Research in End-of-Life Settings: An Ethical Inquiry

Abstract

A fundamental tension surrounds the ethics of conducting research in vulnerable populations, and specifically, research involving patients at or near the end-of-life. In Palliative Medicine, these patients' care has historically been based on compassion, clinical judgment and experience, and anecdote rather than on data generated through high-quality clinical trials. A robust evidence base to support clinical practice in the end-of-life setting is lacking. Multiple ethical objections to the conduct of research at the end of life have impeded efforts to build such an evidence base. Arguments can be categorized into claims that the goals of research conflict with the goals of care; research unduly burdens vulnerable patients and families/caregivers; genuine equipoise does not exist; and research in the palliative care setting is too difficult. The authors explore and respond to these objections, noting the vital importance of research at this stage of the illness trajectory. The authors conclude that barriers to palliative care research are surmountable, and, indeed, that the "research imperative" and principles laid out in the Belmont Report of 1979 require us to rigorously study clinical interventions used for palliative care patients-so as to provide optimal safety and outcomes for present and future patients.

Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

“…18 It is necessary to walk the line between protective and inclusive considerations successfully, but do we succeed? The next conflict suggests that a clearly articulated consensus is lacking.…”

Consensus principles for wound care research obtained using a Delphi process

“…Principles 12 and 13 underscore the issue that the inclusion/exclusion criteria for many wound care studies are often overly restrictive, and therefore results can be limited in terms of generalizability to “real world” wound care populations, especially vulnerable or priority populations . Although all wound care populations are vulnerable in a sense, some populations are highly vulnerable and include females, the elderly (various definitions exist: Medicare population ≥65 years, ≥70 years, and ≥85 years), racial and ethnic minorities, patients with disabilities, patient with multiple comorbidities, and those requiring palliative care . For example, patients with renal failure or frail patients under long‐term care could be considered highly vulnerable.…”

Building the Palliative Care Evidence Base: Lessons From a Randomized Controlled Trial of Oxygen vs Room Air for Refractory Dyspnea

“…Research in end-of-life and advanced illness settings can be challenging, 11 but the aforementioned examples demonstrate that it is important and worth pursuing, as it can facilitate change and improve the quality of care that we provide. The Oxygen Study is an ideal test-case to demonstrate the importance of doing rigorous controlled trials of common clinical practices in palliative care.…”