Medical ethics

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Medical ethics

• Dr Gary Heyburn
• Orthogeriatrician
• Royal Group of Hospitals

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Aims

• Principles
• Human rights
• Case studies
• Rationing
• Research

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• How do we resolve ethical problems in medicine?

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Case 1

• 34 year old Jehovahs Witness is about to give
  birth when she starts to bleed the blood loss
  is life threatening.
• Should we give blood?

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Case 2

• A 25 year old needs a Caesarian Section for the
  safe delivery of her child.
• However she has a phobia about needles and
  refuses to agree to surgery
• How should we proceed?

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Case 3

• A 35 year old man has waited 20 years for a
  transplant. He requires dialysis 3 times per
  week. He is contacted by a company in India which
  says they can sell him a kidney.
• Should he be able to buy a new kidney?

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Duties of a doctor

• make the care of your patient your first concern
  
• treat every patient politely and considerately
• respect patients' dignity and privacy
• listen to patients and respect their views
• give patients information in a way they can
  understand
• respect the rights of patients to be fully
  involved in decisions about their care
• keep your professional knowledge and skills up to
  date
• recognise the limits of your professional
  competence
• be honest and trustworthy
• respect and protect confidential information
• make sure that your personal beliefs do not
  prejudice your patients' care
• act quickly to protect patients from risk if you
  have good reason to believe that you or a
  colleague may not be fit to practise
• avoid abusing your position as a doctor and
• work with colleagues in the ways that best serve
  patients' interests.

The duties of a doctor registered with the
General Medical Council
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Ethical Framework
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Clinical Ethics Framework

• Confidentiality
• Autonomy
• benefits/best interests
• non maleficence

• Justice/equity
• Human rights
• Equality
• other considerations

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The Four Principles

• Autonomy
• Beneficence
• Non-maleficence
• Justice

Beauchamp and Childress Principles Biomedical
Ethics, OUP, 5th edition 2001
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Autonomy

• Respect for autonomy respecting the
  decision-making capacities of autonomous persons
  enabling individuals to make reasoned informed
  choices.

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Beneficence

• this considers the balancing of benefits of
  treatment against the risks and costs the
  healthcare professional should act in a way that
  benefits the patient

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Non maleficence

• avoiding the causation of harm the healthcare
  professional should not harm the patient. All
  treatment involves some harm, even if minimal,
  but the harm should not be disproportionate to
  the benefits of treatment.

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Justice

• distributing benefits, risks and costs fairly
  the notion that patients in similar positions
  should be treated in a similar manner.

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The Rights of Humans

• Article 2 Right to life
• Article 3 Prohibition of torture and inhuman
  and degrading treatment
• Article 4 Prohibition of slavery

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The Rights of Humans

• Article 5 Right to liberty
• Article 6 Right to a fair trial
• Article 7 No retrospective crimes

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The Rights of Humans

• Article 8 Right to respect for private and
  family life, home and correspondence
• Article 9 Freedom of thought, conscience and
  religion
• Article 10 Freedom of expression and right to
  information

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The Rights of Humans

• Article 11 Freedom of assembly and association
• Article 12 Right to marry and found a family
• Article 14 Right not to be discriminated
  against on the grounds of race,sex etc

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Equality Legislation

• Religion
• Political opinion
• Gender
• Ethnic origin
• Disability
• Age
• Marital status
• Dependants
• Sexual orientation

Equality Legislation Section 75 of The Northern
Ireland Act 1998
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Case

• 70 year old is admitted with a chest infection
• He has a background history of lung carcinoma
• The cancer has spread to his bones including his
  ribs
• He was given 3 months to live, 4 months ago
• The family want full resuscitation

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• How do we proceed?

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Survival

• If I have a cardiac arrest in hospital what are
  my chances of leaving alive?

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Advance statements

• Competent adult
• Voluntary
• Medical consequences of advance refusal explained
• Applicable to the circumstances that arise

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DNAR

• Consider a DNAR
• Where the patients condition indicates that CPR
  is unlikely to be successful (BONE METS)
• Where CPR is not in accord with the recorded
  sustained wishes of a competent patient
• Valid applicable advance directive
• Where successful CPR is likely to be followed by
  a length and quality of life that would not be in
  the best interests of the patient

Alert course
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DNAR

• Relatives cannot determine a patients best
  interest, nor demand, give consent to or refuse
  treatment on a patients behalf. Their role is to
  reflect the patients views not take the decision
  on behalf of the patient.

Alert course
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Good Practice in Decision-making

• You should always take the patient's wishes into
  account. You must respect a competent patient's
  decision to refuse CPR. You should usually comply
  with patients' requests to provide CPR, although
  there is no obligation to provide treatment that
  you consider futile. The patient's decision must
  be recorded appropriately and communicated
  clearly to the health care team.

http//www.gmc-uk.org/guidance/current/library/wit
holding_lifeprolonging_guidance .aspCardiopulmona
ry_resuscitation
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Back to Case

• 70 year old is admitted with a chest infection
• He has a background history of lung carcinoma
• The cancer has spread to his bones including his
  ribs
• He was given 3 months to live, 4 months ago
• The family want full resuscitation

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Capacity/Competence

• Capacity is treatment specific - it depends on
  the treatment to be performed.
• Capacity can fluctuate.

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• An adult is presumed to have capacity.
• An adult is a person 18 years and over.
• The 3 stage test can be used to assess capacity

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3 stage test

• A patient has capacity to consent / refuse
  medical treatment if he/she can
• comprehend and retain treatment information
• believe it
• weigh it up to arrive at a choice

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Re C 1994 1 WLR 290

• Patient was an adult detained in Broadmoor mental
  hospital.
• He had gangrene in his left leg and the doctors
  considered that amputation was necessary to save
  his life.
• He refused such treatment.

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• Although he was a paranoid schizophrenic his
  mental illness did not render him automatically
  incapable of making a decision about his medical
  treatment.
• Although C believed that he was a world-renown
  doctor, the experts considered that he passed the
  3-stage test therefore he had capacity to decide
  about his medical treatment

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Children

• In law, children are those who are under 18 years
  of age
• The Family Reform Act 1969 provides that the
  consent to treatment of a 16 or 17 year old is to
  be treated like the consent of an adult.
• This has no application to a refusal of medical
  treatment

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Gillick competent

• This states that if a minor has sufficient
  intelligence and understanding to enable him /
  her to understand the treatment and implications
  of treatment then he / she is 'Gillick competent'
  and can consent to treatment
• However a refusal of treatment may be treated
  differently

Gillick v West Norfolk and Wisbech AHA 1986 AC
112).
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Children

• A child who is competent can consent to
  treatment. However, a refusal of treatment may be
  overridden by a parent or the Court where such a
  refusal would be likely to result in the death or
  permanent disability of the child. Then the
  wishes of the child may be overridden to preserve
  his or her long-term interests.

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Re M 1999 2 FLR 1097

• M was a competent 15 ½ year old who sustained
  acute heart failure and required a heart
  transplant. She stated that she did not want
  someone else's heart and refused to give consent.
  It was considered to be in her best interests to
  have the transplant and (although she ultimately
  consented to the operation) it is clear that
  treatment would have been declared lawful despite
  a refusal

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• The English courts protect strenuously the right
  to be self-endangeringly eccentric
• "The patient is entitled to reject the advice
  for reasons which are rational, or irrational, or
  for no reason.

Lord Templeman in Sidaway v Board of Governors
of Bethlem Royal Hospital 1985 1 AC 171
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Case 1

• 34 year old Jehovahs Witness is about to give
  birth when she starts to bleed ?
• Should we give blood?

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Case 2

• A 25 year old needs a Caesarian Section for the
  safe delivery of her child.
• However she has a phobia about needles and
  refuses to agree to surgery
• How should we proceed?

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Ralph Sandland
An Overview of the Law Relating to the Giving
of, and the Refusal to Give, Consent to Medical
Treatment
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Confidentiality

• Patients have a right to expect that
  information about them will be held in confidence
  by their doctors. Confidentiality is central to
  trust between doctors and patients. Without
  assurances about confidentiality, patients may be
  reluctant to give doctors the information they
  need in order to provide good care.

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Confidentiality

• A 66 year old is admitted with weight loss.
• Tests reveal the presence of cancer
• The family feel their father will give up and die
  if told any bad news
• They demand therefore that he is not told his
  diagnosis under any circumstances
• How do we proceed?

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Confidentiality

• A family doctor is told that one of his patients
  is an epileptic who still drives despite regular
  episodes of fitting
• WHAT SHOULD HE DO?

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Organ Transplantation

• Over 5000 people in the UK are on the national
  transplantation waiting list.
• Over 1000 people died in the period from
  1995-1999 while waiting for transplant of heart,
  lung or liver. This figure does not include those
  in need of renal transplant.
• About 1600 kidney transplants are carried out
  each year in the UK.

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Organ Transplantation

• Active kidney waiting list is over 4000, and
  increasing.
• In 1999, 16 of renal transplants were from
  living donors. This proportion is increasing. The
  majority of organs for transplant, however, is
  from dead donors.
• Of 24,023 deaths in intensive care in 1989-90,
  3266 had a possible diagnosis of brain stem death
  and may therefore have been suitable for
  donation. Only 1232 (37.7) became donors

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Ways of increasing the number of donors

• Making direct appeals to the public
• Addressing public concerns
• Increasing the number of living donors
• Using non-heart beating donors
• Moving to a system of presumed consent
  (opt-out).
• Automatic availability

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• Mandated choice
• Required request
• Elective ventilation of patients in deep coma and
  close to death with no possibility of recovering
• Living kidney exchange
• Payment for organs
• Allowing conditional donations

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• The reasons why 2034 potential donors did not
  become actual donors included
• tests for brain stem death were not carried out
  (39)
• refusal by relatives (27)
• medical contraindication to donation (22)
• relatives not asked about donation (6).

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The legal definition of death

• Patient is pulseless, apnoeic, with fixed
  pupils and no heart sounds
• Organs must be perfused
• Donor would need to be on ventilator and have a
  beating heart
• Concept developed of brain stem death

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Brainstem death

• the patient is in deep coma with no spontaneous
  respiration
• that there is an absence of various possible
  reversible causes for such coma (such as drug
  intoxication, hypothermia or electrolyte
  imbalance)
• that all brainstem reflexes are absent
• Tests have to be carried out twice (typically 24
  hours apart).
• 2 doctors opinions

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Organ Transplantation

• The Human Tissue Act
• The Human Tissue Act came into force on 1st
  September 2006
• The Act regulates the use and storage of human
  tissue, including organ transplantation
• It replaces the the Human Tissue Act 1961, the
  Anatomy Act 1984 and the Human Organ Transplants
  Act 1989.

http//www.ethox.org.uk
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The Human Organ Transplants Act 1989

• This Act was passed hurriedly by Parliament in
  response to a commercial trade in kidneys
• No payment must be made for the organs

http//www.ethox.org.uk
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• Thus relatives have a power of veto if the person
  did not express any wishes about the use of
  organs after his death. Even where the person did
  express a wish that an organ or organs be used
  the advice of the Department of Health suggests
  that relatives may be able to veto this
• Staff need to consider the feelings of
  relatives, who may be under great stress, so that
  in practice any objections raised by relatives
  usually take priority over donors wishes.
• Department of Health, 1998.

http//www.ethox.org.uk
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Consent

• The Human Tissue Act places consent at the centre
  of the system, both from the living and from or
  on behalf of the deceased

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Hierarchy

• Step-parent
• Half sister or brother
• Friend of longstanding

• Spouse/partner
• Parent/child
• Sister/brother
• Grandparent/grandchild
• Niece or nephew

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Case 3

• A 35 year old man has waited 20 years for a
  transplant. He requires dialysis 3 times per
  week. He is contacted by a company in India which
  says they can sell him a kidney.
• Should he be able to buy a new kidney?

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Selling a kidney for transplantation

• In individual cases it may be entirely morally
  justified
• Respecting individuals' autonomy (both
  donors/sellers and recipients),
• Producing net benefit over harm for
  donors/sellers and recipients,
• Involving at least no transgression of rights
  based justice

J Med Ethics 200329267-268
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Selling a kidney for transplantation

• enhancing distributive justice
• no transgression of legal justice (in countries
  that have not banned it involving) BUT
• none the less overall the likely dangers of
  financial exploitation and of postoperative harm
  to predominantly poor donors/sellers
• the likely increased risks to recipients of HIV
  and other infections
• and the likely reduction in volunteer donors

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Conclusion

• will probably result in sufficient excess overall
  of harm over benefit to conclude that a legal
  ban would be justified

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Summary of the Law Relating to Medical Decisions
at the End of Life

• Active euthanasia (mercy killing) is illegal
• Passive euthanasia is not necessarily illegal
• Withdrawing treatment is legally equivalent to
  withholding treatment
• Intending relief of distress, but foreseeing
  death, is normally legal
• Assisting suicide is a criminal offence
• A competent patient who refuses life saving
  treatment is not committing suicide

http//www.ethox.org.uk
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Self inflicted problems

• Should smokers be offered surgery such as cardiac
  bypass surgery ?
• Should HIV patients be treated?
• Should sports injuries be treated?

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Case

• A ten year old girl had non Hodgkin's lymphoma
  with common acute lymphoblastic leukaemia. Her
  father wanted the Health Authority to fund a
  further course of chemotherapy and a bone marrow
  transplant.
• It refused on the grounds that the proposed
  treatment was unproven and that the cost was
  disproportionate to the likely benefit.
• In the court of first instance Laws J. said that
  where a life was at stake then a health authority
  must 'do more than toll the bell of tight
  resources' and must explain the priorities that
  led them to decline to fund the treatment. He
  referred to the fundamental right to life and
  that the Health Authority should justify any
  limitation on that right if it refused to fund
  treatment.
• However, the Court of Appeal did not invoke the
  right to life. The court said that in reviewing
  the decision of the Health Authority it must only
  look at the lawfulness of its decision and not
  the merits.
• "Difficult and agonising judgments have to be
  made as to how a limited budget is best allocated
  to the maximum advantage of the maximum number of
  patients. That is not a judgment which the court
  can make."

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Difficult choices

• Should preference in treatment be given to
• Those who are young and have a longer expected
  time of survival / good health with treatment?
• Those who are parents with dependent children?
• Treating a greater number of patients rather than
  fewer patients with a greater need?
• Treatment that prolongs life or treatment that
  improves the quality of life?
• Established treatments rather than experimental
  treatments?

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Rationing

• Medical criteria
• Age criteria
• Economic criteria
• Philosophical criteria

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Medical criteria

• Priority level 1 Procedures immediately
  necessary to save lives in acute physical or
  mental illness
• Priority level 2 procedures required to avoid
  longer-term harm to patients or groups of
  patients where interventions are supported by
  evidence- diagnosis and treatment of asthma or
  diabetes

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• Priority level 3 procedures with documented
  effects but where the consequences of not
  treating are less serious slightly elevated
  blood pressure
• Priority level 4 services which are in demand
  but where there is no physiological ill effect
  from not treating- examples are IVF, repeated
  ultrasound during pregnancy
• Zero priority- special health services for top
  athletes

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Economic criteria

• Cost-minimization analysis
• Cost-effectiveness analysis
• Cost-benefit analysis
• Cost-utility analysis

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Cost-minimization analysis

• When alternatives accomplish the same desired
  outcome, the economic evaluation is essentially a
  search for the least expensive alternative

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Cost-effectiveness analysis

• Compares the cost per unit of beneficial outcome
  ( ie cost of life saved, cost per year of life
  gained)

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Cost-benefit analysis

• An analysis that measures both the costs and the
  consequences of alternatives in terms of money

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Cost-utility analysis

• Instead of simply comparing how many life years
  can be saved through various interventions, QALY
  analysis weights in how much value or utility
  people attach to a year in a particular status
  complete freedom of pain- severe disability.Death
  is 0, perfect health is 1
• The results of such a cost utility analysis are
  expressed in terms of cost per QALY

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Measurement of benefits
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QALY
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Malek, M. 2001. Implementing QALYs
www.evidence-based-medicine.co.uk
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Philosophical criteria

• Aristotle, explaining his view of distributive
  justice, says, in effect, that equals should be
  treated equally, and unequals treated unequally
  in proportion to the relevant inequalities. This
  is known as Aristotle's "formal principle of
  equality".
• Rawls veil of ignorance

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Rawls veil of ignorance

• In trying to make decisions about allocation of
  resources in the context of different needs, it
  may be helpful to use the concept of the ' veil
  of ignorance' put forward by John Rawls in his
  Theory of Justice. Faced with a range of possible
  societies (or possible methods of healthcare
  resource allocation) you must decide which
  society you would wish to live in given that you
  would not know your position in that society,
  whether you would be old or young, rich or poor
  sick or healthy. Rawls would argue that a
  rational person would choose the society (or to
  allocate resources) so that the most
  disadvantaged were as well off as they could be.

(Rawls J. A Theory of Justice, The Belknap Press,
1971, revised edition 1999).
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Research Ethics

• Nuremberg code first internationally agreed
  ethical code concerning the conduct of clinical
  trials
• Largely superseded by Helsinki declaration (first
  drawn up 1964 and revised several times since)
• Medical research brings many benefits but these
  benefits should not be bought at any price

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Declaration of Helsinki

• The design and performance of each experimental
  procedure involving human subjects should be
  clearly formulated in an experimental protocol
  which should be transmitted for consideration,
  comment and guidance to a specially appointed
  committee independent of the investigator and the
  sponsor.
• The purpose of biomedical research involving
  human subjects must be to improve diagnostic,
  therapeutic and prophylactic procedures and the
  understanding of the aetiology and pathogenesis
  of disease.
• Biomedical research involving human subjects must
  conform to generally accepted scientific
  principles and should be based on adequately
  performed laboratory and animal experimentation
  and on a thorough knowledge of the scientific
  literature

http//www.ethox.org.uk
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Research Principles

• Knowledge the proposed research should be likely
  to produce an increase in knowledge directly or
  indirectly relevant to patient care
• Necessity it should be necessary for the
  research to be carried out with the subjects
  proposed rather than with some less vulnerable
  group

KWM Fulford
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Research Principles

• Benefits the potential benefits arising from the
  research should outweigh any inherent risk of
  harm
• Consent research subjects should give valid (ie
  free and informed) consent to their participation

Parker M and Dickenson D. The Cambridge Medical
Ethics Workbook, case studies, commentaries and
activities. Cambridge University Press 2001
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Ethical Checklist in Medical Research

• Respect for autonomy
• Consent
• Competent
• Informed
• Voluntary
• Confidentiality
• Patient contact details
• Information from medical records
• Research data and results
• Risk of harm to participants
• Physical
• Psychological
• Therapeutic/non therapeutic research
• Value and quality of the research
• Are the aims worthwhile?
• Is the methodology appropriate to the aims?
• Are the outcomes clinically significant?
• Are the outcomes patient centred?
• Justice

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Patients who are not competent to give consent
for research
May be eligible if

• The risk of harm is very low, probably lower than
  the risk that is acceptable in the case of
  competent participants
• that the research aims cannot be achieved by
  other means
• that the research is of considerable value, and
• that a relevant person (usually a close relative)
  gives valid consent.

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REFERENCES

• Extensive use has been made of the following
  resources
• UK Clinical Ethics Network http//www.ethics-netw
  ork.org.uk/index.htm
• The Ethox centre http//www.ethox.org.uk/education
  /teach/seminars.htm
• Parker M and Dickenson D. The Cambridge Medical
  Ethics Workbook,
• case studies, commentaries and activities.
  Cambridge University Press 2001