Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: a qualitative study

Abstract

Background Delivering high quality, patient- and family-centered care depends upon high quality end-of-life and palliative care (EOLPC) research. Engaging patients and families as advisors, partners, or co-investigators throughout the research lifecycle is widely regarded as critical to ensuring high quality research. Engagement is not only an ethical obligation, it also raises ethical challenges of its own. We conducted a qualitative study to understand ethical challenges and potential solutions when engaging patients and families in EOLPC research. Methods We recruited and interviewed 20 clinical investigators and 22 patients or family caregivers through the Palliative Care Research Cooperative Group (PCRC). Interview transcripts were analyzed using constructivist grounded theory methodology. Analysis sought to identify ethical challenges and potential solutions, as well as to synthesize findings into practical recommendations tailored to engaging patients and families in EOLPC research. Results Our study identified 8 ethical challenges considered unique to the EOLPC research context and 11 potential solutions to these challenges. The most frequently described ethical challenges included the need to minimize burdens of engagement for patients and caregivers, challenges of dealing with death and illness, and paternalism or “gatekeeping” (i.e., withholding the opportunity to participate from patients or caregivers). Investigators and patients or family caregivers conceptualized ethics challenges differently; several issues appeared to fall outside a traditional research ethics paradigm and more into the ethics of relationships. We synthesized these findings into 4 practical recommendations hypothesized to support authentic engagement. Conclusions Engaging patients and families in EOLPC research can raise unique ethical challenges. These challenges can be overcome to empower participation, minimize the unique burdens of EOLPC, and promote diversity. Whereas traditional research ethics tend to emphasize protecting research participants who may be vulnerable, an ethics approach based on authentic engagement that explores what it means for investigators and patients or family caregivers to be in a relationship may be needed. Future research is needed to explore this approach and test these recommendations in practice.

A Rapid Review of the Factors That Influence Service User Involvement in Interprofessional Education, Practice, and Research

“…It is noteworthy to highlight the challenges faced by service users with cognitive impairments or high-risk health conditions [ 46 ] noted in this review. Acknowledging the difficulties in engaging specific service user populations in the co-design process, several researchers have provided frameworks and recommendations to mitigate these challenges [ 56 , 57 , 58 , 59 ]. Although not all service users are willing or able to be involved in their own care, it is essential that service providers (i.e., healthcare workers) do not act as gatekeepers of the process.…”

Palliative Care: A Primary Care Pharmacist Perspective

“…Sailing the palliative waters, it is easy to feel out of our professional comfort zone: drug trials were never designed to include the palliative patients, and studies evaluating the effectiveness or safety of any drug or intervention are often inconclusive when applied to the palliative context. Research methodologies and evidence-collection principles in palliative medicine differ significantly to the traditional, quantitative, multi-arm, double-blind approach of the evidence-based medicine that we are so used to [ 20 , 21 , 22 , 23 , 24 ].…”

Early Implementation of Palliative and Supportive Care in Hepatocellular Carcinoma

“…This occurs through change in physician attitudes towards the intervention, particularly when there is no specific limitation to implementing the change due to ethical considerations. This is best highlighted for patients receiving a palliative care intervention as it is unethical to limit a physicians' ability to refer patients to palliative care services that they believe could be of benefit [133]. Thus, cluster-based trial designs, where the level of the intervention is randomised at the level of the facility is considered the gold standard for implementational trials in the palliative care space (figure 1.)…”

“…This is best highlighted for patients receiving a palliative care intervention as it is unethical to limit a physicians' ability to refer patients to palliative care services that they believe could be of benefit. 125 Thus, cluster-based trial designs, where the level of the intervention is randomized at the level of the facility, are considered the gold standard for implementational trials in the palliative care space ( Fig. 1 ).…”