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Independent Reading and Questions Introduction to Medical Law and Bioethics Required Reading: 1. Read the introductory chapter in your preferred textbook. 2. Read the glossary from the Ethical Judgments book (on Learning Central) It will also be necessary for you to have some understanding about the various governmental and quasi-governmental bodies which have some say in the regulation of health care practice in the UK. So, you should spend some time going to the websites of the various organisations listed below and getting a basic understanding of their various remits. The organisations are: Department of Health (http://www.dh.gov.uk/en/index.htm) National Health Service (a useful description of the NHS is found here: http://www.nhs.uk/NHSEngland/aboutnhs/Pages/About.aspx) British Medical Association (http://www.bma.org.uk/) General Medical Council (http://www.gmc-uk.org/) The Royal Colleges (http://www.aomrc.org.uk/) NICE (http://www.nice.org.uk/) Nuffield Council on Bioethics (http://www.nuffieldbioethics.org/) Questions 1. Make sure you understand how the module is going to run this year. 2. Why is it important to study ethics?  The court often defers to medical ethics in contentious cases  Ethics influences the law  Ethics can play a hidden role in decisions, both by HCPs and the law  Ethics can provide a good way to evaluate the law  Ethics can often be a way to avoid legal mechanisms (in a good way)  Proper ethical answers can avoid some of the acrimony of law  people are generally aware of ethics but not the actual law - e.g. they know stealing is wrong but don’t know what happens if you do steal under the law  can often be a divergence between law and ethics - omissions - e.g. can walk past a baby drowning and not help - even though we would see that as morally wrong - more pragmatic approach 3. What are the differences between accountability and responsibility? What part do they play in understanding the difference between law and ethics?  Law is about accountability- ensuring doctors and HCPs do the right thing, law does not care if you agree with the standards it sets out. External to the person.  ethics are about responsibility - what I (or others) ought to do in these situations, does my conduct lead to better or worse outcomes? internal to the person. ethics works provided the person holding that responsibility are good at determining what one should be doing  issue with bolam was that is jeopardised the equilibrium between patients and medical professionals.

4. Be able to explain the role of Bolam in terms of deference to medical professionals. Do you think this is an accurate reflection of what the judge meant in the original case? Do you think this is the best way to regulate medical practice?     

we don’t care about the reasonable man in terms of the bolam standard, it’s the reasonable doctor- reasonable people do not act in the same way doctors do (they would go get a doctor). a man is not negligent just because someone disagrees with him, just because some doctors would’ve provided restraint does not mean this doctor was negligent. as long as you could get someone to agree with you, you were OK. Bolam was criticised for giving too much power to medical professionals and so court began to pull back some power seemed unfair to judge doctors for doing something just because some doctors would do something else, just because other doctors would do something differently doesn’t mean what the doctor did was wrong.

5. Make sure you understand the various approaches to ethics outlined in the lecture (e.g. utilitarianism, Kantian ethics, virtue ethics, feminist ethics, etc.). What are the benefits of the various approaches? What problems do they have? 6. Make sure you understand the remit of the organisations listed above. What place do they have in the determination of legal and bioethical disputes? What should their role be in providing advice or support to doctors? To other health care professionals? To lawyers and judges? To laypersons? To public policy makers?  Department of Health

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supporting and advising our ministers: we help them shape and deliver policy that delivers the government’s objectives

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setting direction: we anticipate the future and lead debate ensuring we protect and improve global and domestic health

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accountability: we make sure the department and our arm’s length bodies deliver on our agreed plans and commitments

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acting as guardians of the health and care framework: we make sure the legislative, financial, administrative and policy frameworks are fit for purpose and work together

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troubleshooting: in the last resort, the public and Parliament expect us to take the action needed to resolve crucial and complex issues

National Health Service (a useful description of the NHS is found here: o

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a move away from relying solely on arm’s-length regulation and performance management to supporting service improvement and transformation across systems and within providers strong governance and accountability mechanisms in place for systems to ensure that the NHS as a whole can secure the best value from its combined resources a reinforcement of accountability at Board, Governing Body and local system ICS level for adopting standards of best practice and making their contribution to critical national improvement programmes, on a comply or explain basis making better use and improving the quality of the data and information that local systems and providers have access to improve patient services.

British Medical Association o ensure members voices are heard nationally and in workplace

provide evidence, briefing and reports to enforce change. We negotiate at a national and local level on key issues facing the medical profession. o We campaign to raise awareness about issues facing the medical workforce and health care. o We offer learning and training o We work with UK governments to improve healthcare policy. General Medical Council (http://www.gmc-uk.org/) o o

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decide which doctors are qualified to work in the UK

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oversee UK medical education and training

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set the standards doctors need to follow throughout their careers

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where necessary, take action to prevent a doctor from putting the safety of patients, or the public's confidence in doctors, at risk.

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The Royal Colleges (http://www.aomrc.org.uk/) o

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The Academy’s role is essentially one of coordination between its member colleges and faculties to help ensure consistency across all the specialities. While there are many official bodies which have oversight over patient care and the way doctors treat patients, the Academy too plays a crucial role in making sure that these standards are maintained and we all get the healthcare we deserve. Our activities concentrate primarily on producing policy and recommendations to inform healthcare. Much of this work is delivered by the Academy’s long standing committees or through working groups and independent short-life projects.

NICE (http://www.nice.org.uk/) o NICE's role is to improve outcomes for people using the NHS and other public health and social care services. o We do this by: o Producing evidence-based guidance and advice for health, public health and social care practitioners. o Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services. o Providing a range of information services for commissioners, practitioners and managers across health and social care. Nuffield Council on Bioethics (http://www.nuffieldbioethics.org/) o Examines and reports on ethical issues in biology and medicine.

Small Group Session 1 Bioethics ethical problem For the first seminar, one of the things I am going to ask you to do is to consider your own approach to ethical problems. In other words, how do you decide what is right or wrong in various scenarios. The best way to explore your own ethical thinking is not in the abstract (i.e. reading the various approaches to ethics and deciding which you are) but in applying the

same to practical (or sort of-kind of practical) problems. To that end, you should read and consider the ethical problem discussed below. When you read this, spend time thinking about how you would address the issues involved and try to actually put yourself in the situation, before actually answering any questions. Also, consider what someone else might say in response to your decisions. I’ve attempted to make the cases as clear as possible, but please let me know if there are any questions. General Information During the summer of 2019, you took a summer job at the Cave of Kokopelli in Colorado, an abandoned mine which has become a tourist attraction because of its interesting geological features, colourful moulds, and extensive stalactites and stalagmites. Your job is to be a tour guide - bringing groups of people through the caverns and discussing the geology and history of the caves. At one point in the tour, visitors are required to take a small lift down to another set of caverns deeper in the mountains. Two people usually work the lift – an operator to work the controls at the top and a guide who goes down to the caverns first to make sure that no problems occur at the bottom. However, only one person is actually needed to run the lift. You are operating the lift and your colleague, Irene, has gone down into the caves below with the visitors. Unfortunately, a calamity has occurred which has resulted in a cave-in and has damaged the lift. There is no other way out from the lower caverns as a consequence of the cave-in and rescue workers are unlikely to be able to get to the visitors before they die. While you cannot get to the visitors (since you must stay at the controls of the lift), you can talk to them via a microphone and loudspeaker. All of them (including Irene) will do exactly what you tell them to do. The following individuals are trapped in the lower levels: 1. Anna – a 27 year-old woman, she is 7 months pregnant with her first child. 2. Barry – a 44 year old man who is a well-known and well-liked national politician. Barry is credited with securing the passage of a number of important bills in Congress. 3. Charles – an 85 year old man. Charles is retired, widowed and does not have any children. 4. Donna – a 38 year old woman who started up and owns a very successful software company. Donna’s company employs 300 people. 5. Edgar and Fiona – Edgar is a 32 year old man. He is on holiday visiting the Cave with his daughter, Fiona, who is 5 years old. Edgar is a travelling salesman. Fiona’s mother (Edgar’s wife) died a year ago from cancer and Fiona is therefore very attached to her father. She is also very scared and will not leave her father’s side so the two of them count as one person. [NOTE: This means that you must always treat Edgar and Fiona together. You cannot save Edgar without saving Fiona nor can you save Fiona without saving Edgar. This also means that the two of them can travel in the lift together even though the lift is limited to one person.]

6. Gogo – a 2 year old orang-utan who stays in the zoo attached to the Cave. Gogo is very well-behaved and likes to ride the lift. The owner allows Gogo to go on the tours because she is so well-behaved. 7. Harrison – a 15 year old high school student. 8. Irene – your 24 year old colleague. Irene has only recently started at the Cave and will defer to you for all decisions as required by the standard operating procedures in the Cave. 9. Jack – a 32 year old former criminal. Jack was incarcerated for running a scam which deprived a number of elderly men and women out of their life savings. He has just been released from prison about 2 months ago. 10. Koko – a 6 year old dog, Koko is the mascot of the Cave. Koko tends to tag along on tours and play with the children hoping to get treats. 11. Lindsey – a 47 year old philosophy professor. 12. one of your relatives although not an immediate family member (such as an uncle, aunt or cousin). They have come to visit you in Colorado and the two of you are quite close. [NOTE: This means one of your actual relatives. Pick one who fits the criteria and pretend that they are in the problem. Do not just decide to use a nameless relative.]

PROBLEM Based on your examination of the lift, you conclude that it is only possible to bring one person at a time back up the lift and out to safety. You also believe that the lift is likely to fail before all of the visitors have been rescued. [Your small group leader will roll a 12-sided die to simulate when the lift breaks but won’t tell you in advance what they number is.] In what order do you ask the visitors to get on the lift? Why have you put them in that particular order? Can you justify your decision if asked to do so? [NOTE: Remember that Edgar and Fiona count as one for the purposes of these problems. They must be saved together.] My answer: 1. Edgar and Fiona- 5 year old child, should save young children first, long life ahead of them. 2. anna - pregnant, likely at risk , counts as 2 people saved. 3. my relative - nick my cousin 22 year old , lots of family to lose, personal connection 4. Harrison – a 15 year old high school student.- young long life ahead 5. Donna – a 38 year old woman who started up and owns a very successful software company. Donna’s company employs 300 people. next youngest- relied on by lots of people.

6. Barry – a 44 year old man who is a well-known and well-liked national politician. Barry is credited with securing the passage of a number of important bills in Congress. 7. Lindsey – a 47 year old philosophy professor. 8. Irene – your 24 year old colleague. Irene has only recently started at the Cave and will defer to you for all decisions as required by the standard operating procedures in the Cave. 9. Jack – a 32 year old former criminal. Jack was incarcerated for running a scam which deprived a number of elderly men and women out of their life savings. He has just been released from prison about 2 months ago. 10. Charles – an 85 year old man. Charles is retired, widowed and does not have any children. 11. Gogo – a 2 year old orang-utan who stays in the zoo attached to the Cave. Gogo is very well-behaved and likes to ride the lift. The owner allows Gogo to go on the tours because she is so well-behaved. 12. Koko – a 6 year old dog, Koko is the mascot of the Cave. Koko tends to tag along on tours and play with the children hoping to get treats.

Independent Reading and Questions Capacity and Consent to Treatment Required Reading: 1. Read the chapter on Consent to Treatment in your preferred textbook. 2. Mental Capacity Act 2005 (Sections 1-4) 3. Re T (adult: refusal of medical treatment) [1992] 4 All ER 649. 4. Montgomery v. Lanarkshire Health Board [2015] UKSC 11 5. Aintree University Hospital NHS Foundation Trust v James [2013] UKSC 67. http://www.bailii.org/uk/cases/UKSC/2013/67.html 6. An NHS Trust v DE (appearing by his litigation friend the OS) and FG and JK, and C Local Authority and B Partnership Trust [2013] EWHC 2562 (Fam) https://www.judiciary.gov.uk/wp-content/uploads/JCO/Documents/Judgments/de-judgment16082013.pdf Suggested Reading: (These are not required readings but provide greater context and critical discussion and would be useful for students wanting to go further into a topic) 1. J Montgomery and E Montgomery, ‘Montgomery on informed consent: an inexpert decision?’ [2016] 42 Journal of Medical Ethics 89-94. 2. AM Farrell and M Brazier, ‘Not so new directions in the law of consent? Examining Montgomery v Lanarkshire Health Board’ [2016] 42 Journal of Medical Ethics 85-88. 3. St. George’s Healthcare NHS Trust v. S [1998] 3 All ER 673. 4. Re C (adult: refusal of medical treatment) [1994] 1 All ER 819. 5. Re B (adult: refusal of medical treatment), sub nom Ms B v. An NHS Hospital Trust [2002] EWHC 429 6. Re A (Medical Treatment) (Male sterilisation) [2000] 1 FCR 193.

7. Re F (mental patient: sterilisation) [1990] 2 AC 1 sub nom F v West Berkshire Health Authority [1989] 4 BMLR 1, [1989] 2 All ER 545 Questions 1. To what extent is autonomy protected in English law on consent to treatment?  very well protected  a patient with capacity may refuse medical treatment at any time even if it isn’t in her best interests - Airedale NHS trust V Bland and Re T- patent has right to refusal even if reasons why seem bizarre, irrational or non-existent.  patients right also protected by article 8 Human rights act - right to respect for her private and family life  often issue with sterilisation - women often refused but not men  pregnancy also doesnt affect patients right to refuse treatment - Re MB and St Georges' NHS trust v S - emergency c section performed on S without her consent held to be unlawful. 2. How do the grounds for the decision in Re T match up to Beauchamp and Childress’ requirements for autonomy?  Beauchamp and Childress' requirements for autonomy: capacity, sufficient knowledge, free from undue influence.  in Re T- patents mother was a Jehovah’s witness - she needed a blood transfusion, doctors didn’t give her all the information and she refused. the failure to provide sufficient information was a reason to vitiate consent of T. also potential undue influence from the mother. 3. What role do assault and battery play in protecting consent? What role does negligence play in protecting consent?  assault and battery are possible options where a patient hasn’t given consent at all.  B. v. NHS Hospital Trust- patient refused ventilator that was given to her, court concluded it was battery to continue to provide it once she refused.  However, if doctor has told the patient in ‘broad terms’ about the nature of the procedure and has received consent, the appropriate action is in negligence See Chatterton v. Gerson 4. Why is capacity important?  capacity = ability to make decisions about own actions and what happens to you.  one of the requirements for autonomy.  case of C (adult: refusal of medical treatment), provides context- sets out an certain presumptions and an approach to capacity but has been superseded by mental capacity act.  mental capacity act 2005 - sets out current test for capacity. 5. What is the diagnostic test for capacity in the MCA? What is the functional test for capacity in the MCA? How do those correspond to the common law test from Re C? What important conclusions from Re C continue to inform the law of consent?  general test for capacity is the diagnostic test- ‘For the purposes of this Act, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain.’ (emphasis added)

 This is called the diagnostic test because it relies on a diagnosis of some sort of mental or cognitive disturbance. This diagnosis must be the cause of the inability to make a decision. undertaken by medical professionals  Section 3 of act sets out the test for determining what it means to be ‘unable to make a decision for himself’ as required by Section 2(1) This is called the functional test -part of section 2 test just helps us to understand whether someone has capacity.  ‘For the purposes of section 2, a person is unable to make a decision for himself if he is unable – o To understand the information relevant to the decision o To retain that information o To use or weigh that information as part of the process of making the decision, or o To communicate his decision (whether by talking, using sign language or any other means)  Note the similarities between the functional test and the Re C test. 6. What happens to patients who need treatment but lack the capacity to consent?  patients who lack capaci...