Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the (...) process of involvement. Twenty‐two guidelines published between 2006 and 2019 were analyzed iteratively. The analysis focuses on values which are emphasized in the guidelines on the distribution of entities, knowledge, and tasks between users and researchers. The analysis indicates that users and researchers are constructed differently; researchers are mainly constructed as responsible initiators and caretakers, while users are constructed as powerless and vulnerable. The guidelines portray the collaboration process as harmonious and assume a normative perspective. In doing so, challenges described in the literature related to power imbalances are not addressed. Based on these findings, we ask if these guidelines might function to maintain existing power imbalances between users and researchers. (shrink)

In their contribution, Wiggins and Wilbanks (2019) discuss the rise of citizen science and elaborate on several ethical issues that go beyond standard approaches in research ethics. They rightly sa...

Discourse and rhetoric of service-user involvement are pervasive in all mental health services that see themselves as promoting a Recovery ethos. Yet, for the service-user movement internationally, ‘Recovery’ was articulated as an alternative discourse of overcoming and resisting an institutionalized and oppressive psychiatric model of care. Power is all pervasive within mental health services yet often overlooked in official discourse on user-involvement. Critical research is required to expose the unacknowledged structural and power constraints on (...) participants. My research problematizes practices of user involvement in one mental health service area in Ireland. Part I of this article examines the background context of policies and practices of user-involvement from the service-user perspective and explains developments in relation to service-user involvement in the case of Ireland. Participants in my study articulate their motivation for engagement with mental health service reform in terms of the right to participate in social justice terms, of wanting to improve services and humanise care. Power dynamics emerge as one of the primary obstacles to equitable involvement. Part II of this article presents an explanatory framework of power, using a model developed in the field of development studies; Gaventa’s (2006) ‘power cube.’ The three dimensions of the cube represent the forms, spaces and levels of power. The explanatory potential of this model to highlight how hidden and invisible power operates in mental health services is illustrated by selected comments from the same participants. The power cube is a useful tool to illuminate the dynamics occurring in service-user involvement spaces. Showing how different forms of power operate in the spaces and levels of mental health involvement can develop service-users’ awareness of the hidden and invisible aspects of power. Through this awareness, they can strategize around their potential to influence decision-making in mental health services. (shrink)

Involving service users and carers in clinical research can help to improve its quality and relevance. By defining the limits of ethical acceptability, improving research design and management, ensuring information for participants is accessible and ensuring the views of participants are properly respected, user involvement can also improve the ethical conduct of research. But research proposals with good quality user involvement have experienced difficulties in obtaining ethical approval. Not all Research Ethics (...) Committees (RECs) fully understand the active role of service user/carer researchers and the current review system can act as a barrier to involving service users and carers in research. This problem urgently needs to be addressed because it is actually in the interests of RECs to promote and support user involvement. This will require adapting the systems of ethical approval, providing further training for REC members and involving service users and carers in developing and implementing these changes. (shrink)

This paper focuses attention on the ethical issues concerning the involvement of young service users as co-researchers. In particular the article offers an examination of the limitations of the term ?service user?, comments on degrees of participation and explores the ethical issues prior to the start of the research, during the research and after the research has been completed. Particular emphasis is focused on the topics of: the funders of research, ethics committees, valuing contributions, (...) informed consent, confidentiality, authorship and ending the research. The article also suggests that this is a complex area worthy of further exploration and that many of the ethical challenges identified for working with young service users also need to be considered for young service user co-researchers. (shrink)

Background Research on the impact of ethics reflection groups (ERG) (also called moral case deliberations (MCD)) is complex and scarce. Within a larger study, two years of ERG sessions have been used as an intervention to stimulate ethical reflection about the use of coercive measures. We studied changes in: employees’ attitudes regarding the use of coercion, team competence, user involvement, team cooperation and the handling of disagreement in teams. Methods We used panel data in a longitudinal design (...) study to measure variation in survey scores from multidisciplinary employees from seven departments within three Norwegian mental health care institutions at three time points (T0–T1–T2). Mixed models were used to account for dependence of data in persons who participated more than once. Results In total, 1068 surveys (from 817 employees who did and did not participate in ERG) were included in the analyses. Of these, 7.6% (N = 62) responded at three points in time, 15.5% (N = 127) at two points, and 76.8% (N = 628) once. On average, over time, respondents who participated in ERG viewed coercion more strongly as offending (p < 0.05). Those who presented a case in the ERG sessions showed lower scores on User Involvement (p < 0.001), Team Cooperation (p < 0.01) and Constructive Disagreement (p < 0.01). We observed significant differences in outcomes between individuals from different departments, as well as between different professions. Initial significant changes due to frequency of participation in ERG and case presentation in ERG did not remain statistically significant after adjustment for Departments and Professions. Differences were generally small in absolute terms, possibly due to the low amount of longitudinal data. Conclusions This study measured specific intervention-related outcome parameters for describing the impact of clinical ethics support (CES). Structural implementation of ERGs or MCDs seems to contribute to employees reporting a more critical attitude towards coercion. Ethics support is a complex intervention and studying changes over time is complex in itself. Several recommendations for strengthening the outcomes of future CES evaluation studies are discussed. CES evaluation studies are important, since—despite the intrinsic value of participating in ERG or MCD—CES inherently aims, and should aim, at improving clinical practices. (shrink)

Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were (...) interviewed who had been involved in using CMHA data for studies. Interviewees discussed the impact on stakeholder interests, sufficiency thresholds and procedural alterations of informed consent, data protection, gathering app user perspectives and representing users in app design and study conduct, and ensuring adequate support. Although the reasoning behind how and why these ethical safeguards and practices should be implemented showed considerable variability and several gaps, interviewees converged on various general lines of reasoning. This allowed for the development of a coherent and nuanced account that could prove useful for future CMHA studies and which could stimulate further normative investigation of the role of ethical safeguards and practices in these studies. (shrink)

This paper examines the role of the general public in informing technology policy, observing that public involvement often occurs only through the electoral process or via feedback after plans have been implemented. Planners and policymakers are not necessarily in touch with the feelings and desires of the public who will be affected by their decisions. For this reason it is important to seek a clearer understanding of the views of citizens who are not typically involved in the planning or (...) design process in order to guide the evolution of technology, as well as to highlight areas where there may be some discrepancy between planners and the needs of everyday users. To broaden the inputs into discussion of emerging problems related to pervasive computing in the State of Hawaii, both information and communication technology specialists and members of the general population were invited to participate in a multi-phase study. Differences in perception between specialists and the general public were identified in all phases of research. Specialists were identified as being more focused on near-term issues related to barriers affecting the growth of high-technology industries within the State. Non-specialists showed greater concern for "human" issues, including issues related to the control of technology. Importantly, both groups independently described a need for increased public participation in the process of technological development. Analysis also revealed that both groups found the problem statements generated by non-specialists to be valuable contributions, arguing for their inclusion in the process of problem identification and further supporting the use of participatory planning methods. (shrink)

Technological development and increased international competition have imposed a significant burden on the product development function of many companies. The growing complexity of products demands a larger product development team with people having various competencies. Simultaneously the importance of good quality, usability and customisation of products is growing, and many companies want to involve customers and users directly in the development work. Both the complexity and quality demand new ways of working that support collaboration between people with various competencies, interests (...) and responsibilities both inside and outside the company. This paper reports experiences from using action research to introduce new user-centred work practices in two commercial product development projects. The interventions varied. In the first project it was found rewarding to engage customers and users in workshops based on participatory inquiry and collaborative design. The design process was iterative and the workshops took place several times involving concept through detailed design. In the second project, new design representations are introduced. The experiences highlight the importance of creating and reifying insights in design representations and using these to both support collaboration, and create continuity in the project. The paper ends with a discussion of scientific rigor in action research and what the new work practices imply for the development team. (shrink)

The acknowledgement of basic human vulnerability in relationships between mental health service users and professionals working in community-based mental health services (in Norway) was a starting point. The purpose was to explore how users of these services describe and make sense of their meetings with other people. The research is collaborative, with researcher and person with experienced-based knowledge cooperating through the research process. Data is derived from 19 interviews with 11 people who depend on mental health services for (...) assistance at least three times a week. Data is analysed according to the Interpretative Phenomenological Analysis (IPA). Results confirm that reciprocity is fundamental for relationships, and that recognizing the individual entails personal involvement. The participants describe a struggle, and recognizing this struggle may help the professional to achieve a deeper understanding of the individual. (shrink)

Automated software engineering has attracted a large amount of research efforts. The use of object-oriented methods for software systems development has made it necessary to develop approaches that automate the construction of different Unified Modeling Language models in a semiautomated approach from textual user requirements. UML use case models represent an essential artifact that provides a perspective of the system under analysis or development. The development of such use case models is very crucial in an object-oriented development method. (...) The main principles used in obtaining these models are described. A natural language processing tool is used to parse different statements of the user requirements written in Arabic to obtain lists of nouns, noun phrases, verbs, verb phrases, etc., that aid in finding potential actors and use cases. A set of steps that represent our approach for constructing a use case model are presented. Finally, the proposed approach is validated using an experiment involving a group of graduate students who are familiar with use case modeling. (shrink)

This study will be of interest to anyone concerned with a critical appraisal of mental health service users’ and carers’ participation in research collaboration and with the potential of the postcolonial paradigm of cultural safety to contribute to the service user research (SUR) movement. The history and nature of the mental health field and its relationship to colonial processes provokes a consideration of whether cultural safety could focus attention on diversity, power imbalance, cultural dominance and structural inequality, (...) identified as barriers and tensions in SUR. We consider these issues in the context of state‐driven approaches towards SUR in planning and evaluation and the concurrent rise of the SUR movement in the UK and Australia, societies with an intimate involvement in processes of colonisation. We consider the principles and motivations underlying cultural safety and SUR in the context of the policy agenda informing SUR. We conclude that while both cultural safety and SUR are underpinned by social constructionism constituting similarities in principles and intent, cultural safety has additional dimensions. Hence, we call on researchers to use the explicitly political and self‐reflective process of cultural safety to think about and address issues of diversity, power and social justice in research collaboration. (shrink)

BackgroundLiving labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far.ObjectiveOur aim was to determine a pragmatic, (...) ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context.MethodsA narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed.ResultsIndividuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 ‘A’s Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).ConclusionsIncluding individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population. (shrink)

The widespread trend to transferirrigation management responsibility from the stateto “communities” or local user groups has byand large ignored the implications ofintra-community power differences for theeffectiveness and equity of water management. Genderis a recurrent source of such differences. Despitethe rhetoric on women‘s participation, a review ofevidence from South Asia shows that femaleparticipation is minimal in water users‘organizations. One reason for this is that theformal and informal membership criteria excludewomen. Moreover, the balance between costs andbenefits of participation is often negative (...) forwomen because complying with the rules and practicesof the organization involves considerable time costsand social risks, whereas other ways to obtainirrigation services may be more effective for femalewater users. Although effective, these other andoften informal ways of obtaining irrigation servicesare also typically less secure. More formalparticipation of women can strengthen women‘sbargaining position as resource users withinhouseholds and communities. Greater involvement ofwomen can also strengthen the effectiveness of theorganization by improving women‘s compliance withrules and maintenance contributions. Furtherdetailed and comparative research is required toidentify the major factors that affect women‘sparticipation and control over resources, ifdevolution policies are to address the tensionbetween objectives of transferring control overresources to community institutions, and ensuringthe participation of all members of the community,especially women. (shrink)

Biomedical research policy in recent years has often tried to make such research more ‘translational’, aiming to facilitate the transfer of insights from research and development to health care for the benefit of future users. Involving patients in deliberations about and design of biomedical research may increase the quality of R&D and of resulting innovations and thus contribute to translation. However, patient involvement in biomedical research is not an easy feat. This paper discusses the (...) development of a method for involving patients in biomedical research aiming to address its main challenges.After reviewing the potential challenges of patient involvement, we formulate three requirements for any method to meaningfully involve patients in biomedical research. It should enable patients to put forward their experiential knowledge, to develop a rich view of what an envisioned innovation might look like and do, and to connect their experiential knowledge with the envisioned innovation. We then describe how we developed the card-based discussion method ‘Voice of patients’, and discuss to what extent the method, when used in four focus groups, satisfied these requirements. We conclude that the method is quite successful in mobilising patients’ experiential knowledge, in stimulating their imaginaries of the innovation under discussion and to some extent also in connecting these two. More work is needed to translate patients’ considerations into recommendations relevant to researchers’ activities. It also seems wise to broaden the audience for patients’ considerations to other actors working on a specific innovation. (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 (...) class='Hi'>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)

Research on sexual violence is fraught with ethical and methodological challenges due to its sensitive nature. This paper describes the ethical and methodological challenges encountered in planning and conducting two exploratory studies on sexual violence that included in-depth interviews of eight female adolescent rape survivors in Ibadan and four married women in Lagos Nigeria who were raped, forced to perform sexual acts and sexually deprived. The first challenge encountered was an Institutional Review Board requirement to obtain parental permission from (...) adolescents, when such a requirement may place the adolescent at risk if a parent was a perpetrator of sexual violence. Using arguments emphasizing the Council for International Organization for Medical Sciences guidelines helped convince the IRB to provide a waiver of parental consent. Second, the privacy required to conduct in-depth interviews for rape survivors was difficult to achieve because five of the rape survivors were apprentices who work in public settings which are typically used to conduct business in the informal sector. To overcome this challenge, interviews were conducted in safe locations, investigator's offices and homes of survivors. The culture of silence associated with sexual violence posed a challenge because it encourages perpetration of violence with impunity causing rape survivors to suffer in silence. None of the affected adolescents had sought judicial redress for rape despite availability of stringent punishment for this behaviour. Referral information was provided on where survivors could seek care. Interviews with the women could not be recorded on audio-tapes because of concerns that their partners might identify their voices from the tapes and punish them for this. Although research on sexual violence poses ethical and methodological challenges, it is not only desirable but also feasible to conduct such research in ways that ensure safety of participants. (shrink)

Biomedical research policy in recent years has often tried to make such research more ‘translational’, aiming to facilitate the transfer of insights from research and development to health care for the benefit of future users. Involving patients in deliberations about and design of biomedical research may increase the quality of R&D and of resulting innovations and thus contribute to translation. However, patient involvement in biomedical research is not an easy feat. This paper discusses the (...) development of a method for involving patients in biomedical research aiming to address its main challenges. (shrink)

Social work students in England now have to register with the General Social Care Council and ?sign up to? the codes of practice. These specify that social workers must not ?behave in a way, in work or outside work, which would call into question [their] suitability to work in social care services'. This paper describes a small and ongoing piece of doctoral research into social work students' perceptions of professional regulation. The policy context for social work regulation is outlined, (...) including the implications for social work educators and students. The paper discusses the ethical and methodological issues which arose when planning the study. In conclusion, regulation has benefits for service users and professionals, but its implementation involves difficult ethical decisions. When students' suitability is called into question, there are implications for their personal and professional identities: exploring these implications will be the focus of the next stage of the research. (shrink)

The importance of patient involvement is increasing in healthcare, and initiatives are constantly implemented to reach the ideal of involved and educated patients. This secondary analysis was initially embedded in a randomized controlled study where the aim was to gain insight into perceptions and experiences within a group of women undergoing fertility treatment through two focus group interviews. In this secondary analysis, we investigated how patient involvement was strived for in both clinical practice and research. During the (...) analysis, it became apparent that the women exercised and maintained a clear perspective on their hope for a child, Project Child, while the interviewer pursued a treatment perspective, Project Treatment. Despite different perspectives, the conversation during the interviews seemed effortless, and it became apparent how the interviewer and the participants were actually focusing partly on the same, but primarily on different issues but without addressing or acknowledging this. Knowledge and awareness of the difference in perspectives is important when healthcare professionals seek to involve patients both in clinical practice and in research. Patient involvement in both research and clinical practice has shown to be a challenge and entails that pathways are organized and decisions shared by healthcare professionals. (shrink)

The author traces the ways in which various patients and collective associations of patients come to regard themselves as the users of future stem cell technologies. The author uses Althusser’s notion of interpellation, whereby an identity is the result of the situated encounter of a subject and an authority, to analyze the ways in which patient associations’ current involvement with basic research is related to the enactment of science as a series of technology development projects. The author argues (...) that this ‘‘project-ness’’ forms a certain privileged logic that interpellates patients and their associations in specific ways. Through the listings of illnesses circulated in the mass media, which are hoped to be treatable or curable with stem cell therapies, patients come to recognize themselves as the projected users of stem cell technologies. The author fleshes out the process of this userfication and the various responses made by patients and their associations when hailed by the entrepreneurial projects of stem cell research. (shrink)

Higher education has been changing radically in recent years, with increasing numbers of students, and complaints about declining standards. This volume brings together leading intellectuals from the US and UK to examine the issues involved.

Increasing pragmatic and ethical concerns have been raised about the inadequacies of conventional approaches to agricultural research and extension worldwide and the lack of integrated efforts among researchers, extension educators, and users. This paper examines three models of these relationships: the diffusion or supply model; the induced innovation or demand model; and the synthesis triangular or supply/demand model. The triangular model builds and improves upon the previous models by focusing on the role of clients or users in the broadest (...) sense in creating a demand for science and extension education, as well as on the role of scientists and extension educators in creating a supply. The triangular model views the relationship as an interactive partnership in which research and extension education are conducted in response to client needs and demands expressed through negotiation, persuasion, and coercion involving all partners. To implement this model will require significant organizational and managerial changes as well as reorientation in the values and attitudes of researchers, extension educators, clients, and their organizations. The remainder of the paper presents a brief discussion of suggested strategies at the individual, institutional, regional, national, and international levels for enhancing this partnership in order to more effectively meet the future needs of our food system. (shrink)

Scandals involving celebrities’ moral transgressions are common in both Western and Eastern cultures. Existing literature, however, has been primarily based on Western cultures. We examine differences between South Korea and the United States in consumers’ support for celebrities engaged in moral transgressions and for the brands they endorse. Across six studies, we find that Korean consumers show lower support for celebrities who engaged in moral transgressions. This effect occurs because Korean consumers have a stronger belief that an individual’s competence and (...) morality are interconnected. Thus, Korean consumers are less likely to separate their judgments of celebrities’ morality and competence in professional performance, thereby lowering support for the celebrities. Building on the proposed mechanism, we identify the moderating role of transgression relevance. When a moral transgression is relevant to the domain of the celebrity’s professional competence, the difference in celebrity support between the two countries is attenuated. This difference extends to the support for a brand endorsed by the celebrity transgressor when the brand retains the celebrity endorser, but not when the brand dismisses the endorser. (shrink)

Studies of how scientists select research problems suggest the process involves weighing a number of factors, including funding availability, likelihood of success versus failure, and perceived publishability of likely results, among others. In some fields, a strong personal interest in conducting science to bring about particular social and environmental outcomes plays an important role. Conservation biologists are frequently motivated by a desire that their research will contribute to improved conservation outcomes, which introduces a pair of challenging questions for (...) managers of science and scholars of policies governing science: 1) How do scientists integrate that goal into their processes of research priority evaluation, and 2) How can managers and funders of science utilize that knowledge in designing and administering funding programs? I use Q method to uncover four distinct schools of thought amongst researchers and knowledge-users about the merits of possible research priorities for coral reefs; one of the axes along which these schools of thought differ is in their interpretation of how science can and should interact with policy. The results reveal that perceived severity of reef stressors plays a role for some participants. Disciplinary training does not appear to be a major influence on research priority evaluation, but individual participants indicated professional expediency does prevent some researchers from pursuing or advocating that others pursue topics outside of that disciplinary specialty. Influences on and processes in research prioritization uncovered in this study have the potential to lead to counter-productive disciplinary path dependencies. From these results and building on outside literature, I conclude that better coordination and communication about research priorities across disciplines and with broader stakeholders – including knowledge users – could improve the research enterprise’s ability to contribute to meaningful societal and conservation goals. These findings are relevant to researchers and research administrators across disciplines that seek to conduct or fund science that is useful in addressing specific goals. (shrink)

SALMON A, BROWNE AJ, and PEDERSON A. Nursing Inquiry 2010; 17: 336–345 ‘Now we call it research’: participatory health research involving marginalized women who use drugsIn this paper, we discuss and analyse the strategies employed and challenges encountered when conducting a recent feminist participatory action research study with highly marginalized women who were illicit drug users in an inner city area of Vancouver, Canada. Through an analysis of the political economy of participatory praxis within current neoliberal contexts, (...) we focus on three main areas: (i) reconceptualizing the pragmatics of participation; (ii) the microeconomic implications of participatory research, including ethical issues in payment for research participation; and (iii) the value and limits of using research as a tool for activism and empowerment. We conclude with a brief discussion of what we see to be some of the most salient social justice implications arising from feminist and participatory approaches to health research within neoliberal political spaces. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and (...) explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

Background Community involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the (...) population affected when conducting research have been established in these fields. But what is the role of community engagement in clinical research and observational studies conducted in biomedical research outside of these specific areas? Main body of the abstract More than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies recommended the constitution of a formal organism, the Community Advisory Board, as part of the study requirements for HIV trials. More recently, CABs have been adopted and used in other fields of medical research, such as malaria. CABs are not without limitations, however, and there is little research on the effectiveness of their use in achieving community protection and participation. Nevertheless, CABs could be a model to import into clinical trials and observational research where no alternative model of community representation is currently being used. Conclusions Allocating more resources to training and shifting more power to community representatives could be part of the solution to current CAB limitations. However, for researchers to be able to apply these recommendations on community involvement, certain conditions need to be met. In particular, funding agencies need to recognize the human and financial resources required for serious community involvement, and the academic environment needs to take community involvement into account when appraising, mentoring, and training researchers. (shrink)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the (...) researcher to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts’ perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social issues in order to lead (...) to socially responsible innovation. Semi-structured interviews were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers in two contexts of use. Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device, to use, and to user influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees’ judgments of acceptability. Giving consideration to researchers’ perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD. (shrink)

Many research institutions and funders have recently stated their commitment to actively support and promote ‘Equality, Diversity and Inclusion’ (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that existing approaches, practical guidelines and initiatives have not adequately addressed. In this paper, we explore how the lack of clear justifications for the EDI commitment in existing guidelines inadvertently complicates the work of (...) those involved with PPI and we stress the need for conceptual clarity for any EDI effort to yield meaningful results. Our focus centres on the first principle of the EDI discourse, ‘equality’, particularly in the form of ‘equality of opportunity’ as outlined in current guidance provided by the National Institute of Health Research in the United Kingdom. We examine challenges related to justifying and implementing a general, unspecified commitment to equality of opportunity and explain that this reflects a lack of consensus regarding the moral value of PPI in research – a profound problem that remains unaddressed. We then discuss how the presence of several opposing moral perspectives on PPI, makes determining the most appropriate way of addressing barriers to involvement complex and controversial, raising ethical implications for the work of health researchers, PPI specialists and coordinators. Finally we make suggestions on how future research can enrich the concept of ‘equality of opportunity’ in PPI and improve practice. While our primary focus is on the NIHR, a strong advocate of PPI in research, this analysis will point to normative and ethical considerations that may be relevant to other research institutions and funding organisations aiming to promote equality of opportunity in their public and patient involvement strategies. (shrink)

This paper outlines a critical, textual approach for the analysis of the relationship between different actors in information technology (IT) production, and further concretizes the approach in the analysis of the role of users in the open source software (OSS) development literature. Central concepts of the approach are outlined. The role of users is conceptualized as reader involvement aiming to contribute to the configuration of the reader (to how users and the parameters for their work practices are defined in (...) OSS texts). Afterwards, OSS literature addressing reader involvement is critically reviewed. In OSS context, the OSS writers as readers configure the reader and other readers are assumed to be capable of and interested in commenting the texts. A lack of OSS research on non-technical reader involvement is identified. Furthermore, not only are the OSS readers configured, but so are OSS writers. In OSS context while writers may be empowered, this clearly does not apply to the non-technical OSS readers. Implication for research and practice are discussed. (shrink)

Pharmacogenomics is a quickly evolving field of research that increasingly impacts individuals and society. As some innovations in biotechnology have experienced strong public opposition during the 1990s, interaction between producers and users of these innovations may help in increasing their success in social and economic terms. However, conditions for effective interaction have so far remained under-explored. This paper explores user-producer interactions in pharmacogenomics from an innovation and science communication perspective in the Netherlands. To find possible ways of engaging (...) stakeholders in an early stage of technology development, ie, when science policy is in the making, we present communication activities derived from the field of policy analysis. To articulate motives for two-way public participation in genomics innovation processes, we describe two levels at which pharmacogenomics developments will have an input:1) at the meso-level of medical practice with already established medical technologies, values and routines, suppliers and health professionals (general practitioners, pharmacists), and 2) at the macro-level of society at large, with established institutions, infrastructures, and broadly shared values and beliefs among citizens in general. Thereby we offer a starting point for optimising decision-making processes in the field of pharmacogenomics innovations, including important aims to be reached, stakeholders to be involved, and some criteria for designing interactive communication activities. (shrink)

I am working as both a TEFL teacher and an SLA researcher in China, doing SLA research. Recently, I have been working on new approaches to data analysis and I’ve found that a book titled “Data Visualization and Analysis in Second Language Research” by Dr. Guilherme D. Garcia is of great significance in empirical research in the field of SLA. This book serves only as a practical and user-friendly guide to beginners involved in SLA research, (...) but also navigation to veteran SLA researchers devoted to new perspectives in data analysis. So far, the author has made his first attempt to connect data visualization under R to SLA research. The author reviews the previous research results and suggests some modifications through running R. From my perspective, it fills a gap in the SLA research practice—to lead readers into a new track of visualizing their reported results. Overall, to make an increasingly higher demand for SLA research, this book is particularly designated for quantitative data analysis in SLA. It is strongly recommended to write a book review to introduce readers to the realm of data visualization and help most SLA researchers better understand the potential value of R and visualization in SLA research. (shrink)

Four research strategies currently employed by mainstream psychologists in researching the experiences and behaviors of human subjects are criticized for diminishing the presence of subjectivity. Two perspectives that tend to exaggerate subjectivity are also criticized. A balanced approach to subjectivity is offered that: acknowledges a theoretical perspective that recognizes that there are invisible or nonsensorial characteristics of subjectivity that have to be theoretically appropriated, and that emphasizes the intersubjective dimension as being critical for properly assessing a balanced approach to (...) human subjectivity. A subject-dependent perspective that can efface its own interests is the attitude that is required for the achievement of objectivity. (shrink)

The ethical issues in conducting research on preventing HIV infection are among the most complex of any area of human subjects research. This article is an update of a 1987 article that addressed potential conflicts between research design and ethics with respect to AIDS prevention among injecting drug users. The present article reviews current ethical issues that arise in the design and conduct of HIV/AIDS prevention research focused on injecting drug users.

Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV serodiscordance among (...) IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention. (shrink)

With its wealth of readily and often publicly available information about Web users’ lives, the Web has created new opportunities for conducting online research. Although digital data are easily accessible, ethical guidelines are inconsistent about how researchers should use them. Some academics claim that traditional ethical principles are sufficient and applicable to online research. However, the Web poses new challenges that compel researchers to reconsider concerns of consent, privacy and anonymity. Based on doctoral research into the investigation (...) of online medicine purchasing, this article presents a case study involving online forums, and reviews the existing ethical guidance surrounding the Web. The suggestion is that new ethical guidelines, particularly in relation to informed consent and participants’ own perceptions of what is public or private, are needed owing to the unique challenges of online research. (shrink)

This paper examines the ethical issues that arise when healthcare providers act as gatekeepers to research involving vulnerable populations. Traumatised refugees serve as an example of this subset of research participants. Highlighting the particular vulnerabilities of this group, we argue that specific ethical considerations are required that go beyond the conventional research approaches. While gatekeeping responds to some of those vulnerabilities, it risks wronging through unwarranted paternalism. Instead, we will propose that a relational ethics of justice and (...) care serves as a more appropriate framework for responding to the challenges of research involving traumatised refugees. Specifically, such a framework allows us to reflect more deeply on the role of the gatekeeper. In conclusion, we recommend that clinicians and researchers collaborate with survivors’ advisory groups in the development of specific research ethical guidelines. (shrink)

In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we (...) fail to observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large. (shrink)

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...) researcher’s ethical responsibilities in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)