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.
The comments section is closed.
Hello!
I am a research assistant, and I am looking for some input regarding the following:
I am currently in the process of constructing a patient-defined scale to measure severity for a dermatological condition.
In order to access the most accurate terminology, I must have patient “collaborators”; that is, patients who are thus informing me of how they are describing their own severity of their disease i.e., “stinging pain”.
They do not fit the category of “participant”, as they are not participating in the research, but more so the development of the actual scale by sharing with me the language of how they describe their symptoms.
I have tried to find definitive guidelines for collaborators in research in Ontario, and have thus far, found nothing definitive. I really need some sort of guideline I can use as a citation when/if this goes to publication. I also want to ensure that my methodology is in concordance with ethics.
I have found one article that states if I offer them authorship, they are therefore collaborators, and I will not need ethics approval. Another that states if the collaborator is not conducting human subjects research, an IRB approval is NOT required.
These individuals are not engaging with participants of this research- I intend to have a focus group with different individuals once a prototype of the scale is developed. However, right now, I am at the stage where I need patient input in order to develop the questions for the scale.
I was wondering if I could be pointed in the right direction as far as Ethics for this process. Is there an article I can cite later on that clearly defines “collaborators in research”? I could find a few articles in the States, but not here in Ontario.
Thank you kindly for any assistance.
Please feel free to email me a response at PDAResearch@outlook.com
Related to the last comment – “patients” often bring enormous real world expertise to the table. Frankly, some have science degrees in other fields and some are statisticians or programmers .
Some I know personally are professionals in public policy, ethics, research funding, writing, published authors, communications, marketing, lawyers, law enforcement, government, politics or bureaucracy, social media engagement and yes University and College Professors and Phds.
Some have been trained and certified long ago in patient-centred care and in the social determinants of health, some know exactly what and how research ethics works and no—we’re not thrilled at being spoken down to and insulted and treated as “just patients.”
Funny story I keep telling—scientists at UHN and Sinai couldn’t figure out why they had so much deadly bacteria infecting the patients, in their brand new hospital wings. All of your doctors and scientists spent months puzzling over why the sinks seemed to be the source.
No, in that entire time they never called a plumber. Because after all, aren’t doctors smarter than plumbers? But when a plumber was finally brought in, guess what? Turns out it was the sink faucets which had been positioned directly over the drains. A basic building code violation, because drains collect bacteria and a faucet directly above it blasts the bacteria out into aerosol form. And all because no one asked a plumber if the sink might be an issue.
Doctors and academic researchers don’t know everything, in fact, outside of their own specialty, they know far less than they think. Sharing credit and respect with all colleagues and contributors is the minimum they should do. Assuming patients don’t know anything about research is not a productive way to start a working relationship.
Oh, and CIHR has some rules and regulations that they have set already—like patients must be paid. And get credit. Those should be linked in the story.
Yes I agree wholeheartedly with patients collaborating with researchers from the get-go. Relegating the Patient role to “storyteller” is demeaning and deflating. We feel we are likely being harmful more than helpful; negative more than positive – distasteful role. I also spoke as Patient/research subject at the recent Cancer Care Ontario Reserach Day. I stresssed the need for patient portals to our medical records to help researchers get it right the first time. Many records are rife with errors, gaps, omissions. UK large study revealed 35% of patient files were deficient for one or many of these reasons. Let us help. “Garbage in: garbage out”- and you know what I mean. Also, researchers share their results with their peers but never with their participants. This is unethical and a big reason there is no incentive to take part. 80% of cohort studies do not meet their quota! If we don’t matter to researchers, then research does not matter to us – until and unless we are at the “Hail Mary pass” desperation stage. Think of what good ambassadors we would become for research if we were respected enough and valued enough to be on the final publication email list. I do agree there should be an overarching agency or panel of ethics experts to assist both researchers and patients navigate this paradigm shift in conducting research.
I server our region as chair of Patient Family Cancer Partnership. I also represent our region serving on the CCO PFAdvisory Council. I am the PFA for Clinical Trials at our Regional Research Institute. I was also a research assistant for 8 years in aquatic toxicology.
Don and Sarah, thank you for the timely piece. I wear two hats in this patient-oriented research world. I work as a liaison between kidney patients/families/caregivers and kidney researchers in an effort to develop and support our research programs ‘patient engagement’ work. My mother also battled chronic kidney disease for over 20 years and so I also sit on the national ‘patient’ council for a SPOR funded chronic disease network (CanSOLVE CKD). The ethical issue I’m currently considering is this; Should we allow patients who are under the direct care of the clinician-researcher to be a ‘collaborator’ / ‘co-investigator’ on the research team? My deepest concern is that the research relationship may either go sour or influence the clinical relationship in a way that is harmful to the clinical care of the patient. I’ve heard from some patients that “if I’m a partner in my care with my doctor why wouldn’t I be a partner with them in research” yet I’ve talked to a few clinician-researchers who say they like to steer clear of that cross pollination ‘if possible’.
What do you two think of this?
How do some of those experienced patient collaborators following this thread feel?
I would certainly appreciate some dialogue in this area.
Cheers;
Leah
Great question! I can share from my experience as a caregiver advisor turned researcher! I became involved in engagement initiatives, for the first time, in 2014 and worked with different healthcare professionals as a caregiver advisor. Later when I started my journey as a research, I found it difficult and confusing to be just a caregiver especially when other researchers/colleague/peers were sitting around the same table offering their professional expertise. At times, I felt uncomfortable sharing my somewhat sad stories as a caregiver with my colleagues; I started thinking this will impact their perception of me as a professional. To sum it up, believe your concerns are valid; but I will ask this question: in your opinion, are there ways to minimize the potential problems around the issue you raised?
I believe we have reached a tipping point where patients and caregivers are giving their time and lived experience expertise to, not just researchers, but to health care professionals. Patients and caregivers are trying to improve the health care system not just for themselves, but for all who come after them. Taking care of my husband through several operations left me angry, frustrated, isolated and depressed. It took a long time to get over the experience, but once I did, I didn’t just get on with my life. I reviewed all my experiences and thought about what could have made it better, easier, safer. I have shared my ideas with many organizations. Some have been very respectful and appreciative of the time I take to help them understand not only the problem, but give them ideas for improvement and they have shown their appreciation in different ways. A couple have simply taken these ideas, used them as their own (which I find out later) and not even attributed them to me. This is a betrayal of trust, unprofessional and unethical. Yes, we need to protect patients and caregivers. Ethical behaviour standards need to be put in place with clear oversight to help health care professionals navigate these new, uncharted waters.
Carole Ann, we admire your dedication to improving the system. And, we are disheartened to hear of your own experience of organizations taking up your suggestions with failure to attribute the source of the innovation. Unfortunately, such occurrences are endemic, even among academics, particularly when the source is someone outside the clique. This is precisely why we feel there is a need for institutions to take responsibility for how their researchers are engaging with patients as advisors, collaborators, partners, etc. The Ethics office of the Canadian Institutes of Health Research (CIHR) is in the process of developing guidance for researchers, patients, and institutions in this matter.
We hope you persist in your efforts to improve the system and that the forthcoming CIHR guidance and institutional involvement reduce the incidence of the kinds of misadventures that you have encountered.
Don & Sara
Thank you for raising these issues related to research ethics and engagement of patients in research. As is often the case, language and words can be so important. When non researchers (i.e. patients, caregivers, the public, clinicians, health services, managers, etc) are invited to participate on the the research team in the spirit of integrated knowledge translation to co-create projects, they should be recognized as and called co-investigators with all the rights and responsibilities that go with that (and they may require additional considerations not be relevant to researcher on the team such as the need to be compensated for their time to participate, etc). I am concerned labeling these research team members collaborators does not signal their equal status on the team as usually collaborators are not investigators. When working in this truly collaborative way, the thing that is often not discussed is the requirement to share decision making power among all members of the research team (including patients) and how to operationalize this- ethical guidance can help with this. While the value of patient co-investigators is promoted by research funders and others, all the implications (including ethical ones) have not been completely considered so thank you for starting the discussion.
Ian, thank you for your very insightful comments. We wrestled with the term to use for these patients and caregivers, including co-creators, partners, and co-investigators. The terminology here is still very fluid. Our choice of “collaborator” was a conservative one, as the closest analogy was the decision-maker partner.
This is a very heterogeneous group. There are formally trained researchers who also happen to be patients; there is no controversy over labelling these individuals “investigators”. Then there are patients who have been trained in a variety of ways to work with researchers, including: (1) the PACER program at the University of Calgary, where they are taught some basic research skills; (2) patients who have been trained through the SPOR initiative; and (3) those who receive informal training by the investigators who are inviting them onto their teams. Even among these groups, there will doubtless be attempts to differentiate among themselves.
You have identified a critical issue: the sharing of decision-making power. There is a continuum of possible ways that researchers may work with patients, from consultation through collaboration, to community-led research. Researchers are probably most familiar and comfortable with the advisory role. Community-led research has generally been more common in public health and social sciences research. The co-creator role may be the most challenging. The problem comes when expectations are not stated and subsequently differ between patient and researcher. There need to be clear terms of reference for the relationship, and an appreciation by researchers and patients of the other’s contribution to the partnership. The term “patient co-investigator” is unambiguous as to the decision-making relationship. Perhaps that is the term to lobby for. We suspect there may be push-back from academic researchers on this matter.
Don and Sara
You mentioned caregivers in the first and last paragraphs but not elsewhere. I think it would make more sense to recognize caregivers as the separate entity they are. I suggest the term “patient and caregiver engagement” or “citizen engagement”.
Reliving some healthcare experiences can be just as traumatizing for unpaid family and friend caregivers.
Angus, we agree with you wholeheartedly. Space constraints limited our ability to go into greater detail, including the experience of caregivers. In the UK, the term commonly used is “patient and public involvement”. It is more inclusive and descriptive.
Don and Sara
Are there ethical concerns for the way Canada’s tort system causes further harm to survivors of medical injury?
Janice, perhaps you could advise us what you see to be the ethical concerns in Canada’s tort system. It is not entirely clear at this time how it relates to what we are writing about patient and caregiver involvement in the research enterprise.
Similar to participation in an advisory group, injured plaintiffs are required to tell their story. That story can be very traumatizing when the plaintiff believes their trust was betrayed by a doctor’s negligence or misconduct.
Similar to patient advisors, injured plaintiffs want their story to matter. Research shows that people turn to the tort system when they want accountability to be taken. They mistakenly believe they will get an explanation of what happened, there will be learning from the incident, and unnecessary harm to others will be prevented.
While participation on an advisory group might lead a patient advisor to feeling that their story has fallen on deaf ears, the majority of injured plaintiffs can receive much more than deaf ears. There can be additional unnecessary physical, psychological and/or financial harm.
Most lawsuits are dismissed, abandoned or discontinued. Some are settled, but an unknown number of these are intimidated into a settlement where there is no admission of any wrongdoing; no lessons learned, and no financial compensation except to the lawyers and medical experts involved. I think it’s unethical.
Janice, thank you for sharing with us your insights. Agreed, there are parallels around the telling of one’s stories. The potential for trauma to the plaintiff is greater in the case of the tort system, which is inherently confrontational in nature. Those plaintiffs who engage in the tort system for the sake of improvement in the system and reduction of harm to others in future are to be commended.
Don and Sara
Hi Don & Sara. You will see from my profile that I am very much involved as a lat rep with several trials. Lay input is necessary at all stages of the study – from inception to publication. Not only are the lay reps important when the ‘plain language’ or ‘patient information’ documents are drafted, but also they hold a key role in keeping the researchers focused on what matters to the trial participants, and what outcome measurements matter most to the patients involved. There are several types of patient/lay reps: those like me who have a deep interest in health matters (in my case through my Pharmaceutical Sales & Marketing work-life) and folks who have experienced the circumstances being investigated and who can bring a very personal perspective to the research. There also needs to be an open minded approach from the clinicians, with a clear willingness to include, listen and support their lay member. Here in the UK the NIHR insist that there are lay reps in the study, and that they have actively worked on all aspects of the development before funding is proffered. If I can be of any help, please let me know.
Nick, thank you for these important additional points. Indeed, lay reps are invaluable in developing patient communication materials – including what information is important to convey as well as how to convey it.
Agreed, also, that they provide an important perspective on what are relevant outcomes to consider.
The point you make about sensitizing investigators around how to support and listen to the patient is key to the point we were making about the role of the institution.
Thanks for offering your help in future. Let’s get in touch offline, through the editor.
Don, Sara, great piece and timely! I agree generally with how you see the need for patient partners in research to handled. If patients are a source of data pertinent to the research through a focus group or other format, then I agree the Ethics Boards need to cover that involvement. If a panel of patients are co-designing the research, then I don’t believe it is necessary. In this instance they bring their perspective as a health system user not their patient story per se. It is a different role. One of a collaborator/colleague with health system user expertise as you rightly point out.
On the subject of support for patient partners: This is an issue everywhere patients are involved. Institutions may provide some support but there is no credible support if the issues are with the institutions or their people. For that an independent body would be best. To that end, a dozen of us from across Canada have created the Patient Advisors Network (patientadvisors.ca) as an independent community of practice for patients partnering in all aspects of healthcare including health research. Our growing membership supports and mentors each other as we deal with issues unique to our roles such as how to handle tokenism. If organizations are looking to support their patient partners, supporting and promoting our network would be a way of doing so.
Alies, thank you for your supportive comments. It is great to see groups like Patient Advisors Network springing up in response to the need for patient supports. This is very complementary to institutional supports. It would be great to see how these will work in concert in the future. Don and Sara