Incision member’s have access to a 24/7, in-house Medico-Legal team, free of charge. The team are on hand to assist with any queries or advice needed to prevent or manage a claim being made, with real life experience.
For further information please get in touch with a member of our team.
Extending far beyond our comprehensive coverage, Incision provides all members with a wealth of risk management material, educational resources and 24/7 in-house medico-legal support.
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