Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded six (...) themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent. (shrink)

It is sometimes objected that anti-individualism, because of its assumption of the constitutive role of natural and social environments in the individuation of intentional attitudes, raises sceptical worries about first-person authority--that peculiar privilege each of us is thought to enjoy with respect to non-Socratic self-knowledge. Gary Ebbs believes that this sort of objection can be circumvented, if we give up metaphysical realism and scientific naturalism and adopt what he calls a “participant perspective” on our linguistic practices. Drawing on broadly Wittgensteinian (...) considerations, I argue that Ebbs is right about this, and I show how two likely objections to his view can be circumvented. I also argue that mere adoption of the participant perspective does not serve to refute external-world sceptic. (shrink)

Objective—To explore the opinions of unpaid healthy volunteers on the payment of research subjects.Design—Prospective cohort.Setting—Southern Alberta, Canada.Participants—Medically eligible persons responding to recruiting advertisements for a randomised vaccine trial were invited to take part in a study of informed consent at the point at which they formally consented or refused trial participation. Of 72 invited, 67 returned questionnaires at baseline and 54 at follow-up.Outcome measures—Proportions of persons who agreed or disagreed with three close-ended statements on the payment of research subjects; themes (...) and categories identified by content analysis of responses to an open-ended question.Results—A minority agreed with paying either patient or healthy volunteer participants. Opinions did not change over time. Participants' comments addressed: benefits and drawbacks to research participation; benefits and drawbacks to paying research participants; conditions under which payment of research subjects would be acceptable, and the nature of acceptable recognition. Acceptable conditions were to improve problematic recruitment, to reimburse costs, and to recognise participants, particularly for their time investment. Both non-monetary and monetary recognition of volunteers were thought to be appropriate.Conclusions—Most unpaid volunteers disagreed with paying research participants. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs. (shrink)

Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and (...) study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: words and regulation; reimbursement, suspicions, and joining; and responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust. (shrink)

Around the world, many schools were closed as one of the measures to contain the spread of the COVID-19 pandemic. School closure brought about important challenges to the students' learning process. This context requires strong self-regulatory competences and agency for autonomous learning. Moreover, online remote learning was the main alternative response to classroom learning, which increased the inequalities between students with and without access to technological resources or for those with low digital literacy. All considered, to level the playing field (...) for students without digital resources, there is an urgent need to promote self-regulatory competences through offline intervention solutions. The current paper describes a project with this purpose, using radio broadcasting and letters to reach elementary students without digital resources. Moreover, potential reach and participants' perspectives of the project implementation are presented and discussed. The project draws on a prior evidence-based story-tool intervention grounded on a self-regulated learning framework. The original intervention was set previous to the COVID-19 pandemic and was implemented in the classroom context (N= 1,103 students). Once the schools had been closed down, the mode of intervention was adapted with the collaboration of the community. Alternative solutions were developed as follows: (i) story chapters were read on the radio and students received to their homes a printed script, prompting reflection, and suggesting related activities; (ii) students were provided with the story-tool to read autonomously and received letters from the main characters of the story which included, for example, suggestions for activities and reflection. These two alternative modes of intervention delivery potentially reached 394 elementary students, including students with digital resources. Interviews conducted with a group of students were provided information about the positive aspects of these two modes of intervention delivery, perceived learning (e.g., planning), constraints, and suggestions to improve the project. The current work is likely to merit attention from researchers and educational practitioners, given the need to use offline alternatives to provide support for students without digital resources to engage in autonomous learning during the pandemic period. This project may also be used as an alternative or a complementary solution to online modality. (shrink)

Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...) of adding a dynamic consent interface to their existing study. Methods Adult participants in the Extended Cohort for E-health, Environment and DNA longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent. Results Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED. Conclusions Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study. (shrink)

The aim of this article was to critically analyse the concept of person-centred participation in healthcare from patients’ perspectives through a review of qualitative research findings. In accordance with the integrative review method of Broom, data were retrieved from databases, but 60 studies were finally included in the study. The diverse attributes of person-centred participation in healthcare were identified and contrasted with participation that was not person-centred and analysed through framework analysis. Person-centred participation in healthcare was found to be (...) based on patients’ experiences, values, preferences and needs in which respect and equality were central. It manifested itself via three intertwined phases: the human-connection phase, the phase of information processing and the action phase. The results challenge in many aspects earlier concept analyses of patient participation in addition to illuminating patient participation that is not positively valued by patients. (shrink)

Genetic results are usually not returned to research participants in Uganda despite their increased demand. We report on researchers’ perceptions and experiences of return of individual genetic research results. The study involved 15 in-depth interviews of investigators involved in genetics and/or genomic research. A thematic approach was used to interpret the results. The four themes that emerged from the data were the need for return of individual results including incidental findings, community engagement and the consenting process, implications and challenges to (...) return of individual results. While researchers are willing to return clinically significant genetic results to research participants, they remain unsure of how this should be implemented. Suggestions to aid implementation of return of results included reconsenting of participants before receiving individual genetic results and increasing access to genetic counseling services. Community engagement to determine community perceptions and individual preferences for the return of results, and also prepare participants to safely receive results emerged as another way to support return of results. Researchers have a positive attitude toward the return of clinically significant genetic results to research participants. There is need to develop national guidance on genetic research and also build capacity for clinical genetics and genetic counseling. (shrink)

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals and Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more (...) than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives. (shrink)

The efficacy of traditional training programs (e.g., neurodevelopmental therapy) in promoting independent mobility and early child development across all three International Classification of Functioning, Disability, and Health levels lacks rigorous research support. Therefore, early power mobility training needs to be considered as a feasible intervention for very young children who are unlikely to achieve independent mobility. This perspective article has three aims: (1) to provide empirical evidence of differences in early independent mobility, motivation, daily life activities, and social participation between (...) young children with typical development and motor disabilities; (2) to discuss the contemporary concepts of and approaches to early power mobility training for young children with motor disabilities and the current need for changes to such training; and (3) to provide recommendations for early power mobility training in pediatric rehabilitation. Independent mobility is critical for social participation; therefore, power mobility can be accessible and implemented as early as possible, specifically for infants who are at risk for mobility or developmental delay. To maximize the positive effects of independent mobility on children’s social participation, early power mobility training must consider their levels of functioning, the amount of exploration and contextual factors, including individual and environmental factors. (shrink)

In European industrialized countries, a large number of companies in the healthcare, hotel, and catering sectors, as well as in the technology sector, are affected by demographic, political, and technological developments resulting in a greater need of skilled workers with a simultaneous shortage of skilled workers (CEDEFOP, 2015, 2016). Consequently, employers have to address workers who have not been taken into account such as low-skilled workers, workers returning from a career break, people with a migrant background, older people, and jobseekers (...) and train them, in order to guarantee the professionalization of this workforce (Festing and Harsch, 2018). Continuing vocational education and training (CVET) is seen as an indispensable tool; because CVET has advantages for both employers and employees, it helps to increase the productivity of companies (Barrett and O’Connell, 2001), to prevent the widening of socioeconomic disparities (Dieckhoff, 2007), and to open up career opportunities for the workforce (Rubenson and Desjardins, 2009). However, participation rate on CVET seems to differ, depending on institutional factors (such as sector and size of the company) and individual characteristics (such as qualification level, migration background, age and time of absence from work) (e.g., Rubenson and Desjardins, 2009; Wiseman and Parry, 2017). In contrast to previous research, our study aims to provide a holistic view of reasons for and against CVET, combining the different perspectives of employers and (potential) employees. The analysis of reasons and barriers was carried out based on semi-structured interviews. Fifty-seven employers, 73 employees, and 42 jobseekers (potential employees) from the sectors retail, healthcare and social services, hotels and catering, and technology were interviewed. Results point to considerable differences in the reasons and barriers mentioned by the disadvantaged groups. These differences are particularly significant between employees on the one side and employers, as well as jobseekers, on the other side, while the reasons to attend CVET of jobseekers are more similar to those of employers. The results can be used to tailor CVET more closely to the needs of (potential) employees and thus strengthen both the qualification and career opportunities of (potential) employees and the competitiveness and productivity of companies. (shrink)

This article is comprised of three sections (each in subsequent regular issues of EPAT) that explore the concept of participation. Section I: Introduction and Early Perspectives grounds our exploration of participation and explores definitions and early perspectives of participation we have identified as ‘historically original’ and ‘philosophical’. Section II: Participation as Engagement in Experience—An Aesthetics Perspective is a continuation of our conceptual exploration of participation that digs into the world of aesthetics. Finally, Section III: The Utilitarian Perspective and (...) Conclusion focuses on utilitarian meanings of participation from political and international development perspectives. Collectively, these sections focus on the meaning and deconstruction of the term, participation. By bringing attention to gradations in meaning, we hope to raise awareness of the superficial use of participation that is reflected in much of the educational literature and highlight possibilities that more thoughtfully formulated and consciously chosen meanings of participation could offer the field of education. (shrink)

Recruiting participants from underserved and marginalized communities for behavioral research is an essential yet challenging task. We examined participants' motivation to participate in a focus group about health communication and their beliefs about appropriate remuneration for participation. Twelve focus groups were conducted with low-income African American and Latina adolescent girls and African American women. We utilized a grounded theory approach and thematic analysis to examine views about research participation and remuneration. This study can inform important considerations about the consent process, (...) study recruitment, and remuneration. (shrink)

Research biobanks are heterogeneous and exist to manage diverse biosample types with the goal of facilitating and serving biomedical discovery. The perspectives of biobank managers are reviewed, and the perspectives of two biobank directors, one with experience in institutional biobanks and the other with national cooperative group banks, are presented. Most research biobanks are not designed, nor do they have the resources, to return research results and incidental findings to participants or their families.

BackgroundA fundamental ethical challenge in conducting genomics research is the question of what and how individual level genetic findings and aggregate genomic results should be conveyed to research participants and communities. This is within the context of minimal guidance, policies, and experiences, particularly in Africa. The aim of this study was to explore the perspectives of key stakeholders' on returning genomics research results to participants in Kenya.MethodsThis qualitative study involved focus group discussions (FGDs) and in-depth interviews (IDIs) with 69 (...) stakeholders. The purposively selected participants, included research ethics committee (REC) members (8), community members (44), community resource persons (8), and researchers (9). A semi-structured interview guide was used to facilitate discussions. Six FGDs and twenty-five (IDIs) were conducted among the different stakeholders. The issues explored in the interviews included: (1) views on returning results, (2) kind of results to be returned, (3) value of returning results to participants, and (4) challenges anticipated in returning results to participants and communities. The interviews were audio-recorded, transcribed verbatim, and coded in Nvivo 12 pro. Thematic and content analysis was conducted.ResultsParticipants agreed on the importance of returning genomic results either as individual or aggregate results. The most cited reasons for returning of genomic results included recognizing participants' contribution to research, encouraging participation in future research, and increasing the awareness of scientific progress. Other aspects on how genomic research results should be shared included sharing easy to understand results in the shortest time possible and maintaining confidentiality when sharing sensitive results.ConclusionsThis study identified key stakeholders’ perspectives on returning genomic results at the individual and community levels in two urban informal settlements of Nairobi. The majority of the participants expect to receive feedback about their genomic results, and it is an obligation for researchers to see how to best fulfil it. (shrink)

The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study (...) at research sites in the Western Cape and Gauteng, South Africa. (shrink)

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures (...) is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. (shrink)

This is the second section of an article (each section in subsequent regular issues of EPAT) that explores the concept of participation. Section I: Introduction and Early Perspectives grounds our exploration of participation and explores definitions and early perspectives of participation we have identified as ‘historically original’ and ‘philosophical.’ Section II: Participation as Engagement in Experience—An Aesthetics Perspective is a continuation of our conceptual exploration of participation that digs into the world of aesthetics. Finally, Section III: The Utilitarian (...) Perspective and Conclusion focuses on utilitarian meanings of participation from political and international development perspectives. Collectively, these sections focus on the meaning and deconstruction of the term, participation. By bringing attention to gradations in meaning, we hope to raise awareness of the superficial use of participation that is reflected in much of the educational literature and highlight possibilities that more thoughtfully formulated and consciously chosen meanings of participation could offer the field of education. (shrink)

This is the third section of an article (each published in subsequent regular issues of EPAT) that explores the concept of participation. Section I: Introduction and Early Perspectives grounds our exploration of participation and explores definitions and early perspectives of participation we have identified as ‘historically original’ and ‘philosophical’. Section II: Participation as Engagement in Experience—An Aesthetics Perspective is a continuation of our conceptual exploration of participation that digs into the world of aesthetics. Finally, Section III: The Utilitarian (...) Perspective and Conclusion focuses on utilitarian meanings of participation from political and international development perspectives. Collectively, these sections focus on the meaning and deconstruction of the term, participation. By bringing attention to gradations in meaning, we hope to raise awareness of the superficial use of participation that is reflected in much of the educational literature and highlight possibilities that more thoughtfully formulated and consciously chosen meanings of participation could offer the field of education. (shrink)

Various quantitative analyses have stressed the connection between lower socioeconomic status (SES) and low political participation. The general argument behind these studies was that since political participation is crucial for democracy, and since low SES compromises political participation, liberal democratic governments cannot afford such a compromise. This paper argues that presenting political participation as a democratic value, corresponding to a ‘positive’ right, places the implied argumentation of such studies in a potential conflict with classical liberalism and its contemporary ‘successors’, emphasizing (...) ‘negative’ rights alone. However, the tension can be reconciled by employing the political thought of John Locke, one of the forefathers of classical liberalism. Thus, the paper illuminates a strong bond in Locke’s thought between democratic political participation and liberal natural rights. In fact, I argue that it is precisely his advocacy of liberal rights that leads to a conception of political participation, converging with democratic theory and redistributive policies. (shrink)

While the need to protect vulnerable research participants is universal, conceptual challenges with the notion of vulnerability may result in the under or over-protection of participants. Ethics review bodies making assumptions about who is vulnerable and in what circumstance can be viewed as paternalistic if they do not consider participant viewpoints. Our study focuses on participant vulnerability in Scholarship of Teaching and Learning (SoTL) research. We aim to illuminate students’ views on participant vulnerability to contribute to critical analysis of the (...) role and processes of ethics review. Additionally, we aim to highlight the importance of seeking the views of participant communities, especially in research environments beyond ethics review’s medical origins. Thirty-four students from a health-related faculty at a university in Aotearoa New Zealand, participated in five focus groups. Participants discussed factors affecting their potential participation in research drawing upon a series of vignettes based on examples of published SoTL projects. Themes, generated using reflexive thematic analysis, built a participant-informed picture of vulnerability. Findings indicate that students do not generally consider themselves vulnerable and instead consider participation in SoTL research through an agentic lens. Students expect that participation will be voluntary, not negatively impact their grades, and not single them out so that others could judge them. Our study also highlights the value students place on relationships with one another and teaching staff and the implications these have for SoTL research participation and future professional practice. This research challenges research ethics committees to think further about vulnerability in the context of SoTL whilst highlighting the importance of providing opportunities for research participants more broadly to explore and vocalize their views as members of participant communities. (shrink)

The study focused on the adventure-based experiential learning component of the North-West University peer helper training program. The aim of this study was to explore and describe a group of peer helpers’ subjective experiences of their participation in an ABEL program, with a focus on how these experiences related to the concept of grit. A total of 26 students at the North-West University, both male and female, participated in the study. A qualitative research approach with a case study research design (...) was used. The participants completed daily reflective diaries for the duration of the three-day ABEL program. After 3 months of performing their duties as peer helpers, the same individuals participated in focus group interviews. Themes were identified through inductive analysis and discussed regarding their relevance to the concept of grit. The main themes that emerged from both phases of data collection included intra-, inter-, and transpersonal/transcendent aspects, within which participants regularly referred to elements of grit. It was concluded that ABEL, due to its unique nature and demands, provides an ideal mechanism for the facilitation of personal growth on various levels. More specifically, through its clear association with the improvement and/or development of participants’ grit, it could equip these students to be more effective in their role as peer helpers. (shrink)

ObjectivesHostile attribution bias is reportedly common from non-clinical population to those with serious mental illness, such as schizophrenia, and is known to be closely related to theory of mind. This study aimed to investigate whether ToM skills mediate the relationship among neurocognitive ability, personality traits, and attribution bias.MethodsA total of 198 non-clinical youths were recruited. To assess their neurocognitive ability and ToM skills, the participants were asked to complete Raven’s Standard Progressive Matrices and the Korean version of the Reading the (...) Mind in Eyes Test. To determine their personality traits, the Eysenck Personality Questionnaire and interpersonal reactivity index were used. To evaluate hostile attribution bias, the Ambiguous Intentions Hostility Questionnaire was administered. Path analysis and bias-corrected percentile bootstrap methods were used to estimate model fit and the parameters of the mediating effects.ResultsBased on model comparison, the best model characterized two direct pathways from psychoticism and the K-RMET to hostility attribution bias and three indirect pathways, wherein SPM, perspective taking, and psychoticism influenced hostile attribution bias through K-RMET. The final model fit indices were good [x2/df = 1.126; comparative fit index = 0.996; root mean square error of approximation = 0.026; standard root mean square residual = 0.026 and Akaike information criterion = 28.251] and the K-RMET fully mediated the association between SPM, perspective taking, psychoticism, and hostile attribution bias.ConclusionThe main findings suggested that ToM skills, such as the RMET, play an important role in explaining the relationship among neurocognitive ability, personality traits, and hostile attribution bias. ToM skills and a remediation strategy may need to be developed to balance the enhanced hostility bias that underlies the paranoia. (shrink)

We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.

This paper asks how the intensity of individual local eParticipation affects users’ perception of democratically valuable effects. Drawing on participatory and deliberative theory literature we extract four participatory effects- internal political efficacy, common good orientation, tolerance, and legitimacy. Furthermore, the paper examines which cognitive factors may moderate the relationship between intensity of participation and perception of participatory effects. Drawing on online survey data from 670 citizens engaged in public budgeting online consultations on the local level, the conducted path analysis shows (...) that intensity of participation seems to foster the perception of common good orientation and tolerance. The other perceptions of participatory effects were not influenced by participation intensity. Findings on moderating factors indicate that the beneficial effects of online participation were not distributed unequally among participants. In conclusion, the research presents evidence for an optimistic view on local eParticipation that is able to promote democratically valuable user experiences. (shrink)

The ethical parameters of business research, especially that undertaken by doctoral candidates, are an under researched area. This exploratory research analyses research ethics in the business and management contexts as espoused in perceived low risk ethics applications from business doctoral candidates in light of the principles of Australian research ethics guidelines. Applications are also analysed in terms of power relationships, methods of access and informed consent, pressure to complete research expeditiously, conflict of interest and cross-cultural understandings. Findings suggest that research (...) design, personal relationships with participants and nuanced understandings of the contextual dimensions of risk may be of concern in the proposed research. However, a reflexive process also questions the cultural and other assumptions of both researchers and ethics administrators underlying these concerns. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

Trust has a great potential for furthering our understanding of organizational change and learning. This potential however remains largely untapped. It is argued that two reasons as for why this potential remains unrealized are: (i) A narrow conceptualization of change as implementation and (ii) an emphasis on direct and aggregated effects of individual trust to the exclusion of other effects. It is further suggested that our understanding of the effects of trust on organizational change, should benefit from including effects of (...) trust on the formulation stage. It should also benefit from exploring the structuring effects of trust in organizations. Throughout this chapter, ways to extend current research on trust in organizations are suggested. The chapter also provides examples of relevant contributions where available. In order to capture organizational effects of trust, it is suggested that trust should be studied over longer time intervals, and include several referents of trust, spanning both horizontal and vertical relationships in the organization. (shrink)

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment (...) of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver. (shrink)

Public health aims to provide universal safety and progressive opportunities to populations to realise their highest level of health through prevention of disease, its progression or transmission. Screening asymptomatic individuals to detect early unapparent conditions is an important public health intervention strategy. It may be designed to be compulsory or voluntary depending on the epidemiological characteristics of the disease. Integrated screening, including for both syphilis and cancer of the cervix, is a core component of the national reproductive health program in (...) Kenya. Screening for syphilis is compulsory while it is voluntary for cervical cancer. Participants’ perspectives of either form of screening approach provide the necessary contextual information that clarifies mundane community concerns. (shrink)

Change is the new normal, but so it has been for ages. Experience to navigate change is something you get just after you needed it, unless you tap into age-old experience. The Fourth Industrial Revolution (4IR) is bringing about wide-ranging changes. With people having to adjust, the question is whether Christianity, with its roots in preindustrial times, may support people to navigate these changes. This conceptual article focusses on the relationships amongst constructs, exploring logical arguments about how these constructs are (...) associated. The 4IR is briefly described from differing vantage points, as to whether it is a valid description thereof. Whether a revolution or evolution, it is a complex system, and therefore the theory of complex systems is used, with the conclusion that one may merely participate in such systems. Being novel situations, one needs to participate creatively, based on a cognitive understanding of creativity. Creative solutions do not materialise out of thin air but are the novel use of existing knowledge structures. Christian traditions include institutional memories of how people managed situations of radical change, as reflected in Genesis 1 and Lamentations 4. These passages provide building blocks that may be used in creative coping strategies during times of change. Both passages suggest the strategy to juxtapose order and chaos, and borrowing from that, a ‘Grip-Grapple-Grow’ scaffolding system is suggested. To test the usability thereof, the issue of face masks during the Coronavirus Disease 2019 pandemic was touched upon, to evaluate how the interplay amongst 4IR, disruption, (Christian) beliefs and technological advancement may play out. Contribution: The Fourth Industrial Revolution is speeding up the pace of change, with people having to adapt. This article explores processes of change management, juxtaposing the theory of complex systems, the cognitive science understanding of creativity and institutional memories afforded by some Christian traditions reflecting on how people managed order and chaos. (shrink)

Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. (...) Methods We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (shrink)

This study explored perceived benefits and risks of participation in HIV research among 33 female sex workers in Tecún Umán, Guatemala. Stigma associated with sex work and HIV was a critical barrier to research participation. Key benefits of participation included access to HIV/sti prevention and testing, as well as positive and trusting relationships between sex workers and research teams. Control exerted by managers had mixed influences on perceived research risks and benefits. Results underscore the critical need for HIV investigators to (...) develop population-tailored procedures to reduce stigma; engage managers; and reinforce trusting, reciprocal relationships between sex work communities and researchers. (shrink)

This article examines Robert Alexy's account of legal validity. It concludes that Alexy's account of legal validity lacks sufficient support given the author's methodological commitments. To reach that conclusion, it assesses the plausibility of simultaneously maintaining that the participant's perspective has conceptual privilege in the explanation of the nature of law, that legal discourse is a special case of general practical discourse, and that unjust considerations can be legally valid norms.

In recent years, many online communities have launched opinion-gathering activities to promote user participation in innovation and improve the quality of new products. The current methods for online innovation activities can be divided into two categories: cognitive guidance and affective guidance. However, the studies on online communities have mainly focused on user engagement motivations, and little attention has been paid to investigating the impact and underlying mechanism of innovation guidance on user participation at the linguistic level. This study first collected (...) secondary data from NetEase.com and conducted an econometric model to explore the impact of cognitive guidance and affective guidance on users’ participation in online innovation activities. Subsequently, we investigated the impact mechanism of different innovation guidance methods on user participation through two experiments, here by drawing on mental simulation theory. The experimental results showed that outcome simulation and process simulation imposed a dual mediating effect of innovation guidance on user participation. In addition, we also found that product types moderate the dual mediating effect of outcome simulation and process simulation. The findings can deepen and expand the research on user participation while providing practical implications for companies and platforms as they attempt to promote user participation in innovation activities. (shrink)