Introduction To Consent 2023 PDF

Introduction to consent Greg Moorlock [email protected] Learning Outcomes By the end of this session you will be able to: – Describe the requirements of a valid informed consent or refusal of treatment including the assessment of capacity, the provision of information and me...

Introduction to consent Greg Moorlock [email protected] Learning Outcomes By the end of this session you will be able to: – Describe the requirements of a valid informed consent or refusal of treatment including the assessment of capacity, the provision of information and measures taken to avoid coercion – Identify different forms of consent and situations when it is appropriate to use them. – Describe the legal standing of a consent form.  Part 1 Consent – The Ethical Underpinnings Informed Consent A starting point for protecting rights and interests of individuals; Consent is remarkably powerful; Informed consent is a legitimacy requirement for certain actions: – Consent is needed to make certain actions legally and ethically permissible; – Lack of consent can turn a seemingly well- intended medical intervention into assault or battery. But from where does it gain its significance? Autonomy Autonomy is a complex and debated philosophical concept; But a simple description prominent in bioethics is as follows: – “Personal autonomy encompasses, at a minimum, self-rule that is free from both controlling interference by others and from certain limitations such as an inadequate understanding that prevents meaningful choice (Beauchamp and Childress) Respecting autonomy is part of respecting the rights and interests of patients. And you can see how we get from respecting autonomy to requiring informed consent. Consent in health care Treatment Investigation Examination Disclosure of information Research Education English law and consent Battery – To avoid a charge of battery a doctor must have a valid consent. For a patient to give a valid consent he/she must understand the broad nature of the procedure. – The patient need not be harmed by the procedure to claim damages if battery is proved. GMC Guidance on Consent https://www.gmc-uk.o rg/ethical-guidance/et hical-guidance-for-doc tors/decision-making- and-consent GMC Guidance Encourages a proportionate approach to consent Emphasises that obtaining consent does not need to be a formal, time- consuming process You need to exercise your judgment  Part 2 The elements of consent Consent Valid consent comprises of three basic elements: – Competence/Capacity – Information – Voluntariness Attempts should generally be made to maximise the quality of consent. Capacity Assessment of a person’s capacity must be based on their ability to make a specific decision at the time it needs to be made. A person is unable to make a decision if they cannot do one (or more) of the following: understand the information given to them that is relevant to the decision retain that information long enough to be able to make the decision use or weigh up the information as part of the decision-making process communicate their decision (by any means). Capacity You must work on the assumption that every adult patient has capacity to make decisions; – So do not assume that because of someone’s age, disability, or communication difficulties that they lack capacity – they may simply need extra support to help them make/communicate decisions. – Capacity can be decision-dependent and can change: a patient may be able to make simple decisions, but not complex ones, at a particular moment. – Special considerations apply to adults who lack capacity, and to children. Information Why does consent need to be informed? – Doctors are experts and know the information already, so why do patients also need to know it? Consent needs to be sufficiently informed, but information provision should be tailored to specific patient and situation; You must give patients the information they want or need to make a decision What might this include? Diagnosis/Prognosis; Uncertainties about these; Options for treating/managing condition – including option to do nothing; Nature of each option, what would be involved, desired outcome Potential benefits, harms, likelihood of success etc You should not rely on assumptions about… Information a patient might want or need; Factors a patient might consider significant; Importance a patient might attach to different outcomes. Places a lot of responsibility on doctors. How have we ended up here? Montgomery v Lanarkshire Health Board UKSC 11 First pregnancy Short stature Insulin dependent diabetes Risk of shoulder dystocia 9-10% in women with diabetes 0.1% risk of hypoxia leading to cerebral palsy or death Montgomery v Lanarkshire Health Board UKSC 11 At 36 weeks patient expressed concern about the size of her baby and whether she would be able to deliver it vaginally Reassured by obstetrician Did not specifically ask about risks and was not told about shoulder dystocia Montgomery v Lanarkshire Health Board UKSC 11 “The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” Para 87 Montgomery v Lanarkshire Health Board UKSC 11 “…the doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by Voluntariness Consent should be freely given, without coercion; Some patients may be under pressure from employers, relatives, or insurers to make particular decisions. – If there is a suspicion of external pressures, efforts should be made to speak to the patient by themselves to establish whether their decision is voluntary. Voluntariness Explicit coercion Implicit coercion Power differentials in the patient/doctor relationship Pressure from family Discussion Point Did I make a truly autonomous decision here?  Part 3 Forms of Consent and Challenges Different Forms of Consent Implied consent via compliance; – A patient may roll up their sleeve to have their blood pressure taken; Oral consent – Appropriate for low risk procedures/treatments; Written consent – Generally sought for complex or higher-risk interventions; – But also if there are significant consequences for patient’s employment, social or personal life; – Or if clinical care is not primary aim of investigation/treatment; – Or if treatment is part of a research study; – Some specific treatments, such as fertility treatment, legally require written consent. Written Consent Forms A signed consent form does not mean that consent is valid: - if the patient - lacked capacity - was not provided with sufficient information - or did not give consent voluntarily their consent will not be valid, regardless of a signed piece of paper. Written consent is simply evidence of consent, rather than evidence of valid informed consent. It is therefore important to also document significant aspects of the consent conversation. Who should receive consent? If you are the doctor undertaking an investigation or providing treatment, it is your responsibility to discuss it with the patient. If this is not practical, you can delegate the responsibility to someone else, provided you make sure that the person you delegate to: a) is suitably trained and competent b) has sufficient knowledge of the intervention and its associated benefits and harms, as well as alternative options for treatment and care c) has the skills to have a dialogue with the patient that’s in line with the GMC guidance d) feels competent to carry out the delegated task and understands and agrees that they will refer to you (or another Consent for history taking and use of patient information The person taking the history and using the information is responsible for taking consent. This includes medical students. Potential obstacles to valid consent Poor information/Time pressure during information provision – Adequate provision of information – Alternative sources of information (other members of healthcare team, information booklets) Being rushed into making a decision – Being given time and ‘space’ to decide, where possible Being pressurised to make particular decisions by third parties (relatives, employers, insurers etc) – Talk to patient alone, establish whether there are any external pressures – Identify appropriate solutions  Emergency Situations – You can treat patient without consent (if they are unable to consent), provided treatment is immediately necessary to save life or prevent serious deterioration; – For full details, see guidance. Language Barriers – English-speaking relatives often act as interpreter for non-English speaking patient, but no certainty that information is translated accurately. Summary Consent is a fundamental aspect of ethical medical practice; But it is more than just a signature or a ‘yes’; Valid consent has strict general requirements; But each situation will be different, and will require its own