Decades of public investment in molecular technologies and data integration techniques have fueled promises of precision medicine (PM) as a novel, targeted, and data-driven approach that takes into...

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking (...) business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. (shrink)

The potential of ChatGPT looms large for the practice of medicine, as both boon and bane. The use of Large Language Models (LLMs) in platforms such as ChatGPT raises critical ethical questions of w...

The combination of decreased genotyping costs and prolific social media use is fueling a personal genetic testing industry in which consumers purchase and interact with genetic risk information online. Consumers and their genetic risk profiles are protected in some respects by the 2008 federal Genetic Information Nondiscrimination Act (GINA), which forbids the discriminatory use of genetic information by employers and health insurers; however, practical and technical limitations undermine its enforceability, given the everyday practices of online social networking and its impact (...) on the workplace. In the Web 2.0 era, employers in most states can legally search about job candidates and employees online, probing social networking sites for personal information that might bear on hiring and employment decisions. We examine GINA's protections for online sharing of genetic information as well as its limitations, and propose policy recommendations to address current gaps that leave employees? genetic information vulnerable in a Web-based world. (shrink)

Precision medicine relies on data and biospecimens from participants who willingly offer their personal information on the promise that this act will ultimately result in knowledge that will improv...

The rise of genomic technologies has catalyzed shifts in the health care landscape through the commercialization of genome sequencing and testing services in the genomics marketplace. The development of consumer genomics into a growing array of information technologies aimed at collecting, curating, and broadly sharing personal data and biological materials reconstitutes the meaning of health and reframes patients into biocitizens. In this context, the good biocitizen is expected to assume personal responsibility for health through consumption of genomic information and acquiescence (...) to public and private efforts at data surveillance and aggregation. These shifts raise fundamental questions about how competing interests of the public, the state, and corporate entities will be reconciled and what trade‐offs are demanded for the promise of precision health. (shrink)

The American Journal of Bioethics, Volume 12, Issue 4, Page 41-43, April 2012.

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information direct-to-consumers. Companies such as 23andme and Navigenics are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science of (...) the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

ELSI efforts long have been troubled by critiques that they privilege scientific frameworks and grant scientists the power to set ethical agendas. As the first director of the Human Genome Project’...

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often‐ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science—including genomewide association studies and polygenic indexes—can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of SBG research. (...) SBG research that compares individuals within a group according to a “sensitive” phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk‐benefit profile. (shrink)

Bioethicists frequently call for empirical researchers to engage participants and community members in their research, but don't themselves typically engage community members in their normative research. In this article, we describe an effort to include members of the public in normative discussions about the risks, potential benefits, and ethical responsibilities of social and behavioral genomics (SBG) research. We reflect on what might—and might not— be gained from engaging the public in normative scholarship and on lessons learned about public perspectives on (...) the risks and potential benefits of SBG research and the responsible conduct and communication of such research. We also provide procedural lessons for others in bioethics who are interested in engaging members of the public in their research. (shrink)

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator (...) and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

Background In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal.Methods Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for.Results We find that ad hoc, opportunistic, and instrumental approaches to CE exacted significant (...) consequences for the time and resources devoted to engagement and the ultimate impacts it has on research. Critical differences emerged when engagement and research decisionmaking were integrated with each other versus occurring in parallel, separate parts of the study organization, and whether community members had the ability to determine which issues would be brought to them for consideration or to revise or even veto proposals made upstream based on criteria that mattered to them. CE was understood to have a range of purposes, from instrumentally facilitating recruitment and data collection, to advancing community priorities and concerns, to furthering long-term investments in relationships with and changes in communities. These choices about who to engage, what engagement activities to support, how to solicit and integrate community input into the workflow of the study, and what CE was for were often conditioned upon preexisting perceptions and upstream decisions about study goals, competing priorities, and resource availability.Conclusions Upstream choices about CE and constraints of time and resources cascade into tradeoffs that often culminated in “pantomime community engagement.” This approach can create downstream costs when engagement is experienced as improvised and sporadic. Transformations are needed for CE to be seen as a necessary scientific investment and part of the scientific process. (shrink)

This paper examines the legal and ethical aspects of traceback testing, a process in which patients who have been previously diagnosed with ovarian cancer are identified and offered genetic testing so that their family members can be informed of their genetic risk and can also choose to undergo testing. Specifically, this analysis examines the ethical and legal limits in implementing traceback testing in cases when the patient is deceased and can no longer consent to genetic testing.

New technologies are transforming and reconfiguring the boundaries between patients, research participants and consumers, between research and clinical practice, and between public and private domains. From personalised medicine to big data and social media, these platforms facilitate new kinds of interactions, challenge longstanding understandings of privacy and consent, and raise fundamental questions about how the translational patient pathway should be organised.This editorial introduces the cross-journal article collection "Translation in healthcare: ethical, legal, and social implications", briefly outlining the genesis of the (...) collection in the 2015 Translation in healthcare conference in Oxford, UK and providing an introduction to the contemporary ethical challenges of translational research in biology and medicine accompanied by a summary of the papers included in this collection. (shrink)

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. (...) Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges. (shrink)

Scientists now agree that common diseases arise through interactions of genetic and environmental factors, but there is less agreement about how scientific research should account for these interactions. This paper examines the politics of quantification in gene–environment interaction research. Drawing on interviews and observations with GEI researchers who study common, complex diseases, we describe quantification as an unfolding moral economy of science, in which researchers collectively enact competing “virtues.” Dominant virtues include molecular precision, in which behavioral and social risk factors (...) are moved into the body, and “harmonization,” in which scientists create large data sets and common interests in multisited consortia. We describe the negotiations and trade-offs scientists enact in order to produce credible knowledge and the forms of discipline that shape researchers, their practices, and objects of study. We describe how prevailing techniques of quantification are premised on the shrinking of the environment in the interest of producing harmonized data and harmonious scientists, leading some scientists to argue that social, economic, and political influences on disease patterns are sidelined in postgenomic research. We consider how a variety of GEI researchers navigate quantification’s productive and limiting effects on the science of etiological complexity. (shrink)

This book provides practical and research-based chapters that offer greater clarity about the particular kinds of teacher reflection that matter and avoids talking about teacher reflection generically, which implies that all kinds of reflection are of equal value.

BackgroundThis study aimed to identify the healthcare providers’ experience and perspectives toward end-of-life care decisions focusing on end-of-life discussion and physician’s order of life-sustaining treatment documentation in Korea which are major parts of the Life-Sustaining Treatment Act.MethodsA cross-sectional survey was conducted using a questionnaire developed by the authors. A total of 474 subjects—94 attending physicians, 87 resident physicians, and 293 nurses—participated in the survey, and the data analysis was performed in terms of frequency, percentage, mean and standard deviation using the (...) SPSS 24.0 program.ResultsStudy results showed that respondents were aware of terminal illness and physician’s order of life-sustaining treatment in Korea well enough except for some details. Physicians reported uncertainty in terminal state diagnosis and disease trajectory as the most challenging. Study participants regarded factors (related to relationships and communications) on the healthcare providers’ side as the major impediment to end-of-life discussion. Study respondents suggested that simplification of the process and more staff are required to facilitate end-of-life discussion and documentation.ConclusionBased on the study results, adequate education and training for better end-of-life discussion are required for future practice. Also, a simple and clear procedure for completing a physician’s order of life-sustaining treatment in Korea should be prepared and legal and ethical advice would be required. Since the enactment of the Life-Sustaining Treatment Act, several revisions already have been made including disease categories, thus continuous education to update and support clinicians is also called for. (shrink)

One of the most salient objections against paternalism is that it is motivated by a negative judgment about other people’s capacity to advance their own goals and interests. Such a negative judgment, according to this objection, is morally wrong because it denies others the status of moral equals who can rationally set and pursue their own conception of the good. Despite the popularity of this objection, I argue that it misfires because rendering a negative judgment about others’ capacities does not (...) deny them equal moral status when there is sufficient _evidence_ for that judgment. However, I argue that in order to determine if there is sufficient evidence of the agent’s incapacity, we must understand the agent’s reasons for action through a rational discursive exchange with them, instead of taking perceived facts about their behavior as sufficient grounds for a negative (or positive) judgment of their capacities. In fact, I argue that if the outcome of the discursive exchange supports a negative judgment of the agent’s capacities, there is a _pro tanto_ case in favor of paternalistic interference. (shrink)

According to T.M. Scanlon, the core idea of contractualism consists in the claim that what we are morally required to do is conceptually grounded in the value of living in “relations of mutual recognition” with others. Specifically, Scanlon's contractualist idea of “living in relations of mutual recognition with others” requires that one act only in ways that cannot be reasonably rejected by all of those affected, according to the results of a hypothetical reflection conducted within one's own mind. I claim, (...) however, that Scanlon is mistaken to rely on a single individual's hypothetical reflection (monological reflection) to determine what no one affected could reasonably reject. Instead, following Jürgen Habermas, I claim that we must engage in actual dialogue with all who stand to be affected, in order to live in relations of mutual recognition with others. (shrink)

Supporters of paternalistic policies argue that interference with risky or dangerous choices for citizens’ own good is permissible, as long as those choices are caused by cognitive irrationality or ignorance. Yet, some liberal thinkers argue that despite human irrationality, paternalistic policies are still wrong because they fail to respect citizens as moral equals. I argue that actually both views are mistaken about what respect for citizens requires, because they conceptualize the citizens’ interests from the wrong standpoint. In order for citizens (...) to be respected as equals, I argue that citizens’ interests must be defined from a joint (second-person) standpoint which is constructed through a dialogical process between policymakers and citizens oriented towards mutual understanding. Furthermore, I argue that engaging citizens in such a dialogue is a distinctive paternalistic intervention in its own right, which unlike other kinds of paternalistic intervention, is compatible with respect for citizens as equals. (shrink)

Supporters of paternalistic policies argue that interference with risky or dangerous choices for citizens’ own good is permissible, as long as those choices are caused by cognitive irrationality or ignorance. Yet, some liberal thinkers argue that despite human irrationality, paternalistic policies are still wrong because they fail to respect citizens as moral equals. I argue that actually both views are mistaken about what respect for citizens requires, because they conceptualize the citizens’ interests from the wrong standpoint. In order for citizens (...) to be respected as equals, I argue that citizens’ interests must be defined from a joint (second-person) standpoint which is constructed through a dialogical process between policymakers and citizens oriented towards mutual understanding. Furthermore, I argue that engaging citizens in such a dialogue is a distinctive paternalistic intervention in its own right, which unlike other kinds of paternalistic intervention, is compatible with respect for citizens as equals. (shrink)

Supporters of paternalistic policies argue that interference with risky or dangerous choices for citizens’ own good is permissible, as long as those choices are caused by cognitive irrationality or ignorance. Yet, some liberal thinkers argue that despite human irrationality, paternalistic policies are still wrong because they fail to respect citizens as moral equals. I argue that actually both views are mistaken about what respect for citizens requires, because they conceptualize the citizens’ interests from the wrong standpoint. In order for citizens (...) to be respected as equals, I argue that citizens’ interests must be defined from a joint (second-person) standpoint which is constructed through a dialogical process between policymakers and citizens oriented towards mutual understanding. Furthermore, I argue that engaging citizens in such a dialogue is a distinctive paternalistic intervention in its own right, which unlike other kinds of paternalistic intervention, is compatible with respect for citizens as equals. (shrink)

Supporters of paternalistic policies argue that interference with risky or dangerous choices for citizens’ own good is permissible, as long as those choices are caused by cognitive irrationality or ignorance. Yet, some liberal thinkers argue that despite human irrationality, paternalistic policies are still wrong because they fail to respect citizens as moral equals. I argue that actually both views are mistaken about what respect for citizens requires, because they conceptualize the citizens’ interests from the wrong standpoint. In order for citizens (...) to be respected as equals, I argue that citizens’ interests must be defined from a joint (second-person) standpoint which is constructed through a dialogical process between policymakers and citizens oriented towards mutual understanding. Furthermore, I argue that engaging citizens in such a dialogue is a distinctive paternalistic intervention in its own right, which unlike other kinds of paternalistic intervention, is compatible with respect for citizens as equals. (shrink)

The purpose of this study was to identify how older Korean people seek information and their desire to participate in decision making about their health care. A total of 165 elderly people living in Seoul, South Korea, participated in the study. Data were collected during individual interviews using the Autonomy Preference Index. The mean information-seeking score was high. The mean score for their desire to participate with a physician in decision making was lower, but this was higher when family members (...) were involved. The study indicates that many older people want to receive information about their health care. Families (or guardians), as well as older people themselves, should be included in the decision-making process. Nurses can encourage older people to express their wishes, while treating each individual with respect. (shrink)

Korean biobanks are now adapting to integrate the new paradigm of precision medicine into their fundamental role of promoting health technology. Since the enactment of Bioethics and Safety Act in 2004, the Republic of Korea has developed a regulatory framework that reflects ethical principles. However, the existing regulation of biobanks has recently proven to be limited in responding to newer ethical and legal issues that have arisen. First, as there is an emerging trend for human biospecimens to be stored, managed (...) and distributed as digitalized data, the current role of the Distributive Review Committee may become less important compared to the Data Access Committee. Second, even if public health data is anonymized, the risk of identifiability is growing. This makes a third point relevant, informed consent is crucial to respect the autonomy of patients and research subjects, but current consent rules need to change to reflect the interactive and dynamic communication process, in which information and communication technology plays an increasingly prominent role. Fourth, even though data sharing for research is expected to be altruistic and the sale of human biospecimens and genome data remains prohibited, data sharing practices have become more complicated and are closer to commercial use and commercialization. Given these challenges, there is a pressing need for continuing and deeper deliberation in order to develop a more comprehensive and responsive governance framework. (shrink)

BackgroundAttention deficit hyperactivity disorder is clinically diagnosed; however, quantitative analysis to statistically analyze the symptom severity of children with ADHD via the measurement of head movement is still in progress. Studies focusing on the cues that may influence the attention of children with ADHD in classroom settings, where children spend a considerable amount of time, are relatively scarce. Virtual reality allows real-life simulation of classroom environments and thus provides an opportunity to test a range of theories in a naturalistic and (...) controlled manner. The objective of this study was to investigate the correlation between participants’ head movements and their reports of inattention and hyperactivity, and to investigate how their head movements are affected by different social cues of different sensory modalities.MethodsThirty-seven children and adolescents with and without ADHD were recruited for this study. All participants were assessed for diagnoses, clinical symptoms, and self-reported symptoms. A virtual reality-continuous performance test was conducted under four conditions: control, no-cue, visual cue, and visual/audio cue. A quantitativecomparison of the participants’ head movements was conducted in three dimensions using a head-mounted display in a VR classroom environment. Task-irrelevant head movements were analyzed separately, considering the dimension of movement needed to perform the VR-CPT.ResultsThe magnitude of head movement, especially task-irrelevant head movement, significantly correlated with the current standard of clinical assessment in the ADHD group. Regarding the four conditions, head movement showed changes according to the complexity of social cues in both the ADHD and healthy control groups.ConclusionChildren and adolescents with ADHD showed decreasing task-irrelevant movements in the presence of social stimuli toward the intended orientation. As a proof-of-concept study, this study preliminarily identifies the potential of VR as a tool to understand and investigate the classroom behavior of children with ADHD in a controlled, systematic manner. (shrink)

Bartky draws on the experience of daily life to unmask the many disguises by which intimations of inferiority are visited upon women. She critiques both the male bias of current theory and the debilitating dominion held by notions of "proper femininity" over women and their bodies in patriarchal culture.

In a rare full-length volume, renowned feminist thinker Sandra Lee Bartky brings together eight essays in one volume, Sympathy and Solidarity. A philosophical work accessible to an educated general audience, the essays reflect the intersection of the author's eye, work, and sometimes her politics. Two motifs connect the works: first, all deal with feminist topics and themes; second, most deal with the reality of oppression, especially in the disguised and subtle ways it can be manifested.

Moral psychology studies the features of cognition, judgement, perception and emotion that make human beings capable of moral action. Perspectives from feminist and race theory immensely enrich moral psychology. Writers who take these perspectives ask questions about mind, feeling, and action in contexts of social difference and unequal power and opportunity. These essays by a distinguished international cast of philosophers explore moral psychology as it connects to social life, scientific studies, and literature.