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Table 6 Transversal issues associated with partnering with patients in healthcare research

From: Partnering with patients in healthcare research: a scoping review of ethical issues, challenges, and recommendations for practice

Themes Issues identified in the literature Recommendations identified in the literature
Challenges in the selection of patient-partners • Patient partners may suffer from unstable health conditions, which can jeopardize their engagement in the research project [21, 33, 35]. • Researchers should select patient research partners in stable health conditions [21, 33, 35].
• Patient partners in research may lose their “lay experience” after multiple previous patient engagement experiences [7].
  o This issue is also referred to “pseudo-professionalization” of patients [36].
• Researchers can recruit a mix of new and more experienced patient partners [36].
• Patient partners experience may not be representative of the larger targeted patients’ population [28].
  o When patient partner is a community leader, he may not be perceived as representing his community, lacking legitimacy [29].
• Patient partners selection may be biased.
  o Patient partners are commonly chosen based on their capacity to be articulate, to understand research and to collaborate with researchers and patients, rather than according to the authenticity of their health experience [19, 28, 34].
  o Discrimination may occur to the detriment of patients from racial and ethnic minorities [24].
  o Commonly, individuals with higher motivation and higher educational level, middle-aged, middleclass, white, are engaged [13, 19, 36].
  o Recruitment methods, such as the use of internet and the selection of patient during annual meetings, may cause bias [33].
• Recruiters of patient partners should commit more to diversity, which mean involving different people who face barriers to participation in research [34].
• Funding agencies may formally encourage the inclusion of these underrepresented groups by making it a criterion for funding [24].
  o However, as pressures from funders to conduct partnered research with vulnerable communities may help to enhance the representation of these communities, it can also lead to several forms of bias and research protocol violation such as tokenism, pressure on individuals to participate and data falsification [25].
• Random sampling method is less common, although it is the least biased methods since the small number of patients to engage [5].
• Patients may feel pressured to engage in research.
  o Pressure can come from being recruited by their own physician [25].
  o Peer pressure can come from being recruited by other patients [25] or by community leaders [29].
• Recruitment by peer recruiters can be a solution [25], but also cause for peer pressure, as indicated left.
• There might be disparity in patients’ access to research partnership.
  o Some patients consider that the main barrier to their participation in research as partners is the difficulties to learn about available research opportunities [37].
• Patient organisation group may play a role in assisting researchers to reach patients who are difficult to identify and reach [33].
Absence of a shared vision of patient partnership • Research team members may diverge in their comprehension of their respective roles, and of the role of patients, in the research process [22]. • There should be transparency and clarity on the purpose of the study and the process of research [34].
• Research teams must ensure informed consent and provide ongoing clarification of study participation and goals [24].
• Training content should focus on the role of each stakeholder but also should situate these roles in the overall project team [25].
• Researchers may mistrust the value of patients’ co;ntribution [28].
  o Researchers consider patient engagement just as complement or support to the research process and that researchers are ethically the first responsible of the methodological integrity of the research [26].
  o Researchers may consider patient engagement as a threat to research integrity [26].
  o Researchers can fear losing control on the decisions regarding the research project if patients have a say in it [26].
• Efforts should be made to convince parties of the value of patients’ contribution.
  o With a concrete curriculum and practical training, patients are capable of contributing to discussions, collaborating to find solutions and impacting the health care system [7].
• Researchers may challenge patients’ objectivity.
  o Patient-partners have a tendency to tell their personal story instead of bringing a reflexive opinion [34].
  o Patients are considered too emotionally involved [7].
• Patient-partners may have misconception of the benefits of their engagement in research [21].
  o Patients can expect therapeutic benefits [19, 24] or services [25], from their participation in research activities.
• Patient-partners may abandon the research project.
  o Patient can drop out of research, due to the lack of full disclosure of all expectations related to research [13], or to the varying and fluctuating levels of commitment or the slow translation of knowledge into practice [38].
• There should be transparency and clarity on the process of research [34].
• Conflict between patient-partners and researchers may arise.
  o Building an equitable relationship between researcher and patient may be challenging since they have different perspectives [9].
• Conflicts should not be considered as negative. Instead they should be seen as opportunities to learn new way of thinking. Conflicts should be addressed in a manner that recognizes differences in values and skills between both sides [9, 34].
• Researchers do not need to agree with patient perspective. They need rather to remain open to debate and discuss [25, 34].
Logistical and practical barriers to research partnership • Time required from patient partners in research can be a barrier to their continued participation in the project [28].
  o Patient bear the burden of frequent and regular meetings [19], which means they have to time and resources for attending [33]. This could create patient frustration toward the length and delays of the research process and the efforts required for attendance [38], and for training activities [5, 32].
• Full disclosure of time required for research partnership is necessary [35].
• Research teams should schedule meetings in accessible locations at suitable times to enable partners to attend [22].
• Research teams should adjust meeting schedule and provide adequate breaks for rest during meetings and research activities in order to accommodate patient health condition [39].
• Research teams can shift their research meeting location to go meet patient partners, which may help to eliminate logistical and practical barriers to patients’ research engagement [24].
• Teams can coordinate research activities with patients’ usual treatment visits (time and location) [35].
  o However, the coordination of research activities and usual clinic visit “may lead to conflation of the obligations, risks and benefits of research participation with other clinical or social services they receive” [24].
• When travelling is involved, teams should provide patient partners adequate travel time, as well as appropriate, and comfortable accommodation [39].
• Individual costs engendered by patient partners for their participation in research activities can be a barrier to their continued participation in the project.
  o E.g.: Transport costs, parking fees, loss of remuneration, absence of compensation, costs associated with attending international conferences, etc. [28, 36].
• When traveling is involved, teams should cover patient’s travel insurance and reimbursement of expenses [22].
• Covering fees of international travel should include accommodation for patients with severe disabilities (e.g.: special travel arrangements such as supplemental oxygen on flights, or personal assistance) [36].
See also recommendations for patient partners’ compensation below
• Communication issues between research partners.
  o Research team members’ usual modes of communication may not suit patient partners (eg. Emails in place of face to face meetings, or phone calls) [22].
  o Patient partners may be reluctant to contact lead investigator when in need of more information or updates about the project [22].
  o Patient partners may perceive a lack of opportunities to exchange opinions [22].
• Privileging face-to-face contact with patient partners may enhance their implication and support them in their role [22].
• Teams should be in regular contact with patient partners, to provide information about the progress of the study, and/or explanations about particular research phases [22].
Lack of resources available to support meaningful research partnership • Patient engagement is likely to increase the cost and length of time to plan and conduct research [5, 19, 33, 38], as well as the care and attention given to the challenges of the process [39]. Complete and meaningful patient engagement is thus negatively affected by the lack of funding and resources to facilitate partnered research [11, 24, 38, 40].
  o There is a lack of funding flexibility for partnered research [32].
  o Appropriate training of patient partners and researchers is not recognized by funding agencies and thus not appropriately budgeted [34].
  o Pre-engagement activities are required to prepare patients and build trust and relationship, but are usually not covered in funding budgets [32].
  o Tight deadlines of funding organizations create pressure on researchers who, under pressure of deadline, may not schedule enough time for training activities for patients. This can inhibit the effective and meaningful contribution of patients in research [26].
• There is a need for more time and more flexible timelines in order to build patient-researcher relationship, trust, and mutual learning processes, as well as to maintain this relation over time [9, 22, 24].
• More time and resources should be granted to training activities [32].
• It behooves to research institution to provide appropriate resource in terms of time, cost and support to offer tailored and relevant training program to research partners [13].
  o Research institutions could offer funding for pre-engagement activities leading to patient partnership [26].
Lack of institutional support offered for partnered research • Researchers, especially novices, lack support from their research institution to engage with patients in research [26]. • Research institutions should provide a research infrastructure that fosters partnered research [13], and especially for novice researchers [26].
  o For example, research institutions could help in establishing working groups, can provide mentorship opportunities for novice researchers, and access to already developed patients networks and partnerships [26].
• Research institutions should provide long-term support for patient and researchers in order to enhance and maintain effective implication of patients in research [34].
• Research institutions should help teams in the development of evidence-based best practices of patient-engagement in research and may keep a registry of patient engagement activities and initiatives, their results and processes [34].
• There is a lack of policies facilitating patient engagement in research [33]. • Establish an advisory panel on patient engagement to “ensure the highest patient engagement standards and a culture of patient-centeredness” [41].
• There is a lack of training on principles and methods of patient engagement research available to both patients and researchers [22, 33].
  o When available, training content is most commonly conceived without considering the point of view of patient partners [25].
  o Web based training modules may lead to underestimate the value of training by research partners and limit direct discussion [25].
  o When available, the length and the complexity of training program can be considered problematic [30].
• Training should be offered to all research partners (researchers and patient) [25].
  o There is a need for “training for patients so they understand the research process [and] training for researchers so they understand how to meaningfully engage patients” [28].
  o Training should be adjusted to the particularities of the addressed health issue [9, 13, 28, 32, 33].
  o Training should be “…easily accessible, both conceptually and logistically to all partners…” [24].
• Research professionals (other than leading investigators) don’t feel recognized and/or rewarded for the efforts made to involve patient partners in research [22].  
• Research ethics and research integrity policies and practices are not adapted to the particularities of partnered research.
  o Traditional models of research integrity, including those typically monitored by institutional review boards, focus on protecting the rights of individual research subjects enrolled in research, but not on protecting patient partners in research [42].
  o Ethic guidelines are predetermined without patient partner consultation [25].
  o Research ethics education may not take into account the particularities of partnered research and its unique ethical issues [25].
• Training content, especially ethical education, should take into account the input from patient partners since they have more specific knowledge about the vulnerabilities of the targeted populations [25].
Power differentials between research team members inhibiting or pressurising patients’ contribution • Power differentials between research team members, especially between patient partners and researchers, may inhibit patient contribution and/or lead to conflicts [7, 22, 25, 34, 39]. • The success of partnership requires mutual commitment to equitable power sharing and open communication about the requirements of the collaborative process [25].
• Power and ownership of the research process between researchers and patient partners need to be clearly addressed to allow patients to discuss, challenge, or reject the opinions of principal investigators [39].
• Engagement research should be democratized. In order to balance power, researchers need to reduce power behaviors and to learn behaviors that reinforce the capacity of patient partners. Equal and constructive partnerships do not occur immediately but are built by developing trust and self-confidence over a longer period of time [22].
• Relational empowerment: Everyone profits from the collaboration [22].
• A pre-existing clinical relationship between researcher and selected patient partner may create a potential conflict of interest in the conduct of the research project [25] and inhibit patient partners contribution. See recommendations in the patient selection section, Table 2
• Patient partners in research may feel overburden by their responsibilities in the research process.
  o When patients or community organizations collaborate with researchers, they “may feel overburdened by academic partners’ requests for input on formal products such as grant proposals or manuscripts, particularly if they have a limited number of paid staff members” [25].
Tokenism • Patient engagement may be tokenistic [5, 28, 38, 43]. • The relation with patient must be genuine and the contribution of patient should be effectively considered [34].
• Researchers should give patient partners the opportunity “to have say and to be empowered in their contribution to the research process” [13, 34].
• Patient/public collaborators should be treated as valued members of the research teams, and not just as tick boxes. The more they are incorporated into the team, the less likely they are to feel just like additional study subjects [44].
• Patient partners engagement and contributions are limited to specific research activities [19, 28, 36]. • Research teams should develop a checklist that identifies roles or tasks in order to ensure the implication of patients and track their activities [22].
Patients and/or researchers insufficient knowledge weakening research partnership • The lack of scientific and methodological background of patient partners is problematic for researchers [21, 28]. • Pairing new patient partners with experienced patient partners (buddy system) could help in the knowledge transfer and the assistance of new patient partners [34, 36].
• While patient engagement in research should be encouraged, principal investigators should maintain authority in developing protocols to ensure scientific rigor [11].
• Researchers may lack knowledge on partnered research principles and process needed to be able to engage with patients in a meaningful way [38]. See recommendations in “lack of institutional support”, Table 6
Conflict of interest affecting research team members • Conflicting interests of researchers may influence their contribution to research.
  o Researchers often bears dual roles as researchers and healthcare provider for patient(s) engaged in research. This can cause competing responsibilities and conflation of obligations [24, 36].
• Potential conflicts of interests must be discussed in advance with parties [11].
• Researcher must consider the separation between their role as treating doctor in the clinic and as a researcher in the context of research project [36].
• Research team could design a consultant doctor for patient partners if they have any health concerns during the research project [36].
• Conflicting interests of patient partners may influence their contribution to research.
  o When patient partner is also a healthcare provider or a service provider, they may be in a situation of conflict of interest due to the dual role they play. In this case, “their nonresearch roles may value social and ethical norms that differ from research norms, creating ethical ambiguity or conflicts of interest” [25].
  o Patient partners or patient organizations may be in relation with industry groups, which can result in conflict of interest [33].
  o Patient partner can also be patient advocate, or member of a patient advocacy organization, which can result in conflict of interest [33].
Harm caused to patient-partners • Patient-partners engagement in research may cause them harm.
  o Their participation might cause a resurfacing of bad memories [44].
  o Discussions on sensitive topics may pose challenges, with the potential for harm to patient collaborators [44].
• Meaningfully implication of patient in the research team may help to reduce bad memories resurfacing [44].
• Teams may provide a psychotherapist for patient, for assistance if needed during their partnership [39].
• “special attention is required for adequate rest, nutrition, debriefing, and emotional support throughout the research process” [39].
• Patients, as opposed to patient representatives or lay members, should be engaged in research ethics committees to ensure that patients’ voices are heard [21].
  o Ethics committee could derive ethics guidelines from patient’s preferences: Through interactive discussion session they can gather their perspective on research ethics issues [37].
• Researchers require specific ethics education relevant to patient engagement [25].
Absence and/or impact of patients’ compensation • Patient-partners may not be compensated for their engagement in research projects [39].
  o This could be the result of absence of appropriate funding for partnered research [28]
• Research teams/institutions should provide appropriate honoraria to the critical expert knowledge that patient/survivor consultants or partners provide to research [39].
  o “the honorarium was equivalent to a physician or researcher fee for participation in a focus group” [39].
• Research teams/institutions often reimburse food or other costs to motivate participation and commitment to research [35].
• Patient-partners could be motivated by financial reward expectation for their implication in research [13]. • Research teams might not disclose in advance they offer patient’s financial compensation in order to mitigate undue influence for participation [39].
• Concerns arise about the impact of the remuneration on the individual situation of patient-partners, such as its potential effects on the government benefits they receive [13].  
Traditional research culture as a barrier to partnered research • Traditional research culture is a barrier to researchers and patient’s engagement in partnered research.
  o Researchers are trained and used to write grants and set research priorities by themselves. Implicating patients can be challenging for them [19, 26, 28].
  o It is difficult to build a research partnership with patients from countries or culture where “participatory research is less recognized and physician–patient relationships are traditionally more paternalistic” [36].
• There is a need for a shift in the research culture and a necessity to rethink traditional research methods in order to make them more opened and favorable to partnered research [28].