In 2017 Ploug and Holm argued that anonymizing individuals in the Danish circumcision registry was insufficient to protect these individuals from what they regard as the potential harms of being in the registry. We argue that Ploug and Holm’s fears in each of the areas are misguided, not supported by the evidence, and could interfere with the gathering of accurate data. The extent of the risks and harms associated with ritual circumcision is not well known. The anonymized personal health data (...) supplemented with the circumcision registry will enable more precise research into the medical consequences of ritual circumcision, and allow parents to make more fully informed decisions about circumcision with minimal, if any, adverse consequences. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues (...) relating to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (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)

Through the use of culturally appropriate videos on precision medicine research (PMR) that were developed and tailored to five racial and ethnic groups of patients, and subsequent focus-group discu...

Key to precision medicine is the development of expert database projects that gather data, integrate them in the pre-existing database, and publish the product of their processing for others to make use of. Increasingly, it is required that data infrastructure managers and curators pursue and lead research projects on the data so as to learn about new ways data could be used or information that could be potentially generated from them. I call these efforts “data curation-research” and (...) use the case study of COSMIC, the Catalogue of Somatic Mutations in Cancer, to analyze the contextual factors shaping the science of data curation-research. I build on March’s organizational learning categories of exploitation and exploration to place these factors within a theory of organizational change and innovation, and contribute to a richer picture of the social drivers of cancer genomics. (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)

Both Morain and Largent (2023) and Garland, Morain, and Sugarman (2023) recognize the ethical challenges inherent in clinician participation in embedded research. Focusing on the question of integr...

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 paper problematizes the precision medicine approach embraced by the All of Us Research Program (US) and by Genomics England (UK) in terms of benefits distribution, by arguing that current “diversity and inclusion” efforts do not prevent exclusiveness, unless the framing and scope of the projects are revisited in public health terms. Grounded on document analysis and fieldwork interviews, this paper analyzes efforts to address potential patterns of exclusion upstream (from participating in precision medicine research) and (...) downstream (from benefitting from precision medicine outputs). It argues that efforts for inclusion upstream are not corresponded downstream, and this unbalance jeopardizes the equitable capacities of the projects. It concludes that enhanced focus on socio-environmental determinants of health and aligned public health interventions as precision medicine outputs would be to the benefit of all and especially of those who are most at risk of (upstream as well as downstream) exclusion. (shrink)

One of the concerns that citizen science shares with the evolving practice of precision medicine is how to approach oversight for N-of-1 or N-of-many-1’s research. In their target article, Wiggins...

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)

In management research, theory testing confronts a paradox described by Meehl in which designing studies with greater methodological rigor puts theories at less risk of falsification. This paradox exists because most management theories make predictions that are merely directional, such as stating that two variables will be positively or negatively related. As methodological rigor increases, the probability that an estimated effect will differ from zero likewise increases, and the likelihood of finding support for a directional prediction boils down to (...) a coin toss. This paradox can be resolved by developing theories with greater precision, such that their propositions predict something more meaningful than deviations from zero. This article evaluates the precision of theories in management research, offers guidelines for making theories more precise, and discusses ways to overcome barriers to the pursuit of theoretical precision. (shrink)

Dr. Galasso’s (2024) insightful article expands the ongoing debate on the utility and equity of precision medicine in public and population health. The initiatives mentioned, Genomics England and t...

Lee emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics a...

The success of precision medicine depends on obtaining large amounts of information about at-risk populations. However, getting consent is often difficult. Why? In this commentary I point to the differentials in social status involved. These differentials are inevitable once personal information is surrendered, but are particularly intense when the studied populations are socioeconomically or socioculturally disadvantaged and/or ethnically stigmatized groups. I suggest how the deep distrust of the latter groups can be partially justified as a lack of confidence that (...) their core values or interests will sufficiently be taken into account. Hence, the ethical challenge here lies not in avoiding status differentials, but in dealing with them appropriately. Scientists should not assume trust from others but adopt a norm of “demonstrating trustworthiness”. (shrink)

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision (...) medicine initiatives, it is important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

Although continued investments in nanotechnology are made, atomically precise manufacturing (APM) to date is still regarded as speculative technology. APM, also known as molecular manufacturing, is a token example of a converging technology, has great potential to impact and be affected by other emerging technologies, such as artificial intelligence, biotechnology, and ICT. The development of APM thus can have drastic global impacts depending on how it is designed and used. This paper argues that the ethical issues that arise from APM (...) - as both a standalone technology or as a converging one - affects the roles of stakeholders in such a way as to warrant an alternate means furthering responsible innovation in APM research. This paper introduces a value-based design methodology called Value Sensitive Design (VSD) that may serve as a suitable framework to adequately cater to the values of stakeholders. Ultimately, it is concluded that VSD is a strong candidate framework for addressing the moral concerns of stakeholders during the preliminary stages of technological development. (shrink)

In their target article, Galasso (2024) highlights the limitations of upstream inclusion in precision medicine research to produce downstream benefits to participants and proposes precision public...

Many countries currently invest in technologies and data infrastructures to foster precision medicine (PM), which is hoped to better tailor disease treatment and prevention to individual patients. But who can expect to benefit from PM? The answer depends not only on scientific developments but also on the willingness to address the problem of structural injustice. One important step is to confront the problem of underrepresentation of certain populations in PM cohorts via improved research inclusivity. Yet, we argue that (...) the perspective needs to be broadened because the (in)equitable effects of PM are also strongly contingent on wider structural factors and prioritization of healthcare strategies and resources. When (and before) implementing PM, it is crucial to attend to how the organisation of healthcare systems influences who will benefit, as well as whether PM may present challenges for a solidaristic sharing of costs and risks. We discuss these issues through a comparative lens of healthcare models and PM-initiatives in the United States, Austria, and Denmark. The analysis draws attention to how PM hinges on—and simultaneously affects—access to healthcare services, public trust in data handling, and prioritization of healthcare resources. Finally, we provide suggestions for how to mitigate foreseeable negative effects. (shrink)

The United States’ ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients’ empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical (...) and sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term “genomic citizenship”; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the development of policies, structures, and procedures that can maximize the initiative's ability to produce equitable and socially sensitive outcomes. Our analysis can also be applied to other population-based, precision medicine research programs. (shrink)

Galasso (2024) provides a strong critique of precision medicine research initiatives regarding their potential for the exclusion of populations based on upstream and downstream factors with “Genomi...

Precision Medicine has become a common label for data-intensive and patient-driven biomedical research. Its intended future is reflected in endeavours such as the Precision Medicine Initiative in the USA. This article addresses the question whether it is possible to discern a new ‘medical cosmology’ in Precision Medicine, a concept that was developed by Nicholas Jewson to describe comprehensive transformations involving various dimensions of biomedical knowledge and practice, such as vocabularies, the roles of patients and physicians and (...) the conceptualisation of disease. Subsequently, I will elaborate my assessment of the features of Precision Medicine with the help of Michel Foucault, by exploring how precision medicine involves a transformation along three axes: the axis of biomedical knowledge, of biomedical power and of the patient as a self. Patients are encouraged to become the managers of their own health status, while the medical domain is reframed as a data-sharing community, characterised by changing power relationships between providers and patients, producers and consumers. While the emerging Precision Medicine cosmology may surpass existing knowledge frameworks; it obscures previous traditions and reduces research-subjects to mere data. This in turn, means that the individual is both subjected to the neoliberal demand to share personal information, and at the same time has acquired the positive ‘right’ to become a member of the data-sharing community. The subject has to constantly negotiate the meaning of his or her data, which can either enable self-expression, or function as a commanding Superego. (shrink)

Galasso (2024) shares findings from narrative analyses of relevant constituting material of and interviews with leaders in two national precision medicine research (PMR) programs: 100KGP of Genomic...

Precision medicine impacts virtually all medical specializations, including psychiatry. Though precision psychiatry, in general, is a flourishing area of research and debate, psychotherapy as one pillar of psychiatry has received little attention. Theoretical discussions about precision psychotherapy are rare; research on precision in psychotherapy is just evolving. In this paper we provide a conceptualization of precision psychotherapy providing a common idea of what should be understood as precision in the context of psychotherapy (...) and what kind of psychotherapy research can be considered to contribute to the aims of precision psychotherapy. (shrink)

BackgroundPrecision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review.MethodsWe used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided (...) 665 different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine.ResultsMany patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health.ConclusionsNational legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine’s benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients’ decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment. (shrink)

Both in the case of colloquial language and in the case of specialized scientific language we always have to face the essential issue : what must we do in order not to be misled by an incorrect use of language? When we refer in general to being misled by some use of language we have two cases in mind: primo, when the language in question wrongly performs its communicative function so that the speaker is unable to convey his ideas to (...) the listener, and, secundo, when the language by means of which we think imposes on us, through its structure and forms fixed by tradition (in the case of natural languages), incorrect ideas about reality (cf. the issues of hypostases). The causes of such and similar difficulties are varied. These difficulties, among other things, suggest the idea that language is not only an instrument, but also an object of research, an idea which induced twentieth century philosophers to engage in the study of language in its ontological, gnosiological, and methodological aspects. The method of semantic analysis, understood as a method of analysis of meanings of words, is directed precisely against these shortcomings of language. That method is meant to prevent semantic and logical errors that encumber the process of thinking with difficulties and hamper communication both with others and with oneself. Among other causes, these errors are due to the ambiguity and vagueness of words. (shrink)

Video surveillance plays a vital role in maintaining the social security although, until now, large uncertainty still exists in danger understanding and recognition, which can be partly attributed to intractable environment changes in the backgrounds. This article presents a brain-inspired computing of attention value of surrounding environment changes with a processes-based cognition model by introducing a ratio valueλof EC-implications within considered periods. Theoretical models for computation of warning level of EC-implications to the universal video recognition efficiency are further established. Imbedding (...) proposed models into the online algorithms is suggested as a future research priority towards precision security for critical applications and, furthermore, schemes for a practical implementation of such integration are also preliminarily discussed. (shrink)

Precision medicine functions by grouping patients along genetic, molecular, and related ‘-omics’ factors. This stratification relies on large, growing databases of patient-volunteered information. Both private companies and government bodies incentivize patients to volunteer this genetic information appealing to the creation of collaborative patient partnerships and the concept of empowerment. This paper aims to address two related questions: (1) what is the actual nature of patient participation in precision medicine research? And (2) is this participation in precision (...) medicine research really that empowering for the average patient? I contend that firstly, the nature of this participation is best conceived of as merely contributory. Contributory participation, as it will be shown, falls short of collaboration. The partnership created by participation in precision medicine research is not one of sharing values, equal say in decisions, or shared benefit. Secondly, I contend that there are important caveats to claims that patient participation in precision medicine is empowering. Empowerment is hindered by the type of participation, the practical use or actionability of genetic data, genetic literacy, the cost of precision drugs for patients that qualify for them, and bioethical considerations of informed consent. (shrink)

There has been a spurt in both fundamental and translational research that examines the underlying mechanisms of the human microbiome in psychiatric disorders. The personalized and dynamic features of the human microbiome suggest the potential of its manipulation for precision psychiatry in ways to improve mental health and avoid disease. However, findings in the field of microbiome also raise philosophical and ethical questions. From a philosophical point of view, they may yet be another attempt at providing a biological (...) cause for phenomena that ultimately cannot be so easily localized. From an ethical point of view, it is relevant that the human gut microbiome comprises data on the individual’s lifestyle, disease history, previous medications, and mental health. Massive datasets of microbiome sequences are collected to facilitate comparative studies to identify specific links between the microbiome and mental health. Although this emerging research domain may show promise for psychiatric patients, it is surrounded by ethical challenges regarding patient privacy, health risks, effects on personal identity, and concerns about responsibility. This narrative overview displays the roles and advances of microbiome research in psychiatry and discusses the philosophical and ethical implications of microbiome big data and microbiome-based interventions for psychiatric patients. We also investigate whether these issues are really “new,” or “old wine in new bottles.”. (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...

In “Obligations of the Gift” Sandra Lee (2021) suggests that social norms of reciprocity and the expectations and obligations associated with gift-giving afford a framework for addressing social justice considerations in precision medicine. Lee is particularly concerned with obligations to marginalized or oppressed racial and ethnic groups, which are also historically under-represented populations in precision medicine. Obligations arise, Lee argues, through the “gift” that research participants make when they contribute their data or biospecimens to precision medicine (...) research. This conceptualization of research participation is distinct from an altruistic donation model that explicitly precludes obligations of reciprocity. I agree with Lee’s overall project to support social justice aims by better recognizing responsibilities of researchers to their research participants, and increasing diverse participation in biomedical research. However, I am not convinced that the account of “the gift” she deploys can achieve the social justice goals she intends because it risks replicating rather than resisting problematic conceptions of labor, property, and ownership of selves and others. However, an alternate conceptualization of “the gift” found in the work of 20th century French philosopher Jacques Derrida recasts ethical obligations on the part of precision medicine to those who contribute their data and biospecimens for precision medicine research. (shrink)

In August of 2018, the results of the largest genomic investigation in human history were published. Scanning the DNA of over one million participants, a genome‐wide association study was conducted to identify genetic variants associated with the number of years of education a person has completed. This measure, called “educational attainment,” is often treated as a proxy for intelligence and cognitive ability. The study raises a host of hard philosophical questions about study design and strength of evidence. It also sets (...) the basis for something far more controversial. Using a new genomic method that generates “polygenic scores,” researchers are now able to use the results of the study to predict a person's educational potential from a blood or saliva sample. Going a step further, some researchers have begun to promote “precision education,” which would tailor students’ school plans to their genetic profiles. The idea of precision education provokes concerns about stigma and self‐fulfilling prophecies. (shrink)

Evidence-Based Medicine (EBM) and Personalized Medicine (PM) share a common goal: reducing the gap between the results of biomedical research and their clinical application. PM is, however, often presented as a “new paradigm” for medicine, just as EBM was in the 1990s. It covers a wide variety of projects but the core idea that generally unites them is the ambition of better taking account of individual specificities than did EBM with its statistical and population-centred approach. In this article, I (...) concentrate on PM in cancerology, the essence of which is to target treatments based on the molecular profile of the patient. This targeting is made possible by gaining better knowledge about the molecular mechanisms of cancers. The classification of patients as a function of their molecular profile entails the creation of patient sub-groups. This creates a problem for the traditional evaluation of therapeutic treatment promoted by EBM, in particular the use of randomized trials using sizeable cohorts. But a better understanding of the mechanisms and the greater precision of treatments could reduce the need for these trials. Does PM thus represent the revenge of a physio-pathological and mechanistic culture in clinical research against the statistical and empirical one of EBM? My objective is to show how current practices of PM leads to epistemological changes in our estimation of what count as relevant types of information and proof in medicine, in particular in the field of therapeutic evaluation. I defend the idea that PM, far from obviating the need for statistical approaches and the search for correlations, ultimately poses new challenges for EBM. PM drives EBM to strengthen the articulation and the integration of statistical and mechanistic data with a view to providing a better service for each patient. (shrink)

Precision medicine research involving human biological material is becoming an increasingly central component of healthcare, and its potential is quickly growing due to rapid technological progress...

Governments are investing in precision medicine with the aim of improving healthcare through the use of genomic analyses and data analytics to develop tailored treatment approaches for individual patients. The success of PM is contingent upon clear public communications that engender trust and secure the social licence to collect and share large population-wide data sets because specific consent for each data re-use is impractical. Variation in the terminology used by different programmes used to describe PM may hinder clear communication (...) and threaten trust. Language is used to create common understanding and expectations regarding precision medicine between researchers, clinicians and the volunteers. There is a need to better understand public interpretations of PM-related terminology. This paper reports on a qualitative study involving 24 focus group participants in the multi-lingual context of Singapore. The study explored how Singaporeans interpret and understand the terms ‘precision medicine’ and ‘personalised medicine’, and which term they felt more aptly communicates the concept and goals of PM. Results suggest that participants were unable to readily link the terms with this area of medicine and initially displayed preferences for the more familiar term of ‘personalised’. The use of visual aids to convey key concepts resonated with participants, some of whom then indicated preferences for the term ‘precision’ as being a more accurate description of PM research. These aids helped to facilitate dialogue around the ethical and social value, as well as the risks, of PM. Implications for programme developers and policy makers are discussed. (shrink)

Precision medicine is an emerging approach to individualized care. It aims to help physicians better comprehend and predict the needs of their patients while effectively adopting in a timely manner the most suitable treatment by promoting the sharing of health data and the implementation of learning healthcare systems. Alongside its promises, PM also entails the risk of exacerbating healthcare inequalities, in particular between ethnoracial groups. One often-neglected underlying reason why this might happen is the impact of structural racism on (...) PM initiatives. Raising awareness as to how structural racism can influence PM initiatives is paramount to avoid that PM ends up reproducing the pre-existing health inequalities between different ethnoracial groups and contributing to the loss of trust in healthcare by minority groups. We analyse three nodes of a process flow where structural racism can affect PM’s implementation. These are: the collection of biased health data during the initial encounter of minority groups with the healthcare system and researchers, the integration of biased health data for minority groups in PM initiatives and the influence of structural racism on the deliverables of PM initiatives for minority groups. We underscore that underappreciation of structural racism by stakeholders involved in the PM ecosystem can be at odds with the ambition of ensuring social and racial justice. Potential specific actions related to the analysed nodes are then formulated to help ensure that PM truly adheres to the goal of leaving no one behind, as endorsed by member states of the United Nations for the 2030 Agenda for Sustainable Development. Structural racism has been entrenched in our societies for centuries and it would be naïve to believe that its impacts will not spill over in the era of PM. PM initiatives need to pay special attention to the discriminatory and harmful impacts that structural racism could have on minority groups involved in their respective projects. It is only by acknowledging and discussing the existence of implicit racial biases and trust issues in healthcare and research domains that proper interventions to remedy them can be implemented. (shrink)

Since the late 1980s, the human genetics and genomics research community has been promising to usher in a “new paradigm for health care”—one that uses molecular profiling to identify human genetic variants implicated in multifactorial health risks. After the completion of the Human Genome Project in 2003, a wide range of stakeholders became committed to this “paradigm shift,” creating a confluence of investment, advocacy, and enthusiasm that bears all the marks of a “scientific/intellectual social movement” within biomedicine. Proponents of (...) this movement usually offer four ways in which their approach to medical diagnosis and health care improves upon current practices, arguing that it is more “personalized,” “predictive,” “preventive,” and “participatory” than the medical status quo. Initially, it was personalization that seemed to best sum up the movement's appeal. By 2012, however, powerful opinion leaders were abandoning “personalized medicine” in favor of a new label: “precision medicine.” The new label received a decisive seal of approval when, in January 2015, President Obama unveiled plans for a national “precision medicine initiative” to promote the development and use of genomic tools in health care. (shrink)

Research integrity is a well-established term used to talk and write about ethical issues in research. Part of its success might be its broad applicability. In this paper, we suggest that this might also be its Achilles heel, since it has the potential to conceal important value conflicts. We identify three broad domains upon which research integrity is applied in the literature: (1) the researcher (or research group), (2) research, and (3) research-related institutions and (...) systems. Integrity in relation to researchers concerns character, although it remains to specify precisely what character traits are the desirable ones in this context and what values researchers should endorse. Integrity in relation to research concerns correct and sufficient description of the research process, data, results, and overall ‘research record’. Hence, it concerns the quality of research. However, whether or not this notion of research integrity covers all ethical aspects of research depends on whether one endorses a wider or a narrower interpretation of the ‘research process’. Integrity in relation to research-related institutions and systems leaves open whether they should be understood as agents in their own right or merely as means to research integrity. Besides the potential lack of clarity that our analysis reveals, we point to how this variety in uses might lead to concealment of value conflicts and propose an open discussion of central values. (shrink)

I take up the call for a more nuanced engagement with race in bioethics by using Creary’s analytic of bounded justice and argue that it helps illuminate processes of racialization, or racial formation, specifically Blackness, as a dialectical processes of both invisibility and hyper-visibility. This dialectical view of race provides a lens through which the ethical, legal, and social implications (ELSI) of genetics and genomics field can reflect on fraught issues such as inclusion in genomic and biomedical research. Countering (...) or interrupting racialization in precision medicine can involve asking how marginalized groups are made invisible or hyper-visible in various aspects of the research process. Incorporating these kinds of questions into biomedical research inclusion efforts could lead to potentially powerful engagements with marginalized groups and could provide the opportunity for stakeholders to engage with the ways that racialization can happen in real-time and might undermine good intentions. (shrink)

Since the turn of the twenty-first century, biomedical psychiatry around the globe has embraced the so-called precision medicine paradigm, a model for medical research that uses innovative techniques for data collection and analysis to reevaluate traditional theories of disease. The goal of precision medicine is to improve diagnostics by restratifying the patient population on the basis of a deeper understanding of disease processes. This paper argues that precision is ill-fitting for psychiatry for two reasons. First, in (...) psychiatry, unlike in fields like oncology, precision medicine has been understood as an attempt to improve medicine by casting out, rather than merely revising, traditional taxonomic tools. Second, in psychiatry the term “biomarker” is often used in reference to signs or symptoms that allow patients to be classified and then matched with treatments; however, in oncology “biomarker” usually refers to a disease mechanism that is useful not only for diagnostics, but also for discovering causal pathways that drug therapies can target. Given these differences between how the precision medicine paradigm operates in psychiatry and in other medical fields like oncology, while precision psychiatry may offer successful rhetoric, it is not a promising paradigm. (shrink)

In this paper, I defend an account of the ethics of precision medicine that can explain both its possibilities and limits. Creating a new conceptual and normative model of the ethics of precision health can ensure that good medicine is also excellent and that excellent medicine is also good by providing a resource to scientists and clinicians. First, I propose a new conceptual analysis of precision health. I argue that precision health is defined primarily by targeted (...) medical interventions and not by stratification, as others have asserted. Next, I argue that failure to be adequately responsive to this conceptual analysis explains common ethical abuses in the field. Third, I argue that this conceptual analysis can also pave the way for future research heretofore overlooked. Thus, we can limit abuses in precision health research and care while at the same time opening new avenues to help historically oppressed communities. (shrink)

A prominent feature of late nineteenth-century psychology was its intense preoccupation with precision. Precision was at once an ideal and an argument: the quest for precision helped psychology to establish its status as a mature science, sharing a characteristic concern with the natural sciences. We will analyse how psychologists set out to produce precision in 'mental chronometry', the measurement of the duration of psychological processes. In his Leipzig laboratory, Wundt inaugurated an elaborate research programme on (...) mental chronometry. We will look at the problem of calibration of experimental apparatus and will describe the intricate material, literary, and social technologies involved in the manufacture of precision. First, we shall discuss some of the technical problems involved in the measurement of ever shorter time-spans. Next, the Cattell-Berger experiments will help us to argue against the received view that all the precision went into the hardware, and practically none into the social organization of experimentation. Experimenters made deliberate efforts to bring themselves and their subjects under a regime of control and calibration similar to that which reigned over the experimental machinery. In Leipzig psychology, the particular blend of material and social technology resulted in a specific object of study: the generalized mind. We will then show that the distribution of precision in experimental psychology outside Leipzig demanded a concerted effort of instruments, texts, and people. It will appear that the forceful attempts to produce precision and uniformity had some rather paradoxical consequences. (shrink)

In this paper, we discuss how access to health-related data by private insurers, other than affecting the interests of prospective policy-holders, can also influence their propensity to make personal data available for research purposes. We take the case of national precision medicine initiatives as an illustrative example of this possible tendency. Precision medicine pools together unprecedented amounts of genetic as well as phenotypic data. The possibility that private insurers could claim access to such rapidly accumulating biomedical Big (...) Data or to health-related information derived from it would discourage people from enrolling in precision medicine studies. Should that be the case, the economic value of personal data for the insurance industry would end up affecting the public value of data as a scientific resource. In what follows we articulate three principles – trustworthiness, openness and evidence – to address this problem and tame its potentially harmful effects on the development of precision medicine and, more generally, on the advancement of medical science. (shrink)

Blended learning has gained increasing popularity in colleges and universities with mixed results. Precision teaching can effectively promote learning performance. The relation between perceived precision teaching and the learning performance of college students in a blended learning environment is investigated in this paper. In the research survey is featuring a structural model, 256 college students who attended blended learning courses featuring precision teaching participated. The model results revealed that PPT is directly and positively related to self-efficacy (...) and learning motivation. Self-efficacy and learning motivation are directly and positively related to cognitive, teaching, and social presence. Additionally, cognitive, teaching, and social presence are directly and positively related to learning performance. Therefore, PPT is remotely and indirectly related to learning performance. These findings provide a new perspective for the theoretical study on blended learning performance and provide a realistic reference for precision teaching practice in the blended learning environment. (shrink)