Palliative care is an approach that aims to improve the quality of life (QOL) of patients facing serious problems – physical, psychosocial, and spiritual – associated with life-threatening illness. Palliative care includes a variety of management approaches to provide symptomatic relief of pain and other distressing symptoms, support systems for patients and families to cope, and to enhance QOL. Some of these approaches, e.g. spiritual support or counselling, go beyond the usual medical treatments. As palliative care is considered an essential component of cancer care, there is a medical need to develop evidence based on rigorous clinical trials. Over 800 clinical trials in palliative care are registered on clinicaltrials.gov. Some of the interventions in these trials are – ketamine for depression, radiation therapy, empathic conversational agents, gratitude-based intervention, technology-enhanced (iPad) transitional palliative care, music therapy, impact of telemedicine, intervention in spirituality and acupuncture. However, palliative care research in humans faces moral and ethical challenges, which create barriers to patient participation.
These barriers are (1) patient issues (2) gatekeeping and (3) ethical issues. The patients are frail, have limited life expectancy, and face impending death. Gatekeeping – discouraging patient participation by the clinicians, ethics committee (EC), or caregivers – is due to assumptions that research will be burdensome, unwelcome, intrusive or upsetting for the patient, has no benefit for the patient, and would give false hope, or is unethical. The patients may be under a therapeutic misconception – believing that the objective of a research study is to administer new therapy rather than to conduct experimental research. EC is concerned that the patients’ terminal illness has impacted their capability to understand the scope and conditions of the research and provide valid consent. Often these patients have exhausted all available therapies. Hence, they may be willing to consent for research on any intervention that can give them a ray of hope.
In contrast to the concerns of the gatekeepers, the majority of palliative care patients appreciate the opportunity to contribute to research and report benefits such as a sense of valuable contribution to society, a sense of meaning to life, a feeling of pride, and the opportunity to reflect on life and the illness experience. Many participants value the altruistic endeavor of participating in research. Hence, it is desirable that researchers take the lead in organizing safe, ethical and impactful palliative care research studies.
Palliative care researchers should make efforts to educate the EC members about the special aspects of patient care, and the need for conducting research to improve the evidence base of diverse palliative care approaches. They should be conscious of the ethical issues of vulnerability, and aware of potential sources of coercion or undue influence in the enrolment process. The burden on clinical research participants, family members, and caregivers should be minimized while conducting research. Palliative care researchers’ proactive and transparent communication with ECs will facilitate the protection of study participants and foster high-quality research to enhance care for patients with serious terminal illness.