In this article Suzanne Creed, clinical risk and education manager at Medical Protection, outlines some of the common risks and dilemmas that staff working in general practice may face relating to patient consent, as well as providing some risk management strategies to mitigate those risks.

What do we mean by the term consent?

Consent is a fundamental principle of clinical practice. The basic rule is simple: no-one has a right to touch anyone else without lawful reason. If healthcare professionals do so, it may well undermine the patient’s trust.

Consent is the giving of permission or agreement for an intervention, receipt or use of a service, or participation in research following a process of communication about the proposed intervention.¹ Every clinical interaction involving a capacitous patient within general practice rests upon a foundation of consent.

Consequences of inadequate consent
Within general practice failure to obtain adequate consent could result in a clinical negligence claim, a complaint to the Medical Council or even civil or criminal proceedings for assault. 

Types of consent
Patients can signify their consent in a variety of ways, for example in writing, verbally face-to-face and, in certain circumstances, by implication, for instance holding out their arm when requesting to take their blood pressure.
  
The Medical Council reinforces the importance of gaining consent stating: “You must make sure that patients have given their consent before you provide any medical investigation, examination or treatment.”² Conversely, it is also important to remember that every adult with capacity is entitled to refuse medical treatment. Clinicians should respect a patient’s decision to refuse treatment, even if they disagree with that decision.

Signed consent forms 
Signed consent is not a legal requirement in Ireland (with rare exceptions, for example,  some treatments under the Mental Health Act 2001). The presence of a signed consent form does not in itself prove valid consent for treatment was obtained. It simply documents that some discussion about the procedure or investigation has taken place. Consent forms are evidence of a process, not the process itself.  

Firstly, for consent to be valid the patient must have the capacity to make the decision in hand. The patient must have sufficient knowledge and information on which to base a decision. The quality and clarity of the information given is the paramount consideration. The information provided should include:

• aim of procedure/ treatment
• risks and benefits
• alternatives – which could include doing nothing, if appropriate
• what the procedure entails.

There should be no coercion, in other words consent must be voluntary. Patients should, wherever possible, be given time to consider their options and an opportunity to ask any questions before deciding to proceed with a proposed treatment.

Patient involvement 

Provision of information is key to obtaining valid consent. Unless patients have sufficient information, they are not in a position to decide what is best for them. Discussion of all the issues surrounding a proposed investigation or treatment is an integral part of the patient’s clinical care. These discussions may take place over several consultations, all forming part of the consent process.³

In Medical Protection’s experience, a significant proportion of clinical negligence claims include allegations of failure to obtain valid consent. Consent rarely forms a whole claim, but it is often a significant part. In the context of a claim, the information and advice provided to the patient would be thoroughly analysed to ensure that the patient was given all the information in order to make an informed decision. It is therefore critical that all information provided and discussed with the patient in relation to the consent process is clearly documented on the patient’s medical record as evidence that these discussions took place. 

Very often we consider consent for treatment as consent for a specific procedure, for example, a surgical operation or an invasive test. It is important to highlight that consent for treatment would also include pharmacological and other therapies such as initiating a new medication or issuing a repeat prescription.  

Data from 2015 shows that we prescribe 73.5 million items a year in Ireland, a task that GPs and nurse prescribers will perform on several occasions in any given day.⁴ When prescribing a new medication or reissuing a repeat prescription, issues relating to the consent process, for example risk/benefits of the medication, should be highlighted to the patient as well as documented in the patient’s record.  

In particular, when using high risk medications such as methotrexate, lithium and sodium valproate, it is important to document the discussions held around the consent process including advice regarding blood monitoring and follow-up appointments. Many clinicians also highlight this important information as a footnote in the ‘special instructions’ section of the prescription. 

A patient information leaflet is a valuable adjunct to counselling prior to any treatment, but must never be seen as a replacement for adequate discussion between doctor and patient. It is best practice to ensure copies of any patient leaflet are included in the patient’s medical record.
 
Practices should consider developing procedure-specific consent forms for the procedures they regularly undertake at the practice, such as minor surgery and childhood immunisations, which should incorporate the advice outlined above.

Medical Protection would strongly advise you obtain written consent in the following circumstances:

• There are significant risks or side effects associated with the proposed
treatment or procedure.
• The patient’s lifestyle, employment or personal relationships could be
adversely affected by the outcome of the treatment or procedure.
• The treatment or procedure is being undertaken as part of a research
programme.
• The main purpose of the proposed treatment or procedure is not the patient’s
clinical care for example cosmetic surgery.

Rights of unmarried fathers in providing consent 

Recent landmark legislation has increased the rights of unmarried fathers in Irish society.⁶ 

Consequently an unmarried father will automatically be a guardian if he has lived with the child's mother for 12 consecutive months after 18 January 2016, including at least 3 months with the mother and child after the child's birth. 

Practices should be aware of these legislative changes and the implications for obtaining parental consent, in particular in relation to childhood immunisations. Where parents are married, the child’s mother and father are automatically the legal guardians.  

An unmarried father can become a joint guardian if both parents sign a statutory declaration agreeing to this, or he can apply to the court to be made a joint guardian. In this case, the decision of whether to make the father a joint guardian is made in the best interests of the child.

Consent and clinical photography

Patient images are used for many purposes in clinical practice. It is important to recognise that they form part of patients’ medical records as a valuable adjunct to clinical care, and are often shared with other members of the primary care team or colleagues in secondary care for discussion purposes. They also provide valuable evidence in the event of a claim or a complaint. 

In all cases it is not only advisable, but necessary, that appropriate consent be obtained and clearly documented in the patient’s file. 

The use of clinical photography is not without risk and this is particularly the case when using mobile phones to take clinical photographs. It is not appropriate to use personal cameras or the camera facility on personal mobile phones for clinical purposes. This has potential to breach patient confidentiality as patient identifiable information may be inadvertently stored on a personal device or backed up in cloud storage. 

Technological advances, in particular mobile applications, have allowed for a number of developments to assist clinicians in clinical photography. Although Medical Protection cannot endorse any particular application, Snap GP is an example of a clinical photography app. This app allows for the patient’s name and signature to be embedded into the image itself. The image is transferred securely from phone to clinical record via an encrypted connection. Once the transfer has taken place images are removed from the phone and transfer device.⁷

Some clinicians use a dedicated digital camera, which is used solely for taking clinical photographs. Such photos should then be immediately attached to the patient file and subsequently deleted from the camera. 

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Scenario

It’s a busy Tuesday morning at the practice and the phones are ringing incessantly. One of the calls is from a patient who is extremely unhappy about a text message appointment reminder she has received which was meant for her 15-year-old daughter. The text message asked the daughter to call the surgery as she had missed her follow up appointment with the doctor.

The mum is both shocked and annoyed. She was unaware that her daughter had previously seen the doctor. This has caused a problem at home between the daughter and mother and the daughter is also very upset as she felt her consultation with the doctor was private and confidential. The mother has phoned the practice to complain.

Could this happen at your practice? What is your practice’s approach to obtaining consent? 

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Consent to text messages 

However, it is important not to assume that just because the practice holds the patient’s mobile telephone number on the patient’s record, that they have provided consent for text messages to be sent. 

Practices should only send text messages to patients when specific consent has been recorded. Patients who consent should be advised of the importance of informing the surgery of any changes to their contact details and it is advisable that the clinicians periodically check patients’ mobile numbers. 

A recent ICGP study on text messaging in general practice examines the common risks and advises of the safeguarding required to ensure patients are appropriately consented and that you have the necessary safeguards in place to protect children and young adults and patient confidentiality. In general, text messages should not be sent to children under the age of 16.⁸ 

Practices should ensure that they have the necessary safeguards in place to ensure that texts messages are not inadvertently sent to a parent’s number, thus breaching patient confidentiality. A policy outlining all the risks and necessary safeguarding procedures is also included in the ICGP document. 
  

Conclusion

Consent is needed for all clinical examinations, investigations and treatment involving patients who have capacity to make the relevant decisions in everyday general practice. The decision-making process should be a partnership between the clinician and patient.  

Failure to obtain appropriate consent may harm patients, could seriously compromise your doctor–patient relationship and could result in a complaint to the Medical Council, a clinical negligence case or even criminal proceedings for assault.  

Medical Protection offers a one hour workshop on Consent in General Practice. For further information please contact our education department: email [email protected] or call +44 113 241 0624.

References

1. HSE, National Consent Policy, 2017. Available from:
hse.ie/eng/about/who/qid/other-quality-improvement-programmes/consent/
2. Medical Council, Guide to Professional Conduct and Ethics for Registered Medical Practitioners, 8th Edition 2016. Available from:
medicalcouncil.ie/News-and-Publications/Reports/Guide-to-Professional-Conduct-and-Ethics-8th-Edition-2016-.pdf
3. Medical Protection, Consent to Medical Treatment in Ireland: An MPS guide for clinicians, 2015. Available from: medicalprotection.org/ireland/booklets/consent-to-medical-treatment-in-ireland
4. Houses of the Oireachtas, Joint Committee on Health and Children, Report on the Cost of Prescription Drugs in Ireland, 2015. Available from: webarchive.oireachtas.ie/parliament/media/committees/healthandchildren/health2015/jchc-report-on-the-cost-of-prescription-drugs-in-ireland-081015.pdf
5. ICGP, General Data Protection Regulation (GDPR) and GPs, 2018. Available from:
icgp.ie/go/in_the_practice/data_protection
6. Children and Family Relationships Act 2015. Available from: irishstatutebook.ie/eli/2015/act/9/section/49/enacted/en/html
7. Snap GP, Patient Imaging App. Available from: snapgp.com/index.html
8. ICGP, Text Messaging in General Practice, 2018. Available from:
icgp.ie/go/search?r=library&q=TEXT+MESSAGING+&x=0&y=0