Is it harder for someone near the end of life to participate in research (or to serve as a research advisor) compared to someone with diabetes? A question like this led a group of researchers to explore ethical challenges posed by study recruitment of patient and family advisors for research on end-of-life or palliative care.1
“The traditional research ethics principles — autonomy, beneficence, and justice — can help in thinking through the ethics of engagement. But they aren’t a perfect fit,” according to Ahmed Alasmar, BS, the study’s lead author and a professional research assistant at the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus.
Alasmar and colleagues focused on individuals recruited as research partners (as with Patient-Centered Outcomes Research Institute studies, where an advisory council helps a study design) as opposed to study participants. “Many of the same issues apply, such as gatekeeping, but not all,” notes Matthew DeCamp, MD, PhD, another study author and an associate professor in the Center for Bioethics and Humanities.
Alasmar, DeCamp, and colleagues conducted one-hour interviews with 20 study investigators and 22 patients or family caregivers. “Patients and family caregivers overwhelmingly wanted to be approached, sensitively and with compassion, to be given the opportunity to participate,” Alasmar reports.
This was true even very near the end of life, or while someone was grieving a recent loss. Investigators often believe it is unethical to approach people about a research study at those highly emotional times. In fact, people viewed not receiving this opportunity as paternalistic. “Researchers should be comforted to know that they can ethically approach patients and families to participate as partners in end-of-life and palliative care research,” Alasmar notes.
Several ethical issues fell outside the traditional research ethics paradigm, more into the ethics of relationships. One example is when patients pass away during a study. “Researchers must be prepared for this possibility, and be ready to respond to both grieving loved ones, and even grief that can occur in other research advisors who were members of the same advisory council,” DeCamp says.
Another “relationship ethics” issue involves boundaries between researcher and study partners. “Because study partners and researchers interact in a different way — not as researcher-participant or as patient-clinician — there can be blurry lines when it comes to friendship outside the study, requests for medical advice, and so on,” DeCamp explains.
In these “relationship ethics” issues, “an ethics of care seemed to be a better approach than thinking through the three principles of autonomy, beneficence, and justice,” DeCamp says.
The ethics of care approach emphasizes the central role of relationships in ethics, seeking authenticity, and concern for the relationship as primary, more so than the protectionist approach typically given to research participants or patients. “How researchers engage study participants matters,” Alasmar says.
Alasmar and colleagues recommended researchers consider ways to minimize burdens. For example, investigators might offer to give feedback sessions at the infusion center to make it easier for the participant. Minimizing burdens is important from the standpoint of beneficence. “But it is also important for justice,” Alasmar adds.
Hosting meetings in the evenings during non-work hours, or at convenient places in the community, can promote inclusivity in participation.
One overarching concern is that research ethics is focused primarily on protecting “vulnerable” human subjects. Researchers expressed the need for IRBs to understand that engagement partners are not “research participants” in the usual sense. “People who participate as research partners advising study investigators aren’t exposed to the same risks as research participants, and don’t see themselves as vulnerable,” DeCamp notes.
End-of-life research presents multiple ethical challenges for informed consent for recruitment of study participants, asserts Leslie E. Wolf, JD, MPH, professor of law at the Georgia State University College of Law. Wolf is a former member of the Secretary’s Advisory Committee on Human Research Protections. Wolf outlines some factors that can compromise the voluntariness of consent for end-of-life research:
• Patients may need time to talk with family, friends, or other trusted individuals before consenting to participation. Building in time for this would not be feasible with emergency research, where an intervention must take place quickly. “However, much end-of-life research can structure recruitment processes to allow prospective participants the time to discuss their decision with others,” Wolf offers.
• Patients’ reliance on their healthcare providers may make them unwilling to refuse participation. Researchers can address this by asking someone outside the care team to recruit and obtain consent. This could be a research coordinator or nurse who is not involved in the patient’s care, but is knowledgeable about the research.
“This approach can reduce the likelihood that patients will agree to participate either out of fear that their care would suffer if they did not, or to please their care team,” Wolf explains.
• There can be uncertainty as to whether a legally authorized representative can consent to research participation. IRBs should develop policies to address under what circumstances they will permit legally authorized representatives to provide research consent on behalf of incapacitated patients.
“Few state statutes regarding surrogate consent specifically address research consent. Some institutions may be reluctant to permit it,” Wolf shares.
• Terminally ill patients may agree to participate in research based on unrealistic hopes for benefit. “IRBs should be asking questions about the consent processes, with particular attention to clinical trials where therapeutic misconception may be an issue,” Wolf says.
IRBs should ask: What steps will be taken to minimize the risk of therapeutic misconception? Some investigators address this by assessing participant understanding of key issues during the consent process. IRBs should ask for strong justification that someone on the care team is soliciting consent. “They should also ask about the timing of consent,” Wolf adds.
Other important questions: Will consent occur during a clinical visit? Can the patient consult with others about their decision?
• Terminally ill patients may lose decision-making capacity. There are well-recognized processes for assessing decision-making capacity, but these are not always conducted routinely.
“Researchers should develop plans for how they are going to assess capacity throughout the research process,” Wolf says.
REFERENCE
- DeCamp M, Alasmar A, Fischer S, Kutner JS. Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: A qualitative study. BMC Palliat Care 2022;21:74.
Is it harder for someone near the end of life to participate in research (or to serve as a research advisor) compared to someone with diabetes? A question like this led a group of researchers to explore ethical challenges posed by study recruitment of patient and family advisors for research on end-of-life or palliative care.
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