Written evidence submitted by Christian
Action Research and Education (CARE)
INTRODUCTION
1. The Welsh Assembly Government is seeking to
introduce a soft opt out system[33]
for organ donation for those living and dying in Wales, in addition
to continuing to participate in the existing UK-wide opt-in system.
The LCO consultation paper recommends the introduction of presumed
consent for organ donation. Their recommendations appear to be
based primarily on the supply and demand for organs, on public
opinion polling and on the views of the BMA. CARE is supportive
of voluntary organ donation, however we have strong reservations
about the introduction of presumed consent, for the reasons detailed
following.
EVIDENCE USED
FOR PROPOSED
ORDER
2. The explanatory memorandum for the proposed
LCO is highly selective in its use of evidence and fails to fully
engage with many significant ethical and practical issues raised
by the proposal to introduce presumed consent and neither does
it consider some of the potential negative effects from introducing
presumed consent.
3. One of the most striking omissions is the
failure to cite the range of views, recommendations and thinking
behind the Organ Donation Task Force (ODTF) 2008. This was only
undertaken three years ago so cannot be considered to be outdated
yet. Moreover, the ODTF looked in far greater detail at a broad
range of issues raised by presumed consent than the LCO memorandum,
including consideration of the ethical issues, and it did not
limit itself to concerns about the supply and demand for organs.
It concluded—we believe correctly—that presumed consent
is neither necessary, nor right, to introduce. Indeed it: "found
considerable evidence highlighting the potential downside of such
a move." (para 1.8). The failure of LCO to
properly consider such evidence indicates a lack of balance and
objectivity.
4. The conclusions of the ODTF should be heeded
as it has been the most rigorous review of this issue that has
been undertaken in the UK. It comprised working groups, literature
reviews, interviews, public events etc and it carried out a thoughtful,
comprehensive, detailed and rigorous investigation of presumed
consent, which was only completed three years ago.
5. In contrast, we note that the LCO primarily
draws on the statement by the BMA on presumed consent to back
up its recommendations for introduction. However, the ODTF notes
that: "the BMA policy may not directly reflect the views
of its professional membership (especially critical care professionals),
since it was determined at an Annual Representative Meeting by
locally elected representatives, rather than by a poll of all
its members. The group advises that the BMA's position on presumed
consent should be regarded as that of a well developed policy
that has been produced by an experienced and respected ethics
group rather than one that is representative of the body of medical
opinion in the UK."
COMMENTS ON
ASPECTS OF
THE PROPOSED
ORDER
6. The LCO asks for comments on the following
aspects of the proposed order:
To what extent is there a demand for legislation
on the matter(s) in question?
7. The LCO document fails to make any comment
on the UK surveys that the ODTF reviewed. Yet these are equally
relevant to those cited by the LCO. The ODTF reports that:
"Among the eight UK surveys reviewed, there was considerable
variation in the level of support for presumed consent, ranging
from 30% to over 60%." (para 12.1) This by
no means suggests a clear majority of the population are definitely
in favour of presumed consent, unlike the suggestion by the LCO.
Again, we are concerned about the selective nature of the evidence
used by the LCO to justify its conclusion.
8. Even if the majority of the population were
in agreement with presumed consent this does not automatically
imply that individuals themselves would want to donate. The ODTF
in Annex E, 10.2 comments that although there appears to be strong
support within the public domain that donation is considered a
"gift", there is limited knowledge about the process
of donation. Three case studies were presented which identified
reasons why families who were generally supportive of donation
nevertheless declined themselves. The main reason why these
families who supported donation but struggled with consent, appeared
to be due to circumstances that came together at the time of death.
The most important of these emerged as:
- (a) The perception of a need to protect the
body and keep it "whole".
- (b) The adverse influence of a poorly timed
or constructed approach to the family.
- (c) A lack of information, or an inability
to process it.
- (d) A desire not to prolong the perceived
"suffering" of the deceased.
- (e) The need to witness the observable end
of life.
9. Clearly therefore, it cannot be assumed that
there is a correlation between a general support for donation
in principle and the personal willingness to donate organs oneself.
Moreover the concerns listed would be better overcome through
better education and advertising on organ donation, not presumed
consent.
10. Not only is the demand argument weak, there
are other reasons why introducing presumed consent is unnecessary.
For example, it may actually make little difference to donor rates:
"…a literature review commissioned by the ODTF showed
that the evidence for a causal relationship between 'opt out'
consent systems and increased donor rates was inconclusive,
because of the competing factors that might affect donation rates."
11. Moreover, the LCO itself notes the success
in increasing donation rates after implementing the ODTF recommendations.
"Evidence was presented from Ms Fiona Murphy, the head
a team of bereavement nurses in the Royal Bolton Hospitals NHS
Trust, who has recently demonstrated impressive increases in organ
donation through the incorporation of donation into standardised
care pathways for patients dying on intensive care units…
this work indicates how substantial increases in donor numbers
can be achieved within current legislative frameworks."
(ODTF para Annex E, 9.1).
12. Thirdly, introducing informed consent may
actually have an adverse effect on donation. "The
experience in France, where various public scandals relating to
organ donation (including an incident involving the taking of
corneas when the donor's parents had not agreed to this, even
though their consent was not required by law) had an adverse
effect on donation rates. We therefore urge the Taskforce
to consider the potential for a negative as well as a positive
impact on donation rates of introducing an opt out system
in the UK."
13. The Committee asks: Does the LCO have
the potential to increase the regulatory burden on the private
or public sector?
14. We believe that the LCO does indeed have
the potential to increase the regulatory burden on the public
sector, as well as an increased financial burden.
15. The introduction of presumed consent would
require a large-scale publicity campaign to reach all societal
groups, irrespective of their culture or first language. A key
message in the campaign would have to be about how people can
exercise their right to opt out and who this applies to.
16. In order to gain a high level of confidence
and trust in the presumed consent system and for organ donation
(and to keep donor numbers sufficiently high to justify the costs)
it would require a vast, sustained and highly effective public
education campaign and genuinely accessible facilities for registering
an opt out decision. Also, rigorous record and regulation would
be necessary.
17. As the ODTF itself concluded, having costed
this carefully: "It became increasingly clear that it
would be both complex in practical terms and also costly to
put in place an opt out system that could command the trust of
professionals and members of the public…real concerns
were expressed about the security of information on an opt out
register; this issue would need to be addressed by using a robust
and secure iT system." (para 1.11)
18. The Committee asks: Does the LCO have
the potential to cause confusion regarding legal jurisdiction
and the individuals to whom any Measure would apply to?
19. Clearly, operating two different systems
in the UK and Wales would have obvious potential to cause complexity,
confusion, extra regulation and extra advertising for individuals
across the two jurisdictions. People across the whole of the UK
would need to be aware of the differences between Wales and the
rest of the UK as many family members, (involved in decision-making
for the soft opt-out presumed consent option), will come from
both jurisdictions.
20. Families prefer to be fully engaged in the
decision-making process to ensure that decisions are made that
are right for each individual case. There is a risk of a loss
of trust in the system if families were to feel in any way pressured
or coerced or, importantly, confused and unprepared.
ETHICAL ISSUES
21. The LCO fails to address some important ethical
issues with presumed consent and organ donation in general which,
we believe, indicates a lack of effective engagement with the
issue. These following issues should have been taken into consideration
before reaching any conclusions about presumed consent.
22. One of the primary problems with organ donation
is the ascertaining and timing of a diagnosis of death—the
blurring of distinctions between life and death is aggravated
by organ donation. Pope John Paul II noted this is "…one
of the most debated issues in contemporary bioethics."
(2000: 2). Truog even suggests that: "the medical
profession has been gerrymandering the definition of death
to carefully conform with conditions that are most
favorable for transplantation." (2008). Should
"death" reference the brain or other organs? How long
must the heart have stopped beating before a patient is unambiguously,
irreversibly, dead? It is difficult to put a specific time on
something that is, in essence, a process.
23. Secondly, there is no consideration of the
concern that treatment before death could be influenced in some
way by the preservation of organs after death. There is need to
discuss whether there is potential for compromising the care of
living patients in favour of potential procurement of organs after
death. Is there danger (as has been claimed with the Pittsburgh
protocol) that the events surrounding the "high tech"
death could be manipulated to accommodate organ retrieval? Even
with "official" safeguards, it seems likely that death
may be hastened, or at least care compromised, if a hospital set
up is to optimise the retrieval of viable organs. As the ODTF
also notes: "Some intensive care staff in particular fear
that a move to an opt out system would make critical care more
difficult." (para 1.9).
24. As noted briefly above (para 8), some individuals
express concerns about keeping the body "whole". There
are important questions with donation about the value of bodily
integrity, and what is sacred about bodily death. Is the donation
of vital organs good in principle or not? In what sense is there
a shortage of organs that must be overcome? (Meilaender
2006). Donation of organs is not therapeutic for donors; they
are given for utilitarian reasons for someone else's benefit.
Is it right to "aim at my own harm in order
to do good to my neighbour?" (Meilaender 1996: 93)[34]
or should it be regarded as an unreciprocal gift?
25. There is a very real danger that presumed
consent could undermine donation as a gift and erode trust in
professionals. The President's Council on Bioethics states that
"the central ethical challenge for any transplantation
protocol is to give the gift of life to one human being
without taking life away from another." (2008: 119).
26. The ODTF reports that representatives from
the Donor Family Network also highlight the importance of the
gift relationship. They were concerned that a system of presumed
consent, however weak, would promote conflict between families
and clinical staff, conflict that would rapidly degrade the trust
that was vital to decision making.
27. Recipients and their families themselves
are concerned that donation should always be a genuine gift: "The
working group considering clinical implications heard powerful
evidence from recipients of organs who stressed their need to
know that organs had been freely given by donors and their families,
and from donor families who often find great comfort in being
an active part of the decision to donate." (Para 1.10).
CONCLUSION
28. The emphasis of the LCO appears to be primarily
directed to the needs of the recipients and we believe is unbalanced
in its use of the evidence for and against presumed consent. There
must be equal care for the prospective donor as well as recipient,
whilst maintaining the intrinsic value of vulnerable human life,
the gift element of donation and awareness of the danger in re-defining
death. There is too little consideration in the LCO for the prospective
donors, for the ethics of organ donation, for maintaining the
gift element of donation and for any of the possible negative
outcomes of presumed consent.
29. Whilst we are not against voluntary organ
donation, CARE cannot support the LCO proposal to introduce presumed
consent and we would instead encourage the Welsh assembly to consider
how to further implement the recommendations of the ODTF to increase
donor rates through public education and information, as it has
successfully done thus far. This would of course be a less complex,
less expensive and less controversial option.
February 2011
REFERENCES
Organ Donation Taskforce. 2008. The Potential Impact
Of An Opt Out System For Organ Donation In The UK: An Independent
Report From The Organ Donation Taskforce.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_090312
Meilaender, G, 2006. Organ Procurement: What are
the Questions? Paper presented to the US President's Council on
Bioethics.
http://www.bioethics.gov/background/meilaender_organs.html#edn17
(accessed 04/01/09).
Meilaender, G, 1996. Bioethics: A Primer for Christians.
Carlisle: Paternoster Press.
Pope John Paul II. 2000. Address to the 18th International
Congress of the Transplantation Society. Catholic Information
Network.
http://www.cin.org/pope/organ-transplant-cloning.html
(accessed 04/02/09).
The President's Council on Bioethics. 2008. Controversies
in the Determination of Death. A White Paper of the President's
Council on Bioethics. Washington DC. www.bioethics.gov. (accessed
03/02/09).
Truog, R & Miller, F, 2008. "The Dead Donor
Rule and Organ Transplantation". The New England Journal
of Medicine. Vol.359 (7), pp. 674-675.
http://content.nejm.org/cgi/content/full/359/7/674?query=TOC
(accessed 30/12/08).
33 A "soft" opt out system, is one in which,
as a safeguard, family members would be consulted about donation. Back
34
As opposed to aiming at my neighbour's good, knowing that in doing
so I may be harmed (Meilaender 2006: 93). Back
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