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 are:
respect for autonomy
beneficence
justice
These three ethical principles are associated with three
practices that protect these rights (Jonsen 1996):
informed consent
risk-benefit assessment
fair-selection
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 required. 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 interviews. References: Addington-Hall I (2002) Researcher sensitivities to palliative care patients. European Journal of Cancer Care 11: 320-224 Aita M, Richer M-C (2005) Essentials of research ethics for healthcare professionals. Nursing and Health Sciences 7: 119-125 Bruera E (1994) Ethical issues in palliative care research. Journal of Palliative Care 10(3): 7-9 Caplan A (1988) Is there an obligation to participate in biomedical research? In: (Spicker S ed) The Use of Human Beings in Research with Special Reference to Clinical Trials. Dordrecht, Kluwer Academic Publishers Casarett DJ, Karlawish JHT (2000) Special ethical guidelines needed for palliative care research? Journal of Pain and Symptom Management 20: 130139
Fayers PM et al (1991) Assessment of quality of life in small-cell lung cancer
using it daily diary card developed by the Medical Research Council Lung Cancer Working Party. British Journal of Cancer 64(2): 299-306 Hermsen MA, ten Have HAMJ (2001) Moral problems in palliative journals. Palliative Medicine 15: 425-431 Janssens MJPA, Zylicz Z, ten Have HAMJ (1999) Articulating the concept of palliative care: philosophical and theological perspectives. Journal of Palliative Care 15(2) 38-44 Janssens R, Gordijn B (2000) Clinical trials in palliative care: an ethical evaluation. Patient Education and Counselling 41: 55-62 Jonsen AR (1996) The weight and weighing of ethical principles. In: Vanderpool HY (ed) The Ethics of Research Involving Human Subjects: Facing the 21st Century. University Publishing Group, Maryland (pp.59-82) Karim K (2000) Conducting research involving palliative patients. Nursing Standard 15(2): 34-36 Lawton J (2001) Gaining and maintaining consent: ethical concerns raised in a study of dying patients. Qualitative Health Research 11: 693-705 Lee S, Kristjanson L (2003) Human research ethics committees: issues in palliative care research. International Journal of Palliative Nursing 9(1): 13-18 Munhall P (1991) Institutional review of qualitative research proposals: task of no small consequence. In: (Morse J, ed)Qualitative Nursing Research: a Contemporary Dialogue. Sage, London (pp.258-272) Pereira J, Hanson J, Bruera E (1997) The frequency and clinical course of cognitive impairment in patients with terminal cancer. Cancer 79: 835-84 Polit DF, Hungler BP (1999) Nursing Research Principles and Methods. Lippincott, Philadelphia Randall F, Downie RS (1999) Palliative care ethics. A good companion (2nd edn.) Oxford University Press, Oxford Rawles J (1971) A Theory of Justice. Oxford University Press, Oxford
Seymour JE, Ingleton C (1999) Ethical issues in qualitative research at the
end of life. International Journal of Palliative Nursing 5(2): 65-73 Seymour J, Skilbeck J (2002) Ethical considerations in researching user views. European Journal of Cancer Care 11: 215-290