I wrote a short piece for the inaugural issue of Brainstorm Magazine/Remue-méninges! This publication is produced by The Pragmatic Health Ethics Research Unit (formerly Neuroethics Research Unit), an interdisciplinary research group based at the Montréal Clinical Research Institute (IRCM). I am on the editorial board.
Issue 1 – Summer 2019
Ethical implications of engaging patients in research: What are we missing?
In recent years, enthusiasm for patient engagement – where patients (and caregivers) are enrolled by healthcare institutions to participate in a wide range of non-clinical activities – has found its way into health research, with the inclusion of patients as research “partners.” Patients, working in collaboration with researchers, now help set research priorities, develop research questions, contribute to research design, participate in data analysis and synthesis, and help disseminate results. This popular trend is reinforced by the Canadian Institute of Health Research’s Strategy for Patient Oriented Research, which outlines a mandate to include patients at all levels of health research.
For many, the inclusion of patients in research appears unproblematic. Indeed, for some, the “patient voice” has been missing from healthcare planning and decision-making for too long, and patient engagement seems an obvious solution. The need to include patients as partners is often deemed a foregone conclusion, which may explain why patient engagement does not seem to be raising concerns in the field of health ethics in Canada. However, I think that this may prove to be a regrettable oversight: the practice of patient engagement is fundamentally changing how we think about and conduct health research, the impact of which has unknown consequences for both patient well-being and health research integrity. As patient engagement programs forge ahead with uncritical and enthusiastic support, health ethics needs to consider the risks and potential harms of such programs.
A GRAND SOCIAL EXPERIMENT
The suggested benefits of partnerships between patients and researchers – such as claims that co-produced research is more relevant to patients or that engaging in a collaborative process is empowering for patients – are not well supported in the literature. Despite this lack of evidence, patient engagement in health research is quickly growing into a robust and self-sustaining industry. It now has its own terminology, professional associations, methodological frameworks, and training and certification programs for patients. Funding agencies often require or strongly suggest the inclusion of patient engagement activities on applications.
In all areas of healthcare where patient engagement is taking place, researchers are actively discussing the best ways to recruit and support patients in their new role as collaborators – and reasonably so: patient engagement is a grand social experiment, and the involvement of patients in activities previously reserved for professionals disrupts the traditional nature of patient-healthcare provider relationships.
THE BIGGER PICTURE: WHAT ARE THE RISKS AND POTENTIAL HARMS?
Broader ethical questions start to appear when we zoom out. As a starting point, think of the fact that engaged patients are self-selected volunteers, often with pre-existing friendly relationships with the researchers with whom they partner. They are unelected, unknown to the wider patient population, and not necessarily representative of interests unfamiliar to them. What’s more, the exact purpose of their participation is rarely specified. As research partners, these patients weigh in on matters that might deeply alter the trajectory of research projects. Indeed, many researchers recognize that engaged patients can influence projects in unanticipated ways. While some may see this as evidence of a successful partnership, as ethics professionals, we must recognize the risks and potential harms in this freeform approach to involving patients in health research. For example, since protections for patients as research subjects do not apply to patients in their role as research partners, there is no recourse or mechanism for redress if patient partners experience malpractice or harm.
Health research is governed by its rigorous adherence to ethical review and oversight, and the integrity of research methodology is paramount to its credibility. Yet, claims of improved health outcomes or relevancy because of patient engagement remain unproven. Instead, relationships between patients and researchers in this context are undefined and without clear boundaries, and the influence of patients is still poorly understood.
A SIGN OF THE TIMES?
It may be no coincidence that patient engagement is gaining momentum at a time when the political climate is one of rising populism, anti-science sentiment, and increasing pressure for market-based healthcare and “relevant” health research. Perhaps patient engagement, bolstered by its strong and vocal support from patients, is an inevitable outcome of these converging trends. We would do well to develop a much better understanding of how engaging patients in this way impacts the very nature of health research before we continue to invest in the future of such partnerships.
This quote caught my attention:
“For example, since protections for patients as research subjects do not apply to patients in their role as research partners, there is no recourse or mechanism for redress if patient partners experience malpractice or harm.”
Would love to know more about the potential harms to patients and caregivers as we continue on this evolving journey of being incorporated into research.
Is there any potential harm if not including patient perspectives? It’s up to researchers to ensure they are broad and representative perspectives – this seems addressable. Is it better to avoid getting these perspectives or ensure potential problems are addressed? Blithe inclusion wouldn’t be encouraged by anyone but hopefully the bar is higher than this. Developing best practices seems smart. Thank you for this work.
This is a very thought provoking piece. It applies to patient engagement in research, guidelines, and policy development as well. Hence, what’s most important is this: “They are unelected, unknown to the wider patient population, and not necessarily representative of interests unfamiliar to them.”
Let me give you an example of how this might play out in the real world of Lyme disease, in which Infectious Diseases of America researchers (IDSA) are pitted against patients and their treating clinicians. The IDSA guidelines harm patients enormously because they provide no room for the exercise of clinical judgment or patient values in a shared medical decision making mode. When the IDSA set about revising its guidelines, it looked for a patient to seat at its powerful table. They asked for a recommendation from Consumers United for Evidence Based Medicine (a Cochrane affiliated group where I sit on the steering committee), my name was advanced. I am the CEO of LymeDisease.org, which has represented the patient interests for over 25 years and well versed in GRADE etc. The IDSA rejected that suggestion and instead chose a woman from Nebraska (a state that essentially has no Lyme disease) and who when asked reported that she did not know anything about the disease, had never had it, and did not know anyone with the disease. Obviously someone unsuited to represent the interests of patients with Lyme disease, but that was the point. What better patient for the IDSA purpose than one who was purely token? So the issue of representation and lived experience with the disease is huge, especially if there is a patient community involved. The National Academy of Medicine guidelines on creating trustworthy guidelines says that the panel should include “those affected”–which is a representational concept. The reason for inclusion is clear “those affected” bear the burden of the decisions which directly impact their lives. When patient communities exist patients selected for these roles should be representatives who are known and acknowledged by the community as being able to represent the interests of that patient community.
Excellent points to consider. Advocates are operating at an advice-level and not decision making at this point. I don’t see that changing however in a litigious atmosphere, caution ought to prevail.