Engaging patients in research has come to be viewed as a vital component of high‐quality research, and funders now regard engaging patients and other stakeholders as a core criterion for funding decisions. In response, numerous empirical and conceptual papers have emerged to guide the process of engagement. However, as Emily Largent and colleagues rightly note, the inquiry of whom to engage has received less attention. While several teams have suggested that the selection of patients for engagement is an important consideration, (...) researchers generally have little guidance on how to undertake this process. To that end, Largent and colleagues offer an important contribution to the literature. I agree with their argument regarding the centrality of critically examining which patients to engage in research and with their recommendations to maximize the positive goals of patient engagement. However, three issues warrant further consideration. (shrink)

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

Background Partnering with patients in healthcare research now benefits from a strong rationale and is encouraged by funding agencies and research institutions. However, this new approach raises ethical issues for patients, researchers, research professionals and administrators. The main objective of this review is to map the literature related to the ethical issues associated with patient partnership in healthcare research, as well as the recommendations to address them. Our global aim is to help researchers, patients, research institutions and research ethics boards (...) reflecting on and dealing with these issues. Methods We conducted a scoping review of the ethical issues and recommendations associated with partnering with patients in healthcare research. After our search strategy, 31 peer reviewed articles published between 2007 and 2017 remained and were analyzed. Results We have identified 58 first-order ethical issues and challenges associated with patient partnership in research, regrouped in 18 second-order ethical themes. Most of the issues are transversal to all phases and stages of the research process and a lot of them could also apply to patient-partnership in other spheres of health, such as governance, quality improvement, and education. We suggested that ethical issues and challenges of partnered research can be related to four ethical frameworks: 1) Research ethics; 2) Research integrity; 3) Organizational ethics, and 4) Relational ethics. Conclusions We have identified numerous ethical issues associated with the recent approach of patient-partnership in research. These issues are more diverse than the issues associated with a more traditional research approach. Indeed, the current discussion on how we address ethical issues in research is anchored in the assumption that patients, as research participants, must be protected from risk. However, doing research with, and not on, the patient involves changes in the way we reflect on the ethical issues associated with this approach to research. We propose to broaden the ethical discussion on partnered research to not only rely on a research ethics framework, but to also frame it within the areas of research integrity, organizational ethics and relational ethics. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they (...) be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)

Background There is now rising consensus that community engagement is ethically and scientifically essential for all types of health research. Yet debate continues about the moral aims, methods and appropriate timing in the research cycle for community engagement to occur, and whether the answer should vary between different types of health research. Co-design and collaborative partnership approaches that involve engagement during priority-setting, for example, are common in many forms of applied health research but are not regular practice in biomedical research. (...) In this study, we empirically examine the normative question: should communities be engaged when setting priorities for biomedical research projects, and, if so, how and for what purpose? Methods We conducted in-depth interviews with 31 members of the biomedical research community from the UK, Australia, and African countries who had engaged communities in their work. Interview data were thematically analysed. Results Our study shows that biomedical researchers and community engagement experts strongly support engagement in biomedical research priority-setting, except under certain circumstances where it may be harmful to communities. However, they gave two distinct responses on what ethical purpose it should serve—either empowerment or instrumental goals—and their perspectives on how it should achieve those goals also varied. Three engagement approaches were suggested: community-initiated, synergistic, and consultative. Pre-engagement essentials and barriers to meaningful engagement in biomedical research priority-setting are also reported. Conclusions This study offers initial evidence that meaningful engagement in priority-setting should potentially be defined slightly differently for biomedical research relative to certain types of applied health research and that engagement practice in biomedical research should not be dominated by instrumental goals and approaches, as is presently the case. (shrink)