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Mapping the path to informed consent in healthcare - here be dragons!

26 November 2020

This article considers the pathway and challenges healthcare practitioners face surrounding the obtaining of informed consent.

Introduction

As a former geography student (who switched to law in my final year) I still have an affinity for maps, and remember fondly those pre Google days when paper gave you a real sense of scale and location. In ancient Rome and medieval times cartographers would insert the phrase ' here be dragons' for those unknown territories, yet to be explored.

My experience of working with healthcare practitioners for over 25 years is that many feel that the landscape of consent is still an alien territory which they struggle to negotiate, in spite of the law providing, what it considers to be, helpful signposts.  Directions are also issued by governing bodies (most recently by the GMC in their guidance, 'Decision making and consent' on 9 November 2020) . So what is so difficult (and generates so many complaints if not claims) about ensuring that a patient has provided their informed consent to undergo a procedure?

The context

For those lawyers amongst us, the pathway to understanding if informed consent has been obtained probably starts with Bolam v Friern Hospital Management Committee [1957] 1 WLR  and did not change significantly until 5 years ago, when the Supreme Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11 ('Montgomery') told us what the regulators had been telling practitioners for some time, namely that patients had the right to be informed of all material risks involved in any recommended treatment and of any reasonable alternatives, including the option of no treatment at all. For those who have yet to view it, the account of Nadine Montgomery (Nadine's Story) recorded on NHS Resolution's website brings home the human cost of getting this fundamental communication between patient and clinician wrong.

The challenges

The clear position set out in Montgomery means that practitioners must ensure they meet those requirements such that there is a clear partnership between the patient and healthcare practitioner (a process often termed 'joint decision making'). Surely if there is dialogue, accurate prediction of relevant risks and documenting of those discussions there can be no doubt that a clinician has discharged their duty, informed consent has been obtained and no cause for doubt on the part of the practitioner or complaint on the part of the patient?

If we look at the case law on consent after Montgomery the challenges become more apparent:

  • Practitioners are told to tailor their approach to the patient in front of them – but in Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058 we then have reference to a duty to cover those risks that an 'ordinary sensible patient' would have wanted to hear about.
  • A subjective approach has subsequently been reinforced in Thefaut v Johnston [2017] EWHC 497 but what about revisiting the decision of a patient who was properly counselled and signed up to an agreed treatment plan?
  • Where risks change (such as during the course of a pregnancy for example) a duty to re-evaluate what was previously agreed for the delivery may well be necessary as was the case in NKX v Barts Health NHS Trust [2020] 4 WLUK 123

Is the type of procedure important?

We know that in an emergency situation the healthcare practitioner should act in the best interests of the patient. Furthest away from that scenario is an elective procedure which is not performed for health reasons, but for aesthetic ones, eg. plastic surgery.

How should a plastic surgeon approach consenting such a patient to reflect the plethora of (mis)-information available on the internet, enthusiasm of the patient and the economics of the transaction that both are considering entering into?

Before Montgomery the approach one typically saw was patient information booklets and lengthy consent forms, with a 'cooling off' period. Could it be argued that Montgomery assists the justifications for performing cosmetic surgery, recognising individual autonomy and freedom for the patient to make their own decisions about their treatment? The reality, as many aesthetic practitioner has found, is the opposite, patients who are enthusiastic pre- procedure can become obsessive about 'sub-optimal' results post intervention and dispute that there was openness at the consenting consultation/s.

Conclusions

The obtaining of informed consent is a journey, for the patient and the clinician. If there is good communication at every stage then there should be no nasty surprises and both should be clear as to the destination and how they are going to get there. If there are uncertainties and the need for a detour along the treatment pathway this must be addressed by both parties head on.

Should you have any comments or queries arising from the above, please contact Vicki Swanton.

The DWF Healthcare Team has a global reach. In the UK our dedicated helplines provide instant access to our expertise which we deploy to resolve regulatory, disciplinary, coronial, criminal and civil disputes (including claims involving product liability). We also deliver risk management, policy and general advice - including guidance on the storage, management and protection of sensitive data.

Further Reading