Maximizing Benefits and Minimizing Risks in Palliative Care Research That Involves Patients Near the End of Life

Abstract

Research in end-of-life care is constrained more by pragmatic, social, cultural, and financial constraints than ethical issues that preclude the application of typical research methodologies. When normally accepted and ethically sound protections for subjects (especially for those who lack independent decision-making) are in place, exclusion of patients with far advanced disease from research is in and of itself unethical. Involvement in research may have a therapeutic, anticomiogenic effect on dying patients and their families. Institutional review boards must be educated to evaluate research protocols involving this group of vulnerable patients with an eye toward assuring that ethical safeguards are in place, conflicts of interest are transparent and minimized, and that the proposed methodology has duly considered all practical exigencies so that resources and peoples' time and emotional investments are not squandered. Investigators and research review committees must be knowledgeable about placebo effects and under what types of circumstances their use is justifiable, preferred or requisite to fulfill both ethical and scientific imperatives. Examples of investigations using various research methodologies, along with their respective ethical considerations are provided.

Dying with Dementia: What We Know after More than a Decade of Research

“…Dementia patients have cognitive impairment so usually only proxies can give consent for the patient's participation. There are also the practical challenges of poor recruitment and limited follow-up [133,134]. Further, the frailty trajectory of decline results in difficult prognostication with the result that dementia may not be recognized as a terminal condition making it difficult to define an end-of-life population.…”

A Phenomenological Inquiry into the Embodied Nature of Occupation at End of Life

“…However, on the other side of the debate, there is growing literature that argues that a marked exclusion of people at end-of-life from research may also be unethical (Fine, 2003). In addition, there is evidence that people at end-of-life want to be involved as participants in research, or at least given the choice as to whether to be involved or not (Addington-Hall, 2002;Tuffrey-Wijne, Bernal, & Hollins, 2008).…”

“…Other potential benefits of participation identified in the literature include the potential therapeutic effects that research can have on dying persons and their families by eliciting feelings of purpose and meaning, and other perceived benefits such as companionship and the validation of being able to engage in a meaningful activity (Fine, 2003;Terry et al, 2006;Tuffrey-Wijne et al, 2008). The terminally ill participants in the study by further reported that they preferred qualitative research methods, stating that they felt "these methods allow people to raise and contextualise issues important to them" (p. 3).…”

Burden and Benefit of Psychosocial Research at the End of Life

“…[2][3][4][5][6][7][8][9] Research that focuses on end-of-life issues is often considered too burdensome, potentially distressing, or harmful to terminally ill patients. 10 Because of the perceived vulnerability of palliative care patients, hospital Institutional Review Boards (IRBs) may be reluctant to permit psychosocial research, for fear that there are minimal benefits and even the potential for harm.10,11 These concerns are even more pronounced when research focuses specifically on topics related to death and dying.…”