The art of consent

By Dr Natalie Blakely and Mandy Luckman / 01 Apr 2014

Dr Natalie Blakely and specialist lawyer Mandy Luckman answer key questions about the ethical and legal issues involved in obtaining consent from patients

Should you re-consent before every procedure?

Informed consent is a fundamental legal requirement with any form of medical procedure undertaken, with many legal disputes centred around the information that was given to the patient at the initial consultation. As aesthetic practitioners we are often in the position of giving the same, regular treatment to the same patient. So, should we re-consent before every procedure?
Undoubtedly, the first time you get consent for any treatment is the most important. It is advisable to provide the patient with literature detailing all aspects of the procedure, including the risks and benefits. This literature should form the basis of the consent form that should be signed by the patient prior to undergoing the procedure. The practitioner should also talk through the details of the procedure with their patient until they are satisfied that they understand it in full.If the procedure is one that may be required on a regular basis, such as botulinum toxin or fillers, the consent form should inform the patient that the treatment is temporary and that to maintain the result, regular treatment is required. If your initial consultation and consent form is thorough enough this should be sufficient. If in doubt, consent before every procedure. However if the primary consent form is comprehensive then subsequent forms can be simpler, referencing the original literature provided to the patient.
Remember that you should ask your patient at each appointment about any changes to their health, for example, if they have developed any allergies, if they are taking any new medication or any other changes since they last saw you.

Should we consent for everything we do, however minor?

Some doctors do not consent for small procedures, for example, skin tag removal, because the patient has given implicit consent by allowing the doctor to do the procedure. However, without consent, invasive actions and medical intervention would be considered an assault; so it is vital that the clinician provides their patients with all the information they need to understand each procedure, thus giving them the opportunity to make an informed decision.
It is advisable to obtain consent for all procedures no matter how simple the procedure, but this becomes more important where there are adverse risks. Consent can be given either verbally or in writing, so for very simple procedures, consent could be purely verbal. However it is strongly advisable for clinicians to obtain consent in writing so that they are able to provide documentary evidence to demonstrate that they have explained the procedure to their patients, including all associated risks, should they be challenged by a regulatory body or in court.

Is it a legal requirement for consent forms to be signed by both practitioners and patients?

General Medical Council guidance says that it is your responsibility to keep clear, accurate and contemporaneous patient records, which report the information discussed with and given to the patient, specific requests by the patient, decisions made and actions agreed. This should be recorded along with information regarding who is making the decisions and who is agreeing the actions1. Therefore it is important for the practitioner to sign the consent form as well as the patient.

Should consent forms be timed and dated?

GMC guidance states that all records should be timed and dated and such records may be crucial if a claim arises in the future.2 Therefore it is important that you are able to demonstrate that informed consent was ob- tained contemporaneously within reasonable proximity of the procedure or treatment.

Should the person consenting the patient have the technical skills to carry out the procedure?

The British Association of Aesthetic Plastic Surgeons says it believes that ethically, consultation should be carried out by the surgeon undertaking the procedure.3 However, this is not a legal requirement; indeed, in the NHS it is standard practice for junior doctors to consent patients for operations performed by the consultant. There is currently little regulation in place in respect of who should be responsible for consulting with the patient; but the person taking the consent must be fully aware about what the treatment involves, and should be able to provide the patient with all necessary information, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if the treatment does not go ahead.

Can data be stored in the cloud, and are digital signatures valid?

The Electronic Communications Act 20004 recognises the legal validity of e-signatures in the UK and provides guidance on data storage, encryption services, and electronic communications for residents of England, Scotland, and Wales. This means that electronic signatures have the same legal consequences as the more traditional forms of executing documents.
In accordance with the Data Protection Act 1998, confidential information should be stored safely and securely.5 This includes the use of secure servers where there are firewalls in place and documentation can be appropriately encrypted. If appropriate security is in place, documentation may be stored electronically but only for as long as necessary. Cloud storage is a model of virtual storage generally hosted by third parties. In using the cloud, practitioners must ensure that the virtual facility is recognised as being secure. The patient’s information including their e-signature may be stored anywhere which is considered to be secure. It is likely that storage in the cloud is more secure than storage on a device such as a laptop or tablet which can be more easily lost, stolen or accessed inappropriately. If the cloud is to be utilised, it is important to ensure that access to this data is limited and closely controlled.

Will a signed consent form prevent you from ending up in court if something goes wrong?

If there is an issue mentioned on the consent form, for example, the risk of necrosis after filler, and it unfortunately occurs and the patient wants to sue you, the consent form alone will not keep you out of court. The fact that you have obtained a signed form from your patient does not mean that the treatment proposed has been completely understood or accepted, and therefore the quality of consent can never be determined just by the signed form. For consent to be legally valid, it must be voluntary and fully informed, and the person consenting must understand the information that they have been given and have the capacity to make the decision. Additionally, if there is evidence to suggest that the procedure was carried out below a reasonably competent standard, then legal action may still be sought by the patient, whether or not informed consent can be proven.

Who owns the consent forms?

Many aesthetic practitioners are self-employed and work from more than one clinic, so do not have control of the storage of their patients’ consent forms. The legal position is that consent forms are part of a patient’s medical records. The patient owns the information contained within the medical records but the healthcare provider owns the paperwork that contains the information. The provider therefore has a duty to protect the confidential information contained within. In the case that the practitioner works from several clinics, he or she would keep the clinical records and the clinic or hospital would keep other records, such as the nursing notes and patient co-ordinator records. Patients have a legal right to access their medical records under the Data Protection Act 1998.6 If a problem results in legal proceedings, a patient is able to authorise their lawyer to access their records on their behalf. In order to do so, the patient will need to sign a consent form authorising their lawyer to make this request.
If a request is made by the patient, healthcare providers are expected to co-operate with the terms of the Pre-action Protocol for the Resolution of Clinical Disputes, which requires disclosure of medical records within 40 days of the request. The lawyers will be responsible for reasonable copying/administration charges under the provisions of the Data Protection Act 1998. This will be at a maximum charge of £50 but is proportionate to the actual amount of copying undertaken.7

Four things that can make consent invalid

  • Patient lacks capacity e.g. they lack capacity to manage their own affairs or have been drinking
  • Patient is not properly informed e.g. the images of the effects of the procedure are unrealistic 
  • Patient has been placed in a pressurised situation e.g. there is a time limit for a discount on a procedure, or a friend is present with the patient who is trying to persuade them
  • Patient is demonstrating signs of body dysmorphia 

Case Study

The English Court of Appeal (O’Keefe v. Harvey- Kemble)8, recently held that a surgeon had failed to inform his patient of the risks associated with her breast implant procedure prior to undertaking the operation, most notably the high risk of encapsulation. When this risk materialised the patient brought a claim on the basis that the surgeon had not informed her that this was a potential risk. The court decided that it was more than probable that the patient would have chosen not to undergo the surgery had she been made fully aware of the risks. This case also highlights the importance at the initial consultation of clinicians assessing patient expectations and providing clear written advice and information about risks for patient consideration at a later date. Consent must be obtained before the procedure so that patients are able to consider the information presented to them and voice any concerns or queries that they may have. 

RELEVANT LINKS:

(Medical Protection Society) http://www.medicalprotection.org/uk

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