Wandering is often perceived as one of the more challenging behavioral symptoms of dementia. Frequent wandering may lead to weight loss, sleep disturbances, fatigue, an increased risk of falls and fractures, early institutionalization, and elopement and getting lost, which carries a high risk of serious injury or death [1-3]. Although the negative aspects of wandering are most often discussed, its potential positive aspects are increasingly being recognized. For instance, wandering can reinforce habitual practices, involve beneficial physical activity, and be a form of exploration, particularly in new environments [4,5]. Furthermore, wandering may be a source of meaning to a person living with dementia, even if caregivers do not fully understand the motivations behind this behavior [6]. Freedom of movement is an important component of autonomy, valued by persons with dementia and their supporters alike [7]. Recognizing these positive aspects more deeply, the care response to wandering behavior has shifted from total prevention to risk mitigation and promotion of safer walking activities [8].

To address wandering in a way that supports autonomy and maintains safety, caregivers are increasingly turning to technology [9-11]. In particular, locator devices—also referred to as location tracking devices, electronic tracking devices, real-time location systems, monitors, personal safety alarms, or surveillance devices [12]—play an increasing role in wandering management, although current evidence for their effectiveness remains mixed [13]. Common devices include watches, bracelets, or fobs that use GPS, radio frequency, radio frequency identification, or Narrowband Internet of Things technology. Two primary features are common to most locator devices: real-time localization, which allows caregivers to determine the location of persons living with dementia, and passive monitoring, which provides alerts or alarms when specific events occur, such as crossing the boundaries of a geo-fenced “safe zone” or detecting a fall [12].

Within the normative and empirical literature, locator devices have primarily been examined from the perspective of their use, leaving the design and development processes comparatively underexplored. Both bodies of literature reflect this pattern. The normative literature has largely focused on the tension between promoting the autonomy of persons with dementia and maintaining their safety within the care environment [14,15]. Most ethical guidance focuses on the use of a particular technology in a particular care setting, such as radio frequency identification locator devices used within institutional care [16-18]. The empirical literature has likewise primarily focused on the perceptions and experiences of end users—persons with dementia, their spouses, family and friends, along with various professional caregivers [7]. Developers have only recently begun to be included in empirical research, mainly within studies exploring factors of locator device usability, acceptability, and adoptability [19-21].

A separate body of technical literature does address locator device development directly. Substantial work has been published detailing the design and development of locator technologies for dementia care [22,23]. However, much of this literature is concerned with technical and engineering challenges, and ethical considerations, when they appear, tend to be peripheral. A more ethically oriented strand has emerged from the broader dementia technology literature, including design guidelines [24], improvements to user-centered design [25,26], and efforts to address the challenges of fully involving persons living with dementia in development [27]. While this work explicitly engages with ethical dimensions, its focus remains methodological rather than constituting a dedicated ethical framework.

The importance of integrating ethics into the entire technology development process has long been recognized—development involves value-laden decisions that inevitably impact end users [28-30]. Developers of dementia technology share this concern, as reflected in the ongoing efforts to improve dementia product development and the experiences of locator device developers across both research and commercial settings [31]. Yet, despite this recognition, most dementia technologies are developed without explicit consideration for ethics [32]. While systematic evidence explaining this gap is lacking, plausible explanations include a combination of organizational pressures such as tight timelines and funding constraints [31,33], the absence of dedicated ethics expertise in smaller development teams that characterize much of the locator device industry [34], and, ultimately, a lack of accessible, practical ethics resources suited to the real constraints of development [35].

There is a clear need for an ethical framework that encourages explicit ethical consideration and supports developers in navigating ethical tensions. However, the complex diversity within the locator device domain makes developing such a framework challenging [36]. Development of locator devices is undertaken within commercial and university settings worldwide, involving teams ranging from individuals and small groups to small- to medium-sized organizations and multinational consortiums or corporations. Similarly, these devices are used by a diverse range of stakeholders, including informal and formal caregivers, home health aides, community volunteers, emergency services, and persons living with various stages of dementia [12]. The development and use of locator devices are shaped by stakeholders’ motivations, values, and priorities, as well as by broader contextual factors such as cultural values, legal regulations, health care organizations, and government support. As such, to meet the needs of developers and users, an ethical framework must be flexible enough to accommodate the diverse contexts of locator device development and use.

In response to this need, this paper introduces a question-based ethical framework to guide the development and use of locator devices in dementia care. A question-based approach has several advantages. Open-ended questions convey ethical content in a nonprescriptive way, encouraging adaptation to specific contexts. Because the questions can be revisited without following a fixed sequence, the framework can be integrated into ongoing ethical dialogue during active locator device development or use. The framework’s creation process, including the theoretical background and methods used, will be described prior to its introduction.

This ethical framework is the result of a research project containing an empirical research line [12,31] and an applied ethics research line [15]. Developing this framework, therefore, requires integrating empirical data and normative analysis. Currently, there are no standard integration methods [37,38]. Indeed, while there are many methodologies, such as consultative, dialogical, or hermeneutical, the actual process of integrating empirical data and normative analysis remains vague even among experienced researchers [39]. At some point, a critical step must be taken that transcends methodological prescription or a priori explanation. What can be thoroughly outlined and explained, however, are the preconditions, tasks, and processes that form the groundwork for this step. Deliberately integrating strengths from various methods of bioethical inquiry improves this groundwork by enhancing the reflexivity, rigor, and transparency of the framework’s development process [40].

Prior to outlining our methods, we want to acknowledge the conceptual commitments shaping our approach. We have chosen to develop a framework intended to be used dialogically. This decision stems from the central role dialogue plays in both dementia care ethics and dementia technology development. In dementia care, the relational encounter between a vulnerable person and a caregiver forms the ethical basis of care—an encounter in which meaningful responses to vulnerability emerge from shared dialogue between persons with dementia (as far as their abilities allow), their families, professional caregivers, and others [41,42]. When a person with dementia begins to wander at night, a dialogue about how to respond will occur that involves the stakeholders’ values: the person’s expressed wishes, the family’s safety concerns, and the caregiver’s duty of care, for example. In dementia technology development, dialogue is equally central. Participatory design methods place the dialogical encounter between developers and end users, including persons with dementia, at the heart of creating more effective and ethically sound technologies [26,27,43,44]. For example, workshops that allow persons with dementia to experience potential design choices and express their opinions. Furthermore, our interview study with developers of locator devices found that engaging in dialogue with end users, domain experts, and peers was a central strategy for navigating ethical challenges in their work [31]. Therefore, working toward a framework rooted in dialogue would complement and strengthen the ethical practices that presently exist in dementia care and dementia technology development.

To ensure reflexivity and rigor, we developed a 4-step process that draws upon the strengths of different methods of bioethical inquiry. Each method typically requires lengthy explanation; however, due to space limitations, only key aspects will be reported. A complete accounting of the methods can be found in Multimedia Appendix 1.

The first step involved a systematic review of empirical and normative literature across 3 areas relevant to locator device development and use [45,46]. Using predefined inclusion and exclusion criteria (Multimedia Appendix 1), 64 papers were identified: empirical literature (n=27), covering stakeholder perceptions, implementation, and usability and acceptability; normative literature (n=18), focused on ethical arguments related to locator devices; and development literature (n=19), comprising guidelines, recommendations, and project outputs (Figure 1). This systematic approach enhances reflexivity and guards against overreliance on our own research.

The second step involved the analysis of the previously gathered literature using a modified inductive qualitative analysis method [49]. The analysis ceased after finalization of codes rather than proceeding to the creation of an explanatory narrative structure. The analysis focused on identifying relevant elements from the gathered literature, such as arguments, insights, perspectives, concepts, recommendations, and themes, and organizing them into coded themes.

Each literature grouping underwent a 2-step coding process. First, in vivo coding was used to create an initial list of big picture concept codes. Second, through constant comparison, we reorganized these codes to identify subthemes. For example, within the empirical literature, all text fragments under the big picture concept “care goals” (identified during in vivo coding) were compared against one another, yielding subthemes such as “provide emotional support to persons with dementia,” “increase the safety of persons with dementia,” and “preserve beneficial aspects of wandering.” Next, the final codes from the 3 literature groups were compared, merged, and abstracted into a single list of ethical insights (Multimedia Appendix 2).

The third step involved drafting a preliminary framework through iterative team discussion and revision, until the team reached agreement on a suitable version.

The ethical insights from step 2 were not reproduced directly in the framework; instead, they served as a reflective tool to identify potential blind spots, with their content synthesized into guiding questions tailored to use and development.

The fourth step entailed a feedback cycle to assess the preliminary framework’s relevance, clarity, and relatability across different stakeholder groups. Four stakeholder groups were consulted via convenience sampling, with deliberate effort to achieve diversity in sex, region, and professional background within each group (Table 1): technology developers, ethicists, health care professionals, and older adults, family members, and dementia patient advocates. This approach was chosen to maximize perspectives within the available time frame. Stakeholders were recruited through email, phone calls, and referrals. After giving informed consent, each participant received the provisional framework with instructions to provide critical feedback on its organization and content. Feedback was received in written and oral forms. Persons living with dementia or other cognitive impairments were not directly included in the feedback cycle due to time challenges, anticipated recruitment difficulties, and the barriers presented by a primarily written process. The feedback cycle was approved by the Social and Societal Ethics Committee of KU Leuven (file: G-2024‐7811-R2(MIN)). The cycle was initiated on January 7, 2025, and concluded on May 31, 2025. The feedback received was discussed within the research team and used to refine the final framework.

The aim of this framework is to facilitate reflection and discussion to aid decision-making around ethical tensions in the development and use of locator devices in dementia care. It is intended for anyone involved in the development or use of locator devices in dementia care.

For users, this could include persons with dementia, families and friends, volunteer organizations, or professional care organizations, such as home health or institutional care facilities. In short, any informal or formal organization of persons devoted to responding to the vulnerabilities and needs of persons with dementia. For developers, this could include both technical and nontechnical professionals working in commercial or university development settings. For instance, engineers of various specializations, user experience and user interface researchers, product managers, marketers, sales and support, etc. This also includes academic researchers of all disciplines engaged in locator device development, whether working individually or as part of a consortium.

The framework has been organized to be inclusive, accommodating individuals with varying levels of expertise—from newcomers to seasoned professionals. To ensure accessibility, technical terms and jargon have been minimized. However, experienced readers will recognize concepts that are considered common knowledge within their respective disciplines.

Unlike conventional chronological ordering that begins with development, this framework begins with guiding ethical questions for the use of locator devices to underscore the importance of stakeholder-driven approaches in dementia care. How care communities want to conceive, integrate, and use locator devices within their care practices provides a robust foundation for considerations in development.

This framework is the result of a larger project combining empirical-ethical and applied-ethics research [12,15,31]. The framework benefits significantly from the inclusion of insights drawn from interviews with developers of locator devices, a stakeholder group largely absent in previous ethical discussions. Our framework possesses 3 overall main strengths: the creation process, its structure, and its content.

The framework’s creation methodology addresses a common shortcoming in health care ethics guidelines: the vague and often undocumented processes behind the creation of ethical guidance and recommendations [69]. While foundational work, such as systematic literature reviews, quantitative and qualitative studies, and stakeholder consultation, is usually documented, the process of moving from this work to final guidance is rarely detailed [17,18,70]. This lack of clarity poses a significant methodological challenge, particularly for integrating empirical and normative insights. To address this challenge, we developed a transparent, well-documented, and rigorous methodology that drew upon established methods of bioethics.

A second key strength of the framework is its question-based structure. As previously noted, this structure reflects and builds upon the importance dialogue plays in both dementia care ethics [41,42] and the development of locator devices [31]. In addition, this structure is well-suited to address the sociomateriality of device development and use—the idea that technologies are socially produced, interpreted, and used [71]. Locator devices are developed through socially embedded practices, including team discussions and stakeholder inclusion [31]. Their use is similarly socially situated: identical devices can be used in radically different ways. As a result, intended benefits are not always realized. This is illustrated clearly in practice: a device intended to increase outdoor freedom for a person with dementia may fail to deliver this benefit if caregivers continue to impose movement restrictions regardless of the device’s presence—the technology alone cannot produce the desired outcome without corresponding changes in social practices and relationships [13,57]. Achieving benefits requires caregivers to organize themselves and adapt their practices accordingly. Thus, there is a need to better align the social (relationships, norms, and policies) and technical (functionality and infrastructure) dimensions of locator device development and use [64,72]. This alignment requires ethical reflection that does not separate a technology from its context of use [73].

Thus, sociomateriality demands flexibility and responsiveness to a particular care context. A question-based approach meets this demand due to its transferability [74]. By providing open-ended prompts to be discussed within specific care practices, it supports communities—families, volunteer groups, care institutions, and development teams—in reflecting deeper on the ethics of device development and use. Thus, a question-based structure supports ethical practice by facilitating the dialogue stakeholders need to ethically align social and technical elements within their care practices.

A third strength is that it broadens ethical reflection by adopting a relational and reflexive approach to the development and use of locator devices. Prior ethical analyses have often taken a narrow, individualistic perspective, focusing predominantly on the tension between autonomy and safety for persons with dementia [14,15]. However, a growing body of literature advocates for a more relational perspective, highlighting interdependencies between persons with dementia and caregivers [60]. Ethical reflection has thus expanded to include not only the best interests of persons with dementia but also their family members [17], potential negative impacts on caregivers—such as privacy concerns or alarm fatigue [14,16,75]—and negative effects on other residents within shared living environments [18]. Despite this relational shift, the existing scope remains relatively limited to caregivers and persons with dementia.

Our framework builds upon these relational insights, further expanding ethical considerations to encompass organizational, societal, and global concerns. By recognizing the broader network of relationships affected by these technologies, the framework provides a more comprehensive relational understanding of their development and use. Moreover, this broader reflection integrates both an ethics of carefulness and desirability [76]. Its open-ended questions regarding vision, process, and impact do more than simply help identify and mitigate potential harms. They actively encourage stakeholders to reflect critically on their motivations, biases, processes, and goals. Thus, this framework fosters thoughtful, self-aware decision-making grounded in ethical dialogue among stakeholders.

Our framework has several important limitations. First, a notable limitation is the absence of persons with dementia from the stakeholder consultation. This is a tension we acknowledge openly: a framework that asks caregivers and developers to center persons with dementia should itself model that commitment. Future iterations should prioritize their direct involvement through adapted formats (eg, verbal rather than written) better suited to their abilities and preferences consistent with the participatory design methods referenced throughout this paper. Second, as a question-based framework, it inherently offers “thin” normative guidance—invoking ethical concepts such as autonomy or safety without prescribing what they specifically mean or require in practice. This stands in contrast to a thicker approach that might stipulate, for instance, how autonomy should be weighed against safety in a particular care setting. While this supports transferability across diverse contexts, it means the framework does not provide definitive ethical answers. Finally, this work is situated predominantly within a Western, Educated, Industrialized, Rich, and Democratic context [77]. The project was conceptualized and conducted by American and Belgian researchers funded by the Flemish government, and both the primary empirical study and normative literature reflect predominantly Western perspectives. Consequently, despite the framework’s highly transferable design, its applicability beyond Western, Educated, Industrialized, Rich, and Democratic contexts may be limited. Future research should incorporate non-Western perspectives by, for instance, conducting a major round of feedback and revisions in an explicitly non-Western context to help adapt the framework to local needs and work to strengthen global approaches to bioethics. Additionally, empirical validation of the framework in practice represents an important next step. Specifically, future research should examine whether and how the framework facilitates meaningful ethical deliberation across diverse development and care contexts.

This paper has presented a question-based ethical framework to help guide the development and use of locator devices in dementia care, created by integrating empirical and ethical insights through a structured, transparent process. This framework (1) supports transferability and context-specific action, (2) broadens ethical reflection, and (3) facilitates reflexivity. Consequently, this framework emphasizes stakeholder dialogue, openness to diverse contexts, and responsiveness to the sociomaterial dynamics of locator tracking device development and use. It is offered not as a finished product but as a starting point—one that invites critical engagement, adaptation, and refinement through the very kind of deliberative dialogue it is designed to support.