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The safety and well-being of the participants and the

protection of their human rights are paramount and will be
safeguarded throughout the study. Written, informed
consent from patients and carers/family will be obtained at
the commencement of the study, and again prior to any
interview for those agreeing to be interviewed. Participants
will be informed that if they do not wish to take part in the
study, or if they wish to withdraw from it at any time, then
they will be able to do so, and their treatment will not be
adversely affected.
It has been argued that palliative care is faced with more
moral problems than are found in other areas of health
care (Randall & Downie 1999). Similarly it is often argued
that palliative care has a specific moral dimension
(Janssens et al. 1999, Hermsen & ten Have 2001).
Hermsen & ten Have (2001), in exploring this, argue that if
this is so, then palliative care will include particular moral
issues that are intrinsically related to it.
With this philosophical and ethical argument in mind, one
of the areas in which the ethical dimensions of palliative
care come to the fore undoubtedly resides in all aspects of
research within this group of patients. However unless
research is undertaken with this group of patients then
their care would never improve. As both Karim (2000) and

Polit & Hungler (1999) strongly point out, it is the

vulnerability of patients undergoing palliative care that is a
major issue arising out of the sensitivity of actually
conducting research with this group.
However, research studies undertaken with any group of
people bring up issues of vulnerability. To this end, all
research involving human subjects requires an ethical
dimension. In 1974 it was established by the Belmont
report that there are three fundamental ethical principles
that underscore acceptable conduct during research
involving human participants (Aita & Richer 2005). These

respect for autonomy



These three ethical principles are associated with three

practices that protect these rights (Jonsen 1996):

informed consent

risk-benefit assessment


Returning now to research involving patients accessing

palliative care and their carers - whether members of the
family, volunteers, or professionals, Polit & Hungler (1999)
point out that conducting research with people who are
dying is problematical because they are particularly

vulnerable due to the fact that they may be at high risk of

unforeseen and unintended side-effects because of their
particular circumstances. Consequently, Polit & Hungler
(1999) feel that these patients need a higher degree of
protection than is given by the general framework and
ethical research guidelines.
So what are these vulnerabilities that have to be taken into
account by any researcher involved in research studies
with patients accessing palliative care and their families?
Karim (2000) tabulates seven particular concerns:
1. Patients often experience complex symptoms as well as
mental and physical exhaustion and may be quite frail.
To put it bluntly, they may not be in any condition to be
participants in any research study.
2. The research, particularly if it raises potentially painful
issues surrounding death, might result in the patients
experiencing psychological distress (Aranda 1995).
3. Although willing to take part in the research, patients
might find it increasingly difficult to actually do what is
being asked of them. Karim (2000) points out that there
may well be cognitive and physical deterioration that
could affect their ability to complete questionnaires, selfassessment, or quality of life scales, or even to be
interviewed. This is supported by Fayers et al. (1991).
Another problem around the issue of cognitive
deterioration raised by Addington-Hall (2002), citing
Pereira et al. (1997) is that where patients have

evidence of cognitive impairment this can lead to

impaired decision-making capacity, and all that that can
imply, particularly in terms of giving informed consent.
4. Patients who have not yet reached the terminal phase
could have other demands on their time, for example
multiple hospital outpatient appointments, as well as
regularly moving between home, hospital and hospice
depending upon their care needs. This could mean that
trying to find time for interviews or to complete
questionnaires could prove to be problematic.
5. Karim (2000) also mentions another problem, namely
that the patients who are relatively well may not find it
easy or convenient to spend their valuable remaining
time filling in questionnaires or taking part in interviews.
Family members also might not want the patient to
spend time taking part in a research project because
they themselves want to spend time with the patient.
Addington-Hall (2002) points out that questions have
been raised about whether it is ethically sound to ask
patients accessing palliative care to participate in
research. This could risk depriving them of energy and
time when the time could possibly be better spent
allowing the patient to complete any unfinished
business, as well as just being with the family.
6. There is then the problem that patients may be trying to
distract themselves from their illness or symptoms of
pain and that involving them in research will focus them
back on their illness and thoughts of dying.

7. Finally, there is the problem that patients might sign a

consent form but only because they fear that refusing to
sign it might cause them to have problems with the way
in which their professional carers manage their care. As
Karim (2000), citing Randall & Downie (1999), points
out, this does raise the question as to whether any
patient participation in health research can ever be
voluntary, because there will always be this (unspoken)
fear that by not taking part in the research, the patient
may be penalised in someway. This point is supported
by Addington-Hall (2002) who argues, as others have,
that it is unethical to ask these patients to participate in
research as they may feel coerced into doing so, or may
be unwilling to give honest evaluations of care.
Addington-Hall (2002) also brings to this discussion the
point that concerns have been raised around the issue of
beneficence. As pointed out previously, all research should
benefit the participants to some extent. However with
many of these patients there is the possibility that they will
not benefit from the research as they may well have died
before any actions as a result of the research can take
place. Janssens & Gordijn (2000) have put forward the
argument that it is possible that research in palliative care
may therefore be unethical as patients have no
opportunity to benefit from the research.
However, Addington-Hall (2002) points out that all these
issues are actually not unique to patients accessing
palliative care, because many patients rely on healthcare
providers and could feel coerced into participating in the

research unless care is taken. She argues that many

patients who take part in research actually do not derive
any benefit from it personally. Similarly many other
patients, as well as those accessing palliative care, could
experience psychological distress as a result of research
and often may be fragile and exhausted as a result of their
illness. Casarett & Karlawish (2000) consider that there is
no reason why palliative care should be a special case
because ethical principles and guidelines have been
developed over time to ensure that all patients are able to
make informed decisions concerning their participation in
research. In addition, as these ethical principles and
guidelines are there to protect all patients from being
exploited in any way by the researchers, these same
ethical principles and guidelines should be sufficient to
protect those patients who are accessing palliative care.
Another issue that is addressed by both Addington-Hall
(2002) and Lawton (2001) is the fact that many patients
accessing palliative care may have rapidly changing
conditions. Consequently what they may have been happy
to do one day, they may be less willing or less able to do
the next day. Munhall (1991) puts forward a possible
solution to this problem. He believes that the concept of
'process consent' developed within qualitative research
will solve this problem. Process consent occurs when the
researcher checks at intervals whether the patients still
want to participate in the research. This does not just
mean checking every week whether or not the patient still
wishes to take part. It also includes checking during an

interview whether the patient wishes to continue or not,

and if not, then stopping the interview at that point.
Yet another ethical issue raised by Addington-Hall (2002)
is that of research involving carers of patients accessing
palliative care. The philosophy of palliative care doesn't
just involve the needs of patients but also the needs of
those caring for them or those close to them, for example
the family. When it comes to research, there may be
conflicting desires regarding participation between the
patient and the family. One example may be that the family
does not want the patient tiring himself or herself out, or it
may be that the family don't want to have the patient
wasting time on research when they could be spending it
with them. The family may feel very protective about the
patient, and may worry that taking part in research may
lead to all the problems as discussed above. AddingtonHall (2002) argues, however, that although this may
present difficult dilemmas to researchers it does not
change the very basic ethical principal of autonomy.
Whether to take part in research or not is a decision of the
patients themselves, although she does state that it may
be appropriate to encourage patients to discuss a study
with their families, or it may be appropriate to explain the
study when the patient and family members can be
together. Again this issue is not unique to patients
accessing palliative care and their families; it also applies
to many vulnerable patients in other situations.
As regards two of the problems mentioned above, namely
the perception that patients and families may feel coerced,

rightly or wrongly, into taking part into a research study,

and the concerns of lack of beneficence for the
participants, Lee & Kristjanson (2003) have an answer.
They point out that patients will be very much aware that
they may not gain any benefit from the research, but they
argue that these patients may have a desire to make their
experience count by contributing to knowledge that may
assist future patients and families. They state that some of
these patients, who may now be stripped of their former
active roles in the family and community, and now facing
death, may feel that being involved in research may
somehow give them a sense of purpose and engagement
in one of the activities of living. In addition, Caplan (1988)
suggests that there is actually an obligation on all
members of the community to share the burden of
healthcare research because everybody derives
significant benefit from research at some stage. Indeed
Bruera (1994) found that, from his experience, some 8090% of palliative care patients approached to take part in
research studies agreed to do so, as long as they were
well-informed regarding the purpose and the potential
benefits, not necessarily for themselves, that can arise
from the study.
Finally, Lee & Kristjanson (2003) stressed that without
research taking place, there is a risk that nothing new
would be attempted and that there would be a failure to
scrutinise how we care for dying people. In addition they
point out that without the use of research to demonstrate
and justify the value of palliative care services, palliative
care providers may find it increasingly difficult to attract

funding. From a social justice perspective, as Rawles

(1971) suggests, all members of the community have an
interest in the provision of good healthcare because each
member of the community has a potential for needing
healthcare in the future. Some of them may need to
access palliative care in the future. Therefore each
member of the community has an interest in ensuring that
there is good palliative care; care that is based on the best
evidence provided by ethical research. Seymour &
Ingleton (1999) argue that it is important that we develop
models of research for accessing user views. However,in
terms of palliative care, as Seymour & Skilbeck (2002:219)
state 'this requires striking a fine balance between the
ethical duties of providing caring support, nurturing
independence and autonomy, and achieving research
outcomes that are rigorous while also being accessible
and meaningful to users'.
Researchers have a responsibility to ensure that their
research will be of value and that the rights of the
participants are protected. They should acknowledge and
honour the rights of palliative care patients, families and
healthcare workers who choose to be involved in their
research. It is only through this research into the
experiences and needs of patients accessing palliative
care, and their families, that palliative care researchers
and clinicians can better understand the needs of the
community and improve the quality of the care provided in
future (Lee & Kristjanson 2003).

Approval to conduct this research will be sought from the

South Bedfordshire Ethical Committee, and permission
obtained from the R&D committees of the Luton tPCT,
Heartlands PCT, the Luton & Dunstable Hospital, and the
Pasque Hospice before approaching any of the patients,
carers, families, or professionals.
All records of the research will be kept confidential and
only the researcher will know who has taken part in the
study. All participants will be given a number or
pseudonym and these will only be known to the
researcher. Nothing will be written in the final report that
could in any way identify a particular participant. All
information, including recorded tapes of interviews, will be
kept in a locked filing cabinet in a locked office at the
University of Hertfordshire, and will be destroyed at the
end of this research project. All electronic data will be
encrypted, and will be protected by a password and the
principal researcher's fingerprint.
The health and comfort of the subjects
The patients and their carers/families who agree to take
part in the interviews will be offered a choice of venue.
They can then choose the venue where they feel most
comfortable. For most, this venue will be their own home.
Each patient and their family/carer will be given the option
to be interviewed together or separately. This will be their
decision only.

Whilst there is no physical intervention involved with this

research, discussing and thinking about their situation may
induce psychological problems, such as depression,
anxiety and withdrawal. With this possibility in mind,
written information will be provided on how they can
contact a named person for support afterwards, if
The risk of inflicting psychological harm to the participants
through unnecessary intrinsic questioning is
acknowledged in the next section on ethical
considerations. This will be avoided by using advanced
interpersonal communication skills, open questions,
allowing the children/families time to detail their
experiences without interruption, and allowing the
participants to ask questions during and after the
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ethics ethics in research