Methodology: Interviews with Canadian dementia researchers

Objective. The objective of the funded project within which findings of the interviews are situated was to understand existing laws, policies, and research practices of the inclusion of PLWD in Canadian research via everyday research practices organized around consent. The project drew together experts from social gerontology, law, and dementia research, including one person with lived experience of dementia as a co-investigator. It was guided by the goal of understanding meaningful participation in the context of human rights frameworks, with particular attention to processes of consent as a mechanism for inclusion. This paper presents the results of thirty-two interviews (33 participants) designed to understand the perspective of academic researchers. The Zoom interviews focused on the everyday perspectives and research practices of dementia researchers.

Research design. Interviews were designed to be conversational in nature (Holstein & Gubrium, Reference Holstein and Gubrium1995; Marvasti & Gubrium, Reference Marvasti and Gubrium2025), and this was reflected in both the formal ethics procedure and the preamble to each interview. Given the interdisciplinarity, size of the team, and funding context of producing practice-relevant results, the team co-developed a set of interview questions that were used flexibly to inform the conversational interviews and allow informants to share their knowledge, processes, ways of working, and challenges. The project received ethical approval for research with human participants through the University of Toronto (approval no. 41440). All members of the team co-developed and refined the interview guide via a series of online meetings, and the first author followed an inductive process asking participants to discuss their experiences, with the questions used as a process and probe rather than a rigid set of questions. Part of this refinement process involved the first author carrying out three interviews with team members. One of the interviews included one co-investigator accompanied by our co-investigator living with dementia, with the second and third conducted with two researchers with extensive practice involving people with dementia. The interview guide was tightened and refined based on these interviews. In addition to asking questions about their research practices, the interviewer (first author) asked for non-identifying concrete case examples to ground participants’ responses and enhance clarity – this was particularly useful given the interdisciplinary background of the participants.

Sample and recruitment. To be included in our study, potential participants must, at the time of interview: have held a faculty appointment at a Canadian University; have had at least one two-year Tri-Council (i.e., CIHR, SSHRC, NSERC) or related funding (i.e., Alzheimer’s Society or the Canadian Health Systems) on dementia (grant could be in progress); and be able to participate in the interview in French or English. Our recruitment process involved generating a list of all researchers in Canada who met these criteria. Our study was exploratory and not intended to be representative. This process was used to include new researchers and teams not already known to our team. This process produced 76 names of researchers with a range of medical and social science backgrounds, research approaches, and various career stages. Researchers working outside of Canada or in organizations without a faculty appointment were excluded. All potential respondents were sent email invitations, with one reminder. Although our original funding proposed approximately 15 participants, as the study progressed, the range of experiences being recounted led to the decision to continue with interviewing. Our initial thought was that the diversity of disciplinary backgrounds (i.e., medical versus health sciences versus social sciences) and organizational structures (that is small versus larger university) was producing different results. Although the question of how many interviews are needed for saturation is a regular debate in the qualitative literature (e.g., Guest et al., Reference Guest, Bunce and Johnson2006), continuing to work with the material and increasing the sample size allowed us to discover that variation and differences across disciplines, sites, and contexts were the strongest emerging theme.

Interviews. Interviews ranged from 60 to 120 minutes, with the three initial interviews conducted to refine the interview guide exceeding this duration. This refinement process is consistent with general guidelines for qualitative research that is both exploratory and intended to be practice-relevant. Given that the four team members’ names had also emerged as part of the sampling process, and met the study inclusion criteria, the three interviews conducted by the first author for the purposes of refining the guide have been included in the data set. All interviews were conducted by the principal investigator, who is a known member of the gerontology research community. This position may have introduced a perceived power dynamic and our high response rate. However, when paired with researcher insights, it would seem that this process provided a much-needed space to discuss challenges in carrying out research with PLWD. Given the small field, detailed disciplinary or institutional affiliations are withheld to protect identities.

Analysis. The Zoom-generated transcripts were cleaned, revised, and analysed by the first, fourth, and fifth authors. Our initial analysis began with familiarizing ourselves with the data through a focused reading of the interview transcripts. Keeping in mind that the first author conducted the interviews and the fourth and fifth cleaned the interviews, this approach helped establish a deeper understanding of each interview. Note-taking was also used to identify key messages and lessons from each interviewee. The first author met weekly with the trainees, and they reviewed three transcripts together as a learning exercise, comparing and refining codes to ensure as consistent coding as possible. We then returned to all interviews to carry out a more detailed analysis using Braun and Clarke’s (Reference Braun and Clarke2006) methods for reflexive thematic analysis as a guide. This included searching for and reviewing themes, considering how each participant engaged with the sets of ideas the team had identified as potentially important, in alignment with the need to develop key recommendations and practical suggestions, a central priority of the funding organization (Braun & Clarke, Reference Braun and Clarke2006; Byrne, Reference Byrne2022). Regular virtual meetings with all authors were held to present material and progress on the analysis. All team members reviewed the thematic structure for the interviews and assisted with naming the themes, producing the report and executive summary, and the revision of the articles. Interview quotes are presented verbatim with context added where needed to preserve confidentiality.

Findings: Achieving inclusion against the odds?

Our findings revealed both a range of systemic challenges in the Canadian research context and a strong commitment to inclusion and meaningful participation of PLWD. Our data suggest that research in the dementia field is characterized not only by the absence of specific frameworks and/or guidelines for including PLWD in research and widespread misunderstanding about consent and mental incapacity of PLWD, but also by knowledge about best practices and frameworks that could be further developed to achieve meaningful inclusion. The following section details five interrelated themes of the interviews: (1) frameworks that guide research practice – TCPS 2, rights and access; (2) variations across Canadian universities and research institutions; (3) biases and assumptions of presumed incapacity; (4) protectionism and risk mitigation as a default response; and (5) strategies to achieve inclusion.

Theme 1: Frameworks that guide research practice – The primacy of the TCPS 2

Theme 1 collates, identifies, and presents the range of frameworks and guidelines that dementia researchers cited using in their research practices. In Canada, there are a number of potential sources that could have been discussed as relevant to consent and dementia. Unsurprisingly, researchers’ responses varied with regard to applicable laws, policy, and/or best practice frameworks. However, the most frequent source of guidance mentioned was adherence to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) (CIHR, 2022), combined with the processes of the institution or setting where the research takes place, with 12 of the 32 participants explicitly mentioning the TCPS 2. Having a sense of how often the TCPS 2 was mentioned is important, given that it is the main document that speaks to the context for Canadian research, but is neither legislation nor law in its general sense.

The lack of clear guidelines for research on dementia was visible in participants’ responses. Our co-investigators with legal training wanted to know whether, and how, researchers understood consent. We used a probe to understand their experiences of research in context, by asking, for example, ‘Are there any forms of legislation, laws, policies, and/or frameworks that are relevant to your work?’, followed by ‘Which have you consulted or used?’ Where some researchers immediately named the TCPS 2, others paused on our legal question landing at the TCPS 2 after a brief period of reflection or venturing into discussions of rights, access, and/or principled notions such as personhood. The following quotes illustrate TCPS 2 as the main default response:

When themes and accompanying quotes were presented and discussed with the team, the team wondered whether researcher pauses reflected a lack of formal guidance about how to implement Tri-Council guidelines, unawareness of relevant laws, and possible uncertainty about how to reconcile contradictions between legal rights and research consent processes. What was clear across the interviews, however, was that beyond TCPS 2 – which many acknowledged was not law – researchers did not consult legal materials or receive legal advice. This was an important finding that speaks to how researchers may not have access to the specific knowledge or training they require where legal issues of consent are concerned. For example:

The frequency of responses that stress the primacy of TCPS 2, but with uncertainty or reservation, underscores the lack of consistent Canadian legislative frameworks and Tri-Council guidelines for the inclusion and participation of PLWD in research. It also possibly reveals the researchers’ lack of comfort with the governing laws that do exist and raises questions about whether researchers are or feel equipped to challenge institutional practices that may be inconsistent with the law. Furthermore, it brings attention to a key gap: few researchers have access to independent legal advice or legal experts as part of their research teams or processes of institutional approval.

In the absence of clear, binding guidance for research including PLWD, many researchers described turning to frameworks. These included international rights-based conventions, jurisdictional legislation, and academic literature on ethical inclusion. A number of researchers referenced international rights-based frameworks such as the Universal Declaration of Human Rights (UDHR) (United Nations General Assembly, 1948), the Convention on the Rights of Persons with Disabilities (UNCRPD) (United Nations General Assembly, 2007), and the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP United Nations General Assembly 2007). For some, these frameworks were mentioned as important ethical and political tools that help them to assert rights to autonomy, inclusion, and participation. For others, they caused more uncertainty and illustrated the disconnected ethical research landscape in which they and their research operate.

While these frameworks were in line with the rights-based vision held by some of the dementia researchers, participants tended to describe them more as aspirational than directive. In interpreting the results, the team noted that although international conventions like the UNCRPD have been adopted by Canada and are embedded within domestic law (i.e., both statute and case), few researchers described them as directly shaping their research practice. In particular, the UNCRPD’s commitment to supporting legal capacity, while having strong relevance, was rarely discussed in the context of PLWD. What we see in the findings is researchers trying to make sense of the contradictions between international rights-based frameworks and finding means of achieving inclusion and rights in their research practices (e.g., See Government of Canada, 2017). As members of our team pointed out, however, under the UNCRPD, it is nearly impossible to be viewed as having ‘lost capacity’ for research participation. Here, there is a notable gap between legal frameworks and research practice. While some participants identified this gap between Canada’s human rights obligations and current research practices, particularly around exclusion, consent, and access, others suggested that a disability-rights-based model might better align ethical research with international legal standards. In doing so, however, they noted that even these models remain largely disconnected from ethics review procedures or institutional practices.

Our interdisciplinary team included legal experts who wanted to know more about the frameworks researchers used in practice. In terms of jurisdictional frameworks, it was primarily researchers located in the province of BC (9 of 32), with a few Ontario-based researchers who made reference to province-specific legislation. In BC, researchers cited the Health Care (Consent) and Care Facility (Admission) Act and the Adult Guardianship Act 1996. In Ontario, the Accessibility for Ontarians with Disabilities Act (2001) was mentioned. While some researchers discussed how these laws raised awareness of inclusion, those located in BC also noted how the act could be a source of confusion when working across jurisdictions, particularly with colleagues in other provinces. While interpreting these findings, it is worth noting that BC’s prominence in these discussions likely stems from its early adoption of supported decision making and its co-creation role in the UNCRPD. Still, despite these localized references, most researchers ultimately relied on REBs, their institutions, and the TCPS 2, reinforcing the latter as the primary reference point for ethical guidance across Canada.

The final source of guidance mentioned by dementia researchers came from the academic literature. Many informants mentioned being guided by best practices that were colloquially referred to as ‘process consent’. This included both the idea that consent is an ongoing process (Dewing, Reference Dewing2008) and processes of access for people with disabilities (i.e., 14 of 32 researchers). Here, it was notable how many of the researchers’ ways of working had been influenced by Jan Dewing’s classic work (Dewing, Reference Dewing2008). In fact, when asked a probe about what helped them achieve inclusion, some highlighted how this paper was instrumental in their efforts to push back against exclusionary feedback from ethics boards or other gatekeepers that questioned the ability of PLWD to participate in research. Researchers also invoked theoretical models such as personhood, citizenship, and rights-based approaches as tools to reframe inclusion as an ethical imperative, not a risk. However, the influence of these models was described as uneven and dependent on the researcher’s own theoretical position. Without structural support or formal institutional recognition from institutions, researchers were left to negotiate implementation of best practices or international frameworks on an individual and case-by-case basis.

Taken together, theme one illustrates that while researchers may consult a range of legal, ethical, and theoretical sources, their use is uneven and constrained by institutional practices and norms. The dominance of the TCPS 2, combined with limited engagement with legal expertise or consistent application of rights-based frameworks, suggests a fragmented ethical research landscape. In the absence of clear guidance on the inclusion of PLWD in research, researchers must navigate conflicting sources of authority. This fragmentation can be considered to create and reinforce uncertainty and contribute to the continued exclusion and/or marginalization of PLWD in the research process, despite the presence of legal and ethical arguments for their meaningful inclusion.

Theme 2: Variations in practices across Canadian universities and research institutions

The second theme in understanding consent as a possible means of inclusion was the significant variation that emerged in research practices and interpretations of Tri-Council policies on consent across Canada. Analysis across the interviews revealed wide-ranging differences between researchers, universities and research institutions, disciplines, research studies, and jurisdictions. Conversational interviews, whereby researchers spoke about everyday practices, revealed, for example, that the ethics processes for research with PLWD differed by discipline, institution, jurisdiction, and research setting. Illustrations provided included differing administrative and/or bureaucratic procedures, ethics board composition, requirements for access to populations, and the inclusion processes deployed across university, hospital, community, and long-term care settings. Disciplinary differences (e.g., medical versus social sciences; primary versus secondary data) also existed across the country and between settings. For example, some researchers had access to direct conversations with REBs versus arms-length processes, some discussed challenges of negotiating ethics across multiple sites with differing processes of approvals at each institution, some recounted how their research was automatically deemed high risk because it included people with dementia, and others outlined how they had either successfully included people with lived experience of dementia in review processes or been asked to secure proxy consent over the participation of PLWD. Note that only British Columbia was identified as having a harmonized ethics review model that linked institutions, though researchers discussed how they still sometimes faced additional local requirements and/or encountered challenges in cross-jurisdictional teams. Although one participant noted that even with harmonized review, one team will get the result in two days and they will get it in 6 months due to the complexity and inconsistency (participant number removed for non-identification). The following quotes illustrate some of these discrepancies:

Some researchers experienced difficulties working with hospital or community institutions that did not have a research mandate, whereas others found their partner institutions helpful in negotiating their university requirements. Illustrations of their research being misunderstood and sent to higher risk level review simply because it involved PLWD were also noted, with some outlining how their REBs were not equipped for the type of research they performed. For example, observational studies were sometimes redirected to clinical trials units, despite lacking clinical components:

The same occurred in low-risk technology studies, such as usability testing, where researchers discussed how simply involving PLWD triggered heightened scrutiny. In the social sciences, securing REB approval was perceived to be particularly difficult for studies involving more sociological approaches asking people about their lives. Yet, oddly, some researchers who carried out arts-based or collaborative approaches where PLWD were heavily involved in the research process were identified to have readily received approval. Although many researchers recounted challenges that were focused on university REB processes, some researchers highlighted how they did not require this approval to complete their work, either because they were in fields such as law which carried out document review or business/technology consulting or because they held a primary appointment at a specific care site (e.g., thereby being covered through institutional REB processes). What became clear is how different the procedures and processes of obtaining consent of PLWD across Canada can be and how varied the landscape is. When asked to talk about successes and failures they had experienced in including PLWD in research, one participant outlined how not all types of research require formal processes such as ethics:

It was difficult to determine whether these challenges were due to disciplinary differences, the size of the institution, the specific processes of each respective REB, or the nature of the projects. In attempting to understand the range of practices and challenges encountered with regard to the inclusion of PLWD in Canadian research, we probed whether practices had changed over time. While some researchers suggested that improvements in their own REB approval processes might be due to gradual shifts in institutional culture over time, careful review of the transcripts suggests that this interpretation was not fully supported by the research evidence, with even seasoned researchers continuing to report major systemic challenges in their interviews. Again, in an attempt to understand the roots of the divergence between those who encountered many challenges and those who did not, we posed a direct question to one of our final interviews. The participant’s response pointed to the role of institutional history and turnover in at least partially shaping how ethics processes are experienced:

Despite the wide variation in institutional practices, disciplinary approaches, and REB processes, a common thread in the interviews was that dementia-related research was often misunderstood, leading to additional scrutiny, delays, or avoidance of particular research paths. Researchers described how, in anticipating ethical hurdles, they sometimes chose less inclusive or less direct methods simply to get their work approved – raising concerns about the chilling effect of current ethics processes on the inclusion of PLWD. Consider the following quote:

Although further research is needed to map systemic, institutional, and procedural differences, researcher accounts highlighted several contextual factors that influenced inclusion. Trusted relationships with ethics boards, opportunities for dialogue with REB representatives, and institutional flexibility were cited as enabling more inclusive practices with PLWD. In contrast, researchers at larger institutions that relied on arms-length written applications or whereby social science researchers were required to apply through medical boards seemed to face additional challenges when contrasted to the discussions of researchers from smaller institutions who could reach out for a discussion or assistance. Many emphasized that variation in REB composition and familiarity with dementia-related issues significantly shaped how guidelines were interpreted and applied. These findings point to the need for the development of greater clarity on achieving inclusion and consistent application of ethics guidance with regard to PLWD.

Theme 3: Biases and assumptions of presumed incapacity

Dementia researchers recounted how many institutional contexts within which they carried out their research operated according to assumptions of presumed incapacity and the idea that PLWD cannot possibly meaningfully participate in research. Theme 3 outlines how assumptions and biases about PLWD can affect participation in research and, more broadly, inclusion. Bias and presumed incapacity were described as having two interrelated parts: first that PLWD were seen to be incapable and second, that, because of this presumption of incapacity, their participation was deemed irrelevant or unimportant. Respondents recounted observations of presumed incapacity that they had encountered in their research practices. For example, some discussed negative feedback they had received in grant reviews or ethics applications, using these to highlight how biases about the contributions of PLWD as unimportant or unnecessary were ingrained into institutional practices. Researchers also mentioned how PLWD were automatically excluded from non-dementia-related research studies, giving the typical ethical process as an example, where researchers had to clearly indicate that they would not be including PLWD in their research samples. The following quote highlights the biases researchers had witnessed:

Presumed incapacity also operated via institutional or gatekeeper requests for proxy consent. Dementia researchers gave examples where they were asked by an institutional gatekeeper or their REBs to automatically seek proxy consent from a substitute decision maker without considering whether the PLWD was capable of consenting and hence had the legal right to make decisions about research participation. The following illustrations detail instances where researchers had been asked to, or required to, default to a proxy caregiver. Researchers highlighted how examples of these practices occurred at every stage of the research process, affecting funding, producing gatekeeping, and/or causing a reliance on substitute decision makers, which prevent the involvement of PLWD in research, particularly among PLWD in long-term care. These examples highlight how assumptions of incapacity and incapability are reproduced through systems and institutional processes that are designed and intended to achieve ethical approval and consent from people with lived experience of a particular phenomenon. The quotes below pertain to the practice of being asked to seek a proxy/substitute decision maker, which regularly came up from gatekeeper institutions and REBsFootnote ¹:

The institutional inconsistencies outlined by dementia researchers in Canada intersected with broader concerns around the legal and ethical interpretations of consent in relation to PLWD. Where some researchers noted that existing REB protocols encouraged the use of substitute or proxy decision makers by default, others provided examples where proxy decision makers might be asked to step in to speak for the PLWD in more ‘complex’ situations. When speaking about these instances, researchers tended to use the language of participation or inclusion. In these cases, researchers expressed concern that such institutional defaults to proxy consent could override the agency of individuals who had capacity and interest in participating. In interpreting the results, members of our team point out that proxy by default, or simply seeking proxy consent for cases considered to be ‘complex’, is problematic. The practice of relying on a proxy subverts the right of PLWD to participate in their own right and is contrary to the laws across Canada. The illustrations from researchers identify important gaps between the law and research practices. It also in part explains why so little research exists in areas such as lived experiences of people in long-term care settings or the analysis of intersecting social issues such as poverty, whereby PLWD occupying both locations would be deemed simply ‘too complex or vulnerable’ to participate. In the following quotes, participant 16 outlines that the path should start with legal rights, followed by consent to participate in research, where appropriate, with some participants speaking more broadly about how to know someone is interested in knowing more and participating:

Theme 3 reveals how biases and assumptions of incapacity permeate the landscape of dementia research and are deeply ingrained in institutional practices. In everyday research practices, this can mean that PLWD are often automatically deemed vulnerable and/or unable to consent or contribute, resulting in PLWD being denied rights and opportunities to make decisions about their own lives, including whether they want to participate in research. This points to important gaps in knowledge and practice between the law and research. It also reveals how negative assumptions and biases about PLWD were considered to operate in ways that increase the risk of exclusion because PLWD are viewed as less capable and less essential contributors.

Theme 4: Protectionism and risk mitigation as a default response

Accounts of everyday practices in the field of dementia research reveal how protectionism and risk mitigation operate as default responses across a range of settings and by actors such as funders, REBs, families, institutions, care settings, and professionals. Participants described how various actors engaged in paternalistic gatekeeping, to ‘protect’ PLWD. A common operating idea in the research community was the idea that conducting research with PLWD assumes additional risk and liability. Where some of our respondents engaged with forms of protectionism, others challenged practices that were not supportive of the rights of PLWD to participate in research. Without question, however, researchers stressed the ethical imperative of doing no harm, and there was a sense that these paternalistic and protective attitudes were rooted in concerned attempts to protect PLWD from risks associated with research. Yet, our participants also engaged in reflexively thinking through risk and, in some cases, directly questioned the nature of these risks, such as whether the risks of exclusion outweigh those of participation.

The distinction between risk and participation was particularly evident when results were considered across the range of disciplines and contrasting types of research. For example, researchers’ illustrations of their research practices caused us to ponder the different types of risks that existed between social science research, which primarily asks participants about their experiences, versus medical sciences, which might involve injections or clinical trials. Some of the dementia researchers engaged in questions about risk within the interviews, raising questions about who is actually at risk, under what circumstances, and how they could achieve their goals of including the perspectives and experience of PLWD. The interview material in this theme grapples with questions about the balance between risk and vulnerability, with these considerations deeply embedded into ethics processes and the abovementioned process of automatic categorization of PLWD as vulnerable subjects who lack capacity. The following quotes highlight how concerns about vulnerability reflect concern and fear that can end up undermining the rights of PLWD. In the absence of clear guidance in legislation and/or policy, research actors and families tend to err on the side of being overly protectionist, often resulting in exclusion:

Participant discussions of the standard processes required to receive funding or proceed with research also reflected how processes sustain protectionist and exclusionary practices. Illustrations provided by researchers detailed how rigid standard research processes, including research deadlines, can pass over the inclusion of those that need more time; how a lack of clear and appropriate guidelines to include PLWD meant researchers and institutions have to interpret what happens in research studies; and how insufficient appreciation for research that includes PLWD can skew results to not be representative of the voices and concerns of PLWD. One of the clearest examples given across contexts was how institutions tended to operate around consent as a one-time, fixed occurrence formalized through a standard written consent form. Researchers contrasted this procedure with best practices of consent in the field of dementia research, where consent is an ongoing process of continuous participant engagement. They emphasized the importance of building relationships and allowing the consent process to remain flexible to meet fluctuating needs and abilities of PLWD to achieve access and fulfil the conditions of informed consent and their rights. They outlined how while PLWD may not want to participate one day, they may be willing to do so on another, and this is in line with legal consent.

The issue of how to design studies and processes that balance risk and inclusion was considered across interviews, with researchers seeming to indicate that more involvement and fluid processes are needed across Canada. While many researchers thought existing requirements and processes could create barriers that hindered participation, others commented on them as necessary, but in need of clarity and adjustment. Some researchers discussed how they used atypical research methods such as co-design, alternative methods of obtaining consent (e.g., images), and incorporating flexibility into their research design to better suit the needs of PLWD and increase the accessibility of research to PLWD, but this was seen as somewhat dependent on their institutional systems for approval. Overall, researchers reflected how over-protectionism, rigid processes, and current institutional responses, which overlook or prohibit the involvement of PLWD, create challenges for researchers and REBs alike and result in missing important insights:

The research landscape operated through protectionism and risk mitigation, thereby impacting whether and how PLWD were included in research. While it was clear that there was a risk of violating human rights by excluding PLWD, researchers discussed how this issue was never raised as a significant concern of REBs. Interviews outlined several illustrations of systemic exclusion, as well as efforts to educate institutions, REBs, and research professionals on how to best achieve inclusion. Researchers’ continued activism, vigilance, and commitment stood out, along with expressions of injustice and disappointment when, for example, they were unable to include a PLWD who had expressed a desire to participate. One participant raised how the very nature of not requiring a discussion and conversation between the researcher and the ethics boards as part of the ethics approval process violated the classical dialogical definition and processes of ethics itself. In an effort to improve research practices in the Canadian dementia research landscape, we now highlight strategies researchers used to facilitate access and meaningful involvement.

Theme 5: Strategies to achieve inclusion of PLWD in dementia research

When asked to tell us about the work they do, dementia researchers described a range of techniques, strategies, and ways of working to include PLWD. Research design was often discussed and articulated as a deliberate act of inclusion, varying according to the research topic and question. Considerable emphasis was placed on the importance of developing a relationship built on trust with care providers, institutions, allied researchers, and groups interested in dementia. Trust was deemed critical for facilitating inclusion, consent, and participation. According to researchers, it was also a necessary foundation from which to build effective involvement and to create a safe place for PLWD and their supporters to provide insights and feedback on the research process. Many informants mentioned how their ways of working developed over time through lessons learned from PLWD, including lessons about what did not work. They also emphasized nurturing relationships over time, which allowed them to detect and respond to the limits and needs of PLWD. Although models of inclusive design varied by discipline, research question, and/or setting, a frequently mentioned practical strategy was co-design, where researchers collaborated with PLWD when crafting the study’s design from the outset, ensuring their lived experiences shaped the most relevant and inclusive research approach. Acknowledging that co-design was not always possible, researchers also noted including PLWD on advisory boards, member checking, and deploying a range of accessibility features (e.g., pictorial representations) as crucial to inclusive and meaningful participation with PLWD.

Other methods that researchers described using to include PLWD in research entailed creating advisory committees comprised of PLWD who provided ongoing consultation throughout the study, seeking input from PLWD on research environments or questions, and making use of documents or guidelines created by PLWD to ensure meaningful practices:

In some cases, researchers outlined how their institutions had developed processes and guidelines for researchers to follow. For example, one participant noted that some care facilities are helping to develop inclusive strategies by asking more questions of the researchers who seek involvement. A question that emerges, however, is whether such practices foster more meaningful participation of PLWD or whether they consolidate gatekeeping practices rooted in protectionism and ideas of vulnerability rather than the realization of human rights:

Dementia researchers who discussed co-design as a strategy to achieve inclusion made it clear that co-design requires considerable adaption. Researchers outlined the need for creative research techniques that accommodated possible issues related to cognition and centred the needs, capabilities, and priorities of PLWD. Note that some researchers worked only with secondary data or pre-selected groups in a medical context. For those with direct contact with PLWD, strategies for meaningful inclusion included flexible scheduling, providing both verbal and written cues, and integrating breaks into participation sessions. Several researchers also employed alternative forms of consent, such as ongoing dialogue, the ‘teach-back’ method to assess understanding, supported decision making, and when necessary, proxy involvement. The following quotes outline researchers’ attempts to create access and inclusion:

Several researchers stressed the importance of having personal or professional experience with PLWD (i.e., family members or friends). They outlined how the knowledge they gained from PLWD helped ensure a solid, shared understanding of the challenges PLWD might face, enabling researchers to tailor their work with a neurodiverse, inclusionary approach. For example, some discussed how working with PLWD taught them to avoid multitasking and break material down into accessible information. Researchers also believed that prior experience with PLWD helped them better evaluate consent and capacity to participate. Several participants contrasted research teams with this experience to those without it, noting that the latter often lacked the essential skills and knowledge to meaningfully include and accommodate PLWD. There was a flexibility required in finding the strategy that worked, with many researchers pointing to how their efforts to be inclusive and accommodating could be unsettling and require humility and openness:

The research practices described by participants underscore the critical role of relationship-building, adaptability, and experience in fostering meaningful inclusion of PLWD. While strategies such as co-design, advisory boards, and flexible consent processes are vital for ensuring accessibility, they also highlight the tension between the ideal of inclusion and the institutional constraints that can hinder it. These findings point to the need for continued advocacy and creativity and a shift in research culture to fully integrate PLWD into all stages of research.

Recommendations for action

Based on our research, the team developed six practical and actionable recommendations to improve the meaningful inclusion, participation, and fulfilment of rights of PLWD in policy, practice, and research. These recommendations are intended to guide researchers and institutions to respect human rights and achieve access and meaningful inclusion of PLWD while, at the same time, protecting people who are vulnerable from harm:

1. 1. Research the implications of the continued exclusion of PLWD, including how exclusion affects their well-being, autonomy, and representation, as well as the quality and relevance of findings in dementia research. Findings can inform best practices consistent with human rights law and supported decision making (e.g., UNCRPD).

2. 2. Revise REB processes and research guidelines to comply with Canadian/provincial/territorial laws regarding mental capacity and consent. Ensure these concepts are understood as part of an ongoing process and not mere signatures on a standardized form. This recommendation also calls for consistency between research contexts and institutional guidelines to create a unified approach that upholds ethical standards and protects participants’ rights. There should also be access to independent legal advice for REBs and researchers, as needed.

3. 3. Develop explicit guidelines, procedures, and mechanisms to facilitate access and involvement of PLWD compliant with Canadian laws including both civil and human rights law. This includes defining the criteria for participation, clarifying the process for obtaining informed consent, and establishing methods for providing support and accommodations tailored to the needs of participants. Procedures could also address how to create an inclusive research environment that fosters trust and considers communication styles, cultural sensitivity, and the provision of resources.

4. 4. Offer a variety of roles that recognize the value of contributions of PLWD, aligned with both study needs and the preferences of PLWD. This could include roles as co-investigators, collaborators, advisory members, focus group participants, outreach assistants, or reviewers of materials.

5. 5. Draw on equity, diversity, and inclusion frameworks and key insights from disability studies to achieve the most comprehensive inclusion possible. For example, one researcher referenced how using a neurodiverse inclusionary lens aided their inclusion of PLWD by sharpening their focus on accessibility accommodations and framing dementia as one aspect of a complete, diverse identity.

6. 6. Educate REBs and institutional gatekeepers on stigma, capacity and consent, ableism and ageism, universal design, inclusion, and human rights. Pair this with the provision of deep training on best practices of mental capacity, substitute and supported decision making, and disability rights across research contexts. Educate REBs and their respective institutions on the risks and liabilities associated with not complying with Canadian governing laws regarding mental capacity and consent. Increase the inclusion of PLWD through the education of emerging scholars, the meaningful integration of experiences of PLWD into research curricula, fostering peer-to-peer knowledge exchange among students and PLWD, and establish mentorship programs where experienced researchers and PLWD guide trainees on inclusive research practices.