Supplementary memorandum by the British
Transplantation Society
LEGAL AND
ETHICAL ISSUES
IN NON-HEART-BEATING
ORGAN DONATION
(NHBOD)
The summary issues are:
— avoiding conflict of interest when
defining ongoing active support as futile;
— the ethics and lawfulness of any
alteration to clinical care (including investigations and interventions)
that is directed solely towards maintaining or improving organ
viability; and
— working within an unambiguous and
universally acceptable definition of death.
1. Decisions to withdraw treatment are made
frequently on intensive care units when the goals of treatment
are no longer achievable. Such decisions are always made in the
patient's best interests. If the patient is conscious (rare) the
issues can be discussed with them directly but, if not, the decision
to withhold or withdraw treatment involves liaison with all disciplines
involved in the patient's care as well as with the next-of-kin,
in order to establish the patient's values, beliefs and any expressed
wishes. When carried out to the defensible standard defined by
professional and regulatory bodies, and solely directed towards
the best interests of the patient, such decisions constitute a
mandatory discharge of professional responsibilities and are supported
by established ethical and legal frameworks.
Once a consensus on the withdrawal of futile
treatment has been reached and, if it is anticipated that death
will follow within a short time frame, it seems reasonable to
confirm the patient's known wishes in relation to organ donation
by review of the UK Organ Donor Register and by seeking the views
from the next-of-kin as to the patient's known or predicted position
on organ donation. If this process is free from patient harm and
the family are not exposed to time pressures or coercion, it is
difficult to see how consideration of NHBOD at this stage can
be perceived to be ethically or legally unacceptable. However,
there are those who believe that, because such actions are not
strictly in their patient's best interests, they represent a conflict
of interest for the practitioner and therefore fall outside current
ethical and legal frameworks.
2. The ethical and legal issues are even
less clear if it is necessary to make alterations in clinical
care that are primarily directed towards maintaining or improving
organ viability. The main issue centres on what measures a doctor
could or should take in order to facilitate organ donation from
a patient who is dying but not yet dead. In order to minimise
warm ischaemia it is necessary, as a minimum, to maintain the
potential donor on the current level of cardio-respiratory support
until such time as the surgical team has been mobilised and is
ready to commence the retrieval process.
Interventions such as pre-mortem cannulation,
drug infusion and efforts to restore a systemic circulation after
the onset of asystole are performed in some countries in order
to facilitate NHBOD. Such practices are extreme, play no part
in any controlled NHBOD program in this country, are not endorsed
in our national guidelines and are not defensible. However, it
is accepted by those who support NHBOD that it is reasonable to
manipulate the timing of withdrawal of treatment (and therefore
the time of death), and to perform pre-mortem investigations,
in order to facilitate NHBOD. What is less clear is what a practitioner
should do if the patient's condition deteriorates before withdrawal
of treatment, whilst still awaiting mobilisation of the retrieval
team. Is it reasonable to increase cardio-respiratory support
and, if so, to what degree? How does this actually differ from
the provision of cardiopulmonary resuscitation to a potential
donor who suffers a cardio-respiratory arrest? Because of these
questions, the opponents of NHBOD argue, not unreasonably, that
the current UK position is fundamentally no different from that
in other countries that allow more invasive interventions and
that both are ethically, and perhaps legally, unacceptable. Their
position is that current UK practice merely represents one end
of an unacceptable spectrum of practice. The fundamental ethical
and legal question is therefore, if cardio-respiratory support
has been deemed to be no longer in a patient's best interests,
how can it be acceptable to continue or increase such support
simply in order to facilitate NHBOD?
The answer might lie in the concept of "best
interests," and this has assumed a central role in guiding
the actions of clinicians who care for incompetent patients. "Best
interests" and "necessity" are the principles in
law that govern the care of the incompetent adult and these have
been incorporated into statute under the Mental Capacity Act.
Although "best interests" need not strictly be limited
to medical best interests, there is no explicit definition of
this extension. None of the interventions necessary to facilitate
controlled NHBOD, including the prolongation of the current level
of cardio-respiratory support, are easy to accommodate under a
narrow interpretation of "best medical interests." For
example, it is difficult to see how it can be in a patient's medical
interests to continue to be treated if such treatment has already
been judged to be futile. However, if the concept of best interests
is extended beyond the physical to include the broader wishes
and aspirations of the patient, then an indication that the patient
would wish to donate their organs after death, such as through
registration with the UK Organ Donor Registry or discussion with
the next of kin, is interpreted by some to authorise clinicians
to take reasonable steps to facilitate donation after cardiac
death, providing that the primary duty of care to the comfort
and dignity of the patient is not breached. This expanded view
of best interests easily accommodates prolongation, and possibly
increase, of cardio-respiratory support to facilitate NHBOD, particularly
if it receives the informed support of the next of kin. This is
similar to the way in which clinicians readily grant requests
to delay withdrawal of cardio-respiratory support to allow family
members to travel from afar to attend the bedside.
This broader definition of best interests is
used to support the ethical and legal basis of NHBOD but is declared
to be spurious by opponents. In defence of this broader definition
is its parallel with other aspects of health-care where "best
interests" is not limited to "best medical interests"
but incorporates the patient's wishes and beliefs when competent,
their general wellbeing and their spiritual and religious welfare.
Although there is a substantial view that this position is ethically
defensible, there is no certainty that it is similarly defensible
in law. This is one of the issues on which the Organ Donations
Taskforce has called for urgent clarification.
3. The uncertainty as to when death can
be legitimately confirmed is particularly relevant to NHBOD. Whilst
this "uncertainty" is also used by opponents of NHBOD
to highlight their concerns, it is my opinion that this issue
is less open to ethical or legal challenge. Much attention has
been given to the minimum period of continuous cardio-respiratory
arrest that is sufficient to allow the diagnosis of death to be
made with certainty and indicate the point at which organ retrieval
can begin. A period of no less than five minutes has been recommended
in the UK by the Intensive Care Society and this position will
be supported by the Academy of Royal Medical Colleges when their
guidance is finally published. A similar period has been recommended
in North America by the Canadian Council for Donation and Transplantation,
the US Institute of Medicine and the Society of Critical Care
Medicine. The latter reviewed the published evidence of continuous
observation of asystole, apnoea and unresponsiveness and concluded
that an observation period of no less than two and no more than
five minutes of observation was adequate to allow the confirmation
of death.
April 2008
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