Presumed Consent to Organ Donation - Whose Body Is It Anyway?

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Presumed Consent to Organ Donation - Whose Body
Is It Anyway?

• Dr Joyce C Stuart
• Consultant in Anaesthetics Intensive Care
• Western General Hospital
• Edinburgh
• joyce.stuart_at_luht.scot.nhs.uk

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Deceased donors, transplants and active
transplant list UK
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(No Transcript)
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Spanish model

• 35 donors pmp cf UKs 13 donors pmp
• 15 years ago, not much difference
• Have systematically addressed barriers to organ
  donation
• Large investment in infrastructure
• Local senior medical in-house co-ordinators
• Public education programme
• High profile
• Soft opt-out (presumed consent) legislation

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• In the UK up to 90 of people say they support
  organ donation
• 27 are on the NHS Organ Donor Register
• Approximately 60 of families agree to organ
  donation (i.e. 40 adopt a default position of
  not donating)
• Families rarely refuse to authorise donation if
  the deceased has a documented wish to donate

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Organ Donation Taskforce

• UK wide, government funded
• Multidisciplinary
• Set up in December 2006
• First report published January 2008

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Organ Donation Taskforce - Original Remit

• To identify barriers to organ donation and
  transplant
• To recommend ways, within existing operational
  and legal frameworks, to support and improve
  transplant rates

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Organ Donation Taskforce - Aim

• To increase organ donation by 50 in 5 years
• i.e. an additional 1200 transplants per year, of
  which gt700 would be kidney transplants

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Organ Donation Taskforce - 3 key issues
identified - 14 recommendations

• Donor identification referral
• Donor co-ordination
• Organ retrieval arrangements

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The Next Stage

• Taskforce then given the task of investigating
  the likely benefits, feasibility, and
  acceptability of introducing presumed consent, or
  soft opt-out legislation, in the UK
• Produced report in November 2008

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The Current Legal Position

• Human Tissue (Scotland) Act 2006
• Human Tissue Act 2004 (E, W, N.I.)
• Previously expressed views of deceased paramount
• Strictly speaking, previous authorisation by
  deceased sufficient, although in practice the
  nearest relative will always be asked to agree to
  donation
• Donation may not proceed if deceased known to
  have objected

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Legislative Options

• Opt-in (informed or express consent)
• Hard opt-out (routine removal of organs without
  consulting relatives if deceased has not opted
  out)
• Soft opt-out (if right to opt out not
  exercised, assumption that no objection to
  donation, but relatives have right of veto)

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Arguments for Presumed Consent

• Most people support organ donation
• Promotes patient autonomy because it reflects the
  wishes of the majority of people
• Proxies notoriously bad at exercising substituted
  judgement
• Lots of organs are being wasted because families
  are adopting the default position of not donating
• Families would still have right of veto

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Arguments against presumed consent

• Contrary to principles of informed consent -
  doesnt protect autonomy - paternalistic
• Concept of personhood - it is still my body after
  I am dead
• Erosion of civil liberties
• Invasion of privacy
• Failure to register objection does not equal
  consent
• Danger of jeopardising the culture of altruism,
  gift giving, around organ donation

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Taskforce Approach

• Commissioned systematic review from University of
  York
• Series of 7 public consultation events across UK
  (ngt350)
• Input from various experts
• Analysis of cost of changing to opt-out
• Discussions with faith groups

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• A systematic review of presumed consent systems
  for deceased organ donation
• A Rithalia, C McDaid, S Suekarran,
• L Myers, A Sowden
• Center for Reviews and Dissemination, University
  of York
• May 2008

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• 1ry objective to examine the impact of presumed
  consent legislation on organ donation rates by
  identifying, appraising and synthesising
  empirical studies looking at this
• 2ry objective to identify, appraise and
  synthesise data on the attitudes of the public,
  professionals and any other stakeholders to
  presumed consent.

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Studies included in review

• Comparative studies
• Between countries with without presumed consent
  - 8 studies, of which 4 were of sufficient
  quality to provide reliable results
• Before after introducing presumed consent - 5
  studies, representing 3 countries
• Surveys of attitudes - 8 UK lay surveys, 4 from
  other countries, 1 international survey of
  transplant-related healthcare professionals

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Countries which have presumed consent legislation

• Austria, Belgium, Bulgaria, Czech Republic,
  Finland, France, Greece, Hungary, Italy, Latvia,
  Luxembourg, Norway, Poland, Portugal, Slovak
  Republic, Slovenia, Spain, Sweden, Switzerland
  (some cantons), Singapore

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Variations between countries with presumed
consent legislation

• Hard v soft opt-out ( degrees of softness)
• Required request
• Donor register
• Opt-out register
• Rigour of administration
• Documentation

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Countries with informed consent legislation

• Croatia, Denmark, Estonia, Germany, Ireland,
  Israel, Lithuania, Netherlands, Romania, UK, USA,
  Canada, Australia, New Zealand, Switzerland (some
  cantons), most Asian countries

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Data from 4 studies comparing different countries

• All showed ve correlation between presumed
  consent laws and donation numbers (3 plt0.05, 1
  NS)
• Magnitude of increase approx 25
• All assessed impact of other factors
• Important factors were mortality from RTAs
  CVA, transplant capacity, GDP health
  expenditure per capita, Catholicism, education,
  public access to information, common law legal
  system

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Data from before after studies

• Austria, Belgium Singapore
• All reported increased donation rates after
  change in legislation
• Limited exploration of confounding variables
• No information about impact of legislation on
  public attitudes

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Austrian before after study

• Single centre. 3 time periods-
• Before 1982 legislation - donor rate 4.6pmp/yr
• 1982-1985 - 1st 4y post-legislation - donor rate
  10.1pmp/yr
• 1985-1990 - 5y following introduction of
  full-time transplant coordinators - donor rate
  27.2pmp/yr
• In 1990, 42 donors pmp
• Little exploration of confounding variables

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Conclusions

• Presumed consent associated with increased
  donation rates, but presumed consent alone does
  not explain the variation in donor rates between
  different countries.
• Other factors include availability of donors,
  transplant infrastructure, wealth investment in
  healthcare, education public attitudes.
  Relative importance of each unclear.

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Surveys

• 8 UK surveys. 4 full reports obtained, 4 from
  secondary sources. Trend towards increasing
  support for presumed consent in more recent
  years.
• Surveys from Spain, Belgium and USA
• All broadly similar levels of support for opt-out
  (60-70), similar majority that potential donor
  or family should be consulted

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Survey of Transplant-Related Healthcare
Professionals

• 2002 - survey of 739 members (from 15 countries)
  of International Society for Heart and Lung
  Transplantation
• 74 thought presumed consent would have a
  positive impact on organ donation rates
• 39 thought presumed consent was the single most
  effective way to improve donation rates
• gt50 rated higher indirect compensation,
  improved education, more medical staff to talk to
  families legally binding donor cards

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Conclusions about surveys

• Difficult to interpret because of lack of
  information and methodological inconsistencies
• Questions phrased in different ways, not always
  clear what the question was
• General trend towards acceptance of concept of
  presumed consent
• Majority believed family should be consulted
• Not sufficiently convincing to justify changing
  law in UK

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Taskforce Conclusion

• Not convinced that the British people are ready
  for opt-out legislation
• Too much risk of anti-donation backlash
• Better to invest in raising profile of ODR
  improving transplantation infrastructure

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Does the status quo facilitate informed consent?

• Donor cant give informed consent at the time of
  donation.They must anticipate the eventuality and
  give consent in advance.
• Carry donor card.
• Sign up to NHS organ donor register.
• Possible to do this with little or no
  information.
• 52 Qs As on UKT website. Useful, but not
  necessary to read this.
• At best, statement of intent.

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Role of Proxy

• Several studies have demonstrated that proxies
  are very bad at substituting judgement for
  others.
• Random chance of making the same decision

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Would presumed consent improve on this?

• 90 of people say they agree with organ donation
• Perhaps 70-80 would say yes at the time if asked
• Perhaps 10 of people would sign an opt-out
  register
• 60 actually donate at present
• With presumed consent, if donor rate increased by
  25 it would be 75. Most, but not all of the new
  donors would have said yes if asked.
• But does that miss the point??

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What are the ethical difficulties with this?

• Objectors required to take an active step to
  avoid an unwanted violation
• No other medicolegal situation in which doing
  nothing is regarded as equivalent to consent
• Precedent of conscientious objectors to military
  service. Must make a case for this.
• Spectre of Alder Hey, etc. Potential for adverse
  publicity and loss of public goodwill
• People might sign opt-out register in protest
• Vulnerable groups at most risk of failing to opt
  out when this reflects their true position

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Further ethical difficulties

• Assumption that ignoring the unstated wishes of
  objectors is equivalent to ignoring unstated
  wishes of potential donors.
• Is that reasonable?
• Is it morally worse to remove organs from an
  unrecognised objector than not to remove them
  from an unrecognised potential donor?
• Does the happiness created for organ recipients
  justify it?

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Rebuttal Arguments

• There would be an extensive information campaign
• It would be easy to opt out
• Vulnerable groups would be specially targeted for
  assistance
• Better to believe a potential donor would act
  altruistically than not
• Relatives relieved of burden of decision making
• Evidence that relatives often benefit from having
  agreed to organ donation

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Medical Opinion Divided

• In favour
• BMA has officially endorsed soft presumed
  consent with safeguards since 2000
• Recent BMJ pro con debate - majority of
  correspondents in favour
• Chief Medical Officer of E W spoke in favour
  in 2007
• Cabinet Secretary for Health Wellbeing in
  Scotland has endorsed the idea in 2008

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Medical Opinion Divided - Against

• Intensive Care Society pro-con debate May 2008
• Of 70 delegates, 56 were opposed to presumed
  consent, 8 were in favour, 6 didnt know

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ICS Position

• Concerns about diagnosis and timing of death,
  particularly for NHBOD - Academy of Royal
  Colleges Code of Practice (2008) may have helped
  with that
• Concerns about conflict of interest for ICU staff
• Would ICU Consultants be reluctant enforcers of
  new opt-out legislation?

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Other Options

• Compulsory registration of wishes - yes/no How
  would this be enforced?
• Required request. All potential donor families
  must be asked. Clinical Governance issue.
• Improve the way that we ask for authorisation
• Incentivised registration. Financial inducement?
  Priority on organ donor waiting list?
• Register of objectors without presumed consent
  legislation. Low priority on organ donor waiting
  list?

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What I Think

• Lots of public consultation required before any
  change can be made.
• I would probably be comfortable with very soft
  opt-out legislation if sufficient public
  approval. Not sure how I would define that,
  dont think we have it yet
• Should be accompanied by strongly encouraged, but
  not compulsory, expression of wishes, eg via GP
  targets - GP practices to have financial
  incentives

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What do you think??
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www.uktransplant.org.uk