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While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post‐trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings—or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post‐trial responsibilities, and then identify challenges for post‐trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision‐makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real‐world practice. [ABSTRACT FROM AUTHOR]

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows. [ABSTRACT FROM AUTHOR]

The article focuses on developing a bioethics research agenda for Artificial Intelligence (AI)-enabled decision-making tools, particularly the Personalized Patient Preference Predictor (P4). Topics include the ethical implications of using AI systems to make substituted judgments in healthcare, challenges in capturing accurate personal preferences, and the potential benefits of AI tools when human surrogates are unavailable or incapable of making decisions.

The author comments on the Ethical Data Practices Framework advanced in the target article by M. S. McCoy and colleagues. Topics include the pragmatic approach taken by McCoy and colleagues to helping companies respect substantive ethical principles in routine company operations that involve processing and sharing personal data, brief historical accounting of the past 20 years of data privacy negotiations between the U.S. and European Union (EU), and the EU-U.S. data privacy framework.

In this paper, we contend with whether we still need traditional ethics education as part of healthcare professional training given the abilities of chatGPT (generative pre-trained transformer) and other large language models (LLM). We reflect on common programmatic goals to assess the current strengths and limitations of LLMs in helping to build ethics competencies among future clinicians. Through an actual case analysis, we highlight areas in which chatGPT and other LLMs are conducive to common bioethics education goals. We also comment on where such technologies remain an imperfect substitute for human-led ethics teaching and learning. Finally, we conclude that the relative strengths of chatGPT warrant its consideration as a teaching and learning tool in ethics education in ways that account for current limitations and build in flexibility as the technology evolves. [ABSTRACT FROM AUTHOR]

The authors comment on the article "Epistemic rights and responsibilities of digital simulacra for biomedicine" by M. Cho and N. Martinez-Martin wherein they argue that developers and users of digital simulacra for modelling health and disease should involve a focus on causality of health states. Topics include a step to avoid reliance on narrow performance metrics, causal opacity and social determinants of health (SDOH), and recommended approaches to responsibly advance simulation modeling.

Sharing cancer gene variant and relevant clinical data could accelerate progress in cancer genomics. However, data sharing is currently impeded by issues related to financial sustainability, equity, incentives, privacy and security, and data quality. Evidence-based policy options to facilitate data sharing in these domains, and ultimately improve interpretation of cancer-associated genomic variants, are therefore needed. We conducted a modified policy Delphi with expert stakeholders that involved generating, evaluating, and ranking potential policy options to address these issues, with a focus on the US context. We found policy options in the financial sustainability domain were highly ranked, particularly stable funding for trusted entities. However, some Delphi panelists noted that the culture of public research funding has favored short-term grants. Panelists favored policy options focused on action by funders, which had the highest overall total scores that combined effectiveness and feasibility ratings and priority ranking within domains. Panelists also endorsed some policy options connected to actors such as journals, but they were more skeptical of policy options connected to legislative actors and data resources. These findings are critical inputs for policy makers as they consider policies to enable sharing of cancer gene variant data to improve health. [ABSTRACT FROM AUTHOR]

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust. [ABSTRACT FROM AUTHOR]

Smart toilets are a key tool for enabling precision health monitoring in the home, but such passive monitoring has ethical considerations. [ABSTRACT FROM AUTHOR]

This article describes a mixed-methods protocol to develop and test the implementation of a stewardship maturity matrix (SMM) for repositories which govern access to human genomic data in the cloud. It is anticipated that the cloud will host most human genomic and related health datasets generated as part of publicly funded research in the coming years. However, repository managers lack practical tools for identifying what stewardship outcomes matter most to key stakeholders as well as how to track progress on their stewardship goals over time. In this article we describe a protocol that combines Delphi survey methods with SMM modeling first introduced in the earth and planetary sciences to develop a stewardship impact assessment tool for repositories that manage access to human genomic data. We discuss the strengths and limitations of this mixed-methods design and offer points to consider for wrangling both quantitative and qualitative data to enhance rigor and representativeness. We conclude with how the empirical methods bridged in this protocol have potential to improve evaluation of data stewardship systems and better align them with diverse stakeholder values in genomic data science. [ABSTRACT FROM AUTHOR]

Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts. We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently requested. The survey response rate was 18.4%, with 55.4% of respondents reporting their institution's IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%). Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality. [ABSTRACT FROM AUTHOR]

The authors comment on the proof-of-concept study by Meier and colleagues which describe the purpose and programming decisions underpinning Medical Ethics Advisor (METHAD), an automated decision support (ADS) system used to guide treatment interventions. Topics discussed include justice as a consideration in ads development and implementation, ADS strengths for enhancing substantive and procedural justice, and significance of cross-cutting research to sophisticated algorithms.

Background and Objectives: Medical educators and researchers have increasingly sought to embed online educational modalities into graduate medical education, albeit with limited empirical evidence of how trainees perceive the value and experience of online learning in this context. The purpose of this study was to explore the experiences of hybrid learning in a graduate research methods course in a family medicine and primary care research graduate program.Methods: This qualitative description study recruited 28 graduate students during the fall 2016 academic term. Data sources included qualitative group discussions and a 76-item online survey collected between March and September 2017. We used thematic analysis and descriptive statistics to analyze each data set.Results: Nine students took part in three group discussions, and completed an online survey. While students reported positive learning experiences overall, those attending virtually struggled with the synchronous elements of the hybrid model. Virtual students reported developing research skills not offered through courses at their home institution, and students attending the course in person benefited from the diverse perspectives of distance learners. All stressed the need to foster a sense of community.Conclusions: Quality delivery of online graduate education in family medicine research requires optimizing social exchanges among virtual and in-person learners, ensuring equitable engagement among all students, and leveraging the unique tools afforded by online platforms to create a shared sense of a learning community. [ABSTRACT FROM AUTHOR]

The article presents the discussion on ethics of artificial intelligence (AI) and machine learning (ML). Topics include critiquing the insufficiency of current ethics and regulatory solutions for adequately protecting communities at higher risk for ML bias; and debating the usefulness and applicability of the current U.S. approach to governing research with humans.

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research. [ABSTRACT FROM AUTHOR]

Background: In this paper we assess the quality of six deliberative stakeholder consultations regarding the implementation of a precision diagnostic for life-threatening pediatric brain tumors. Decision makers who base policy recommendations on the outputs of consultative exercises can presuppose that all deliberants are well informed of the policy issue, that participation in the deliberative process was fair, and that overcoming implementation barriers will necessarily result in practice change. Additional evidence is therefore needed to substantiate the informational quality of the deliberation, measure the equality of participation and study the effects on stakeholder reasoning to appropriately guide uptake of proposed recommendation(s). Methods: Using the DeVries framework for assessing the deliberative quality, we analyzed data from 44 post-consultation evaluation surveys completed by pediatric oncology and palliative care teams at two tertiary pediatric healthcare centers in Canada. We also conducted turn-taking and word-contribution analyses from the text transcriptions of each deliberation to assess equality of participation using descriptive statistics. Results: Deliberants agreed the quality of the deliberative process was fair (median ratings ranging from 9–10 out of 10) and the opportunities to receive expert information and discuss with others about the implementation of a new LDT were helpful (9.5 out of 10). While the session improved understanding of the implementation barriers and opportunities, it had marginal effects on deliberants' reasoning about whether LDTs would change their own clinical practice (3–10 out of 10). Participation was proportionate in at least four of the six deliberations, where no deliberant took more than 20% of total turns and contributed equal to, or less than 20% of total words. Conclusion: The quality assessment we performed demonstrates high informational value and perceived fairness of two deliberative stakeholder consultations involving pediatric palliative care and oncology teams in Canada. Quality assessments can reveal how the process of deliberation unfolds, whether deliberative outputs are the result of equitable participation among deliberants and what, if any, stakeholder voices may be missing. Such assessments should be routinely reported as a condition of methodological rigor and trustworthiness of deliberative stakeholder engagement research. [ABSTRACT FROM AUTHOR]

Background: In this paper we assess the quality of six deliberative stakeholder consultations regarding the implementation of a precision diagnostic for life-threatening pediatric brain tumors. Decision makers who base policy recommendations on the outputs of consultative exercises can presuppose that all deliberants are well informed of the policy issue, that participation in the deliberative process was fair, and that overcoming implementation barriers will necessarily result in practice change. Additional evidence is therefore needed to substantiate the informational quality of the deliberation, measure the equality of participation and study the effects on stakeholder reasoning to appropriately guide uptake of proposed recommendation(s). Methods: Using the DeVries framework for assessing the deliberative quality, we analyzed data from 44 post-consultation evaluation surveys completed by pediatric oncology and palliative care teams at two tertiary pediatric healthcare centers in Canada. We also conducted turn-taking and word-contribution analyses from the text transcriptions of each deliberation to assess equality of participation using descriptive statistics. Results: Deliberants agreed the quality of the deliberative process was fair (median ratings ranging from 9–10 out of 10) and the opportunities to receive expert information and discuss with others about the implementation of a new LDT were helpful (9.5 out of 10). While the session improved understanding of the implementation barriers and opportunities, it had marginal effects on deliberants' reasoning about whether LDTs would change their own clinical practice (3–10 out of 10). Participation was proportionate in at least four of the six deliberations, where no deliberant took more than 20% of total turns and contributed equal to, or less than 20% of total words. Conclusion: The quality assessment we performed demonstrates high informational value and perceived fairness of two deliberative stakeholder consultations involving pediatric palliative care and oncology teams in Canada. Quality assessments can reveal how the process of deliberation unfolds, whether deliberative outputs are the result of equitable participation among deliberants and what, if any, stakeholder voices may be missing. Such assessments should be routinely reported as a condition of methodological rigor and trustworthiness of deliberative stakeholder engagement research. [ABSTRACT FROM AUTHOR]

The author discusses the article "Privacy and Health Practices in the Digital Age" by M. Pyrrho and colleagues. Topics include the frustration by M. Pyrrho and colleagues that health data privacy is seldom discussed as something other than sacrificial, reason that relaxing privacy and confidentiality rules during a public health crisis does not signal the State's devaluation of privacy, and criticism made by Pyrrho and colleagues on technology companies for converting data into economic value.

Background: The highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.Methods: Twelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists' ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists' written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQR at least 1.0) and strong support.Results: Nine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.Conclusions: The validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities. [ABSTRACT FROM AUTHOR]

Background: Effective communication in support of clinical decision-making is central to the pediatric cancer care experience for families. A new laboratory derived pharmacogenetic test (LDT) that can diagnose difficult-to-treat brain cancers has been developed to stratify children based on their ability to respond to available treatment; however, the potential implementation of the LDT may make effective communication challenging since it can potentially remove the option for curative treatment in those children identified as non-responders, i.e. those with a catastrophic diagnosis. Objective: We solicited the perspectives of parents of children with difficult-to-treat brain cancer on communication preferences surrounding the potential implementation of the LDT in standard care using deliberative stakeholder consultations. Methods: Eight bereaved parents of children who succumbed to difficult-to-treat brain cancer, and four parents of children currently undergoing treatment for similar cancers attended separate small-group deliberative consultations – a stakeholder engagement method that enables the co-creation of recommendations following the consideration of competing arguments and diverse opinions of parents with different experiences. In the small-group consultations (Phase I), parents discussed four questions about potential communication issues that may arise with the LDT in practice. In Phase II, a total of five parents from both stakeholder groups (4 bereaved and 1 in current treatment) attended a consultation, known as the 'mixed' consultation, with the purpose of co-developing concrete recommendations for implementation of the LDT. Results: Explaining the risks, benefits, and accuracy of the LDT were considered essential to parents. Once an LDT-based diagnosis/prognosis can be made, parents valued honesty, empathy, and clarity in communication. Parents also requested that all results and treatment options be presented to them in measured doses, and in an unbiased manner over the course of several meetings. This communication strategy allowed sufficient time to understand and accept the diagnosis/prognosis, particularly if it was catastrophic. Continuous access to the appropriate psychological and social support or counselling at and post-diagnosis was also strongly recommended. Conclusions: Deliberants co-created family-centered recommendations surrounding communication issues of the LDT, providing guidance to pediatric oncologists that could implement the test in practice. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic response in the United States has exposed significant gaps in information systems and processes that prevent timely clinical and public health decision-making. Specifically, the use of informatics to mitigate the spread of SARS-CoV-2, support COVID-19 care delivery, and accelerate knowledge discovery bring to the forefront issues of privacy, surveillance, limits of state powers, and interoperability between public health and clinical information systems. Using a consensus-building process, we critically analyze informatics-related ethical issues in light of the pandemic across 3 themes: (1) public health reporting and data sharing, (2) contact tracing and tracking, and (3) clinical scoring tools for critical care. We provide context and rationale for ethical considerations and recommendations that are actionable during the pandemic and conclude with recommendations calling for longer-term, broader change (beyond the pandemic) for public health organization and policy reform. [ABSTRACT FROM AUTHOR]

The article presents the discussion on favor of evidence-based policy development for expanding prenatal genetic testing. Topics include "severe" medical conditions categorized as such according to "actual patient goals and desires;" and beliefs regarding family planning laying the foundation for shared decision-making before, during, and after pregnancy.

Progress in precision medicine relies on the access to, use of, and exchange of genomic and associated clinical data, including from children. The ethical, legal, and social issues (ELSI) of such data access, use, and exchange may be accentuated in the pediatric context due in part to the highly sensitive nature of genomic data, children's consent-related vulnerabilities, and uncertain risks of reidentification. Systematic analyses of the ELSI and scientific reasons for why and how genomic data may be shared responsibly are, however, limited. Methods: We conducted a modified systematic review of reasons according to Sofaer and Strech to examine the ELSI and scientific reasons for "responsible" sharing of children's genomic and associated clinical data. Empirical articles, commentaries, and data-sharing policies indexed in Medline, Scopus, Web of Science, and BIOSIS were included in the analysis if they discussed ELSI and were published between 2003 and 2017 in English. Results: One hundred and fifty-one records met our inclusion criteria. We identified 11 unique reasons and 8 subreasons for why children's genomic data should or should not be shared. Enhancing the prospect of direct and indirect benefits and maximizing the utility of children's data were top reasons why data should be shared. Inadequate data privacy protection was the leading reason why it should not. We furthermore identified 8 reasons and 30 subreasons that support conditional data sharing, in which recontact for the continued use of children's data once they reach the age of majority was the most frequently endorsed condition. Conclusions: The complete list of ELSI reasons and responsible conditions provides an evidentiary basis upon which institutions can develop data-sharing policies. Institutions should encourage the sharing of children's data to advance genomic research, while heeding special reconsent and data protection mechanisms that may help mitigate uncertain longitudinal risks for children and families. [ABSTRACT FROM AUTHOR]

Purpose: Healthcare innovation, exemplified by genomic medicine, requires increasingly sophisticated understanding of the interdisciplinary-organizational context in which new innovations are implemented. Deliberative stakeholder consultations are public engagement tools that are gaining increasing traction in health care, as a means of maximizing the diversity of roles and interests vested in a particular policy or practice issue. They engage participants from different knowledge systems ("cultures") in mutually respectful debate to enable group consensus on implementation strategies. Current deliberation analytic methods tend to overlook the cultural contexts of the deliberative process. The paper aims to discuss this issue. Design/methodology/approach: This conceptual paper proposes adding ethnographic participant observation to provide a more comprehensive account of the process that gives rise to deliberative outputs. To underpin this conceptual paper, the authors draw on the authors' experience engaging healthcare professionals during implementation of genomics in the care for pediatric oncology patients with treatment-resistant glioblastoma at two tertiary care hospitals. Findings: Ethnography enabled a deeper understanding of deliberative outcomes by combining rhetorical and non-rhetorical analysis to identify the implementation and coordination of care barriers across professional cultures. Originality/value: This paper highlights the value of ethnographic methods in enabling a more comprehensive assessment of the quality of engagement across professional cultures in implementation studies. [ABSTRACT FROM AUTHOR]

The article discusses key reforms of the Common Rule, as the most significant modification towards a single institutional review board (sIRB) system, from an organizational ethics and governance perspective. Topics include regulatory change for an existing regulation more pressing than devising a new regulation relying on existing rules, the revised rule addressing demand from stakeholders to reduce the procedural inefficiencies and delays and elements of a sIRB such as proportionate scrutiny.

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Background: This paper defends the ethical and empirical significance of direct engagement with terminally ill children and adolescents in PPC research on health-related quality of life. Clinical trials and other forms of health research have resulted in tremendous progress for improving clinical outcomes among children and adolescents diagnosed with a life-threatening illness. Less attention has been paid, however, to engaging this patient population directly in studies aimed at optimizing health-related quality of life in PPC. Though not restricted to care at the end of life, PPC--and by extension PPC research--is in part dependent on recognizing the social complexities of death and dying and where health-related quality of life is a fundamental element. To explore these complexities in depth requires partnership with terminally ill children and adolescents, and acknowledgement of their active social and moral agency in research. Discussion: Principles of pediatric research ethics, theoretical tenets of the "new sociology of the child(hood)," and human rights codified in the United Nations Convention on the Rights of the Child (UNCRC) underpin the position that a more engagement-centered approach is needed in PPC research. The ethics, sociologies and human rights of engagement will each be discussed as they relate to research with terminally ill children and adolescents in PPC. Qualitative method(ologies) presented in this paper, such as deliberative stakeholder consultations and phenomenology of practice can serve as meaningful vehicles for achieving i) participation among terminally ill children and adolescents; ii) evidence-bases for PPC best practices; and iii) fulfillment of research ethics principles. Conclusion: PPC research based on direct engagement with PPC patients better reflects their unique expertise and social epistemologies of terminal illness. Such an approach to research would strengthen both the ethical and methodological soundness of HRQoL inquiry in PPC. [ABSTRACT FROM AUTHOR]

The article focuses on the multi-jurisdictional reviews on biomedical research conducted by the research ethics boards (REBs) and expert committees on data access in Canada. Topics include the ethical aspects of collaborative research, the criticisms faced by independent REBs in terms of poor central coordination and inconsistencies of information, and certain federal conditions imposed to researchers when accessing data on cohort studies.

Progress in understanding childhood disease using next-generation sequencing (NGS) portends vast improvements in the nature and quality of patient care. However, ethical questions surrounding the disclosure of incidental findings (IFs) persist, as NGS and other novel genomic technologies become the preferred tool for clinical genetic testing. Thus, the need for comprehensive management plans and multidisciplinary discussion on the return of IFs in pediatric research has never been more immediate. The aim of this study is to explore the views of investigators concerning the return of IFs in the pediatric oncology research context. Our findings reveal at least four contextual themes underlying the ethics of when, and how, IFs could be disclosed to participants and their families: clinical significance of the result, respect for individual, scope of professional responsibilities, and implications for the healthcare/research system. Moreover, the study proposes two action items toward anticipatory governance of IF in genetic research with children. The need to recognize the multiplicity of contextual factors in determining IF disclosure practices, particularly as NGS increasingly becomes a centerpiece in genetic research broadly, is heightened when children are involved. Sober thought should be given to the possibility of discovering IF, and to proactive discussions about disclosure considering the realities of young participants, their families, and the investigators who recruit them. [ABSTRACT FROM AUTHOR]

Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular biology and clinical care. The field of translational medicine is charged with mediating this revolution. Sequencing innovations are far outpacing guidelines intended to ease their practice-based applications, including in primary care. As a result, genomic medicine's full integration in primary care settings especially, has been slow to materialize. Researchers and clinicians alike face substantial challenges in navigating contentious ethical issues raised in translation and implementation, namely preserving the spirit of whole-person approaches to care; maintaining respect for persons and communities; and translating genetic risk into clinical actionability. This commentary therefore explores practical barriers to, and ethical implications of, incorporating genomic technologies in the primary care sector. These ethical challenges are both philosophical and infrastructural. From a primary care perspective, the commentary further reviews the ethical, legal and social implications of the Center for Disease Control's proposed model for assessing the validity and utility of genomic testing and family health history applications. Lastly, the authors provide recommendations for future translational initiatives that aim to maximize the capacities of genomic medicine, without compromising primary care philosophies and foundations of practice. [ABSTRACT FROM AUTHOR]

Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular biology and clinical care. The field of translational medicine is charged with mediating this revolution. Sequencing innovations are far outpacing guidelines intended to ease their practice-based applications, including in primary care. As a result, genomic medicine's full integration in primary care settings especially, has been slow to materialize. Researchers and clinicians alike face substantial challenges in navigating contentious ethical issues raised in translation and implementation, namely preserving the spirit of whole-person approaches to care; maintaining respect for persons and communities; and translating genetic risk into clinical actionability. This commentary therefore explores practical barriers to, and ethical implications of, incorporating genomic technologies in the primary care sector. These ethical challenges are both philosophical and infrastructural. From a primary care perspective, the commentary further reviews the ethical, legal and social implications of the Center for Disease Control's proposed model for assessing the validity and utility of genomic testing and family health history applications. Lastly, the authors provide recommendations for future translational initiatives that aim to maximize the capacities of genomic medicine, without compromising primary care philosophies and foundations of practice. [ABSTRACT FROM AUTHOR]