Obtaining Valid Consent
Igor Blum, Rebecca Moazzez and Nikki Doyle
Obtaining a patient’s valid consent prior to any examination or the delivery of treatment is a fundamental aspect of the provision of dental care. Without a thorough understanding of the principles of gaining valid consent to investigations and/or treatment, dentists, therapists and hygienists may find themselves susceptible to legal repercussions, not least those of assault and/or negligence – which in turn could lead to criminal charges and/or civil claims. A growing number of complaints reported to the General Dental Council (GDC) and allegations against dentists in GDC fitness to practise investigations are focusing upon the subject of consent. However, more importantly, it is every patient’s right to have a thorough understanding of what is going to happen to them, be agreeable to going ahead with what is suggested, and provide necessary and appropriate consent. If this is not carried out properly, with due consideration to the legal implications, the patient may not only lose trust in the dental professional involved but also the profession.
This chapter looks at recent changes in case law in relation to obtaining valid consent and considers key guidance on the subject of consent, including professional and clinical standards (Royal College of Surgeons of England, 2016), Consent: Patients and Doctors Making Decisions Together (General Medical Council (GMC), 2008), Reference Guide to Consent for Examination or Treatment (Department of Health, 2009), Standards for the Dental Team (GDC, 2013) and Consent (Dental Protection, 2015). It aims to offer dentists and other dental care professionals practical advice on how to meet the legal and regulatory requirements around the consent process and how to protect a patient’s rights to make decisions about their treatment.
In addition, consideration is given to some of the key areas of note, while also offering practical and real‐world advice. The chapter will briefly describe the process of consent in relation to clinical research. The intention is not to provide comprehensive information about the regulations related to consent across the UK, let alone elsewhere in the world, but merely to help the reader understand the principles, ethical as well as legal, that they need to consider in relation to consent. Readers are advised to find out about the regulations applicable to them locally and ensure they have a thorough understanding of the relevant regulations and their responsibilities.
Respect for patients’ autonomy is expressed in consent law; to impose care or treatment on people without respecting their wishes and right to self‐determination is not only unethical, but illegal. Touching another person without permission is the definition of battery, so the patient’s consent is a necessary step prior to starting any patient examination or treatment.
Update in Law in Relation to Consent
The law is continually changing and developing as the courts interpret both the common law and legislation. The doctrine of precedent means that judgements from a higher court will bind a lower court.
The Montgomery Case – a New Era of Consent in Dentistry?
The law in relation to consent has changed following the handing down of the Supreme Court judgement in Montgomery v Lanarkshire Health Board in March 2015. The Montgomery standard states that legally, clinicians, including dentists and other dental care professionals, must take now take reasonable care to ensure that patients are aware of any risks that are material to them, and they should inform their patients of alternative treatments. Although this case has changed the law, it has simply brought the law into line with GDC standards (2013) that were already applicable when obtaining consent.
The concept in England and Wales was, therefore, until the case of Montgomery, that of the prudent dentist. When disclosing risks, what would a ‘prudent dentist’ explain to a patient? The answer, found in Bolam v Friern, was ‘the information which a dentist in that situation would normally be expected to explain to a patient who needs that information’. However, the Montgomery case changed this and the Bolam principle no longer applies to the provision of information about risks of proposed treatment. It should be noted that the Bolam principle still applies in all other aspects of clinical practice apart from consent.
The perspective of the ‘prudent dentist’ needs to be balanced first against that of the ‘prudent patient’, that is, what would a normal patient of sound mind reasonably expect to know before being able to make a decision as to whether or not to proceed with the treatment? The Montgomery case emphasised the need to tailor information to the specific and individual needs and wishes of the patient before deciding whether or not to proceed with treatment. D’Cruz and Kaney’s (2015) advice is that, ‘…it is prudent to get to know your patients so that you can discuss with them risks that any patient would want to know, plus any risks that you would consider would be relevant to the particular patient concerned’. This resolute move away from the paternalistic traditional model of consent towards a more patient‐centred perspective requires a change in attitude from practitioners in discussions about consent, as they are no longer the sole arbiter of determining what risks are material to their patients. No treatment should ever be undertaken without giving the patient the opportunity to ask questions and/or raise any concerns or fears. An inadequate consent process can damage the dentist–patient relationship and result in legal challenges and litigation.
Assumptions about a patient – based on, perhaps, their appearance, religious beliefs, dental attendance patterns, disability, apparent inability to articulate their dental problem or the fact that they make a decision with which the practitioner disagrees – are unwise. You should not make assumptions regarding the wishes of a patient and what they might perceive as the best option available, perhaps resulting in restricted offers of options for treatment. Furthermore, you should not assume that the patient has the same set of values, wishes or life priorities as you would have in a similar situation. It should be acknowledged that the patient as an individual has his or her own views (Mills et al., 2014).
Informed Consent versus Valid Consent
The 2009 Department of Health England Reference guidance to consent for examination or treatment emphasises the term ‘valid consent’ rather than ‘informed consent’.
Principle Three of the General Dental Council’s 2013 Standards focuses on how to ‘Obtain Valid Consent’.
So, what is the difference between informed consent and valid consent?
Traditionally, healthcare professionals have understood that merely providing a patient with information about what is going to happen to them and the patient then agreeing to give consent (i.e. informed consent), is enough to assume patient consent. Although the provision of information to the patient is an enormous part of the consent process, it should not be considered to be sufficient to be all that is required. Informed consent and valid consent should not be viewed on equal terms; informed consent is an element in the process of gaining valid consent.
The document Consent: Supported Decision‐Making – a good practice guide published by The Royal College of Surgeons of England (2016) states that for consent to be valid, it must be:
- Given by a person with the capacity to make the decision in question.
- Given voluntarily.
- Based on appropriate information (informed) and understood.
If any of these factors are missing, the patient is not considered to have given valid consent and therefore has not granted permission to proceed to treatment.
It is the responsibility of the treating practitioner to assess the capacity of their patients to make decisions about their care. In this assessment, practitioners must comply with the Mental Capacity Act 2005 (England and Wales), the Adults with Incapacity (Scotland) Act 2000, and the Mental Capacity Act (Northern Ireland) 2016, including the Codes of Practice.
The consent must be continuous throughout each stage of examination or treatment and it must be understood by the patient as something that can be withheld or withdrawn even during treatment.
Practitioners must be satisfied that their patient has received and understood sufficient information about their diagnosis, as well as the proposed treatment and its implications, to allow them to make a decision they deem to be in line with their own values and wishes.
Failure to Obtain Valid Consent
A significant proportion of clinical negligence claims are settled simply because valid consent was not obtained. In theory, where harm has befallen the patient and consent was not obtained, this could also give rise to claims for assault or battery and, in extreme cases, criminal charges, but fortunately this is exceptionally rare. Disregarding the GDC’s standard on consent can result in charges of professional misconduct and action by the GDC on the dental registrant’s registration.
The signing of a consent form by a patient does not constitute proof that the consent was valid and is not sufficient evidence of validity in a court of law. If there is any dispute over whether valid consent was obtained, the key issue will not be whether the patient signed a form or not, but whether they were given all the appropriate information they needed in a way that they could understand sufficiently well to make a considered decision. It is, therefore, crucial that the essential elements of discussions with the patient are documented in the patient’s clinical records.
The notes do not need to be exhaustive but should state the nature of the proposed procedure or treatment and the reasons for reaching the decision, and itemise the risks, benefits and alternatives brought to the attention of the patient, even if the patient decided not to undergo a procedure, or have any treatment. Any fears or concerns raised by the patient should also be noted.
To understand the information provided, and to give the necessary authority for consent, a patient must be competent. ‘Competence’ in this context means the patient’s ability to understand the explanations given about:
- The nature and purpose of a particular procedure.
- Its likely effects and risks.
- Any alternative treatment and how these alternatives might compare.
Only if a patient is competent to consent can the patient’s consent be considered valid.
In England and Wales, the Children Act 1989 defines who has parental responsibility and the consequent right to give consent to a child’s treatment. Understanding who holds parental responsibility is not always straightforward and, depending on the child’s date of birth, a father may hold parental responsibility for one child but not for their older sibling.
All mothers have automatic parental responsibility. Parental responsibility rests with both parents, provided they are named on the birth certificate and regardless of whether they are married or not, for children whose births were registered from:
- 15th April 2002 in Northern Ireland.
- 1st December 2003 in England and Wales.
- 4th May 2006 in Scotland.
In England and Wales, the relevant legislation for defining the age at which children can normally be considered capable of making their own decisions is to be found within the Family Law Reform Act 1969. It permits an individual of 16 years of age or over, and of sound mind, to give legally valid consent to dental treatment; it does not preclude children under 16 years of age from also giving consent.
Many readers will be familiar with the Gillick (1986) case in England, which related to the provision of contraceptive aids to girls under 16 years of age without parental consent. Because of this case, the view is generally held that children, if they can fully understand the proposed treatment, can give consent to that treatment. Practitioners should always try to confirm that both the child and the parent understand the treatment to be given. Even in cases where it is believed that the child may be capable of giving consent which (according to Gillick) would negate the need to obtain parental consent, it is still wise to try to seek the child’s permission for a discussion with the parent to confirm their agreement. If a parent is not available when children under 16 years of age are examined, then extreme caution is advised. In 1991, the Court of Appeal in England, in the case Re‐R, decided that where a child under 16 refuses consent to treatment, that consent could be obtained from a parent. Whilst a child of 16 or 17 can consent to treatment in accordance with the Family Law Reform Act 1969, a person with parental responsibility can also consent to the treatment of a child aged 16 or 17. If a child of 16 or 17 consents to treatment, consent cannot be withdrawn by the person with parental responsibility.
The Consent Communication Process
As part of the communication process, practitioners should concentrate their focus not only on ensuring that the patient thoroughly understands the information being provided to them but that they are provided with an impartial and precise overview of the advantages and disadvantages of the proposed treatment. Thus, patients should be comfortable in the fact that they comprehend the important issues relating to what is going to happen to them and which in turn will affect their decisions in whether to agree to embark on the recommended procedure or course of treatment.
In accordance with the GDC Standards for the Dental Team (2013), information which should be provided to the patient regarding procedures includes:
- Options for treatment, the risks and the potential benefits.
- Why, in the opinion of the clinician, a particular treatment is necessary and appropriate for them.
- The recommended treatment options.
- The consequences, risks and benefits of the proposed treatment.
- The likely prognosis of treatment.
- If applicable, the cost of the proposed treatment.
- What might happen if the proposed treatment is not carried out.
- Whether the treatment is guaranteed, how long it is guaranteed for and any exclusions that apply.
Additional information that is good practice and should be provided to patients includes:
- Potential follow‐up treatments.
- If applicable, the materials and their constituents used during treatment.
- The clinicians involved in the treatment.
The emphasis therefore lies in maintaining an ongoing effective channel of communication between practitioner and patient for both parties to be satisfied that consent is not only informed but also valid.