1. Informed Consent Professor Deirdre Madden School of Law

2. Overview General principles of consent Constituent elements Disclosure of risk Documentation of consent Refusal of treatment (c) D Madden 2016

3. Respect for autonomy “Every human being of adult years and sound mind has a right to determine what shall be done with his own body and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.” Schloendorff v Society of New York Hospital (1914) (c) D Madden 2016

4. HSE National Consent Policy (2013) The Policy applies to all interventions conducted by or on behalf of the HSE on service users in all locations. Part One: Underpinning principles Part Two: Children and Minors Part Three: Research Part Four: Do Not Attempt Resuscitation Orders http://www.hse.ie/eng/about/Who/qualityandpatientsafety/National_Cons ent_Policy/ (c) D Madden 2016

5. What is valid informed consent? Consent is the informed exercise of a choice. It entails an opportunity to evaluate knowledgeably the options available and the relevant risks. The success of informed consent depends on patients being able to understand and sufficiently retain the information they are given so as to enable them to analyse that information and use it to make a decision. It is a process not a once-off event. (c) D Madden 2016

6. Constituent elements Decision-making capacity Disclosure of risks and other relevant information Substantial understanding Voluntary choice (c) D Madden 2016

7. Assisted Decision-Making (Capacity) Act 2015 All adults are presumed to have capacity to make their own decisions The presumption of capacity should only be challenged if, having been given all appropriate help and support, P is obviously unable to understand and use the information to make and communicate a clear and consistent choice. (c) D Madden 2016

8. What information? Information about the reasonably foreseeable consequences of each of the available choices at the time the decision is to be made or the consequences of failing to make the decision. Must give P information in a way he can understand and give him as much support as possible to enable him to make his own decision (c) D Madden 2016

10. Disclosure – who, when, what and how? Who? It is the responsibility of the person providing treatment to discuss it with the patient Delegation is acceptable only where the person seeking consent is suitably trained, has sufficient knowledge of the procedure and understands the risks involved When? Timing is important – treatment options must be discussed at a time and place when the patient is best able to understand and retain the information - Fitzpatrick v White (2007) (c) D.Madden 2016

11. What must be disclosed? Patient-centred test of disclosure – Legal obligation to warn of risks that might affect the judgement of a reasonable patient - Geoghegan v Harris (2000); Fitzpatrick v White (2007) Discussion with patient should include Diagnosis and prognosis Treatment options (also option of doing nothing) Reason and purpose of the intervention Potential benefits and risks Alternatives Costs (if relevant) If possible, patients should be invited to take time to understand and ask questions (c) D Madden 2016

12. Montgomery v Lanarkshire Health Board (2015) P was diabetic and of short stature Shoulder dystocia - baby sustained acute hypoxia leading to renal damage, epileptic seizures and cerebral palsy Court held P should have been warned of risk of shoulder dystocia and given the option of a caesarean section Not a matter of percentages – nature of risk, likely effect on P, importance of intervention on P and any alternative treatments must all be considered Information must be communicated in a way P can understand. (c) D Madden 2016

13. Recent Irish cases O’Leary v HSE [2016] IECA 25 – no note of consent given by mother to vaccination of child No evidence adduced that there was an obligation or accepted practice to put such consent in writing Therefore no proof to ground inference that Dr had failed to obtain consent (or disclose risks) Healy v Buckley [2015] IECA 251 – plaintiff misunderstood gravity of her condition but Dr was unaware of this Dr could not be blamed for deficiencies in knowledge of her condition (c) D Madden 2016

14. Scope of consent Unless it is an emergency, the doctor should not exceed the scope of consent given Try to anticipate and discuss what might possibly arise during surgery If within scope - proceed If outside scope - preferable (if possible) to wait until another day even if this requires a 2 nd operation (c) D Madden 2016

15. Is consent always necessary? In some circumstances the amount of information to be given may be abbreviated e.g. emergency treatment which is immediately necessary to save life or preserve health Where patient declines information – no legal precedents. In principle this should be respected and documented but some basic information about major interventions should be given so that consent may be obtained. Therapeutic privilege – very exceptional circumstances only. The fact that a patient may become upset at hearing information, or where family members request that information be withheld from the patient, is not a valid reason to withhold information that they need to know. (c) D. Madden 2016

16. Documentation of consent It is not a legal requirement that consent must be in writing (with some exceptions e.g. clinical trials) but, if given verbally, consent should be recorded in the patient’s notes. It is important to document the consent process particularly if the intervention is invasive, complex or involves significant risks or consequences for the patient. No set time period for ‘expiry’ of consent but should be refreshed prior to commencement of procedure. Should also be facility for patients with literacy issues to be given information in alternative format and have their consent recorded. (c) D. Madden 2016

17. Consent forms Over-reliance on forms rather than genuine communication is counter-productive. A negligence action might still be taken alleging lack of consent even if a consent form has been signed as the patient may allege he/she was not given the relevant information and opportunity to ask questions to facilitate true understanding. Therefore the process of communication is more important than the form. (c) D.Madden 2015

18. Tools to aid understanding: Use simple clear language; translate medical terminology into plain English (use patient networks) Use visual images, explanatory videos and diagrams Use different formats for patients with hearing or visual impairments Offer material in other languages, electronic forms and other IT solutions Professional interpretation services may be required Avoid Yes/No questions like ‘do you understand?’ – instead ask patient ‘what do you think is that cause of the problem?’, ‘what are your main concerns about the treatment?’- Listen to patient! (c) D.Madden 2015

19. Refusal of treatment An adult with capacity is entitled to make a voluntary and informed decision to refuse treatment – ADM (Capacity) Act 2015 This decision must be respected even if perceived to be unwise or where the decision may have serious or fatal consequences. The discussion and decision should be accurately documented. If there are doubts about P’s capacity to make a decision, the law on capacity assessment should be followed. (c) D Madden 2016

20. Refusal of treatment in obstetric care Balance between maternal autonomy and right to life of the foetus Early English cases held that if a pregnant woman refused treatment - she lacked capacity:  Re T (adult: refusal of treatment) (1993)  Re S (adult: refusal of medical treatment) (1992)  Rochdale Healthcare (NHS) Trust v C (1997) Later cases held that P is entitled to refuse even if risk of death to foetus:  Re MB (adult: medical treatment) (1997)  St George’s Healthcare NHS Trust, R v Collins, ex parte S (1998)  HE v A Hospital NHS Trust (2003) (c) D Madden 2016

21. Irish cases JM v Board of Management of St Vincent’s Hospital (2003) – P lacked capacity to refuse Fitzpatrick v K (2008) – P lacked capacity to refuse Attorney General v X (1992) – balance between right to life of mother and foetus South Western Area Health Board v K (2002) – refusal of treatment to prevent HIV transmission – case settled HSE v F (2010) – court ordered treatment to prevent HIV transmission but media reports indicate judge said he would not have ordered C-section Unreported case March 2013 – refusal of C-section settled Law on refusal of caesarean sections therefore unclear (c) D Madden 2016

22. Advance Healthcare Directives All adults with capacity may refuse treatment in advance by way of an AHD At the relevant time P must lack capacity to give consent The treatment to be refused must be clearly identified in the directive The circumstances in which the refusal of treatment is intended to apply must be clearly identified in the directive. If these conditions are met it is as effective as if made contemporaneously An AHD must be in writing, be signed and witnessed. A request for a specific treatment is not legally binding but must be taken into consideration where relevant Planned registration system under 2015 Act (c) D Madden 2016

23. AHDs and pregnancy S. 85(6) (a) Assisted Decision-Making (Capacity) Act 2015: Where a person making an advance directive is pregnant and her directive does not specifically state whether or not she intended her refusal of treatment to apply if she were pregnant, and the healthcare professionals involved in her treatment consider that her refusal would have a deleterious effect on the unborn, there is a presumption in favour of providing or continuing the relevant treatment. (c) D Madden 2016

24. Section 85 (6) (b): Where the woman has specified that her refusal should apply even if she were pregnant and the healthcare professionals involved in her treatment consider that her refusal would have a deleterious effect on the unborn, an application should be made to the High Court to determine whether or not the treatment should be provided. The Court must consider the potential impact of the refusal on the unborn, the invasiveness and duration of the treatment and the risk of harm to the woman if the treatment were to be provided. (c) D Madden 2016