Presumed Consent?

1
Presumed Consent?

• An examination of the bioethics involved in
  opt out methods of human organ procurement and
  the impact such systems may have on the future
  role of xenotransplantation.
• Stephen J Doyle

2
Introduction

• Some of the most important initiatives in
  medicine in the last 50 years have been in the
  field of organ transplantation. Since the first
  transplants were carried out in the 1950s and
  60s, there has been an imbalance between the
  amount of donated organs available at any one
  time, and the number of hopeful recipients.
• Organ donation was originally viewed as a purely
  altruistic choice for an individual but many
  models have since been used to try to address the
  issue of organ availability.
• One method used by various countries has been to
  change the responsibility of a person to opt in
  to a system of donation and to instead actively
  opt out if they do not want to donate their
  organs after death. This so called presumed
  consent system has many ethical considerations
  that will be addressed in this presentation.
• Another approach to the problem of insufficient
  organ supply is to grow the organs in animals.
  Xenotransplantation. We will look at his briefly
  later in the presentation and ask the question of
  how presumed consent systems, if implemented on a
  wide scale, may affect it.

3
Current System

• At the moment in the UK we can only harvest from
  people who have joined the donor register, carry
  a donor card or have made their wishes clear to
  their nearest and dearest.
• This policy is known as expressed consent and
  ethically relies on the assumption that express
  or explicit consent is always prospective
  informed consent.
• Current legislation is provided by the Human
  Tissue Act 2004(1)and the Human Tissue (Scotland)
  Act 2006(2).
• Last year in the UK, there were 7300 people on
  the waiting list for a life saving transplant.
  However, only 3235 transplants were carried out
  using the organs from just 1665 donors, moreover,
  851 of these were living donors.
• 400 people die each year in this country due to
  this shortage of organs.
• Although there are nearly 16 million people
  registered on the UK national transplant
  database, statistical analysis indicates that
  closer to 40 million would be willing to donate
  but just havent signed the register.
• Up to 40 of possible donations are not carried
  out because of opposition from the relatives of
  the deceased even though they have no legal right
  of veto.
• (all statistics taken from the UK national
  database on 20th October 2008)(3)

4
Alternatives

• Increased promotion/ education.
• Paid or compensated donor schemes.
• Priority for transplants given to those that have
  agreed to donate.
• Mechanical engineered organs.
• Biologically engineered organs.
• Living donors.
• Paired/pooled schemes.
• Required referral.
• Aggressive consent pursuit.
• Forced donation.
• Donation after cardiac death donation (DCD).
• Xenotransplantation.
• Presumed consent.

5
Presumed consent

• Presumed consent takes the onus away from the
  individual to register in order to become an
  organ donor. Instead, the individual must sign a
  register in order to make his views known that he
  does not want to donate. Therefore everyone is
  treated as a donor unless they implicitly opt
  out.
• This removes the anomaly that (in the UK), 25 of
  people are registered on the national transplant
  database whilst up to 80 of individuals are
  willing to donate their organs after death but
  have never got around to signing the database(3).
• There are two methodologies applied to the
  presumed consent approach. The soft (lenient)
  system as carried out in Spain which still takes
  into account the views of relatives and the hard
  (stringent) system as instigated in Austria (the
  only country to use this system), where no
  consultation with family is legislated for(4).
• 22 nations have so far implemented presumed
  consent laws and evidence points to them doing
  slightly better than informed consent
  countries(4), however, their performance in many
  cases improved long after the laws were
  implemented and seem to be due in part to other
  effectors(5).
• Interestingly, in most countries using presumed
  consent, there is only a 2 rate of individuals
  opting out of donation, which may indicate a
  procrastination on behalf of people who may well
  not want to donate(6).

6
Presumed consent

• The success of the system is difficult to assess.
  In Sweden, an advocate of the system, donation
  rates are lower then in the UK. Whereas in Spain,
  donation rates are three times what they are
  here(7).
• What clouds the issue is that in Spain, there are
  transplant coordinators in all major hospitals,
  more intensive care beds, and a higher rate of
  fatal road traffic collisions which all lead to
  higher take up rates of organ donation(8)
• The consensus however, seems to indicate that
  although presumed consent is not the panacea of
  organ procurement strategies, it does seem to
  increase donation levels. In 2003 countries
  implementing opt-out systems had donation rates
  of over 20 people per million compared with the
  UK levels of 12.3(4). Furthermore, in 2006,
  Abadie and Gay published a detailed regression
  study taking into account other determinants that
  may effect donor rates and concluded that
  presumed consent systems still increased rates of
  donation by 25-30.(9). Some studies however,
  indicate no higher donation rates despite
  implementation of opt-out systems(10).
• Moreover, some authors as illustrated below, tend
  to compare effective consent rates rather than
  actual procurement rates which exaggerate the
  success of countries using presumed consent.
• Table 1 from http//www.iq.harvard.edu/blog/sss/ar
  chives/2008/04/do_defaults_sav.shtml
• Table 2 from http//www.kieranhealy.org/blog/archi
  ves/2008/04/09/psychology-vs-organizations-in-orga
  n-procurement/

7
Graphical illustration of effective consent rates
and donor procurement rates in European countries.

• .

8
Ethical arguments for presumed consent

• It is considered obscene by many people that huge
  numbers of perfectly good hearts, livers, kidneys
  and lungs are destroyed each day by cremation or
  burial while people are dying for want of these
  organs.
• Possible donors may have just not got around to
  registering. Surveys have shown up to 80 of
  people are willing to donate organs after they
  die, but only a quarter register. Most people do
  not consider it likely that they may die
  prematurely and it is therefore difficult to
  persuade them to consider donation in advance.
• Levels of organ availability are greatly reduced
  by relatives refusing donation. The stringent
  system of presumed consent could be justified
  from a utilitarian viewpoint in that it should
  result in more donors. However, even in countries
  using the lenient system, donation veto by
  relatives is reduced.(9)
• As between 60-80 of people would be willing to
  donate according to surveys, changing the default
  position would better reflect public opinion.
• A shift to presumed consent may instigate more
  discussion within families about organ donation.
• Presumed consent laws may lead to a culture
  change meaning that people would view organ
  donation as the norm rather than the exception.

9
Ethical arguments against presumed consent

• It could be very easy to regard very ill patients
  as just a source of multiple organs that could
  help many recipients. In today's climate,
  distrust of some fields of medicine and certainly
  those concerned with organ retention e.g. the
  Bristol enquiry(11), could lead to paranoia
  amongst patients and their relatives.
• Surely organ donation should be an altruistic
  choice rather than coerced. Indeed many patients
  who have received an organ say that it was more
  easily accepted because it was freely given as a
  gift. Some recipients may therefore feel some
  degree of guilt in receiving an organ that was
  maybe not 100 freely given.
• The non signing of a register cannot
  automatically be taken as a willingness to
  donate, many people will just not get around to
  signing it. It is difficult for people to
  envisage a future that may entail an early demise
  for them.
• There are concerns that the rules for the
  definition of donor death may need tightening up.
  For decades, organs would only be removed when a
  patient was declared brain dead. However, a
  procedure called donation after cardiac death is
  being used more and more, often as a way to make
  organs more plentiful, leading to some
  controversy.(12) Last year in the UK, there was a
  36 increase in organ retrieval from non heart
  beating donors(3).
• Further concerns are evident in the mental
  aptitude of a large proportion of the population
  to make an informed decision on opting out. Not
  signing the register may indicate a lack of
  understanding rather than a willingness to
  donate. The burden of ensuring respect for their
  wishes will be shifted from the state to
  themselves.

10
Ethical arguments against presumed consent

• The age of consent may be another minefield of
  unsure legislation. Should presumed consent only
  apply to those aged above sixteen? eighteen? This
  age of autonomy once decided upon could lead to
  questioning of Gillick competency(13). A Gillick
  competent child although below the age of
  autonomy is considered mature enough to be
  treated as an adult.
• The responsibility for maintaining and securing
  an up to date and accessible database is not
  something the government has a very good record
  with. It is unsure and improbable that 100
  safeguards can be given. Situations will occur
  where information is erroneously recorded, not
  found, or have issues with concurrency.
• Maintaining that 60-80 of people could be
  willing to donate, by looking at systems in
  Europe which may have only a 2 opt out could
  mean that 20-40 of individuals may be caught in
  the trap of donating against their will.
• The state should not presume ownership of an
  individuals body after death. It is akin to
  nationalisation.
• Various religions may not only have theological
  objections to organ donation, but also have
  concerns on how a body is treated after death.
  Not to mention concerns with the legal definition
  of death as mentioned previously with non beating
  heart donation. The state is therefore imposing a
  secular viewpoint and in states such as
  Singapore, exemptions have had to be made for
  Muslims on religious grounds(14).

11
Ethical arguments against presumed consent

• There is evidence that, certainly in the UK,
  people on the donor register now will leave it in
  protest at state intervention although this may
  be seen by some as political manoeuvring(15).
  Could presumed consent reduce donation rates in
  countries where autonomy is highly prized? It had
  to be withdrawn in Brazil because of mistrust in
  the health system(16).
• Could the system, taken to extreme, result in
  total removal of all organs? At the moment, many
  individuals cherry pick which organs theyd like
  to donate and for instance would not donate
  corneas thinking they may need them in the next
  life'. Once this legislation is introduced,
  doctors may consider the presumption of consent
  allows major harvests of all parts of the body
  leaving an empty shell.

12
Xenotransplantation

• Xenotransplantation is the transplantation of
  tissues or organs or tissues from one species to
  another. Many issues stand in the way of allowing
  it to be used clinically.
• Originally, it was proposed that primates may be
  the most useful donor animals, however, problems
  were encountered including small organ sizes,
  long gestation periods, ethical concerns in using
  one of mans close relatives and risk of disease
  transmission because of their close phylogenetic
  distance to humans.
• Current uses involve porcine pancreatic tissue
  for diabetes control, heart valve replacements,
  and porcine livers as temporary bedside
  replacements pre human liver transplants.
• Many barriers are still to be overcome in regards
  to immune rejection. The response is generally
  stronger than in allotransplants because of
  antigenic dissimilarity. Much scientific research
  is being carried out in immunosuppressive
  techniques in order to overcome the various acute
  and chronic rejection problems. Transgenic
  (genetically engineered) animals are seen as
  possible solution to this.
• Inter species disease transmission,(xenosis) is
  another hurdle that must be overcome. Porcine
  viruses include circovirus, parvovirus and
  rotavirus and the animals must be carefully
  screened in order to eliminate these risks,
  especially with potential organ recipients likely
  to be immunocompromised(17).

13
Xenotransplantation

• A major cause for concern are endogenous
  retroviruses. These are fragments of old viral
  infections integrated into the DNA of most
  species. About 50 Porcine retroviruses (PERVS)
  are harboured by pigs and although not disease
  causing in the host, may become infectious in
  another species.
• Other concerns are evident. Pigs live for about
  15 years and their organs age at different rates
  to humans throwing into confusion the estimates
  of donation viability. Their organs are smaller,
  work at different temperatures, different fluidic
  pressures and there could be problems with some
  proteins and hormones being incompatible.
• Amongst many other organ procurement initiatives,
  xenotransplantation also has quite complicated
  ethical issues attached. Is it right to use
  animals purely as hosts to grow organs for
  humans? How will religious beliefs reconcile with
  the use of pigs as a donor source? Is it right
  (in the case of transgenic animals) to
  permanently alter the genetic code of a species?
  How do we maintain informed consent of potential
  recipients with such an experimental procedure?
• However, there has been no magic bullet for the
  problem of organ shortages and any solution is
  likely to involve a multi faceted approach. For
  this reason, xenotransplantation would appear to
  still remain a viable technology even after the
  adoption of other procurement techniques such as
  presumed consent legislation.

14
Conclusions

• A policy of presumed consent although potentially
  beneficial is highly problematic. Evidence may
  suggest an increase in donor rates where
  countries have implemented such systems, however
  such increases are neither guaranteed nor
  obviously due to the opt out system alone.Indeed
  many countries that have more donors per million
  of population also have stronger systems of
  transfusion coordination and a more pro active
  system of pursuing family approval. It is
  therefore important to attempt to identify the
  variables that together may increase organ
  donation and try to implement the less ethically
  debatable options including improved education
  before we go down the route of presumed consent.
  One possible solution would be to adopt a system
  of required referral or mandated choice and
  protect these choices from familial veto.
  Although the system has been adopted elsewhere,
  it is by no means accepted that it would increase
  donation rates in the UK. We are a rebellious
  people by nature and any coercive solution I
  think could be opposed.
• Even in countries lauded as ideal proponents of
  presumed consent, waiting lists have not been
  eliminated and this is likely to worsen due to
  increased prevalence of diseases like hepatitis
  C, and so it seems likely that no single strategy
  is likely to solve it. Therefore, even if the opt
  out system is adopted widely, other strategies
  such as research into Xenotransplantation are
  unlikely to be disregarded for the foreseeable
  future.

15
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