Am I a control?: Genotype-driven research recruitment and self-understandings of study participants

Genotype-driven research recruitment complicates traditional study roles and may leave those recruited worried about unwelcome surprises from their DNA. This study investigated the ways that individuals experience genotype-driven recruitment, and conceptualize their roles as research participants

The Meaning of Genetic Research Results: Reflections from Individuals with and without a Known Genetic Disorder

In the debate about whether to return individual genetic results to research participants, consideration of the nature of results has taken precedence over contextual factors associated with different study designs and populations. We conducted in-depth interviews with 24 individuals who participated in a genotype-driven study of cystic fibrosis: 9 of the individuals had cystic fibrosis, 15 had participated as healthy volunteers, and all had gene variants of interest to the researchers. These interviews revealed that the two groups had different ideas about the meaningfulness of genetic results. Our findings point to the importance of understanding research context, such as participants’ relationship with the researcher and whether they have the disease condition under study, when considering whether to return individual results

What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty — that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted “in the public square.

Research Participants' Perspectives on Genotype-Driven Research Recruitment

Genotype-Driven Recruitment is a potentially powerful approach for studying human genetic variation but presents ethical challenges. We conducted in-depth interviews with research participants in six studies where such recruitment occurred. Nearly all responded favorably to the acceptability of recontact for research recruitment, and genotype-driven recruitment was viewed as a positive sign of scientific advancement. Reactions to questions about the disclosure of individual genetic research results varied. Common themes included explaining the purpose of recontact, informing decisions about further participation, reciprocity, “information is valuable,” and the possibility of benefit, as well as concerns about undue distress and misunderstanding. Our findings suggest contact about additional research may be least concerning if it involves a known element (e.g., trusted researchers). Also, for genotype-driven recruitment, it may be appropriate to set a lower bar for disclosure of individual results than the clinical utility threshold recommended more generally

Breaking barriers: using the behavior change wheel to develop a tailored intervention to overcome workplace inhibitors to breaking up sitting time

© The Author(s). 2019. Background: The workplace is a prominent domain for excessive sitting. The consequences of increased sitting time include adverse health outcomes such as cardiovascular disease and poor mental wellbeing. There is evidence that breaking up sitting could improve health, however, any such intervention in the workplace would need to be informed by a theoretical evidence-based framework. The aim of this study was to use the Behaviour Change Wheel (BCW) to develop a tailored intervention to break up and reduce workplace sitting in desk-based workers. Methods: The BCW guide was followed for this qualitative, pre-intervention development study. Semi-structured interviews were conducted with 25 office workers (26–59years, mean age 40.9 [SD=10.8] years; 68% female) who were purposively recruited from local council offices and a university in the East of England region. The interview questions were developed using the Theoretical Domains Framework (TDF). Transcripts were deductively analysed using the COM-B (Capability, Opportunity, Motivation – Behaviour) model of behaviour. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate change in sitting behaviour of office workers in a future intervention. Results: Qualitative analysis using COM-B identified that participants felt that they had the physical Capability to break up their sitting time, however, some lacked the psychological Capability in relation to the knowledge of both guidelines for sitting time and the consequences of excess sitting. Social and physical Opportunity was identified as important, such as a supportive organisational culture (social) and the need for environmental resources (physical). Motivation was highlighted as a core target for intervention, both reflective Motivation, such as beliefs about capability and intention and automatic in terms of overcoming habit through reinforcement. Seven intervention functions and three policy categories from the BCW were identified as relevant. Finally, 39 behaviour change techniques (BCTs) were identified as potential active components for an intervention to break up sitting time in the workplace. Conclusions: The TDF, COM-B model and BCW can be successfully applied through a systematic process to understand the drivers of behaviour of office workers to develop a co-created intervention that can be used to break up and decrease sitting in the workplace. Intervention designers should consider the identified BCW factors and BCTs when developing interventions to reduce and break up workplace sitting

This broken vessel: Living religion in an independent Pentecostal church

In collective worship and in their everyday lives, religious believers continually fuse together the ideas and practices they encounter in their community and society, in their places of worship, and in their personal experiences of the divine. This dissertation, based on six years of engaged, intensive ethnography with a community of Pentecostal believers in the southern United States, flows from the proposition that people’s individual religious identities are not simply products of their faith community. Rather, religious people constantly negotiate individual and communal religious identities, and both are continually changing as they shape one another in dynamic relationship. In this work, three spaces of religious practice serve as lenses through which to view religious identity production. The first, music and musical worship, offers a perspective on the crucial role of music in the church and its often transformative role in individual and collective identity formation. The second, a creative effort at evangelistic outreach through drama ministry, presents an opportunity to look at the choices a body of believers makes in order to present itself and its vision of Christian life to the surrounding community, and at the ways that individual and group identities change, conflict, and grow through collective creativity. The third space of religious practice, entrances and exits from the church community, invites a closer examination of the ways that relationships between individual and communal religious identities are built and dismantled, and the ways that identities are formed as narrative constructions. All of these spaces of practice and identity production take shape between the individual, the social, and the divine, as believers continually take into account their relationships not only with other believers and non-believers, but also with God and lesser supernatural agents. Taking seriously these believers’ accounts and insights reveals understandings of the everyday process of building religious identities that have much in common with complex social theories of identity and everyday life, but are in some ways broader and more holistic

What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty — that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted “in the public square.

The Meaning of Genetic Research Results: Reflections from Individuals with and without a Known Genetic Disorder

In the debate about whether to return individual genetic results to research participants, consideration of the nature of results has taken precedence over contextual factors associated with different study designs and populations. We conducted in-depth interviews with 24 individuals who participated in a genotype-driven study of cystic fibrosis: 9 of the individuals had cystic fibrosis, 15 had participated as healthy volunteers, and all had gene variants of interest to the researchers. These interviews revealed that the two groups had different ideas about the meaningfulness of genetic results. Our findings point to the importance of understanding research context, such as participants’ relationship with the researcher and whether they have the disease condition under study, when considering whether to return individual results

Impact of Telehealth on the Delivery of Prenatal Care During the COVID-19 Pandemic: Mixed Methods Study of the Barriers and Opportunities to Improve Health Care Communication in Discussions About Pregnancy and Prenatal Genetic Testing

BackgroundThe COVID-19 pandemic brought significant changes in health care, specifically the accelerated use of telehealth. Given the unique aspects of prenatal care, it is important to understand the impact of telehealth on health care communication and quality, and patient satisfaction. This mixed methods study examined the challenges associated with the rapid and broad implementation of telehealth for prenatal care delivery during the pandemic. ObjectiveIn this study, we examined patients’ perspectives, preferences, and experiences during the COVID-19 pandemic, with the aim of supporting the development of successful models to serve the needs of pregnant patients, obstetric providers, and health care systems during this time. MethodsPregnant patients who received outpatient prenatal care in Cleveland, Ohio participated in in-depth interviews and completed the Coronavirus Perinatal Experiences-Impact Survey (COPE-IS) between January and December 2021. Transcripts were coded using NVivo 12, and qualitative analysis was used, an approach consistent with the grounded theory. Quantitative data were summarized and integrated during analysis. ResultsThematic saturation was achieved with 60 interviews. We learned that 58% (35/60) of women had telehealth experience prior to their current pregnancy. However, only 8% (5/60) of women had used both in-person and virtual visits during this pregnancy, while the majority (54/60, 90%) of women participated in only in-person visits. Among 59 women who responded to the COPE-IS, 59 (100%) felt very well supported by their provider, 31 (53%) were moderately to highly concerned about their child’s health, and 17 (29%) reported that the single greatest stress of COVID-19 was its impact on their child. Lead themes focused on establishing patient-provider relationships that supported shared decision-making, accessing the information needed for shared decision-making, and using technology effectively to foster discussions during the COVID-19 pandemic. Key findings indicated that participants felt in-person visits were more personal, established greater rapport, and built better trust in the patient-provider relationship as compared to telehealth visits. Further, participants felt they could achieve a greater dialogue and ask more questions regarding time-sensitive information, including prenatal genetic testing information, through an in-person visit. Finally, privacy concerns arose if prenatal genetic testing or general pregnancy conversations were to take place outside of the health care facility. ConclusionsWhile telehealth was recognized as an option to ensure timely access to prenatal care during the COVID-19 pandemic, it also came with multiple challenges for the patient-provider relationship. These findings highlighted the barriers and opportunities to achieve effective and patient-centered communication with the continued integration of telehealth in prenatal care delivery. It is important to address the unique needs of this population during the pandemic and as health care increasingly adopts a telehealth model