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Making Consent Fit For Purpose in the Digital Era

What is consent?

Consent is defined as the process of giving permission or agreement for something to happen. Within medicine consent is required for investigation and treatment. Consent occurs at the end of a process of shared decision making, when an informed choice is made. 

Legal Basis of Consent

The law surrounding consent was clarified by the Supreme Court in 2015 in the case of Montgomery v Lanarkshire Health Board . This clarified the nature of information, which must be disclosed to a patient, in order for them to make an informed choice. It established a duty of care to warn of material risks. It defined the test of “materiality” as whether “a reasonable person in the patient’s position would be likely to attach significance to it”. Prior to this, the ultimate legal test of what information should be disclosed to a patient was covered by the principles also applied to professional negligence: the Bolam test in England & Wales, and the Hunter-Hanley test in Scotland. In essence, these tests were professionally based. The adequacy of disclosure, in a disputed case, would be compared to another doctor of ordinary skill acting with ordinary care, by an expert medical witness. The Montgomery decision ultimately affirmed principles, that had already been put forward by the General Medical Council (GMC), in their guidance on consent .

How is Consent Expressed and Recorded?

The GMC note that the exchange of information between doctor and patient is central to good decision-making. The information should be tailored based on their needs, wishes and priorities, the complexity of the treatment and the nature and level of associated risk. In particular it states that patient should be given time to reflect, before and after they make a decision, especially if it is complex and/or involves significant risks. The GMC Consent guidelines also states, “you must use the patient’s medical records or a consent form to record the key elements of your discussion with the patient. This should include the information given to the patient, and details of any decisions that were made.” (Paragraph 52).

Following exchange of information with the patient, there are no legal regulations over how consent can be expressed and recorded. While the GMC guidance states that it must be recorded in the medical record, it may be given orally or in writing, or it may also be implied (i.e. by rolling up a sleeve to allow a blood sample to be taken). For minor or routine investigations or treatments it is usually enough to have oral or implied consent. Where cases involve higher risk, it is important to obtain written consent. This provides a record of what was explained and agreed. This is also the case where treatments are complex and/or have significant risk. 

Where written consent is required, hospitals have developed “consent forms”. These documents are designed to satisfy the requirements of the GMC guidance. It is anticipated that they would serve as evidence in future legal proceedings, if informed consent is retrospectively called into question. In these cases a patient may allege that they did not receive adequate information about material risks and had they known these, they would not have opted to proceed with treatment. 

Current written consent forms are often hand written, with the clinician writing the procedure, along with risks. Occasionally they may be pre-printed with risks already typed. The clinician usually signs and dates the form and gives it to the patient who then also signs and dates it. The consent form may provide additional consent to other actions such as medical photography, or the use of surgical discard material for research. There are sometimes specific sections covering objections to the administration of blood products, for religious reasons. 

The consent form is then stored in medical records, but no copy is usually available to the patient. Patients may also be given literature about the operation such as information leaflets. It is difficult to record administration, reading and comprehension of these leaflets routinely in the patient record. 

Consent Visits in Patient Pathways

The traditional consent process also results in an additional visit to hospital, with a reliance on the provision of a physical signature. This is usually undertaken a few weeks prior to surgery to allow time to reflect on the decision, but to be close enough as to maintain knowledge. As such, this adds to the burden for patients for transport, parking and time off work. Clinical space is required and this may prevent other new or return patients from being reviewed. 

Digital Consent: The Future?

Many “virtual” care pathways are currently being developed across medical specialties. These result in patients only attending hospital when specifically required for examination, investigation and treatment. There is increasing use of telephone and video technology. The physical visit to sign a consent form is becoming increasingly incongruous, and questionable to patients and clinicians. Patients are increasingly used to providing electronic consent for a variety of uses. The current COVID-19 pandemic has accelerated the deployment of these pathways, with an avoidance of hospital attendance where possible. There are also situations of tertiary referral, where patients may be travelling significant distances for treatment.

It is clear that there is a need for a solution that delivers:

  • Clear presentation of information, using multimedia options where available
  • Stored record of information presented about the proposed procedure
  • Explanation and tailoring of side-effects, complications and failure to achieve the desired aim
  • Ongoing access to the information by the patient to allow re-reading and reflection
  • Ability to ask further questions and contact the clinical team when required
  • Recording of consent by patient that is legally acceptable
  • Secure and compliant cloud storage to allow for future ease of retrieval by clinicians and patients
  • Access by the clinical team around the time of surgery to recheck consent with patient and facilitate surgical safety practices such as WHO (World Health Orgaisation) checklisting.

Conclusions

The traditional consent form has not adapted to modern requirements. It is inadequate at conveying and recording information. It cannot be relied upon to provide adequate recording of the consent. Therefore it cannot be relied upon as evidence of a robust consent process. It also has not adapted to the rapid changes in patient pathways and expectations in the digital era. 

The Consentwise Digital Consent system aims to provide a modern, compliant system to support shared decision making and consent, whilst enabling new models of care. The ultimate aim is to provide high clinician and patient satisfaction in its use.

Paul Jenkins MD FRCSEd(Tr & Orth) MFSTEd
Consultant Orthopaedic Surgeon

About the Author:

Paul Jenkins is a Consultant Orthopaedic Surgeon and Clinical Director of the Department of Trauma & Orthopaedic Surgery at Glasgow Royal Infirmary. He specialises in Shoulder & Elbow trauma and disorders. He has a wide research interest and has been involved with the development of virtual patient pathways in trauma and elective orthopaedic management. He has also provided expert witness opinion in a variety of pursuer and defender, civil and criminal litigation. 

Declarations:

Paul Jenkins holds shares in Digital Consent Ltd and is on their Surgical Advisory Panel.

[i] Montgomery v Lanarkshire Health Board [2015) UKSC 11
[ii] https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent

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