Med law and ethics Flashcards
What is personal responsibility in health?
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.
What do different governments think of personal responsibility in health?
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.
What are treatment contracts?
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.
What does the NHS constitution say regarding personal responsibility for health?
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
What does the GMC say regarding personal responsibility for health?
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”
What is the legal position on personal responsibility in health?
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
What are the different types of transplant?
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
What is the resource dilemma?
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??)
What is the legislation/regulation of transplants?
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
What does the human tissue act (2004) say?
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.
What are the types of assisted reproduction treatment?
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
What is assisted reproduction?
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)
What does the Human fertilisation and Embryology Act 1990 [amended in 2008] say?
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
What were the human fertilisation and embryology act 2008 amendments?
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
What is the HFEA?
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
What are the rules of parentage?
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
What is positive and negative right to reproduce?
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
What are the nice guidelines on access to fertility treatment?
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
What is the european regulation of fertility treatments?
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
What is the background facts on neonatology survival?
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
When do different countries begin treatment in neonatology?
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
What is the UK law on neonatology?
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)
What is the abortion act?
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
What are the legal criteria for termination of pregnancy?
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
What is the mental capacity act?
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
What are the basics of capacity?
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
What does it mean that capacity is dynamic?
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.
What is the criteria for capacity in the mental capacity act 2005?
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
What does the BMA law society guidelines suggest capacitous individuals should be able to do?
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
How do you maximise capacity?
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
What should you do when a patient is not capacitous?
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
What happens if a patient is unconscious?
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
What is anti-psychiatry?
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
What is the “pharma and mental health” argument?
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
Expand on mental health does not equal mental capacity?
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?
What are the ethics/law of sexual perversion?
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?
What is the mental health act (1983) NOW (2007)?
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)
What is a section 2?
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
What is a section 3?
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
What is a section 5?
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
What are the exceptions to mental disorder?
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
What were the 2007 changes to the mental health act w/r to ECT/psychotherapy?
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
What is the MHA w/r to discharge?
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
What is the MHA w/r to self harm?
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
What are the guidelines to regulate research ethics?
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
What are the research legislation bodies & Law?
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
What are the ethical issues raised by research?
Scientific validity Consent Confidentiality Balance of risks vs benefits Equipoise Placebo Reciprocity
in research ethics what is reciprocity?
Reciprocity
Is there a duty to participate given that the vast majority of us benefit from medical research?
In research ethics what is placebo?
Placebo
Ethically acceptable when no alternative treatment available or if the research is non-therapeutic
In research ethics what is equipoise?
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
In research ethics what is the balance of risks vs benefits?
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
In research ethics what is considered with confidentiality?
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
in research ethics how should consent be regarded?
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
How should scientific validity be considered in research ethics?
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
What are research ethics committees?
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
What are the 3Rs of ethical animal experimentation?
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
What is the legislation for animal research?
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
