Are new ethics rules needed to guide research with patient collaborators?
There has been a wave of interest on the part of researchers in involving patients or caregivers as advisors or collaborators in research, from writing proposal to dissemination of the findings.
Yet, as the field is fairly new, there is little guidance to help researchers, patients and advocates navigate thorny ethical issues.
Consider a research team working with several patients collectively in an advisory capacity. If the patients are speaking to their expertise as either people with the lived experience of a health condition or as a prior research participant, one may argue that they very much resemble a panel of subject matter experts, in which event neither research ethics approval nor a formal consent would be required.
However, if they were regarded as participants in a focus group or similar consultative process, the consultation is likely to require ethics approval and an explicit consent for participation. The risks of harm from participation are essentially the same, whether one labels these individuals “expert advisors” or “focus group participants.”
For example, participation on one of these advisory groups frequently involves telling one’s story as either a patient or research participant. If this included a very negative experience, recounting the story can be traumatizing. The response to this storytelling is critical. If it is treated as an event disconnected from the rest of the business, the patient may feel that their story has fallen on deaf ears. This, too, may be traumatizing. Certainly, it is less than respectful of their story.
In some instances, a research team may take on one or two patients as active collaborators in the project, where their contributions include idea generation around patient-relevant outcomes and ways to improve recruitment and retention, or they are involved in grant writing.
Here, the level of involvement of the patient is equivalent to an institutional partner or collaborator. Hence, the rules of engagement that are applied to one’s peers should be applied to these individuals as well.
Now, suppose the grant application was successful and the patient co-applicants are either dropped from the team or remain but in a diminished capacity. Trust would be lost and the working relationship eroded.
In both cases, patients may feel they are being treated in a tokenistic fashion. They may find receptivity to and uptake of their ideas but no attribution to them as the source.
In the first case, if treated as a focus group, it is common practice that there is no attribution of ideas to individuals. This should be explicit from the outset. If regarded as an expert panel, attribution may be negotiable.
In the case of patient collaborators, the rules of intellectual property should be the same as those governing co-investigators or decision-maker collaborators.
One may argue that the patient advisors in the first scenario are still patients and changing labels from research “participants” to “advisors” does not change their function: to provide data for decision-making. Nor does it eliminate the potential for harms from involvement in the research.
At this point in time, we recommend patient advisory bodies be treated as equivalent to a focus group, and subject to the provisions of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans – particularly, if this is a one-off consultation.
In the case of the patient collaborators, they should be afforded the same respect as an expert advisor or collaborator. In this circumstance, the appropriate guidance may be the Tri-Agency Framework on the Responsible Conduct of Research.
Who is responsible for looking out for these engaged patients? The principal investigator may not be equipped to address these issues, particularly if he or she is the source of the concerns.
A researcher’s home institution can and should provide supports for both researchers and patients. Institutions can mentor their researchers on how to work with patients and provide a supportive environment for patients by offering training for patients to provide a better understanding of the research process and how they may contribute.
They should provide an ombudsperson to whom patients may turn in the event they feel they are poorly treated. They could also provide opportunities to network with other patients engaged in similar roles. Research ethics boards are neither resourced nor oriented to provide these services, nor should they be the ones to take on this role. They could actually be very complementary institutional services.
Patient involvement has the potential to enrich research substantively. It does, however, offer a new set of relationships to consider.
Do we need new rules? Probably not, though we do need some guidance in how to interpret existing rules in these new contexts. Do we need oversight? Most definitely. Whether or not this is the purview of the research ethics board, now is the time for research-intensive organizations to consider their responsibilities in this matter.
We have provided two examples of ethics challenges in patient and public involvement in research. Many more exist. We invite patients and caregivers who have become involved in a research team and experienced firsthand their own ethics challenges to share their experience in the comments section below. As well, we welcome comments from any researchers who have identified ethics challenges when embarking on collaborations with patients in research.
Don Willison is associate professor in the Institute of Health Policy, Management and Evaluation, University of Toronto. He conducts research in the areas of information governance and patient engagement, and he teaches research ethics at IHPME. Sara Shearkhani is a co-founder of Family Caregivers Voice and a PhD student at Institute of Health Policy, Management and Evaluation, University of Toronto.