September 30, 2023

  1. Emma Kenney-Herbert, scientific oncology registrar1,
  2. Michael Mylonas, barrister2,
  3. Tony Murphy, affected person and public consultant3,
  4. Tom Roques, vice chairman, and scientific oncology and, a advisor scientific oncologist45

  1. 1Oxford

  2. 2Serjeants’ Inn Chambers

  3. 3Affected person consultant

  4. 4Royal School of Radiologists

  5. 5Norwich

Knowledgeable consent within the medical context is outlined within the Oxford Dictionary as “permission from a affected person for a medical skilled to hold out remedy, with full understanding of the attainable dangers and penalties.” In each medication and surgical procedure, clinicians take consent usually for routine and emergency remedies and procedures. Ethically, we should take consent to respect affected person autonomy. Legally, performing a process with out consent is a prison offence and the doctor may be charged with battery.

Within the post-Montgomery period, and in gentle of the up to date tips from the Normal Medical Council (GMC) on consent there has by no means been a extra acceptable time to evaluate consent processes.1 The brand new steerage, in step with the Montgomery judgment,2 takes a agency step away from the earlier patriarchal (“your physician is aware of finest”) strategy and focuses as a substitute on dialogue with the affected person to determine the actual dangers which that affected person would want to grasp earlier than remedy, in addition to emphasising the significance of discussing any ranges of threat, together with critical hurt, even when such an prevalence is uncommon.

It’s typically accepted that one of the best moral and authorized apply is to make sure legitimate written, signed consent is sought earlier than beginning remedies, procedures, or surgical procedure. Taking written consent ought to observe a full dialogue with the affected person of the meant advantages and unwanted side effects of the remedy in addition to any different remedies. Ideally sufferers must be given time to mirror earlier than giving their consent. The GMC emphasises the significance of an understanding of particular person affected person priorities.1 Whereas signing a consent type will not be an alternative choice to a significant dialogue and dialogue of remedy, it might probably assist present a spotlight for the dialogue, a reference for unwanted side effects, and in addition documentation of a part of the consent course of which will also be utilized in courtroom proceedings.

Throughout the UK, docs are taking consent for a similar procedures, however utilizing completely different consent types with completely different dangers recognized. An audit of the consent course of for prostate radiotherapy indicated half of hospitals had been annotating unwanted side effects by hand on a generic consent type, whereas the rest had created their very own pre-populated consent type.3 When evaluating unwanted side effects included on pre-populated consent types in several hospitals there was important variation.3 Whereas it’s attainable that there are regional variations within the degree of threat from particular procedures that is much less possible with extremely protocolised remedies like radiotherapy. In any occasion, there are clear benefits in commonality within the consent course of for a single process. Uniform consent documentation will simplify the coaching of healthcare professionals in acquiring consent and keep away from confusion once they transfer between hospitals. If all docs use the identical types and undertake comparable approaches within the “dialogue” with sufferers, will probably be simpler for peer evaluate to determine and assist any docs who’re utilizing sub-optimal strategies to acquire consent. Nationwide types will keep away from duplication of effort in producing native consent types. The place advances in medical information imply that the dangers or advantages of a process change, that studying may be disseminated nationally and concurrently in a uniform approach to all docs by updating one type and never many. Most significantly, a nationwide strategy will cut back any pointless variation and guarantee readability for sufferers and kin. If completely different dangers are recognized for a process in several hospitals, the extra complete types could also be utilized by litigators performing towards these hospitals with much less detailed types, so a nationwide strategy will cut back time and useful resource spent litigating claims alleging a failure of consent.

We consider that scientific and surgical specialties ought to use nationwide standardised consent types for procedures and surgical procedure to enhance the consent course of for sufferers and clinicians. The Royal School of Radiologists (RCR) developed nationwide website particular consent types for radiotherapy for healing and palliative remedies. The strong course of which was adopted led to the crew being awarded most cancers care crew of the 12 months on the BMJ awards in 2021.4 The primary 10 radiotherapy consent types had been generated in 10 months involving 115 people, however most significantly with a robust concentrate on affected person involvement. The protocol used might be adopted by different specialties to develop nationwide consent types for procedures.56 The RCR types are actually used within the majority of UK most cancers centres and have been downloaded greater than 68 000 occasions, demonstrating the massive clinician assist for such a mission.

Nationwide commonplace consent types designed by consultants together with sufferers and reviewed and authorized by legal professionals would put docs in a stronger place each ethically and legally. We recommend different specialties observe this strategy.

Table of Contents

Footnotes

  • Competing pursuits: Emma Kenney-Herbert is a scientific fellow of the RCR and led the RCR mission to develop nationwide commonplace consent type for radiotherapy. Michael Mylonas has offered professional bono authorized assist for the RCR consent mission. Tony Murphy was made an Honorary Member of the RCR in 2016. He acted because the affected person consultant on the RCR consent types steering group. Tom Roques oversaw the event of nationwide commonplace consent types for radiotherapy.

  • Provenance and peer evaluate: not commissioned, not externally peer reviewed.

References

  1. Montgomery v Lanarkshire Well being Board (2015) UKSC11.

  2. The2021BMJ Awards Showcase | Watch our brief minute movies