Med law and ethics

Question 1

What is personal responsibility in health?

Answer 1

 Personal responsibility in Health – This is the concept that a significant amount of human health depends on our own human behaviour and the choices we ourselves make. Therefore we as individuals should have to face the consequences if we choose to make poor health decisions.

Question 2

What do different governments think of personal responsibility in health?

Answer 2

 Governments:
 The UK has a very primitive personal responsibility doctrine, only merely mentioning it in the NHS Constitution. However many other countries, including possibly the UK in future years have incorporated personal responsibility into health care policies.
 Insurance companies in Germany change prices depending on patient health choices. For example, if you exercise regularly your insurance will be reduced, if you choose to involve yourself in risky health behaviour it will be increased.
 Japan has penalised companies financially if workers had a high waist:hip ratio, this provides an incentive for employers to ensure the fitness of their workers.

Question 3

What are treatment contracts?

Answer 3

 Treatment contracts:
 These sometimes are used in order to lay out the expectations that HCPs have for a patient regarding their co-operation and involvement with the treatment process. They are non-legally binding contracts that patients sign, stating that they will promise to adjust their lifestyle appropriately
 Usually in return for some kind of benefit
 e.g. promise to give up smoking for a quicker access to surgery, promise not to drink anymore after transplant.

Question 4

What does the NHS constitution say regarding personal responsibility for health?

Answer 4

 NHS constitution:
 Explicitly refers to personal responsibility for health
 However while the NHS does encourage wise health behaviour, patients will not be penalised if they do not follow advice. So while the NHS encourages non-smoking, smokers will still receive treatment.
 Fundamentally the NHS instead promotes healthy behaviours instead in order to save money

Question 5

What does the GMC say regarding personal responsibility for health?

Answer 5

 GMC: “You must NOT allow your views about a patient’s lifestyle, culture, beliefs, race, colour, gender, sexuality, age, social status or perceived economic worth to prejudice the treatment you offer…You must not refuse or delay treatment because you believe a patients actions have contributed to their condition”

Question 6

What is the legal position on personal responsibility in health?

Answer 6

 Legal position:
 Whilst the legal position is still relatively unclear, it is very likely that a doctor who denies healthcare to patients on the grounds of personal responsibility will be acting unlawfully.
 Nonetheless taxing products (e.g. tobacco) lawful to reduce negative behaviours

Question 7

What are the different types of transplant?

Answer 7

Transplantation is the movement of organs or tissues or cells from one person to another. For example blood and other tissues, the heart and other organs, gametes and other cells.
 Allotransplantation = transplant from another human
 Xenotransplantation = Transplant from another species
 Directed donation = specifying who the organ goes to
 Non-directed donation = not specifying who the organ goes to
 Paired donation = Potential donor A and potential recipient B are in a relationship (relation, friend or partner) but are not genetically compatible. Potential donor C and potential recipient D are in the same position. A is compatible with D and C is compatible with B. Thus A gives to D and C gives to B.
 Pooled donation = like paired but even more people involved and even more complicated
 Domino donation = very unusual situation where a donated organ is again donated

Question 8

What is the resource dilemma?

Answer 8

 Resource dilemma = Sadly when it comes to the NHS organ donation services there is a resource dilemma. Essentially there are not enough donors for the number of people who require a transplant, thus many people dying on waiting lists.

 Solutions to the Resource Dilemma:
Opt in (england),
opt out (wales), mandated choice (texas, part of driving license - 80% said no though),
mandatory donation (no-one),
benefits in kind (israel, sign up to get priority if they need organ donation),
markets (iran, allows regulation??)

Question 9

What is the legislation/regulation of transplants?

Answer 9

NHS Blood and Transplant
-> This body is responsible for the efficient supply of blood, organs and associated services to the NHS

Human Tissue Act (2004)
-> This is the legal framework for organ donation

The Human Tissue Authority
-> This body aims to ensure that human tissue is used safely, ethically and with proper consent

Question 10

What does the human tissue act (2004) say?

Answer 10

The Human Tissue Act
 The human tissue act makes consent the most important principle for the lawful retention and use of human tissue
 It then establishes the Human Tissue Authority to ensure it is adhered to
 HTA04 makes it an offence to transplant organs unless the regulations of the Act are adhered to
 Makes it an offence to be involved in the sale of organs in any way

• States ALL living donations require HTA approval, an HTA assessor will meet the donors and recipients and report back to HTA. An HTA Panel must consider special cases
• Deceased donations do not require HTA approval, all its requires is patient consent. If a patient has nominated a person to make a decision then the nominee can give proxy consent. Finally if a patient has not expressed any wishes either way, people in “Qualifying Relationship” with the deceased can consent e.g. partner, child/parent, brother/sister grandparent/child. Note that these are ranked.

Question 11

What are the types of assisted reproduction treatment?

Answer 11

Assisted reproduction treatment (ART):
Cryopreservation (CP)
 Cells and tissue susceptible to damage preserved by cooling to sub-zero temperatures
In Vitro fertilisation (IVF)
 Ovum fertilised by spermatozoa outside the body
Gamete Intrafallopian transfer (GIFT)
 Oocytes removed from a woman’s ovaries and placed in one of the fallopian tubes along with spermatozoa
Intracytoplasmic sperm injection (ICSI)
 IVF procedure in which a single spermatozoa injected directly into an ovum
Donor insemination (DI)
 Spermatozoa placed into the vagina
 Spermatozoa normally obtained from someone other than the woman’s husband or partner

Question 12

What is assisted reproduction?

Answer 12

Infertility = couple who have failed to conceive (when trying) for over 12 months or with more than 3 miscarriages
Causes = ⅓ male, ⅓ female. ⅓ unknown
Prevalence - 40,000 couples a year receive fertility treatment. 1% of UK children born as a result of assisted reproduction treatment (ART)

Question 13

What does the Human fertilisation and Embryology Act 1990 [amended in 2008] say?

Answer 13

Act to regulate embryo/gamete research and most forms of ART
Also prohibits certain kinds of research/treatment entirely unless approved by HFEA (Human fertilisation and embryology authority)
 Prohibits human cloning
 Prohibits placing of a non-human embryo in a woman’s uterus
Consent is at the heart of the HFE act
 Patient consent needed for
- Investigations/treatment
- Disclosure of information e.g. need patient consent before informing GP or anyone else (except in emergencies)
- Storage and use of sperm, oocytes, embryo
- Use of information held on HFEA database for research
 Patients can withdraw/change consent so long as sperm/oocytes/embryos have not already been used in treatment/research/training

Question 14

What were the human fertilisation and embryology act 2008 amendments?

Answer 14

Creation and use of all human embryos outside the body subject to regulation
Ban on sex selection for social reasons
Requiring clinics to take account of “the welfare of the child” when providing fertility treatment
Removing previous requirement that clinics take account of the child’s “need for a father”
Legal recognition of both partners in a same-sex relationship as legal parents of children conceived through use of donated sperm/eggs or embryos

Question 15

What is the HFEA?

Answer 15

HFEA:
Human fertilisation and embryology authority
Enforce HFA act
To be abolished and roles transferred to Care Quality Commission, Health and Social care information Centre and new research regulator

Question 16

What are the rules of parentage?

Answer 16

Parentage:
Legal mother is the mother who gives birth to the child even if surrogate or donor ovum used
Donor has no legal rights over child
Male sperm donor is not legally the father of the child
Male partner who is receiving treatment services together with a women and consented to this will become legal father even if the women receives donated sperm/embryo
To be noted:
 Child may not have a legal father e.g. single woman using donated sperm
 A child cannot have multiple legal mothers or fathers

Question 17

What is positive and negative right to reproduce?

Answer 17

Right to reproduce:
Can be negative i.e. no state interference
Can be positive i.e. active assistance by the state
Many contraceptive cases concerned with “right to bodily integrity” not “right to reproduce”

Access to fertility treatment
If we assume people have a positive right to reproduce then people ought to have a equitable access to healthcare

Question 18

What are the nice guidelines on access to fertility treatment?

Answer 18

NICE Guidelines
 Fertility treatment available on NHS
- For women aged between 23-39
- In whom there is a 3+ year history of infertility of identifiable cause
- 3 cycles of IVF should be ideally funded

Question 19

What is the european regulation of fertility treatments?

Answer 19

Treatment Abroad:
HFE act only for UK clinics
Clinics in other countries may or may not be regulated to local standards and regulations
EU Tissues and Cells Directive sets out standards of quality and safety that should be met within EU countries

Question 20

What is the background facts on neonatology survival?

Answer 20

o Some background:
o Technological advances in achieving viability and greater understanding of long term prognosis but still much uncertainty
o Of children born 22-25 weeks and surviving to 5 years
- 55% had severe or moderate disabilities
- 35% mildly disabled
- 20% had no disabilities
o Tension between protecting the vulnerable and ambivalence about interfering with nature

Question 21

When do different countries begin treatment in neonatology?

Answer 21

o Beginning treatment:
o USA - American academy of paediatrics advocates non initiation of resuscitation before 23 weeks
o Netherlands - infants born before 25 weeks gestation not treated on the grounds of “poor prognosis”
o In the UK the RCPH (Royal College of Paediatrics and Child Health) states each case should be determined on its merits not gestational age

Question 22

What is the UK law on neonatology?

Answer 22

o UK Law:
o Case law generally supports clinical opinion based on best interests
o But slowly shifting towards more integrated family + clinician decision
o Best interests more broader than medical interests
 Includes potential to develop awareness
 Interact and capacity for self direction
 Child likely to endure unavoidable pain and suffering
o Withdrawing/withholding treatment in cases of clinical futility is lawful
o In a audit 84% of NICU/PICU (neonatal/paediatric intensive care unit) deaths as result of withdrawing/withholding treatment
o Legal rationale is distinction between killing (active) and letting die (passive)
o In neonates non-voluntary
o If uncertain about prognosis resuscitation is favoured

o “These decisions are undeniably difficult, but you are never working alone on a neonatal unit. All decisions are team decisions, and the team includes the parents. And more often than you’d expect, the baby decides for you.” (Dr H)

Question 23

What is the abortion act?

Answer 23

Made in 1967
 Termination of pregnancies (ToPs) must be notified to Chief medical officer
 Statistical data recorded/analysed
 Provides right of conscientious objection to clinicians save for emergencies
 If one does object legal and professional duty to refer patients to an appropriate clinician within a reasonable period of time
 Main changes have been to gestational stages at which terminations can be performed

Question 24

What are the legal criteria for termination of pregnancy?

Answer 24

 Approved by two doctors (apart from in an emergency) and performed by registered doctor on a approved site
 Can be justified if
 Pregnancy has not exceeded 24th week and the risk of injury to mental or physical health of woman or existing child greater than ToP
 Prevent grave permanent injury to mental/physical health of woman
 Prevent injury to physical/mental health of existing children
 Substantial risk of foetus being “seriously handicapped”
 In cases of risk of grave injury, life saving circumstances or disability ToPs can be performed up to 40 weeks

Question 25

What is the mental capacity act?

Answer 25

 Mental Capacity Act:
 If a person is aged over 16 then the act applies to how professionals and other paid carers work with them
 You must always assume capacity
 All practicable steps must be taken to help the person make a decision e.g. provide accessible information
 If in doubt capacity must be assessed
 Someone lacking capacity cannot do one or more of the following four things:
1. Understand information given to them
2. Retain that information long enough to be able to make a decision
3. Weigh up the information available to make a decision
4. Communicate their decision
 Lacking capacity leads to safeguarding: best interests or DoLS
 Any decisions taken on behalf of a person who lacks capacity must be in the persons best interests

Question 26

What are the basics of capacity?

Answer 26

Basics of capacity - Mental Capacity Act 2005 principles:
All adults are presumed to capacitous (starting point is ALL patients have capacity, onus is on you to see if they don’t)
Every adult has the right to make his/her own decisions
 Everyone should be encouraged and enabled to make his/her decisions or participate as fully as possible in decision making
 This can be done by being given the help and support needed to make and express a choice
 Individuals must retain the right to make what may be seen as unwise decisions
Assessments of capacity should only be carried out where there is legitimate doubt
 Not because a patient disagrees with a clinician
The criteria in the Mental Capacity Act 2005 are used to assess capacity
 This is a general clinical skill not just the field of psychiatry
Decisions made on behalf of someone without capacity should be made in their best interests

Question 27

What does it mean that capacity is dynamic?

Answer 27

Capacity as a dynamic concept:
Capacity may change over time and patients may be capacitous at some times and for some choices but not others
 If someone was not capacitous yesterday they might be today and vice versa
Be wary of placing too much emphasis on previous assessments of capacity
Doctors can do a great deal to influence whether or not a patient is capacitous
 e.g. environment, demeanour, manner
Capacity also can vary between situation, so a patient may have capacity to consent/refuse one treatment but not another.

Question 28

What is the criteria for capacity in the mental capacity act 2005?

Answer 28

A person is unable to make a decision for himself if he is unable to
1. Understand the information relevant to the decision
2. Retain that information
3. Use or weigh that information as part of the process of making the decision
4. Communicate decision (by any means)
No time limit on retaining the information - being able to retain the relevant information for a short period does not prevent someone from being capacitous

Question 29

What does the BMA law society guidelines suggest capacitous individuals should be able to do?

Answer 29

Understand in simple language, what the medical treatment is, its nature and purpose and why it is being proposed
Understand its principle, benefits, risks and alternatives
Understand in broad terms the consequences of not receiving the proposed treatment
Retain the information for long enough to make an effective decision
Making a free choice

Question 30

How do you maximise capacity?

Answer 30

How to maximise capacity:
 	Appropriate time and location
 	Treat inhibiting conditions
 	Diagrams
 	Educational models
 	Videos and audio
 	Translators and interpreters
 	Adequate time

Beware using diagnosis as a short cut to capacity:
Any preceding or current diagnosis may of course affect a person

’

s capacity
However doctors must assess capacity with reference to the formal test of capacity and anew for individual patients
Likewise non-cooperation with a capacity assessment does not mean a patient is incapacitous

Question 31

What should you do when a patient is not capacitous?

Answer 31

Is there a valid lasting power of attorney (LPA) or advanced directive
There are two types of LPA, for finance and for welfare.
Is there anyone who can advocate the patient?
 If there is no person other than a professional carer who can be consulted about patients best interest ideally an IMCA (independent mental capacity advocate) should be appointed
 IMCAs try to ascertain the feelings, beliefs, values and preferences of the individual lacking capacity
 IMCAs must be appointed if the proposed treatment is “serious” (unless it is an emergency)
Document all assessments and rationale for conclusions/decisions
Treat in patients best interests on the basis of “necessity”
Is it possible to wait until the patient gains capacity, so they can make a decision

Deprivation of Liberty Safeguards
- Keeping patients in hospital against their will

Question 32

What happens if a patient is unconscious?

Answer 32

With unconscious patients the doctrine of necessity is used to allow emergency treatment
Emergency to be interpreted conservatively - to avert immediate danger or risks
Treatment given must be in the patients best interests

Question 33

What is anti-psychiatry?

Answer 33

 Antipsychiatry:
 Definitions of and criteria for many psychiatric disorders are vague, arbitrary and unscientific
 At its most extreme argue that mental illness is a myth
 Rosenhan the pseudopatient experiment
 12 healthy pseudo patients including Rosenhan pretended to be suffering from hallucinations and all of them admitted to psychiatric hospitals and diagnosed with mental disorders
 After admission behaved normally and told staff they felt fine however staff failed to detect a single pseudopatient and instead believed all of them to be exhibiting symptoms of ongoing mental illness with several confined for months
 All the pseudopatients were forced to admit to having a mental illness and agree to take antipsychotic drugs as part of their release
 Rosenhan the non-existent imposter experiment
 Used a well known research and teaching hospital whose staff claimed errors in his previous study could not be made at their institute
 Rosenhan arranged that over a three month period would send pseudopatients
 Out of 193 patients 41 were considered imposters and further 42 considered suspicious
 Rosenhan had in fact sent no pseudopatients

NB: Demise of antipsychiatry?:
 Advances in neuroscience e.g. brain imaging, genetic, psychopharmacology has reduced criticism of psychiatry
 However reduction has not been as significant as might have been expected
 Problems very much still exist around “sexual deviancy”, “personality disorder”, “drug/alcohol addiction”, “ADHD”, “low libido” etc

Question 34

What is the “pharma and mental health” argument?

Answer 34

 Criticism of the relationship between pharmaceutical companies and psychiatric definitions
 Many argue pharmaceutical companies encourage behavioural traits and “normal” experiences to be defined as mental illness
 So that they can say pharmacological therapy is the answer e.g. ADHD and ritalin

Question 35

Expand on mental health does not equal mental capacity?

Answer 35

 Law states that the existence of a mental disorder does not equate to a lack of mental capacity
 We cannot legally assess, treat and detain people who have capacity and are mentally well when they refuse consent
 But we legally are allowed to assess, treat and detain people against their will who have capacity so long as they have a mental disorder
 Is that fair?
 Is someone whose mental health condition impacting their decision making incapacitious by default?

Question 36

What are the ethics/law of sexual perversion?

Answer 36

 Mental Health act 1983 allows people to be detained, assessed and treated for sexual perversion
 Aim is to justify the detention of sex offenders (paedophiles, rapists) in hospital
 Is sexual perversion a mental disorder? What counts as sexual perversion?
o Sexual deviancy:
o Mental Health Act permits treatment for sexual deviancy
o This was previously excluded under the MHA 1983
o A controversial change making it easier to justify the detention of sex offenders in hospital
o However what is the definition of sexual deviancy? Is it a mental disorder? Is this a case of making doctors jailors?

Question 37

What is the mental health act (1983) NOW (2007)?

Answer 37

o Majority of patients with mental disorders are treated in circumstances where the MHA 1983 does not apply
o Remember the Mental Health Act 1983 (2007) is not the same as the Mental Capacity Act (MCA) 2005

o	Mental Health Act:
o	Allows for compulsory admission and treatment of patients with a mental disorder who have capacity and are refusing assessment and treatment 
o	Key areas
	Section 2 
	Section 3
	Section 4
	Section 5 (2)
	Section 5 (4)

Question 38

What is a section 2?

Answer 38

o Section 2 = admission for assessment:
o 28 day detention
o Application made by nearest relative or AMHP (approved mental health professional e.g. social worker, occupational therapy) and supported by 2 doctors (1 a specialist i.e. psychiatrist)
o Conditions
 Patient must be suffering from “mental disorder of a nature of degree” warranting admission for assessment
 Must be in the “interests of his own health or safety or the protection of others”
o Appeal via MHRT(mental health review tribunal)
o Compulsory treatment is lawful

Question 39

What is a section 3?

Answer 39

o Section 3 = admission for treatment:
o 6 months detention period
 renewable and reviewable at 6 months and then every 12 months
o Application made by nearest relative or AMHP and supported by 2 doctors (1 a specialist)
o Conditions
 Patient must be suffering from mental disorder which they need treatment in hospital
 Necessary for health or safety of patient or others that treatment given
 Appropriate medical treatment is given
- Changed from “to alleviate or prevent a deterioration”
- This means that the treatability condition has been weakened
o Appeal via MHRT (mental health review tribunal)
o Compulsory treatment is lawful

Question 40

What is a section 5?

Answer 40

o	Section 5 = detention of a patient:
o	Gives time for a section 2 or section 3 to be applied
o	S 5 (2)
	Detention of a patient who is already in hospital voluntarily who then changes his/her mind and wants to leave
	72 hours detention maximum
o	S 5 (4)
	Detention by a nurse
	6 hours detention maximum

Question 41

What are the exceptions to mental disorder?

Answer 41

o Exceptions to mental disorder:
o Learning disability/autistic spectrum disorder
 on list of mental disorder but can only be detained if accompanied by “aggressive or seriously irresponsible conduct”
o Alcoholism and drug dependency
 Mental disorder caused by alcohol/drugs then detention allowed
 But alcoholism and drug dependency not classified as mental disorders in their own right

Question 42

What were the 2007 changes to the mental health act w/r to ECT/psychotherapy?

Answer 42

o Due to 2007 amendments to the MHA separate rules for ECT/psychosurgery
o Consent of patient and second opinion is now needed for psychosurgery
o ECT may not be given to a capacitous patient who refuses (unless urgently needed)
 If a patient is not capacitous then second opinion needed from a special panel

Question 43

What is the MHA w/r to discharge?

Answer 43

o If a patient is discharged after being detained under the MHA 1983 (2007) certain forms of aftercare/support must be provided
o 2007 amendment allows for “community treatment order”
 Form of conditional discharge
 Patients permitted to remain in the community if compliant with treatment otherwise returned to hospital
 Compulsory treatment can only take place in community if it is an emergency

Question 44

What is the MHA w/r to self harm?

Answer 44

o Self harm:
o Suicide is not unlawful (but assisting suicide is)
o MHA legislation has limited practical application in cases of patient who harm themselves
o Doctrine of necessity and best interests cannot be used where patient has made a capacitous refusal
o Complex area always seek advice immediately if in doubt

Question 45

What are the guidelines to regulate research ethics?

Answer 45

Research involving humans is heavily regulated
 Medical research has a murky past and regulation needed to protect participants
Guidelines
 Nuremberg code
 Declaration of Helsinki (many countries have adopted as law)
 GMC

Question 46

What are the research legislation bodies & Law?

Answer 46

Legislation
 Data protection Act 1998
 Human Tissue Act 2004
 Mental capacity Act 2005
 Medicines for Human Use (CT) Regulations 2004
Criminal law and common law
 Cannot administer “noxious substance” unless this is part of a “properly approved research” with proper consent

Question 47

What are the ethical issues raised by research?

Answer 47

Scientific validity
Consent
Confidentiality
Balance of risks vs benefits
Equipoise 
Placebo
Reciprocity

Question 48

in research ethics what is reciprocity?

Answer 48

Reciprocity

 Is there a duty to participate given that the vast majority of us benefit from medical research?

Question 49

In research ethics what is placebo?

Answer 49

Placebo

 Ethically acceptable when no alternative treatment available or if the research is non-therapeutic

Question 50

In research ethics what is equipoise?

Answer 50

Equipoise
 The idea that research can only be justified if there is genuine uncertainty
 Once there is sufficient evidence research stopped since clinical equipoise met

Question 51

In research ethics what is the balance of risks vs benefits?

Answer 51

Balance of risks vs benefits
 An assessment of risks & benefits must be made for research to be legal
 Generally the benefit must outweigh the risk

Question 52

In research ethics what is considered with confidentiality?

Answer 52

 Research participants have a moral and legal right to have their confidentiality protected by researchers
 Data Protection Act 1998 requires all data be adequately protected

Question 53

in research ethics how should consent be regarded?

Answer 53

 Requirement for valid consent more stringent in research than medical practice with a signed consent form not being sufficient
 Threats to voluntariness of consent are payment and vulnerable groups
- Patients (especially with terminal illness)
1. Therapeutic misconception - think research is standard care
2. Gratefulness/Sense of duty
3. Fear of withdrawal of care if decline to join
- Healthcare students
 Researchers must ensure that information is provided in a way that participants can understand
 If no capacity Medicines for Human use (CT) regulations 2004
- Consent must be obtained from a legal representative
- Research must be likely to benefit the patient or other people who suffer the same condition
- Efforts must be made to gain consent and that any sign of dissent should be should be taken seriously

Question 54

How should scientific validity be considered in research ethics?

Answer 54

 Whether research is important/relevant and is the methodology appropriate
 Unethical to expose people to risk for no good reason
 Additionally cannot fund research which is a waste of resources

Question 55

What are research ethics committees?

Answer 55

Are local (LREC) or multi-centre (MREC)
Have 12-18 members
Offer ethical review but do not give legal advice
National research Ethics Service (NRES)
 Triages research proposals
 All proposals needing review are examined by a REC

Question 56

What are the 3Rs of ethical animal experimentation?

Answer 56

3Rs of ethical animal experimentation
 Replacement = non-animal methods to be used where possible
 Reduction = number of animals used should be kept to a minimum
 Refinement = smallest amount of pain and distress should be caused and should only be caused for a justifiable purpose

Question 57

What is the legislation for animal research?

Answer 57

NB: All drugs licensed for use in Britain have been tested on animals
Rodents most commonly used (84%) and research on great apes (gorillas, chimpanzees, orangutans and bonobos) banned

Legislation in the UK is “The Animals (scientific procedures) Act 1986”
 Provides special protection for primates, cats, dogs and horses
 Requires that there be an ethics committee in institutions